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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether extending sleep can reduce health issues related to obesity among African American adults. Participants will either follow a new sleep extension plan (Sleep Extension Intervention) or receive educational support. The goal is to determine if more sleep can boost physical activity and improve health markers linked to obesity and cancer. Suitable candidates are African American adults who are overweight, sleep six or fewer hours per night, and have low activity levels. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to explore this innovative approach.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that getting more sleep can be safe and manageable. For example, one study found that people who slept more did not experience any serious negative effects. Instead, they benefited by sleeping longer and eating less, which helped them lose weight. Another study found that people added about 72 minutes of sleep each night without major safety issues. These findings suggest that the sleep extension treatment under study should be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Sleep Extension Intervention because it targets sleep deprivation by extending sleep duration, which is a novel approach compared to standard treatments like sleep medications or cognitive behavioral therapy. Unlike these traditional methods, which often focus on improving sleep quality or managing insomnia symptoms, the Sleep Extension Intervention aims to directly increase the total amount of sleep, potentially addressing the root cause of sleep deprivation. This approach could be particularly beneficial for sedentary and short-sleep African American adults with overweight or obesity, a group that might not respond as well to typical interventions.

What evidence suggests that this trial's treatments could be effective for reducing obesity-related health disparities?

This trial will compare two approaches: a Sleep Extension Intervention and a Contact Control Intervention. Research has shown that increasing sleep can extend sleep time for both children and adults. Studies have found that these methods not only lengthen sleep duration but also enhance other health aspects, such as lowering blood pressure. One study found that more sleep reduced food intake, potentially aiding overweight adults in losing weight. Another study demonstrated that individuals who typically sleep less than 7 hours a night can increase their sleep duration. Overall, these findings suggest that more sleep can be a healthy change that enhances well-being. ^{1 2 3 6 7}

Who Is on the Research Team?

Ivan Wu, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10476177/

Behavioral interventions to extend sleep duration 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.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079223000631

Interventions to increase sleep duration in young people The findings indicate that behavioral and combination interventions were consistently effective in increasing sleep duration in healthy young people.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10566182/

a randomized controlled study of a behavioral sleep ... The objective of this study is to test the effects of a behavioral sleep extension intervention on sleep duration, blood pressure, and other measures of ...

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2788694

Effect of Sleep Extension on Objectively Assessed Energy ... This trial found that sleep extension reduced energy intake and resulted in a negative energy balance in real-life settings among adults with overweight.

5. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(22)02761-7/fulltext

Sleep extension is a feasible lifestyle intervention in free-living ... We assessed the feasibility of a personalized sleep extension protocol in adults aged 18–64 y who are habitually short sleepers (5 to <7 h), ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S003306202500074X

A social ecological perspective on interventions to address ... Few existing interventions have a primary aim to increase sleep duration in individuals with insufficient sleep, and none specifically target individuals ...

7. academic.oup.com academic.oup.com/sleep/article/47/5/zsae016/7577643

Waking up to sleep extension for cardiometabolic health The increase in total sleep time, the primary study outcome, achieved with the sleep extension intervention was about 72 minutes. There were ...