Sleep Extension for Sleep Deprivation
Recruiting in Palo Alto (17 mi)
Overseen byIvan Wu, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: University of Minnesota
Disqualifiers: Organ disorders, Pregnancy, Infant, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The proposed research aims to reduce obesity-related health disparities by promoting healthy lifestyle behaviors among African Americans (AAs), given the high disease burdens associated with low physical activity, insufficient sleep, and obesity. There will be two phases to the proposed research. Phase 1 (Aim 1) will encompass formative research and community engagement activities, and Phase 2 (Aim 2a and 2b) will be a randomized clinical trial.
The primary goal of Aim 1 is to conduct in-depth qualitative interviews in order to: (1) better understand sleep-related social contextual factors, knowledge, behaviors, and beliefs, and (2) discuss and receive feedback on an existing sleep intervention design and materials. The primary goal of Aim 2 is to explore the feasibility, satisfaction, and preliminary efficacy of a sleep intervention to increase sleep and physical activity (PA) among sedentary and short sleeping (≤6 hrs/night) African American adults with overweight/obesity, compared to a contact control group. (Aim 2a) An additional exploratory (Aim 2b) examines changes in cancer-relevant biomarkers between those who received the intervention vs the control condition (n = 20). Data will be collected from a sample of 20 participants (10 per condition) who volunteer to have their blood drawn pre- and post-intervention.
There are two phases of the study, and information gained during Phase 1 (Aim 1) will be used to inform Phase 2 (Aim 2). Thus, additional modifications to the protocol will be submitted prior to engagement in Phase 2.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the Sleep Extension treatment for Sleep Deprivation?
Research shows that sleep extension treatments, which involve increasing the time spent in bed, can significantly improve sleep duration and reduce daytime sleepiness. These treatments have been effective in various groups, including those with short sleep duration, and can enhance attention and alertness, especially in individuals who are already sleep-deprived.
12345Is sleep extension generally safe for humans?
The studies reviewed do not report any safety concerns related to sleep extension interventions, suggesting that they are generally safe for humans.
13456How does the Sleep Extension Intervention differ from other treatments for sleep deprivation?
The Sleep Extension Intervention is unique because it focuses on increasing the amount of time spent in bed to improve sleep duration, using tools like wearable sleep trackers and coaching. Unlike medications, this approach aims to naturally extend sleep time and improve alertness without the use of drugs.
12347Eligibility Criteria
This trial is for African American adults who are not very active, sleep less than 6 hours a night, and are overweight or obese. It's designed to see if improving sleep can help with weight and health issues. People with certain medical conditions that could affect the study may not be able to join.Inclusion Criteria
I am 21-75, overweight, sleep ≤6 hours, and identify as Black/African American.
I am 21-75, overweight, sleep ≤6 hours, and identify as Black/African American.
Exclusion Criteria
I have a chronic condition like COPD, heart rhythm problems, or stomach issues, am currently pregnant or recently had a baby, and have an infant at home.
I have a chronic condition like COPD, heart rhythm problems, or stomach issues, am currently pregnant or recently had a baby, and/or have an infant under 1 year old at home.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Formative Research and Community Engagement
Conduct in-depth qualitative interviews to understand sleep-related factors and discuss feedback on sleep intervention design
Not specified
Randomized Clinical Trial
Explore feasibility, satisfaction, and preliminary efficacy of a sleep intervention to increase sleep and physical activity among participants
10 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests whether a program aimed at helping participants sleep more (sleep extension intervention) can improve their health compared to regular check-ins without specific sleep advice (contact control intervention). The first phase gathers information, while the second phase tests the actual interventions.
2Treatment groups
Experimental Treatment
Active Control
Group I: sleep extension intervention armExperimental Treatment1 Intervention
sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to the sleep extension intervention.
Group II: education contact control armActive Control1 Intervention
sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to contact control intervention.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
A feasibility study to understand the components of behavioral sleep extension. [2023]The goal of this study was to examine the contribution of sleep extension intervention components (wearable sleep tracker and coaching) on sleep extension outcomes.
Benefits of Sleep Extension on Sustained Attention and Sleep Pressure Before and During Total Sleep Deprivation and Recovery. [2019]To investigate the effects of 6 nights of sleep extension on sustained attention and sleep pressure before and during total sleep deprivation and after a subsequent recovery sleep.
Sleep extension in sleepy and alert normals. [2019]Twenty-four healthy, young (21-35 years old) men with no complaints of daytime sleepiness, no habitual napping, and polysomnographically verified normal nocturnal sleep extended their time in bed (TIB) to 10 h for 6 consecutive nights to assess the effects of sleep extension on daytime sleepiness and performance. Twelve subjects had basal average daily sleep latencies of less than or equal to 6 min on the Multiple Sleep Latency Test and 12 had latencies of greater than or equal to 16 min before TIB was extended. The sleep extension improved daytime sleepiness differentially in the two groups. The degree of improvement was greater in the sleepy subjects than the alert subjects and the pattern of improvement differed between the groups. Sleepy subjects showed an immediate and uniform increase in alertness, while alert subjects did not show improvements until late in the extension. However, sleepy subjects never achieved the baseline level of sleepiness/alertness seen in the alert subjects.
Predictors of Intervention Interest Among Individuals With Short Sleep Duration. [2020]Over one-third of the United States population sleeps less than the recommended 7 hours a night, which increases risk for chronic diseases. The aim of this study was to evaluate the acceptability of sleep extension interventions and preferences in sleep extension interventions among adults with short sleep duration.
Behavioral interventions to extend sleep duration: A systematic review and meta-analysis. [2023]The goal of this study was to examine the effects of behavioral sleep extension interventions on sleep duration outcomes in children and adults ≥ age 12. We conducted a systematic literature review, article extraction and meta-analysis. Our search yielded 42 studies from 14 countries. The majority of studies (n = 19) enrolled adults, 10 studies enrolled college students, 13 enrolled children (high school or middle school aged). Results from the meta-analysis demonstrated behavioral sleep extension resulted in a significantly higher sleep duration as compared to control group or baseline, with pooled standardized mean difference (SMD) that was similar for both two-arm 0.80 (95 % CI 0.28 to 1.31; p < 0.01; I2 = 99.2%) and one-arm studies 0.75 (95% CI 0.39 to 1.11; p < 0.01; I2 = 86%), and there was significant heterogeneity among both study types. Subgroup analyses revealed that studies with direct interventions on sleep duration (i.e., specified the sleep schedule) had larger effects compared to indirect methods (coaching, educational approaches) and a greater number of curriculum components was associated with smaller effects. Results of this review demonstrate that sleep extension studies are effective at extending sleep in a variety of populations but improving the description of intervention methods and use of more rigorous study designs will improve the quality and reproducibility of this area of research.
Feasibility of sleep extension and its effect on cardiometabolic parameters in free-living settings: a systematic review and meta-analysis of experimental studies. [2022]Inadequate sleep is a global health issue and has been associated with an increased risk for cardiovascular diseases. As a part of sleep hygiene, intentional lengthening of night-time sleep duration (i.e. sleep extension) might be a behavioural intervention to improve cardiometabolic health. To examine the feasibility of sleep extension and its effects on cardiometabolic parameters in free-living settings.
A two-week sleep extension in sleepy normals. [2009]Thirty-four healthy, normal young men and women (21-35 years), with no sleep complaints and a normal screening polysomnogram, some with short ( or = 16-minute) average daily sleep latencies on a screening multiple sleep latency test, were studied on two baseline nights (8 hours) and in the "sleepy" group, for 14 consecutive nights of extended (10-hour) or habitual (7.8 +/- 0.7-hour) bedtimes. The screening differences between the groups in average daily sleep latency were consistently seen on the two further baseline nights and days. The extension of bedtime in sleepy subjects was followed by an increase in average daily sleep latency relative to randomly chosen sleepy subjects maintained on their habitual sleep schedule for the 14 nights. The increase in average daily sleep latency was associated with a gradual reduction in sleep efficiency over the 14 nights. Some (36%) of the sleepy subjects did not have increased average sleep latencies during the 10-hour bedtime extension. Those showing no increase in average daily sleep latency had an immediate drop in sleep efficiency when the bedtime was increased to 10 hours, suggesting they were unable to sleep longer during the extension. Their short average daily sleep latency was a result of causes other than chronic insufficient sleep.