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Sleep Deprivation clinical trials

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NCT ID: NCT05790161 Recruiting - Caffeine Clinical Trials

Consequences of Caffeine Intake in Sleep Restricted Teenagers

Start date: March 31, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to systematically investigate two prominent factors in teenagers' daily life: Caffeine and sleep restriction (SR) and their combined influence on sleep, cognition, and behavior in healthy adolescents. The main questions it aims to answer are: The effects of caffeine under conditions of SR and SE: - on sleep pressure and sleep continuity. - on BOLD activity differences in reward related areas during a reward task (monetary incentive delay task) and on reaction times (behavioral aspect) in the same task. - on BOLD activity differences during a risk taking task (wheel of fortune task) and on risky decision-making (behavioral aspect) in the same task. Participants will be either in the SR or SE condition (between-subject). The protocol consists of 2x of approximately one week in which a participant will receive caffeine or placebo (within-subject) at the last two evenings. The experiment consists of an ambulatory and a laboratory phase: - The ambulatory phase consists of 5 nights, including 3 stabilization nights (8h sleep opportunity) prior to 2 nights consisting of either SR with 6h sleep opportunity or SE with 9.5h sleep opportunity. Participants will wear an actiwatch and fill out sleep diaries during this period. - The laboratory phase will be the 6th evening, night and morning of the protocol and will be spent in our lab. Participants will do the following: - treatment (caffeine vs. placebo) intake - saliva sampling - drug screening - cognitive tests, including risk-taking and reward task - filling in questionnaires (sleep diary, sleep quality, sleepiness, mood, expectancy) - waking and sleep with EEG The next day, participants will undergo an fMRI scan, including the following: - resting-state scan - structural scan - arterial spin labeling scan - reward task scan - risk-taking task scan Around the scan, participants will fill out/undergo: - saliva sampling - questionnaires (reward task, mood, sleepiness, expectancy)

NCT ID: NCT05789212 Recruiting - Sleep Insufficiency Clinical Trials

A Personalized Mind-Body Intervention (MBI) for Improving Sleep Among Women Working in Healthcare

Start date: May 22, 2023
Phase: Phase 2
Study type: Interventional

The goal of this pilot study is to determine if a personalized trial testing a Mind-Body Intervention (MBI) can produce a meaningful increase in the average daily sleep duration among women 40-60 years of age working in healthcare. A total of 60 eligible participants will be randomized to one of two possible orders of treatment exposure comprised of three components: mindfulness, yoga, and guided walking, each assigned in 2-week block sequences for a total period of 12 weeks. The study will include a 2-week baseline period during which their baseline sleep duration and adherence to the Fitbit wear and survey submission will be assessed. Following the 2-week run-in period, participants deemed eligible and achieved at least 80% adherence of Fitbit wear and survey submission will be randomized to one of the two intervention arms. Exploratory aims include assessments of sleep quality, physiological factors and their direct and indirect relationships with participants' perceived stress, anxiety, and depression.

NCT ID: NCT05775627 Recruiting - Obesity Clinical Trials

Sleep and Metabolism

SAM
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to uncover sleep and circadian mechanisms contributing to adverse metabolic health. The protocol is a 21 day (7 outpatient days, 14 inpatient days) mechanistic randomized-crossover study designed to identify the impact of chronic sleep restriction and circadian timing, independently and in combination on energy metabolism and identify the independent and combined effects on glucose tolerance.

NCT ID: NCT05703347 Recruiting - Obesity Clinical Trials

Optimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children

Start date: September 21, 2023
Phase: N/A
Study type: Interventional

The overall objective of this application is to develop a mobile health platform for the pediatric care setting to promote longer sleep duration for childhood obesity prevention.

NCT ID: NCT05698693 Recruiting - Obesity Clinical Trials

Social Determinants of Sleep and Obesity

Start date: November 1, 2023
Phase: Early Phase 1
Study type: Interventional

African American adults sleep less and obtain worse quality sleep compared to the national average, and emerging evidence links inadequate sleep with greater morbidity and mortality from chronic diseases such as diabetes, obesity, and cancer. To address this public health concern, the proposed research seeks to use a multi-method approach to adapt a sleep intervention for African American adults with overweight/obesity not meeting national sleep duration or physical activity recommendations. The overall goal of the project is to reduce cancer and obesity-related health disparities among African Americans.

NCT ID: NCT05588934 Recruiting - Sleep Deprivation Clinical Trials

Caffeine Optimization Versus Standard Caffeine Dosage (2B-2)

2B-2
Start date: June 9, 2023
Phase: N/A
Study type: Interventional

This clinical trial will be a comparison between personalized recommended caffeine dosing regimen versus the standard recommended caffeine dosing regimen for sustaining performance during sleep deprivation and minimizing side effects and subsequent sleep disruption. The questions this study aims to answer are: Whether the personalized caffeine recommendations improve vigilance, sleepiness, and cognition after total sleep deprivation, compared to standard recommendations; Whether the personalized caffeine recommendation better addresses the physical and emotional side effects of total sleep deprivation, compared to standard recommendations; And whether personalized caffeine recommendations aids in better recovery sleep after total sleep deprivation, compared to standard recommendations. Participants will be asked to: 1. Complete a 13-day at-home portion, wearing an actigraph watch to measure activity and sleep, and complete motor vigilance tests up to six times a day. 2. Complete a 4-day in-lab portion, where participants will have to complete one night of baseline sleep, undergo 62-hours of total sleep deprivation, and then complete one night of recovery sleep. 3. During the in-lab portion of the study, participants will be asked to complete more motor vigilance tests. Researchers will be comparing the personalized caffeine recommendation group against the standard caffeine recommendation to see if it is better at addressing each of the main questions.

NCT ID: NCT05563688 Recruiting - Hypoxia Clinical Trials

Effect of Acute Sleep Restriction on Responses to Hypoxia

HypSom
Start date: October 26, 2022
Phase:
Study type: Observational

At altitude, humans are exposed to environmental hypoxia induced by the decrease in barometric pressure. On duty or in training, mountain troops, paratroopers or aircrew are regularly exposed to altitude. The effects of altitude on humans occur gradually from 1500 m and depend on both the duration of exposure and the altitude level. Cognitive disorders can occur from 3500 m (threshold of disorders) but there is a very large inter-individual variability. The countermeasure to altitude hypoxia is oxygen but its use is not systematic between 3000 and 4000 m. Its use depends on the duration of exposure, without clearly established standards. Incapacitating effects on the operational capacity and health of soldiers can therefore occur as early as 3500 m. In operations or during training, altitude exposure is often associated with a significant sleep debt (particularly during night or early morning missions), jet lag or precarious rest conditions in overseas operations. These sleep restrictions promote the degradation of mental performance with effects similar to those observed in hypoxia. The combination of these constraints induces a physiological stress which can favour alterations in mental performance, an increase in incapacity, intolerance to altitude or the occurrence of altitude-related pathologies in military personnel. This could occur in particular in the operational zone around the threshold of disorders (3500 m) where the indication of oxygen is discussed. The objective of this study is to assess the impact of acute sleep restriction on hypoxia tolerance.

NCT ID: NCT05551325 Recruiting - Critical Illness Clinical Trials

Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle

ReAlign-ICU
Start date: May 13, 2024
Phase: N/A
Study type: Interventional

More than 5 million patients are admitted to the intensive care unit every year in the United States; most of these patients experience profound sleep and circadian disruption. Promotion of circadian alignment (i.e., alignment of the body's clocks) would make it possible to strategically schedule behaviors such as sleep and eating at normal body clock times, which is predicted to improve sleep quality and metabolic function. This project will test the ability of a sleep chronobundle (i.e., sleep promotion and circadian treatment bundle) to normalize circadian alignment and subsequently test if this realignment also improves sleep and metabolism.

NCT ID: NCT05531734 Recruiting - FATIGUE Clinical Trials

MONITORING OF ATTENTION ACCORDING TO FATIGUE IN THE HEALTHY SUBJECT

MOTIVATES
Start date: March 22, 2023
Phase: N/A
Study type: Interventional

To develop an easy-to-use measurement tool for monitoring fatigue and alertness, particularly in sleep-deprived subjects.

NCT ID: NCT05519644 Recruiting - Sleep Deprivation Clinical Trials

Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction

STAK-Sleep
Start date: June 20, 2023
Phase: N/A
Study type: Interventional

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.