Clinical Research Directory

Study on the Mechanism of Central Obesity Induced by Sleep Restriction and the Therapeutic Effect of n-3 Polyunsaturated Fatty Acid: a Randomized, Double-blind, Placebo-controlled Trial (COSPA Study)

This randomized, double-blind, placebo-controlled trial aims to investigate whether n-3 polyunsaturated fatty acid (PUFA) supplementation attenuates abdominal visceral fat accumulation induced by experimental sleep restriction. Forty healthy adults aged 18-50 years will be randomly assigned to receive n-3 PUFA supplementation (approximately 1.1 g/day of EPA and DHA) or a matching placebo. The intervention will last approximately 75 days, including a 19-day residential sleep protocol consisting of 3 adaptation days, 14 days of sleep restriction (4 hours per night), and 2 recovery days. The primary outcome is the change in abdominal visceral adipose tissue area measured by CT. Additional assessments include body composition, metabolic and inflammatory markers, gut microbiota, microbial metabolites, and adipose tissue molecular profiles.

Sleep and Circadian Rhythm Intervention in ICU

Intensive care unit (ICU) patients are frequently exposed to various stressors that contribute to severe sleep disruption and circadian rhythm disturbances. Growing evidence suggests that circadian rhythm disruption plays a critical role in the development of multiple adverse outcomes in critically ill patients. Therefore, implementing interventions that prioritize the maintenance of normal circadian, sleep, and behavioral patterns may represent an important strategy to improve outcomes in ICU patients.

Evolution of Sleep in Intensive Care Unit Patients

Sleep plays a key role in immune, metabolic, and neurological regulation, particularly in critically ill patients. However, the intensive care environment significantly disrupts sleep due to noise, light exposure, and frequent medical interventions, leading to circadian rhythm disturbances. Poor sleep in ICU patients is associated with increased morbidity, mortality, prolonged mechanical ventilation, and long-term psychological complications. Current studies report fragmented sleep with reduced deep sleep stages but are limited by short monitoring periods and small sample sizes. No study has yet assessed longitudinal sleep evolution throughout ICU stay. This study aims to characterize sleep dynamics from the acute phase to recovery using a simplified EEG device (Sleepscan®). Sleep will be recorded during the first three nights and the last night before ICU discharge. Environmental factors (noise, light) and clinical data will also be collected. This longitudinal intra-individual analysis will identify critical periods of sleep disruption. Results may guide future targeted interventions to improve sleep quality and patient outcomes in ICU.

The Effect of Sleep Deprivation and Recovery Sleep on Emotional Memory and Affective Reactivity

To further understand the impact of acute sleep deprivation and recovery sleep on the processing of emotional information the investigators will address and attempt to answer three questions, (i) how both undisturbed sleep and sleep deprivation affect the processing and retrieval of emotional information, (ii) what neural and psychophysiological mechanisms are associated with these behavioral effects, and (iii) to explore the ability of recovery sleep to reverse the effects of sleep deprivation. Together, these studies will provide a greater breadth and depth of knowledge concerning sleep's role in emotion processing and regulation. Given the growing societal tendency to view sleep as unproductive-foregoing it to lengthen work days and increase social opportunities- such knowledge would be of practical importance for understanding the role of sleep in healthy emotional functioning, particular for individuals experiencing periods of increased stress and emotional distress (e.g., new parents, hospital staff, or combat troops).

Mind After Midnight

This study examines whether wakefulness during the biological night (2:00-4:00 AM) is associated with increased negative mood, impaired decision-making, and suicidal thoughts. Adults with a history of suicidal ideation in the past six months will complete laboratory and home-based assessments under varying levels of sleep pressure. Participants will be evaluated during late-night wakefulness and under conditions of both higher and lower sleep pressure. The goal of the study is to better understand the biological and behavioral mechanisms that may contribute to elevated suicide risk during nocturnal wakefulness.

Reliability of Standardized IQ Testing Under Modafinil, Racetam-Class Compounds, Sleep Restriction and Daily Activity

This study examined whether standardized IQ test scores in healthy adults aged 18-35 are stable measures of cognitive ability and evaluated whether standardized cognitive-test performance and response-initiation measures vary across pharmacological and sleep conditions. Seventy healthy volunteers were assessed at seven in-person timepoints over six months, with 25 participants receiving an inert matched preparation and 45 receiving modafinil or one of four racetam-class compounds (oxiracetam, pramiracetam, phenylpiracetam, aniracetam) administered orally before testing. A different standardized instrument was administered at each timepoint to limit item-level recall and practice effects, and change in the placebo group was used as the reference for estimating practice effects. Participants were assessed under both rested and sleep-restricted conditions, two psychologists were present at every administration to code response initiation (hesitation), and physiological state was monitored using a consumer wearable. Psychometric changes were evaluated relative to the standard error of measurement of the instruments and the study's prespecified minimum detectable effect. Response-initiation measures were analysed separately from psychometric scores to evaluate potential effects on response initiation and execution time.

Study of Single Doses of HBS-104 in Acutely Sleep-deprived Healthy Participants

This is a study to evaluate the pharmacodynamic effects, safety, tolerability, and pharmacokinetics of HBS-104 in acutely sleep-deprived healthy adult participants.

Sleep Harmonization Via Bundled Team-Based Interventions in the ICU

SHANTI-ICU compares the effectiveness of two evidence-based multicomponent ICU sleep promotion bundles on delirium and patient-reported sleep quality in critically ill adults. Bundle A is a non-pharmacologic strategy. Bundle B includes all components of Bundle A plus pharmacist-led pharmacologic strategies. Sixteen intensive care units across eight hospitals implement one of the two bundles as a unit-level change to routine care, using a concurrent multiple-intervention stepped wedge randomized design. The primary outcome is delirium incidence, measured using the Confusion Assessment Method for the ICU (CAM-ICU) as documented during routine clinical care. Secondary outcomes are delirium duration, ICU length of stay, nightly patient-reported sleep quality, and overall patient-reported ICU sleep quality. Patients receive the assigned bundle as part of routine care. The study operates under an IRB-approved waiver of informed consent and waiver of HIPAA authorization; there is no individual enrollment procedure.

Modafinil to Optimize the Performance of Cold-Stressed Sleep-Deprived Personnel

Environmental and workplace stressors are common and often unavoidable in military operations. Two critical stressors are cold stress and sleep loss. They both can substantially degrade operational effectiveness. Various countermeasures are available to mitigate the adverse effects of these stressors, but due to operational requirements many are of limited use in the field. Modafinil is a drug that mitigates the effects of sleep deprivation and potentially cold stress, and modafinil may prevent performance degradation due to the combination of these stressors. This study will help determine if modafinil alters body-heat production and prevents cognitive and physical performance degradation due to cold stress in rested and sleep-deprived volunteers.

EEG Analysis for the Objective Assessment of Drowsiness

The objective of this clinical study is to develop solutions for the evaluation and management of drowsiness, based on 2 EEG sensors only, aiming at reducing the risk of accidents related to secondary hypersomnolence (sleepiness induced by sleep restriction or abnormal sleep/wake cycle). This project will allow a better understanding of the determinants of drowsiness and its impact on cognitive performance and the development of methods and models for the evaluation and prediction of cognitive performance deficit related to sleepiness. The secondary hypersomnolence will be objectified by continuous EEG recording and analysed by visual reading according to Objective Sleepiness Scale (OSS) criteria and automatically analyzed using the MEEGAWAKE algorithm (developed by PHYSIP). The level of secondary hypersomnolence will be modified by varying the duration and maintening of prior sleep or the sleep timing. The ability to stay awake will be measured by the maintenance of wakefulness test (MWT). Subjective sleepiness and mind wandering will be measured before and/or after all measurements. Simulated driving task, maintenance of wakefulness tests and several cognitive tasks to measure sustained attention, alertness, selective attention will be performed every 4 hours.

The Neurocognitive Effects of Total and Partial Sleep Deprivation in Younger Adults.

This study aims to examine how total and partial sleep deprivation affect brain function, cognitive performance, and biomarkers related to stress and inflammation in the same participants using a crossover design. The study will also compare the effects of total and partial sleep deprivation to determine whether these conditions affect the brain and body differently. The findings may improve our understanding of the consequences of sleep deprivation and help inform strategies to reduce its negative impact on health and society. * How does total versus partial sleep deprivation affect brain activity during rest and cognitive tasks? * How does sleep deprivation affect functional connectivity between brain networks? * How does sleep deprivation affect working memory, attention, and executive control? * How does sleep deprivation affect biomarkers of stress and inflammation, such as cortisol? * Are changes in brain activity and connectivity associated with changes in cognitive performance and biological markers? * Can combining MRI-based and non-MRI-based measures provide a more complete picture of the effects of sleep deprivation? Participants will complete three study conditions in a randomized order: Total Sleep Deprivation (TSD): 28 to 32 hours of continuous wakefulness. Partial Sleep Deprivation (PSD): sleep restricted to 4 hours per night for two consecutive nights. Normal Sleep (control condition): a night of habitual sleep without sleep restriction.

Relieving Pain and Improving Sleep: Evaluating Topical Pain Relief and Sleep Patches

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.

Metabolic and Cognitive Parameters Following Partial Sleep Deprivation

The purpose of this study is to determine whether partial sleep deprivation, as compared with normal sleep, influences certain metabolic and cognitive parameters, related to food intake, hunger and memory functions, when participants are shielded from external time cues.

Neurobehavioral Changes Following Spaceflight Stressors

This study aims to investigate the impairing effects of known central nervous system (CNS) stressors in a controlled environment in order to predict and mitigate analogous risks in spaceflight. Up to 56 healthy individuals aged 25-60 will spend approx. 110 hours in a laboratory, where they will be exposed to 27 hours of sleep deprivation and will consume alcohol to reach a BAC of 0.08 on a separate day. They will perform cognitive and sensorimotor tasks and undergo MRIs and blood draws.

Effect of Sleep Extension on Ceramides in People With Overweight and Obesity

The overall goal is to determine how a sleep extension intervention (increasing time in bed) in individuals who maintain less than 6.5 hours sleep per night affects their plasma ceramides and insulin sensitivity. Participants will undergo a randomized controlled trial, with sleep extension (intervention) and healthy lifestyle (control) groups. The sleep extension is designed to increase participant's time in bed by 2 hours per night. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).

Sleep Chatbot Intervention for Emerging Black/African American Adults

Unhealthy sleep and cardiometabolic risk are two major public health concerns in emerging Black/African American (BAA) adults. Evidence-based sleep interventions such as cognitive-behavioral therapy for insomnia (CBT-I) are available but not aligned with the needs of this at-risk group. Innovative work on the development of an artificial intelligence sleep chatbot using CBT-I guidelines will provide scalable and efficient sleep interventions for emerging BAA adults.

Evaluating Worksite Sleep Health Coaching in Firefighters: The Sleep Assistance for Firefighters Study

Insufficient sleep is a significant public health issue, particularly affecting shift workers like firefighters, nearly half of whom report short or poor-quality sleep, with 35-40% screening positive for sleep disorders. Cognitive Behavioral Therapy for Insomnia (CBTi) is a recommended and effective treatment, but access to such interventions remains low. This study will recruit 20 fire agencies in Arizona (400 firefighters) to test if a CBTi-informed intervention, including sleep health coaching and agency-wide promotion, improves sleep more effectively than usual care. The trial will also explore factors that influence successful implementation across agencies.

The Acute Effects of Onnit Alpha Brain on Cognition and Mood States

The purpose of this randomized, double-blind, placebo-controlled crossover study is to evaluate the efficacy of the acute effects of an investigational supplement (Alpha Brain or Alpha Brain 2.0) on improving cognitive performance, vigilance, and subjective mood in healthy adults compared to placebo during a period of acute sleep deprivation under conditions of controlled sleep deprivation.

Menstrual-phase-dependent Differences in Response to Sleep Loss

This study is designed to assess how healthy premenopausal women respond to different patterns of sleep loss at different times in the menstrual cycle.

Ketone Conferred Resiliency Against Sleep Restriction With Nutritional Intervention.

Sleep deprivation is a major problem in military populations. Some major consequences of sleep loss are inability to concentrate, poor work efficiency, and increase in errors during daily tasks. Ketogenic supplementation is speculated to alleviate some sleep deprivation issues via action of ketones. Ketones are small molecules that appear in the blood when following a ketogenic diet or consuming ketone supplements. The goal of this project is to find out if diet and/or ketones can improve sleep deprivation detriments over 5 days of sleep restriction (-50% from habitual sleep).

The Microbiome and Resilience to Sleep and Circadian Disruption

This study is about how sleep loss and being awake at night impacts the ability to think, changes molecules in the blood, and alters the bacteria that live in the gut that typically help keep people healthy. This work will have important implications for the development of treatments and countermeasures for people who do not sleep enough and need to be active at different times of the day and night (e.g., emergency workers and military personnel).

Microbiota Profiles in Newly Married Couples: Potential Effects on Vision, Sleep and Psychometric Parameters

Oral, fecal and conjunctival samples will be collected from participants and will be stored (at - 20 and - 80 ◦C) until further processing. On Day 1 and Day 2, all couples will participate in an oral, conjunctival and gut microbiota composition study. Optometry examinations will be completed for each participant Three and Six months later, oral, conjunctival and gut microbiota composition will be analyzed again with the same protocol. The participants will complete a validated Persian version of Pittsburgh Sleep Quality Inventory (PSQI), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), global sleep assessment questionnaire (GSAQ) and Ocular Surface Disease Index. Consecutive couples will undergo a standard ophthalmology exam and specific assessments for dry eye, including non-anesthetic Schirmer's test and fluorescein tear break-up time on Day 1 and Day 90.

Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction

Sleep deprivation is a major problem in military populations. Some major consequences of sleep loss are inability to concentrate, poor work efficiency, and increase in errors during daily tasks. There is some evidence that ketone ester supplements may lessen the adverse effects of sleep restriction. The main purpose of these supplements is to raise your blood concentration of ketones, which are safe, small molecules that appear in the blood during fasting, when following a ketogenic diet, or consuming ketone supplements. The main purpose of this study is to examine if ingesting a ketone ester supplement, twice daily, can improve cognitive and physical performance during short-term sleep restriction.

Chronic Sleep Restriction and Driving

Young subjects and patients with nocturnal respiratory disorders are frequently involved in sleep-related accidents. This study assess the impact of chronic sleep restriction (4 hr of sleep during 5 days) or total sleep deprivation in young or mature healthy subjects or snorers on simulated driving, objective and subjective sleepiness and objective and subjective cognitive performances. The effects of recovery night on these parameters are also assessed.