Author Interviews, Dermatology, Geriatrics, Sleep Disorders / 07.08.2021

MedicalResearch.com Interview with: Dr. Jonathan L. Silverberg MD PhD MPH Associate Professor Director of Clinical Research Director of Patch Testing George Washington University School of Medicine and Health Sciences Washington, DC  MedicalResearch.com: What is the background for this study? Response: Atopic dermatitis affects people of all ages, including geriatric patients. Previous studies found age-related differences in the clinical manifestations of atopic dermatitis between children and adults. Though, few studies examined whether there are age-related differences of AD severity between geriatric and younger adults. We performed a cross-sectional real-world observational study and found that geriatric age (≥65 years) was not associated with atopic dermatitis severity. However, geriatric age was associated with increased sleep disturbances, delays falling asleep and nighttime awakenings from itch, as well as fatigue. (more…)
AHA Journals, Author Interviews, Obstructive Sleep Apnea, UCSF / 21.06.2021

MedicalResearch.com Interview with: Yerem Yeghiazarians, MD Professor of Medicine Leone-Perkins Family Endowed Chair in Cardiology San Francisco Board Past-President, American Heart Association Co-Director, Adult Cardiac Catheterization Laboratory Director, Peripheral Interventional Cardiology Program Director, Translational Cardiac Stem Cell Program Cardiovascular Research Institute Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research Associate Member in Experimental Therapeutics, UCSF Helen Diller Cancer Center University of California, San Francisco MedicalResearch.com: What is the background for this study? Response: Obstructive sleep apnea is very common, undiagnosed and undertreated. The AHA Scientific Statement was prepared to increase awareness amongst physicians and patients about this condition and to encourage more screening and therapy as appropriate. Obesity is certainly one of the significant risk factors for sleep apnea and we highlight this in the Scientific Statement: “The risk of OSA correlates with body mass index, and obesity remains the one major modifiable risk factor for OSA. In a population-based cohort study of 690 subjects, a 10% weight gain was associated with nearly 32% increase in the apnea-hypopnea index (AHI), and even modest weight control was effective in reducing the new occurrence of sleep-disordered breathing. An even stronger correlation exists between OSA and increased waist circumference and neck size. Neck sizes predisposing to OSA are usually >17 and 16 in for men and women, respectively.” (more…)
Author Interviews, COVID -19 Coronavirus, Sleep Disorders, Technology / 03.06.2021

MedicalResearch.com Interview with: Michele Ferrara, PhD. Professor of Psychobiology and Physiological Psychology Chair of the Psychology Didactic Council Department of Biotechnological and Applied Clinical Sciences University of L'Aquila MedicalResearch.com: What is the background for this study? Response: During the current period of social distancing, the pervasive increase in the use of electronic devices (smartphones, computers, tablets and televisions) is an indisputable fact. Especially during the long lockdown period of Spring 2020, technologies played a pivotal role in coping with the unprecedented and stressful isolation phase. However, exposure to backlit screens in the hours before falling asleep can have serious repercussions on sleep health: on the one hand, by mimicking the effects of exposure to sunlight, and thus interfering with the circadian rhythm of the hormone melatonin, and on the other hand, counteracting the evening sleepiness due to the emotionally and psycho-physiologically activating contents. In light of this assumption, we decided to test longitudinally during the third and the seventh week of lockdown a large Italian sample (2123 subjects) through a web-based survey. We assessed sleep disturbances/habits and the occurring changes of electronic device usage in the 2 hours before the sleep onset. (more…)
Author Interviews, Circadian Rhythm, Heart Disease, Occupational Health, Sleep Disorders / 27.04.2021

Circadian misalignment is associated with a high cardiovascular risk among shift workers: MedicalResearch.com Interview with: Sara Gamboa Madeira Medical Doctor - General & Family Physician PhD Student - EnviHealth&Co - Faculty of Medicine Lisbon University MedicalResearch.com: What is the background for this study? Response: One in every five employees work in shifts across Europe1. Shift work have been associated with an increased risk for several cardiovascular diseases2 and three main mechanism have been proposed: unhealthy behaviours, disturbed sleep, and circadian misalignment. This study focused on the role of circadian misalignment, which we assessed via social jetlag. Social jetlag is calculated using the Munich Chronotype Questionnaire3 by the difference between sleep behaviour on free-days (mainly driven by the individual “biological clock”, also called chronotype) and sleep behaviour on workdays (mainly drive by the “social clock”, namely work schedules). Chronotype is an individual feature which ranges from early/morning people to late/evening people (from proverbial lark to owls), with the majority of the population falling in between as a Gaussian distribution. Therefore higher levels of social jetlag mean a greater mismatch between what your biological clock need (e.g. go to sleep at 9pm) and what your social obligations impose on you (e.g. work until midnight). (more…)
Alzheimer's - Dementia, Author Interviews, Cognitive Issues, Obstructive Sleep Apnea, Pulmonary Disease, University of Michigan / 16.04.2021

MedicalResearch.com Interview with: Galit Levi Dunietz  MPH, PhD Assistant Professor

Tiffany Braley, MD, MS Associate Professor

University of Michigan, Medical School Department of Neurology Department of Nutritional Sciences Ann Arbor, MI 48109-5845 MedicalResearch.com: What is the background for this study? Response: Dementia is a public health crisis that affects more than 6 million Americans.  As no treatments to effectively reverse dementia are currently available, interest has shifted toward modifiable risk factors for dementia, which may offer a critical window for prevention or intervention. Recent research suggests that obstructive sleep apnea (OSA) is a common, yet undiagnosed, risk factor for cognition impairment in older adults. However, few studies have examined whether treatment of OSA with positive airway pressure (PAP) therapy could protect those with OSA against developing dementia, says principal investigator, Dr. Tiffany Braley, MD, MS, Associate Professor of Neurology from the University of Michigan. To address this gap, Dr. Braley and Dr. Galit Levi Dunietz, PhD, MPH, Assistant Professor and sleep epidemiologist, examined associations between PAP therapy use and 3-year incidence of Alzheimer’s disease, mild cognitive impairment (MCI), or other forms of dementia (DNOS, “dementia not otherwise specified”). (more…)
Author Interviews, Brigham & Women's - Harvard, Endocrinology, Insomnia, Menopause, Sleep Disorders, Weight Research / 23.03.2021

MedicalResearch.com Interview with: Leilah K. Grant, PhD Postdoctoral Research Fellow in Medicine Brigham and Women’s Hospital Harvard Medical School  MedicalResearch.com: What is the background for this study? Response: The prevalence of obesity increases in women around the age of menopause which increases the risk of diseases like diabetes and heart disease. Changes in hormones, like estrogen, are thought to contribute to weight gain during menopause, but other common symptoms of menopause such as sleep interruption may also play a role. While short sleep is known to adversely affect metabolism, little is known about the metabolic consequences of the type of sleep disruption most common in menopausal women – increased nighttime awakenings (i.e., sleep interruption) caused by hot flashes, but no change in overall sleep duration. We therefore did this study to see how an experimental model menopause-related sleep interruption would affect metabolic outcomes that may contribute to weight gain.  (more…)
Author Interviews, Brigham & Women's - Harvard, COVID -19 Coronavirus, Insomnia, Obstructive Sleep Apnea, Sleep Disorders / 29.10.2020

MedicalResearch.com Interview with: Salma Batool-Anwar, MBBS, MPH Instructor, Harvard Medical School Pulmonary and Critical Care, Sleep Medicine Brigham and Women's Faulkner Hospital MedicalResearch.com: What is the background for this study? Response: A well functioning sleep-wake cycle is vital to our health and prevention of chronic diseases. During previous disaters sleep disturbances have been reported. When Massachusetts governor declared a state of emergency in March’20, we hypothesized that sleep duration would be adversely affected by covid-19 related lockdown and stress. The study was approved by the institutional review board and information was collected retrospectively using the electronic medical records.  (more…)
Author Interviews, General Medicine, Sleep Disorders / 06.10.2020

MedicalResearch.com Interview with: Nathan Warren is a Ph.D. candidate in marketing at the University of Oregon. His research examines how people respond when social norms, such as masculinity norms, are disrupted by social change. He hopes that his research can empower people who are struggling to adapt to changing norms to live healthier, happier, and more productive lives. For more information on his research, please visit: www.nathanwarrenresearch.com Dr. Troy Campbell is a behavioral scientist (PhD, Duke University), former marketing professor (University of Oregon), former art, film, and psychology scholar (UC Irvine), professional designer and researcher (Netflix Insights, Disney Imagineering, UnitedHealth) and currently chief scientist at On Your Feet.  Troy believes everything can be awesome when you start with the right science and follow with the right creative process, and he hopes his professional services or public guides can help his clients make something awesome and impactful. For more information on Troy Campbell, please visit: www.troy-campbell.com MedicalResearch.com: What is the background for this study? What are the main findings?  Response: In the United States, the average American sleeps less than the minimum seven hours of sleep per night recommended by the Center for Disease Control, and nearly half of Americans report negative consequences from insufficient sleep. This problem appears to be especially prevalent in men, who report getting significantly less sleep, on average, than women. A cultural complication is the notion that getting less than the recommended amount of sleep signals something positive about an individual. For example, US President Donald Trump has boasted about getting less than four hours of sleep per night and regularly derogates his political opponent Joe Biden as “Sleepy Joe.” "The Sleep-Deprived Masculinity Stereotype," a new paper in the Journal of the Association for Consumer Research, examines a possible stereotype connecting sleep and masculinity along with its underlying mechanisms and its social implications. Authors Nathan B. Warren and Troy H. Campbell conducted 12 experiments involving 2,564 American participants to demonstrate that a sleep-deprived masculinity stereotype exists.  In one experiment, participants were asked to imagine seeing a man shopping for a bed. Then, a salesperson asked the man, “How much do you normally sleep?” The results found that the mean masculinity rating for participants in the lots of sleep condition was significantly lower than the mean masculinity rating for participants in the little sleep condition. In another experiment, participants were asked to ascribe different attributes to a male character, assigned to either a “very masculine and manly” man or a “not very masculine and not very manly” man. Participants in the masculine condition described their character sleeping 33 minutes less sleep per night than the characters described in the not masculine condition. A final experiment showed that participants who imagined stating they sleep more than average felt significantly less masculine than participants who imagined stating they sleep less than average. Collectively, the experiments found that men who sleep less are seen as more masculine and more positively judged by society. The same patterns were not consistently observed for perceptions of women.   (more…)
Author Interviews, Eisai, Insomnia / 02.10.2020

MedicalResearch.com Interview with: Margaret Moline, PhD Executive Director, Neurology Business Group, Eisai, Inc Lemborexant International Program Lead and Global Medical Lead MedicalResearch.com: What is the background for this study? What are the main findings?
  • SUNRISE 2 was one of two pivotal Phase 3 studies evaluated in the U.S. Food and Drug Administration’s approval of DAYVIGO (lemborexant) CIV in December 2019.
  • SUNRISE 2 was a pivotal six-month placebo-controlled treatment trial with a 6-month active treatment period including adult patients age 18 or older who met DSM-5 criteria for insomnia disorder.
  • Patients were randomized to placebo (n=325), DAYVIGO 5 mg (n=323), or DAYVIGO 10 mg (n=323) once nightly for the first six months of the study (Treatment Period 1).
  • The primary efficacy endpoint was the mean change from baseline to end of treatment at six months for subjective sleep onset latency (sSOL; the estimated minutes from the time that the patient attempted to sleep until sleep onset).
  • Secondary efficacy endpoints were mean change from baseline to end of treatment at six months subjective sleep efficiency (sSE; the proportion of time spent asleep per time in bed) and subjective wake after sleep onset (sWASO; the minutes of wake from the onset of sleep until wake time). These endpoints were measured by sleep diary.
  • At Virtual SLEEP 2020, a post-hoc analysis of SUNRISE 2 was shared in an oral presentation, which looked specifically at the long-term efficacy and safety of lemborexant in elderly adults with insomnia disorder.
  • Insomnia disorder, a chronic condition with long-term consequences for health and well-being, is prevalent in older adults.
  • This analysis of the SUNRISE 2 data reflects new learnings on the sustained impact of DAYVIGO on sleep onset and sleep maintenance in an older patient population. 
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Author Interviews, Cognitive Issues, JAMA, Sleep Disorders / 21.09.2020

MedicalResearch.com Interview with: Wuxiang Xie, PhD Peking University Clinical Research Institute Peking University First Hospital Beijing, China MedicalResearch.com: What is the background for this study? Response: Dementia is one of the most common and serious disorders in later life. A strong relationship between sleep and cognitive function had been previously reported, while the relationship between sleep duration and the trajectory of cognitive decline remains unclear.  (more…)
Author Interviews, ENT, JAMA, Obstructive Sleep Apnea, Sleep Disorders, Surgical Research / 09.09.2020

MedicalResearch.com Interview with:   Prof Stuart MacKay BSc (Med) MB BS (Hons) FRACS Honorary Clinical Professor Otolaryngology Head and Neck Surgery Clinical Professor at University of Wollongong Graduate School of Medicine Adjunct Professor Faculty of Health Sciences   MedicalResearch.com: What is the background for this study?
  1. Sleep Apnea is common and impairs daytime function and carries health risk.
  2. Many patients have difficulty with CPAP, the main treatment.
  3. Surgery offers an alternative, and we tested this at a very high level in this clinical study.
MedicalResearch.com: What are the main findings? 
  1. Surgery creates marked improvement in stoppages (apnea) and droppages (hypopnea) in airflow.
  2. Surgery significantly improves patient reports of daytime sleepiness.
  3. Many other outcomes related to quality of life, snoring and general well being improve with surgery.
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Author Interviews, Insomnia, Sleep Disorders / 09.07.2020

MedicalResearch.com Interview with: Jakob Weitzer MSc Department of Epidemiology Center for Public Health Medical University of Vienna Vienna, Austria  MedicalResearch.com: What is the background for this study? Response: Chronic insomnia is a highly prevalent, often underdiagnosed and undertreated disease. Previous research has linked dispositional optimism to a better sleep quality and to insomnia symptoms, and showed that optimism can be trained. Since we think that positive psychology plays an important role for our health we wanted to further shed light on this topic.  (more…)
Author Interviews, JAMA, Sleep Disorders, Stanford / 07.07.2020

MedicalResearch.com Interview with: Eileen B. Leary, Ph.D. Student Epidemiology and Clinical Research Stanford University MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by REM sleep? Response: Sleep is a regulated, reversible, and recurring loss of consciousness that is a critical requirement for a happy, healthy life. REM sleep is an important component of sleep defined by rapid eye movements and commonly associated with dreaming. We learned from previous studies that sleep duration is associated with mortality, however little was known about how the different sleep stages relate to timing or cause of death. (more…)
Author Interviews, Brigham & Women's - Harvard, Cognitive Issues, Sleep Disorders / 01.07.2020

MedicalResearch.com Interview with: Dr. Rebecca Robbins, PhD MS Fellow at Brigham & Women's Hospital and Harvard Medical School MedicalResearch.com: What is the background for this study? Response: Sleep difficulties are common among older adults and are associated with cognitive decline. We used data collected over 10 years from a large, nationally representative longitudinal survey of adults over the age of 50 in the U.S. We examined the relationship between specific sleep difficulties and cognitive function over time. MedicalResearch.com: What are the main findings?  Response: Our results show that early difficulty falling asleep and early morning awakenings, when experienced "most nights" of the week, were each associated with worse cognitive function. Conversely, reports of waking feeling rested was associated with better cognitive function, over time.   (more…)
Author Interviews, Circadian Rhythm, COVID -19 Coronavirus, Sleep Disorders / 15.06.2020

MedicalResearch.com Interview with: Dr. Christine Blume PhD Centre for Chronobiology Psychiatric Hospital of the University of Basel Transfaculty Research Platform Molecular and Cognitive Neurosciences Basel MedicalResearch.com: What is the background for this study? Response: In modern societies, human rest-activity rhythms and sleep are between the often-conflicting poles of external social time (e.g., work hours and leisure activities) and an individual’s internal biological time. This can lead to so-called “social jetlag”, which has repeatedly been associated with detrimental health effects. With the restrictions to control the pandemic, social timing relaxed as people many started working from home and public life came to a standstill. In an online survey with 435 respondents, we investigated the effects of the phase with the strictest COVID-19 restrictions on the relationship between social and biological rhythms as well as sleep during a six-week period (mid-March until end of April 2020) in three European societies (Austria, Germany, Switzerland). (more…)
Author Interviews, ENT, JAMA, Obstructive Sleep Apnea, Pediatrics / 03.02.2020

MedicalResearch.com Interview with: Dr. Jonathan R. Skirko, MD , MHPA, MPH Assistant professor Division of Pediatric Otolaryngology University of Utah Health  MedicalResearch.com: What is the background for this study? Response: Obstructive sleep apnea is a common problem that that impacts the lives of many people. Understanding treatment effectiveness is important and Health-State Utility is a standardized way of assessing quality of life.  Before this study, we didn't have a way of measuring quality of life in this population in this important way. You have to accurately measure something before you can improve it. (more…)
Author Interviews, JAMA, Sleep Disorders / 28.12.2019

MedicalResearch.com Interview with: Margaret Moline, PhD Lemborexant International Program Lead and Global Medical Lead Executive Director, Neurology Business Group Eisai, Inc.  MedicalResearch.com: What is the background for this study? This study, called SUNRISE 1, is one of two pivotal Phase 3 studies in the lemborexant clinical development program that supported the recent FDA approval of DAYVIGO (lemborexant).
  • On December 20, the U.S. Food and Drug Administration (FDA) approved DAYVIGO (lemborexant) 5 mg and 10 mg, an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, which is characterized by difficulties with sleep onset and/or sleep maintenance.1
  • DAYVIGO will be commercially available following scheduling by the DEA, which is expected to occur within 90 days.
  • SUNRISE 1 was a one-month, randomized, double-blind, placebo- and active-controlled, multi-center, parallel-group clinical trial in adult female patients age 55 and older and male patients 65 years and older who met DSM-5 criteria for insomnia disorder. Patients were randomized to placebo (n=208), lemborexant 5 mg (n=266) or 10 mg (n=269), or active comparator (n=263) once nightly.1
  • The primary efficacy endpoint was the mean change in log-transformed latency to persistent sleep (LPS; defined as the number of minutes from lights off to the first 10 consecutive minutes of non-wakefulness) from baseline to end of treatment (Days 29/30), as measured by overnight polysomnography (PSG) monitoring.1
  • The pre-specified secondary efficacy endpoints in Study 2 were the mean change from baseline to end of treatment (Days 29/30) in sleep efficiency (SEF) and wake after sleep onset (WASO) measured by PSG.1
  • SUNRISE 1, lemborexant 5 mg and 10 mg demonstrated statistically significant superiority on the primary efficacy measure, LPS, compared to placebo. lemborexant 5 mg and 10 mg demonstrated statistically significant improvement in SEF and WASO compared to placebo.1
  • The effects of lemborexant at the beginning of treatment were generally consistent with later timepoints.
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Author Interviews, Blood Pressure - Hypertension, Obstructive Sleep Apnea / 13.09.2019

MedicalResearch.com Interview with: Mireia Dalmases Cleries, MD Hospital Universitari Arnau de Vilanova and Santa Maria Group of Translational Research in Respiratory Medicine Lleida, Cataluña, Spain MedicalResearch.com: What is the background for this study? Response: Obstructive sleep apnea has been associated with poor blood pressure control and resistant hypertension. Moreover, it has been described that its treatment with continuous positive pressure (CPAP) could be an effective means of controlling blood pressure in this population. Nevertheless, studies assessing OSA prevalence, characteristics and association with blood pressure control in resistant hypertensive patients are limited and that’s the reason why we decided to perform this study. (more…)
Author Interviews, BMJ, Heart Disease, Sleep Disorders / 10.09.2019

MedicalResearch.com Interview with: Dr Nadine Häusler Department of Medicine, Internal Medicine University Hospital of Lausanne Lausanne, Switzerland MedicalResearch.com: What is the background for this study? Response: There are controversial results regarding the effect of napping on cardiovascular disease (CVD) exist i.e. some studies report adverse effects of napping whereas other find beneficial effects of napping on CVD. Most studies compare nappers to non-nappers or study nap duration but neglect to take the frequency of napping into account. Moreover, studies measure naps in a different way, study different populations and include different confounders, which makes it hard to compare the results. Thus, we aimed to study the association between CVD and napping as a more holistic behavior i.e. not just the duration but also the frequency of napping. (more…)
Alzheimer's - Dementia, Author Interviews, JAMA, Mental Health Research, Sleep Disorders / 23.08.2019

MedicalResearch.com Interview with: Chenlu Gao, MA Graduate Student Department of Psychology and Neuroscience Baylor University Michael Scullin, PhD Assistant Professor Department of Psychology and Neuroscience Baylor University  MedicalResearch.com: What is the background for this study? Response: According to the World Alzheimer Report, dementia affects 50 million adults worldwide, and this number is expected to approach 131 million by 2050. Dementia patients often require assistance with daily activities from caregivers. The Alzheimer’s Association reported that, in the United States, 16 million caregivers spend on average 21.9 hours per week providing care for patients with dementia. Being a caregiver is stressful, which not only challenges emotional, cognitive, and physical health, but is also associated with shorter and poorer sleep at night. If a caregiver cannot obtain restorative sleep at night, their quality of life and their abilities to perform the caregiving role can be compromised. For example, sleep loss may jeopardize caregivers’ memory, causing them to forget medications or medical appointments for the patients. Sleep loss can also impair immune functions, causing the caregivers to suffer from illnesses. In the long-term, sleep loss is associated with cortical thinning and accumulation of beta-amyloid and tau, which increase the risks of dementia. Undoubtedly, there is a need to systematically study whether caregivers sleep less or worse during the night and whether we can improve their sleep quality through low-cost behavioral interventions. To answer these questions, we systematically reviewed and meta-analyzed 35 studies with data from 3,268 caregivers of dementia patients.     (more…)
Author Interviews, Race/Ethnic Diversity, Sleep Disorders, Tobacco / 12.08.2019

MedicalResearch.com Interview with: Christine Spadola, M.S., LMHC, Ph.D. Assistant Professor Florida Atlantic University Phyllis and Harvey Sandler School of Social Work Boca Raton, FL 33431-0991 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Short sleep duration and sleep fragmentation are associated with adverse health outcomes including cardiovascular disease, diabetes, hypertension, certain cancers, and mental health challenges such as depression and anxiety. Avoiding the use of alcohol, caffeine, and nicotine close to bedtime represent modifiable behaviors that can improve sleep. Nonetheless, among community dwelling adults (e.g., adults in their natural bedroom environment as opposed to research laboratories) and specifically African Americans, there is a lack of longitudinal research investigating the use of these substances and the associations with objective measures of sleep.. (more…)
Author Interviews, Sleep Disorders / 07.08.2019

MedicalResearch.com Interview with: Shahab Haghayegh, Ph.D. Candidate Department of Biomedical Engineering Cockrell School of Engineering University of Texas at Austin MedicalResearch.com: What is the background for this study? What are the main findings? Response: I'm a sleep researcher and I wanted to find the link between warm bath and sleep. Body temperature which is involved in the regulation of the sleep/wake cycle, exhibits an endogenous circadian cycle, that is a 24-hour pattern, being highest by 2-3°F in the late afternoon/early evening than during sleep when it's lowest. The average person’s circadian cycle is characterized by a reduction in core body temperature by ~ 0.5 to 1° F the hour or so before one’s usual sleep time, dropping to its lowest level between the middle and later span of nighttime sleep. It then begins to rise, acting as a kind of a biological alarm clock wake-up signal. The temperature cycle leads the sleep cycle and is an essential factor in achieving rapid sleep onset and high efficiency sleep. (more…)
Author Interviews, Melatonin, Pharmacology, Sleep Disorders / 23.06.2019

MedicalResearch.com Interview with: David C. Brodner, M.D. Founder and Principle Physician The Center for Sinus, Allergy, and Sleep Wellness Double Board-Certified in Otolaryngology (Head and Neck Surgery) and Sleep Medicine Assistant Clinical Professor Florida Atlantic University College of Medicine Medical Director, Good Samaritan Hospital Sleep Laboratory Senior Medical Advisor, Physician’s Seal, LLC® MedicalResearch.com: What is the background for this study? Response: Chronic disorders of sleep and wakefulness affect an estimated 50-70 million adults in the United States. The cumulative long-term effects of sleep loss have been associated with a wide range of damaging health consequences, including obesity, diabetes, impaired glucose tolerance, cardiovascular disease, hypertension, anxiety and depression. In terms of preventing health consequences, sleeping 6-8 hours per night consistently may provide optimal health outcomes. Comprehensive data from two recently completed patient-reported outcomes (PRO) studies provide further evidence of the observed hypnotic effects of REMfresh, demonstrating statistically significant improvements in sleep onset, sleep duration, sleep maintenance and sleep quality. PRO studies of this kind, which more closely address real-world patient experience, are increasingly being recognized by regulatory authorities and academia in evaluating new therapies. In addition to the traditional randomized, placebo-controlled trial studies, regulatory authorities are now incorporating the patient perspective in their decision making, including PRO studies. A PRO study is a measurement based on a report that comes directly from the patient about the status or change in their health condition and without amendment or interpretation of the patient's response by health-care intermediaries. PRO measures can be used to capture a patient's everyday experience outside of the clinician's office, and the effects of a treatment on the patient's activities of daily living. Together, clinical measures and PRO measures can provide a fuller picture of patient benefit. REMfresh, the first and only continuous release and absorption melatonin (CRA-melatonin) formulation, is designed to give patients up to 7 hours of sleep support. It is a clinically studied, drug-free, nonprescription, #1 sleep doctor-recommended melatonin sleep brand. (more…)
Alzheimer's - Dementia, Author Interviews, Sleep Disorders / 21.06.2019

sleep-alzheimers-dementia-insomniaSleep patterns can predict the increase of Alzheimer’s pathology proteins tau and β-amyloid later in life, according to a June 2019 study published in the Journal of Neuroscience. The findings shed hope on earlier diagnosis of Alzheimer’s and the adoption of preventive measures earlier in life. Researchers found a decrease in sleep spindle synchronization, which is linked to higher tau levels. Reduced amplitude of slow wave activity, meanwhile, is closely related to higher β-amyloid levels. In younger people, both slow oscillations and sleep spindles are synchronized. This changes as people grow older, with less coordination between the two being visible. The researchers also noted that subjects who slept less had a higher chance of having Alzheimer’s proteins when they were older. The findings show that both reduced sleep quantity and quality can serve as important warnings of the onset of Alzheimer’s. (more…)
Author Interviews, Gender Differences, Sleep Disorders / 16.06.2019

MedicalResearch.com Interview with: Ambra Stefani, MD Sleep Disorders Clinic Department of Neurology Innsbruck Medical University Innsbruck, Austria  MedicalResearch.com: What is the background for this study? Response: Restless legs syndrome (RLS) is a common neurological disorder, affecting up to 10% of the general population in Europe and North America. It is a sensorimotor disorder characterized by unpleasant sensations and an urge to move, mainly involving the legs. These symptoms appear or worsen in the evening/at night and improve with movement. Background for this study was the idea that there might be gender differences in the phenotypical presentation of RLS, as the pathogenesis of this disease is multifactorial and gender specific factors also play a role. (more…)
Author Interviews, Opiods, Pain Research, Sleep Disorders / 05.06.2019

MedicalResearch.com Interview with: Nicole Tang, D.Phil, C.Psychol (Reader) Department of Psychology Warwick Sleep and Pain Lab University of Warwick MedicalResearch.com: What is the background for this study? What are the main findings? Response: Current guidelines recommend non-opioid therapy as the preferred treatment of chronic non-malignant (CNP) pain, with opioids reserved to situations “when benefits for pain and function are expected to outweigh risks” [1,10]. Whilst the effectiveness of opioid therapy is usually measured in terms of pain outcomes, less is known about its effect on day-to-day functions. A particular function of concern to patients with chronic non-malignant pain is the ability to get a good night's sleep. The current systematic review has identified a set of papers with relevant outcomes regarding the effect of opioid therapy on sleep quality and sleep architecture in CNP patients. It extends our understanding from the drug's respiratory depression effect in healthy individuals to the potential risks and utility of opioid therapy for chronic non-malignant pain patients with sleep disturbances. Whilst the narrative synthesis and the exploratory meta-analysis of a subset of data both suggest that the use of opioid therapy is associated with an overall report of sleep quality improvement, such an improvement is not consistently replicated across studies or substantiated by improvements in sleep parameters linked to deeper and better-sleep quality. Moreover, the improvement may be accompanied by undesirable side effects and increased daytime sleepiness that contradict with the very idea of improved sleep quality. We are also painfully aware of the methodological limitations of the studies reviewed; their exposure to different sources of biases has heightened the risk of result inflation. To many patients with chronic non-malignant pain, improved sleep is a top priority when evaluating the performance of a new drug and non-drug intervention. If we were to advance our current understanding of the opioid-sleep relationship, future trials need to be designed with this interdisciplinary question in mind such that validated measures of sleep can be incorporated as an outcome measure alongside pain. (more…)
Author Interviews, CDC, Pediatrics, Sleep Disorders / 23.04.2019

MedicalResearch.com Interview with: Alexa B. Erck Lambert, MPH DB Consulting Group, Inc, Silver Spring, Maryland Centers for Disease Control and Prevention Contractor  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Unintentional suffocation is the leading cause of injury death among infants under 1 year old in the US. This study investigates cases in CDC’s SUID Case Registry that were assigned the category of explained suffocation with unsafe sleep factors per CDC’s SUID Case Registry classification system, which was developed to consistently differentiate SUID cases into well-defined categories (including no autopsy or death scene investigation, incomplete case information, no unsafe sleep factors, unsafe sleep factors, possible suffocation with unsafe sleep factors, and explained suffocation with unsafe sleep factors) using standardized criteria and definitions. Cases classified as possible and explained suffocation were assigned one more mechanisms to which the airway obstruction was attributed including soft bedding, wedging, overlay and other – other was excluded from this analysis. Most explained suffocations (69%) were attributed to soft bedding like a blanket or a pillow followed by overlay (19%), and wedging (12%). Although explained suffocation deaths represent a small proportion of all sudden unexpected infant deaths (14%), these losses are particularly tragic because they can be prevented by placing a baby to sleep in a safe environment.  (more…)
Author Interviews, Memory, NIH, Sleep Disorders / 17.04.2019

MedicalResearch.com Interview with: Leonardo G. Cohen, M.D., Ph.D., Senior Investigator Marlene Bönstrup, M.D., Postdoctoral fellow in  Dr. Cohen's lab NIH's National Institute of Neurological Disorders and Stroke MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Learning a new skill is typically divided into online (during practice) and offline (after practice has ended) components. Particularly motor skill learning occurs to a considerable degree offline, meaning that performance further improves even after practice has ended. A single practice session itself however, is typically divided into short (level of seconds) periods of practice and rest. In this study, we set out to investigate the contribution of those short periods of practice and rest to the learning during a practice session (i.e. online learning). We found that during early motor skill learning, when most of the total learning occurs, performance improvements actually precipitate during short periods of rest whereas during practice periods, performance mostly stagnated. We found a signature of neural activity predictive of those performance improvements during rest: The lower the beta rhythmic activity in the parietofrontal regions of the brain during those short periods of rest, the higher were participant’s performance jumps.  (more…)
Author Interviews, Dermatology, JAMA, Pediatrics, Sleep Disorders, UCSF / 26.03.2019

MedicalResearch.com Interview with: Dr. Katrina Abuabara, MD, MA, MSCE Department of Dermatology Program for Clinical Research, University of California, San Francisco MedicalResearch.com: What is the background for this study? Response: The wellbeing and development of children is strongly influenced by parents’ physical and psychosocial health. Parents of children with chronic illness, in particular, are susceptible to poor sleep, and previous studies have found major sleep impairments among parents of children with ventilator dependency and cystic fibrosis, but few studies have examined sleep patterns among parents of children with more common chronic illnesses like atopic dermatitis (also known as eczema). (more…)
Author Interviews, Blood Pressure - Hypertension, Heart Disease, Sleep Disorders / 07.03.2019

MedicalResearch.com Interview with: Dr Manolis S Kallistratos MD, PhD, FESC,EHS Asklepeion General Hospital Greece  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Lifestyle changes represent the cornerstone of treatment of arterial hypertension. Alcohol and salt reduction may decrease blood pressure levels by 2 to 8 mmHg. In our study 60 minutes of midday sleep decrease 24 hours systolic blood pressure levels by up to 3 mmHg in well controlled hypertensives. That is an effect as potent as other well-established life style changes. The magnitude of blood pressure decrease might seem small, but a drop in blood pressure as small as 2 mmHg can reduce the risk of cardiovascular events by up to 10 percent.  (more…)