Sleep Extension for Obesity

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Utah

Must not be taking: Sleep aids, Glucose drugs, Anticoagulants

Disqualifiers: Sleep disorder, Diabetes, Heart disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

If you are taking prescription drugs or substances that affect sleep or blood sugar levels, or if you are on blood thinners, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Sleep Extension Intervention for obesity?

Research shows that extending sleep can improve metabolic health in overweight or obese individuals, such as lowering fasting insulin levels and blood pressure. A study found that a sleep-extension program increased sleep duration and improved markers of metabolic health in male short sleepers at risk of type 2 diabetes. ^{1 2 3 4 5}

Is sleep extension safe for humans?

Research on sleep extension, which involves intentionally increasing sleep duration, suggests it is generally safe for humans. It has been studied as a way to improve health outcomes, such as reducing the risk of heart disease, without significant safety concerns reported. ^{1 2 6 7 8}

How does the Sleep Extension Intervention treatment differ from other treatments for obesity?

The Sleep Extension Intervention is unique because it focuses on increasing sleep duration to improve metabolic health and reduce obesity risk, unlike traditional treatments that often emphasize diet and exercise. This approach leverages the relationship between sleep and metabolic processes, potentially improving insulin sensitivity and reducing appetite-related hormones. ^{1 2 3 7 9}

Research Team

Eligibility Criteria

This trial is for people who are overweight or obese, sleep less than 6.5 hours a night, and may have issues with insulin sensitivity. It's not suitable for individuals with certain allergies, eating disorders, or other conditions that could interfere with the study.

Inclusion Criteria

I am between 18 and 45 years old.

Sleep Habits: habitual self-reported average total sleep time (TST) <6.5 hours per night for prior 6 months

Body mass index (BMI): 25.0-34.9 kg/m2

Exclusion Criteria

Currently smoking

Alcohol intake>14 drinks per week or >3 drinks per day

I have been diagnosed with a sleep disorder or major psychiatric illness.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 overnight visit (in-person)

Baseline

Participants undergo a ~1-week ambulatory real-world monitoring segment

1 week

Ambulatory monitoring

Intervention

Participants are randomized to either sleep extension or control group for 8 weeks at home

8 weeks

Daily monitoring with actiwatch and sleep log

Follow-up

Participants complete rigorous overnight laboratory visits to assess plasma ceramides and insulin sensitivity

Immediately after intervention

Overnight laboratory visits

Treatment Details

Interventions

• Sleep Extension Intervention (Behavioral Intervention)

Trial Overview The study tests if sleeping more (2 extra hours per night) can change blood levels of ceramides (fats) and improve how the body uses insulin compared to just getting healthy lifestyle advice without added sleep.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

Sleep extension-based intervention focused on increasing time in bed by 2 hours per night.

Group II: Control Group Active Control 1 Intervention

Provided with general health information on diet and physical activity.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Findings from Research

Sleep extension has the potential to improve health outcomes related to obesity, such as glycemic control and blood pressure, based on preliminary findings from studies on habitually short sleepers.

While there are challenges in implementing sleep extension interventions, they may help mitigate the health risks associated with short sleep and obesity, indicating a need for further research to optimize these strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Extension: A Potential Target for Obesity Treatment. Hoddy, KK., Potts, KS., Bazzano, LA., et al.[2021]

In a study of 13,030 participants over four years, sleep problems were linked to a higher risk of significant weight gain (11% increase) and waist size gain (19% increase), even after adjusting for various factors like age, sex, and lifestyle.

However, when accounting for common mental disorders, the associations between sleep problems and weight or waist size gain were no longer significant, suggesting that mental health may play a crucial role in this relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep problems and their association with weight and waist gain - The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil). Camargo, TR., Luft, VC., Duncan, BB., et al.[2021]

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]

References

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

Sleep Extension: A Potential Target for Obesity Treatment. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The better weight-better sleep study: a pilot intervention in primary care. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Sleep extension and metabolic health in male overweight/obese short sleepers: A randomised controlled trial. [2022]

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

A two-year weight reduction program in obese sleep apnea patients. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Sleep problems and their association with weight and waist gain - The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil). [2021]

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

Impact of lifestyle modifications on snoring and mild sleep apnoea patients. [2021]

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

Effect of Sleep Extension on Objectively Assessed Energy Intake Among Adults With Overweight in Real-life Settings: A Randomized Clinical Trial. [2022]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

The effects of sleep extension on cardiometabolic risk factors: A systematic review. [2020]