Sleep Extension for Sleep Deprivation

Overseen By Rachel Price, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Minnesota

Disqualifiers: Organ disorders, Pregnancy, Infant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 3 4 5 6}

How 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. ^{1 2 3 4 7}

Research Team

Ivan Wu, PhD

Principal Investigator

University of Minnesota

Eligibility 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.

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

Treatment Details

Interventions

• Contact Control Intervention
• Sleep Extension Intervention

Trial Overview 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.

Participant Groups

Group I: sleep extension intervention arm Experimental Treatment 1 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 arm Active Control 1 Intervention

sedentary and short sleep (=\<6 hrs/night) African American adults with overweight/obesity randomized to contact control intervention.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

In a study of 38 adults with sleep duration less than 7 hours, the combination of a Fitbit and coaching showed potential for improving sleep duration, although the results were not statistically significant compared to a self-management control group.

Coaching alone led to significant improvements in sleep-related impairment, highlighting that while all interventions were feasible and acceptable, the added accountability from coaching may enhance the effectiveness of sleep extension strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study to understand the components of behavioral sleep extension. Baron, KG., Trela-Hoskins, SR., Duffecy, J., et al.[2023]

Extending sleep to nearly 10 hours for 6 nights significantly improves sustained attention and reduces sleep pressure in healthy men, as shown by better performance on psychomotor vigilance tasks and longer sleep latencies.

These benefits not only help during periods of total sleep deprivation but also persist after a single night of recovery sleep, indicating that sleep extension can have lasting positive effects on cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Sleep Extension on Sustained Attention and Sleep Pressure Before and During Total Sleep Deprivation and Recovery. Arnal, PJ., Sauvet, F., Leger, D., et al.[2019]

Extending sleep time to 10 hours for 6 nights significantly improved daytime alertness, especially in individuals who initially had shorter sleep latencies (less than or equal to 6 minutes).

The improvement in alertness was immediate and consistent for the sleepier group, while those who were already alert did not show benefits until later in the sleep extension period, indicating that the effects of sleep extension can vary based on baseline sleepiness levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep extension in sleepy and alert normals. Roehrs, T., Timms, V., Zwyghuizen-Doorenbos, A., et al.[2019]

A study involving 92 adults with short sleep duration (average of 5:49 hours) found that 84% of participants were interested in interventions to increase their sleep, particularly using wrist-worn devices.

Participants with sleep disorders, such as insomnia, showed a higher interest in sleep extension interventions, indicating that wearable technology could be a promising solution for those struggling with sleep issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Intervention Interest Among Individuals With Short Sleep Duration. Adkins, EC., DeYonker, O., Duffecy, J., et al.[2020]

Behavioral sleep extension interventions significantly increase sleep duration in both children and adults aged 12 and older, with a pooled effect size indicating substantial improvement compared to control groups.

Direct interventions that specify sleep schedules are more effective than indirect methods like coaching, suggesting that clearer and more structured approaches to sleep extension yield better results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral interventions to extend sleep duration: A systematic review and meta-analysis. Baron, KG., Duffecy, J., Reutrakul, S., et al.[2023]

Sleep extension is a feasible intervention that can increase total sleep time by an average of 51 minutes, which may help improve sleep hygiene in free-living adults.

In individuals with pre-hypertension or Stage 1 hypertension, sleep extension significantly reduced both systolic and diastolic blood pressure, suggesting potential cardiovascular benefits for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of sleep extension and its effect on cardiometabolic parameters in free-living settings: a systematic review and meta-analysis of experimental studies. Zhu, B., Yin, Y., Shi, C., et al.[2022]

In a study of 34 healthy young adults, extending bedtime from a habitual 7.8 hours to 10 hours led to increased average daily sleep latency in those who were initially 'sleepy', indicating improved sleepiness levels.

However, 36% of the sleepy participants did not experience increased sleep latencies with the extended bedtime, suggesting that their short sleep latencies were due to factors other than chronic sleep deprivation, as they showed decreased sleep efficiency instead.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A two-week sleep extension in sleepy normals. Roehrs, T., Shore, E., Papineau, K., et al.[2009]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A feasibility study to understand the components of behavioral sleep extension. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Benefits of Sleep Extension on Sustained Attention and Sleep Pressure Before and During Total Sleep Deprivation and Recovery. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Sleep extension in sleepy and alert normals. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Predictors of Intervention Interest Among Individuals With Short Sleep Duration. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Behavioral interventions to extend sleep duration: A systematic review and meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Feasibility of sleep extension and its effect on cardiometabolic parameters in free-living settings: a systematic review and meta-analysis of experimental studies. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A two-week sleep extension in sleepy normals. [2009]