95 Clinical Trials for Various Conditions
Anesthesiology residency requires extended and overnight shifts, which may negatively impact the quantity and quality of sleep. Previous studies have investigated the effect of night float shift work on anesthesiology resident sleep and performance and demonstrated that total sleep quantity and time spent in deep and rapid eye movement (REM) sleep were significantly reduced during night float and did not return to baseline after 3 nights of recovery. Melatonin is a hormone produced by the pineal gland, which regulates the circadian rhythm that governs sleep. Exogenous melatonin may be used as a sleep aid and is available over the counter in the United States. Melatonin is effective in realigning the circadian rhythm disorder caused by night shift work and increasing sleep duration; however, melatonin's effect on improving sleep in resident trainees has not been investigated. The investigators propose a prospective double-blinded randomized control trial to investigate the effect of melatonin on sleep quantity and quality in resident physicians assigned to a night float system.
Current methods for assessing circadian timing require sampling over hours (or even up to a day) while the patient is in controlled conditions. The investigators aim to develop a method that can estimate individual circadian time with a single blood sample taken at any time of the day or night. To do this, the investigators will use two state of the art methods, a plasma proteomics-based method to identify a panel of rhythmic proteins (extending our preliminary data) and a whole blood-derived monocyte-based method using a panel of 15 transcripts (to validate and extend a recent study). We will test both methods in a series of patients with circadian rhythm sleep disorders. We will validate separately the proteomics-based biomarker and the monocyte-based transcript biomarker, and also explore whether combining them can improve the accuracy of our timing estimates. In all cases, circadian phase estimates from the biomarker panels will be compared with those derived from plasma or saliva melatonin (the current "gold-standard" circadian phase marker).
The objective of this project is to develop an effective, yet feasible strategy to extend school-night sleep duration of older adolescents.
The goal is to collect pilot data on an adapted version of the Transdiagnostic Sleep and Circadian intervention (TranS-C), referred to as 'Fitted TranS-C'.
Residency training requires hospital presence twenty-four hours a day. At times this necessitates working extended shifts, including night shifts, resulting in altered sleep patterns and sleep deprivation. Since 2003, the Accreditation Council for Graduate Medical Education (ACGME) has enforced duty hour regulations limiting shift length, the amount of weekly hours worked, and other variables governing shift work. Numerous studies have sought to determine the impact of duty hour regulations on the quality of patient care and resident education. In addition to affecting patient care, medical resident sleep deprivation also has the potential to affect residents' well-being and their ability to perform basic tasks. A study in surgical residents showed reduced efficiency and safety in performing simulated laparoscopy following a period of sleep deprivation that was worse with novices compared to experienced residents. Recently, UVA found that resident physicians have greater difficulty controlling speed and driving performance with increased reaction times and minor and major lapses in attention in the driving simulator following six consecutive night shifts. To comply with duty hour restrictions, residency programs have adopted various strategies including the creation of night float systems where residents are required to work multiple nights in a row. Reduced shift length has been associated with decreased medical errors, motor vehicle collisions, and percutaneous injuries.Surgical residents who transitioned to a night float system from 24-hour call every 3rd day reported reduced fatigue, more time for sleep and independent reading and increased family time, while nurses and patients reported improved communication and quality of patient care. In a pilot study of urology residents assigned to a 12-hour day shift (Monday-Friday), 12-hour night float (Sunday-Friday) or 24-hour home call, actigraphy was used to measure total sleep time, sleep latency and depth of sleep. Night float did not impact total sleep time or quality of sleep. However, these studies did not establish the optimal shift duration
The study examines and illustrates the utility of utilizing actigraphic measurements to assess treatment response.
The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.
Jet lag and some sleep disorders are caused by a disruption in an individual's "internal clock." Understanding the most effective way to quickly re-adjust the body's internal clock will be beneficial for treating individuals with these conditions. This study will evaluate the combined effectiveness of light and non-light therapies at regulating sleep cycles and improving sleep quality.
Circadian rhythms are 24-hour cycles that influence natural functions in the body such as heart rate, blood pressure, and body temperature. Circadian rhythms provide the body with an internal clock and affect sleep patterns. The purpose of this study is to determine the effects of vitamin B12 supplements on circadian rhythms and sleep-wake regulation.
This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture. Objectives: The primary goals of the trial are to determine: 1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep. 2. Whether PSTx increases the duration of REM and/or NREM sleep. 3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency). Participants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan/Propofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep. Participant Criteria: Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation. Exclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II. Study Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy. Participants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit. Therapy Methodology: PROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan/Propofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function. Outcome Measures: Primary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency. Secondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx. Significance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments. Study Process: Recruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy. Therapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan/Propofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages. Post-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators. Potential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options. Key Concepts: Homeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.
This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved study with functional measurements, will evaluate pain relief and sleep improvement after use of a drug- free, non-invasive patch (FREEDOM or REM Patch; The Super Patch Company Inc.); using validated scales and functional measurement tools along with crossover and control groups within the same subject group not receiving an 'active' patch.
Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. There is considerable evidence that multiple dimensions of sleep health, including sleep duration, efficiency, timing, and regularity, as well as the disorders sleep apnea and insomnia, affect cardiometabolic disease risk. However, there is currently a lack of systematically developed sleep data in rural populations. The RURAL Sleep Study is an ancillary study to a recently initiated longitudinal epidemiology study in rural Appalachia and Mississippi Delta (the RURAL Study). The RURAL Sleep Study will add measures of sleep health to the complex individual, social and environmental factors and health outcome measures being evaluated by the RURAL Study, by incorporating minimally burdensome measures of multiple dimensions of sleep health. The results are expected to inform health care providers, public health officials, and the general public of the prevalence, risk factors, and consequences of impaired sleep health in these rural communities, providing a critical basis for prevention, recognition, and management of sleep disorders and improvement of sleep and cardiometabolic health.
To evaluate the feasibility of a pragmatic, large scale, comparative effectiveness, randomized evaluation of patient experience of intravenous propofol versus inhaled volatile anesthesia.
This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.
Insufficient sleep has both health and safety risks, but currently there are no quick, accurate and inexpensive ways to measure sleep deficiency. The current study aims to use a cutting-edge technology, small molecule analysis (e.g. metabolomics), to detect compounds in breath that reliably change with sleep-wake state and those whose levels vary by time of day.
Study investigators want to learn more about the underlying biological clock and to see if the timing of that clock can be estimated from a single blood sample.
Circadian rhythm disorders are a class of sleep disorders characterized by misalignment between the timing of sleep and the timing of rhythms driven by the biological clock. Light therapy can effectively treat these disorders, but the intensity and duration of light exposure required to do so has limited its practical use. In this study the investigators will test whether pre-exposure to dim light may enhance the response of the circadian system to light therapy. If so, this could result in shorter treatments that would have greater practical applications.
The goal of this project is to determine whether the sleep and circadian rhythms of critically ill patients undergoing mechanical ventilation can be improved through practical strategies that can be employed at the bedside.
The investigators will perform a prospective, cohort study of 100 older intensive care unit (ICU) patients, to investigate the association between sleep disruption and ICU delirium.
This study will examine the effect of bright light or melatonin treatment on sleep in children with Smith-Magenis syndrome (SMS), a genetic disorder characterized by certain physical, behavioral and developmental features. Patients have a disrupted sleep cycle involving early waking, frequent daytime napping and frequent nighttime awakenings. Melatonin is a hormone normally produced at night in healthy people. People with SMS produce high levels of melatonin during the daytime and very low levels at night. This may affect their behavior, mood, attention span and sleep patterns. Healthy volunteers between 18 and 45 years of age and children with SMS who are between 3 and 16 years of age may be eligible for this study. Healthy subjects are admitted to the NIH Clinical Center overnight. In the morning they take one dose of time-release melatonin and have blood and saliva samples collected hourly from 7:00 AM to 6:00 PM. Children with SMS participate in a 2-part study, as follows: Part 1 Inpatient Trial Pre-trial at-home phase: During the month before NIH inpatient admission, participants do the following: * Wear an actiwatch device or keep a daily sleep diary to monitor daytime alertness, mood shifts and sleep patterns. * Complete a behavior assessment survey related to the child s behaviors and sleep patterns. * Obtain frequent body temperature measurements. * Collect several saliva samples over a 24-hour period. NIH admission phase: * Children are admitted to the NIH Clinical Center for 2-3 nights for bright light treatment. They remain in their rooms for alternating periods of exposure to standard dim room light and bright light, using a light box placed within 3 to 5 feet of the child. An electroencephalogram (EEG) with additional electrodes to track eye movements is used to monitor the child s attention. Between 8AM and 6PM serial blood samples are collected to measure melatonin levels. A parent rates the child s mood and behavior during the 2-day test period. * Children are admitted to the NIH Clinical Center for 2-3 nights for melatonin treatment. They take a single dose of melatonin or placebo tablet at bedtime. During the daytime, EEG electrodes are placed to track eye movements. Between 7 PM and 7 AM serial blood samples are collected to measure melatonin levels. A parent rates the child s behavior and mood as described for the bright light study. * Children may receive either or both of the bright light and melatonin treatments. Part 2 Outpatient Trial Children participate in a combined bright light with melatonin trial at home. They undergo the same procedures outlined in the pre-trial at-home phase of Part 1 (actiwatch, behavior assessments, body temperature measurements, saliva samples) over an 11-week period. If saliva samples cannot be collected for melatonin testing, 24-hour urine samples may be collected instead.
Police officers work some of the most demanding schedules known, which increases their risk of sleep deprivation and sleep disorders. The need to work frequent overnight shifts and long work weeks leads to acute and chronic partial sleep deprivation as well as misalignment of circadian phase. The public expects officers to perform flawlessly, but sleep deprivation and unrecognized sleep disorders significantly degrade cognition, alertness, reaction time and performance. In addition, both acute and chronic sleep deprivation adversely affect personal health, increasing the risk of gastrointestinal and heart disease, impairing glucose metabolism, and substantially increasing the risk of injury due to motor vehicle crashes. We propose to conduct a randomized, prospective study of the effect on the safety, health, and performance of a police department of a Comprehensive Police Fatigue Management Program (CPFMP) consisting of the following interventions: 1. identification and treatment of police with sleep disorders; 2. caffeine re-education; and 3. initiation of a sleep, health and safety educational program. These interventions were chosen because we believe them most likely to lead to measurable improvements on work hours, health, safety, and job performance, and because they are cost effective. The success of the CPFMP will be assessed through an experimental comparison with a standard treatment group that will receive sleep education in the absence of any accompanying interventions. The overall goal of our team will be sleep health detection and treatment program that can be disseminated to practitioners, policymakers and researchers nationwide to reduce police officer fatigue and stress; enhance the ability of officers to cope with shift schedules; improve the health, safety and performance of law enforcement officers; and thereby improve public safety.
The purpose of the study is to test the effect of a sleep disorders detection and treatment program for police officers on their safety, quality of life, and job performance. The program is called Operation Healthy Sleep. We will develop and test a sleep health detection and treatment program that we aim to apply nationwide to reduce police officer fatigue and stress; enhance the ability of officers and their families to cope with police work; improve the health, safety and performance of law enforcement officers; and thereby improve public safety. Part of this program will include a questionnaire asking about about work hours and health related issues. We will then look at how these survey data relate with data on police officer safety and job performance that we are collecting through police department's databases. Sleep disorders are common and treatable, but often remain undiagnosed and untreated. Police officers work some of the most demanding schedules known, which increases their risk of sleep disorders. The public expects officers to perform flawlessly, but unrecognized sleep disorders lead to severe disruption of sleep, which significantly reduces an individual's ability to think clearly and perform well. In addition, sleep loss and sleep disruption affect personal health, increasing the risk of gastrointestinal and cardiovascular. We also know that sleep loss increases the risk of injury due to motor vehicle crashes. The goals of Operation Healthy Sleep are to improve officers' health, safety, and performance by reducing the impact of fatigue. The study will take place over two years. In the first year, half of the police officers will take part in Operation Healthy Sleep, and in the second year, the second half will participate. We will carefully select the year 1 and year 2 groups so that the data collected across the two years can be validly compared.
People who experience repeated bouts of circadian misalignment, such as shift workers, are at higher risk of cardiovascular disease (CVD) and Type 2 diabetes (T2D) compared to daytime workers. However, the mechanism(s) by which shift work and associated circadian misalignment increase CVD and T2D risk are unknown. This project will examine whether elevated plasma lipids are a mechanism by which circadian misalignment impairs vascular function, insulin sensitivity, glucose homeostasis and muscle lipid accumulation, which could be targeted to prevent and treat cardiometabolic disease in people who chronically experience circadian misalignment, which includes more than 20% of the US workforce.
The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers.
The aims of this study are to compare 3 different treatments for circadian adjustment to a laboratory protocol which will mimic westward air travel across 8 time zones. One treatment will involve simply following the new schedule for 3 days. Another treatment will also involve exposure to bright light for 1 hour per day. A third treatment will involve exposure to bright light + exercise for 1 hour per day + consuming a melatonin tablet. Adjustment to the shifted schedule will be assessed by comparing measures of sleep, mood, mental performance, physical performance, and timing of melatonin across the 3 treatment conditions.
Insufficient sleep and circadian misalignment are independent risk factors for the development of obesity and diabetes, yet few strategies exist to counter metabolic impairments when these behaviors are unavoidable. This project will examine whether avoiding food intake during the biological night can mitigate the impact of circadian misalignment on metabolic homeostasis in adults during simulated night shift work. Findings from this study could identify a translatable strategy to minimize metabolic diseases in populations that include anyone working nonstandard hours such as police, paramedics, firefighters, military personnel, pilots, doctors and nurses, truck drivers, and individuals with sleep disorders.
This study will compare eating behaviors and measures of hunger and fullness between day and night workers in order to better understand why night workers are at increased risk for obesity and related diseases.
To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.
The purpose of this study is to determine whether night time eating that coincides with elevated endogenous melatonin impairs glucose tolerance, particularly in carriers of the MTNR1B risk allele.
Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.