Sleep Restriction's Impact on Microbiota and Health

Overseen By Laura Hammel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Breastfeeding, others

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

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sleep patterns affect the body's microbiota, which might influence health and disease risks. Researchers are testing whether changes in sleep, such as sleep restriction (also known as Sleep Restriction Therapy or Sleep Compression) or maintaining normal sleep, can impact these microorganisms. Participants will either have their sleep restricted or maintain normal sleep, and some may also join a group examining weight gain. Individuals already part of ongoing approved studies are eligible to participate. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on the connection between sleep and microbiota.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research shows that short-term sleep restriction is generally safe for people. Studies have found that the gut microbiome, the collection of tiny organisms in the intestines, doesn't change much during brief sleep loss. This suggests that short-term sleep restriction might not cause significant harm.

However, some animal studies have raised concerns. For instance, in rats, long-term sleep loss increased substances that cause inflammation. These effects, however, haven't been observed in humans over short periods.

The situation differs with weight gain. Some studies link weight gain to changes in gut bacteria, which have been associated with obesity and potential health problems over time. The direct impact of intentional weight gain on gut health remains unclear.

In summary, short-term sleep restriction appears safe based on human studies, while the effects of weight gain on gut health are still under investigation. Participants should consider these findings when deciding whether to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring sleep restriction as a potential method to study its impact on gut microbiota and overall health. Unlike traditional treatments for sleep-related conditions, which often involve medication or behavioral therapy, this approach focuses on altering sleep patterns to observe biological responses. By examining how sleep restriction affects the microbiome, scientists hope to uncover new insights into the relationship between sleep and health, potentially leading to innovative strategies for improving well-being. This trial could reveal groundbreaking connections that aren't addressed by existing treatments.

What evidence suggests that this trial's treatments could be effective?

This trial will compare the effects of sleep restriction and weight gain on gut health. Research has shown that short-term sleep deprivation can reduce the variety of gut bacteria in healthy young men, potentially affecting overall health. Sleep and gut bacteria are closely linked, indicating that changes in sleep patterns could impact gut health and possibly disease risk.

Regarding weight gain, studies indicate that gut bacteria play a significant role in obesity. Individuals with obesity often have different gut bacteria, which can influence weight gain. These findings suggest that altering gut bacteria might help manage weight.

Both sleep patterns and weight changes, as studied in the different arms of this trial, could potentially affect gut health and overall wellness. ^{1 3 4 5 6}

Who Is on the Research Team?

Virend Somers, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who are part of ongoing IRB-approved studies, focusing on how sleep affects the body's microorganisms. Pregnant or breastfeeding women are not eligible to participate.

Inclusion Criteria

Only subjects who are eligible for ongoing IRB-approved studies will be deemed eligible for this protocol.

Exclusion Criteria

Pregnant or breast-feeding women

Subjects who are ineligible for ongoing IRB-approved studies will not be included in this protocol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sleep Restriction

Participants undergo sleep restriction to study its effects on human microbiota

4 weeks

Normal Sleep

Participants maintain normal sleep patterns to serve as a control group

4 weeks

Weight Gain

Participants experience weight gain to study its effects on human microbiota

4 weeks

Follow-up

Participants are monitored for changes in microbiota and health outcomes after interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep restriction
• Weight gain

Trial Overview The study examines if and how sleep patterns influence human microbiota, which could potentially affect health and predict diseases. It involves observing weight changes and imposing sleep restrictions on participants.

How Is the Trial Designed?

Group I: weight gain Experimental Treatment 1 Intervention

Weight gain

Group II: sleep restriction Experimental Treatment 1 Intervention

Sleep restriction

Group III: normal sleep Active Control 1 Intervention

Normal sleep

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11260001/

Gut microbiota and sleep: Interaction mechanisms and ... Sleep is crucial for wellness, and emerging research reveals a profound connection to gut microbiota. This review explores the bidirectional relationship ...

2. withpower.com withpower.com/trial/phase-9-2015-a0033

Sleep Restriction's Impact on Microbiota and Health Research shows that short-term sleep restriction can reduce the variety of gut bacteria in healthy young men but does not significantly change the overall gut ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02743338

CompRest - a Comparison Between Sleep Compression ... Sleep compression includes gradually compressing bed time over several weeks to approach sleep time as registered during the first week of treatment, and ...

4. 2minutemedicine.com 2minutemedicine.com/nurse-delivered-sleep-restriction-therapy-effective-for-treatment-of-chronic-insomnia/

Nurse-delivered sleep restriction therapy effective for ... The primary outcome of self-reported insomnia severity at 6 months was significantly lower in the sleep restriction therapy group compared to ...

5. journalslibrary.nihr.ac.uk journalslibrary.nihr.ac.uk/hta/RJYT4275

Nurse-delivered sleep restriction therapy to improve ... Brief nurse-delivered sleep restriction therapy in primary care is clinically effective for insomnia disorder, safe, and likely to be cost- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9816096/

Severe, short-term sleep restriction reduces gut microbiota ... This study aimed to determine the effects of severe, short-term sleep restriction on gut microbiota composition and intestinal permeability in healthy adults.