Sleep Extension for Obesity

Overseen By Christopher M Depner, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

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

Disqualifiers: Sleep disorder, Diabetes, Heart disease, others

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

Compensation: Varies

Number of Visits: 1

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how increased sleep affects health factors such as insulin sensitivity and ceramides (a type of fat in the blood) in individuals who typically sleep less than 6.5 hours per night. Participants will be divided into two groups: one will increase their time in bed by 2 hours each night as part of the Sleep Extension Intervention, while the other will receive general health tips. Individuals who have slept less than 6.5 hours a night for the past six months and have a BMI (a measure of body fat based on height and weight) between 27.5 and 34.9 may qualify. As an unphased trial, this study provides a unique opportunity to contribute to understanding the broader health benefits of improved sleep.

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 prior data suggests that this sleep extension intervention is safe?

Research has shown that getting more sleep can safely address health issues like obesity and insulin resistance. In studies, participants who slept about an hour more each night did not report serious side effects. Instead, they often felt more energetic and experienced better heart health.

These findings suggest that spending more time in bed might be an easy way to improve health. So far, increasing sleep has not caused significant problems for participants. This method focuses on naturally increasing sleep, which appears to have positive effects without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the sleep extension intervention for obesity because it approaches weight management from a novel angle—sleep. While typical treatments for obesity focus on diet changes, exercise, or medications, this intervention aims to increase nightly sleep duration by two hours. By extending sleep, the treatment may help regulate metabolism and appetite hormones, potentially leading to weight loss without the need for dietary restrictions or increased physical activity. This approach could offer a simple, non-invasive strategy with fewer side effects compared to conventional obesity treatments.

What evidence suggests that sleep extension might be an effective treatment for obesity?

Research has shown that getting more sleep might help lower the risk of obesity. For every hour less of sleep each night, the risk of obesity increases by 9%. Studies suggest that more sleep could aid weight control in both children and adults. This trial includes an intervention group where participants will undergo a sleep extension-based intervention, focusing on increasing time in bed by 2 hours per night. When combined with lifestyle changes, improved sleep has also been shown to help manage obesity. Sleeping a couple of extra hours each night might positively affect weight and overall health. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Extension 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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

A 2-year weight reduction program for 33 obese patients with obstructive sleep apnea syndrome (OSAS) led to significant improvements in oxygen desaturation index (ODI), arousal index, and body mass index, indicating better respiratory function and reduced daytime sleepiness.

While the program had limited success in significantly reducing the apnea-hypopnea index (AHI), it still showed positive effects on quality of life and metabolic status, suggesting it can be a helpful adjunct treatment for motivated patients with OSAS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A two-year weight reduction program in obese sleep apnea patients. Nerfeldt, P., Nilsson, BY., Mayor, L., et al.[2021]

A 6-week sleep-extension program based on cognitive behavioral principles significantly increased total sleep time by an average of 79 minutes in overweight/obese men who were short sleepers, compared to just 6 minutes in the control group.

Participants in the sleep-extension group also showed improvements in metabolic health markers, including lower fasting insulin levels, reduced blood pressure, and improved insulin resistance, indicating that longer sleep durations can positively impact metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep extension and metabolic health in male overweight/obese short sleepers: A randomised controlled trial. Hartescu, I., Stensel, DJ., Thackray, AE., et al.[2022]

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]

Sleep extension interventions, lasting from 3 days to 6 weeks, successfully increased total sleep time by 21 to 177 minutes in a combined sample of 138 participants, primarily short-sleeping adults.

These interventions were linked to improved insulin sensitivity and reduced appetite, suggesting that increasing sleep duration may help lower cardiometabolic risks in individuals with short sleep patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of sleep extension on cardiometabolic risk factors: A systematic review. Henst, RHP., Pienaar, PR., Roden, LC., et al.[2020]

A sleep extension intervention increased sleep duration by about 1.2 hours per night in adults with overweight, leading to a significant reduction in daily energy intake by approximately 270 kcal compared to a control group.

The study suggests that improving sleep duration can help create a negative energy balance, which may be beneficial for obesity prevention and weight loss, highlighting the importance of sleep in managing body weight.

NCBI (Pubmed)

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. Tasali, E., Wroblewski, K., Kahn, E., et al.[2022]

In a 12-week trial involving 49 overweight or obese adults, those who received a combined weight management and sleep intervention (better weight-better sleep) lost weight faster compared to those who only received weight management support.

Participants in the combined intervention group also showed improved coping self-efficacy, suggesting that integrating sleep management with dietary and exercise interventions may enhance overall effectiveness in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The better weight-better sleep study: a pilot intervention in primary care. Logue, EE., Bourguet, CC., Palmieri, PA., et al.[2018]

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]

A one-year study involving 72 patients (36 in the test group and 36 in the control group) demonstrated that increasing nutritional awareness and providing customized dietary changes significantly improved snoring severity and daytime sleepiness in obese snorers and mildly sleep apnoeic patients.

The test group showed highly significant improvements in quality of life measures after 6 and 12 months, while the control group did not show any significant changes, highlighting the effectiveness of dietary intervention in managing sleep-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of lifestyle modifications on snoring and mild sleep apnoea patients. Sahni, N., Arora, K., Bansal, S., 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8140617/

Sleep Extension: A potential target for obesity treatment Sleep extension has the potential to attenuate obesity risk and cardiometabolic dysfunction. There is tremendous opportunity for future research.

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

Effect of Sleep Extension on Objectively Assessed Energy ... Another meta-analysis of prospective cohort studies found that the risk of obesity increased by 9% for each 1-hour decrease in sleep duration.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3120054/

Treatment of obesity with extension of sleep duration This proof-of-concept study on a randomized sample will assess whether sleep extension is feasible and whether it influences BMI.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079221001179

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.

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-17708-6

a systematic review and meta-analysis | BMC Public Health This systematic review examines the efficacy of sleep interventions alone or as a part of lifestyle interventions for the management of overweight or obesity ...

6. 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 ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07658-6

a randomized controlled study of a behavioral sleep extension ... 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 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03814512

Improving Insulin Resistance and Energy Metabolism ... The investigators propose to deliver a 4-week sleep extension intervention to adolescents to evaluate feasibility of the protocol and obtain preliminary data on ...