The Short Sleep Study (NCT07567560) | Clinical Trial Compass
RecruitingNot Applicable
The Short Sleep Study
United States34 participantsStarted 2025-10-23
Plain-language summary
Natural Short Sleepers are defined as individuals who sleep fewer than 6 hours per night without any impact on health or daytime mental fatigue levels. Emerging evidence suggests that, in the general population, the gut microbiota would be negatively influenced by this sleep duration. It is possible that Natural Short Sleepers have a distinct gut microbiome. Identifying differences in microbiota composition may lead to an opportunity to improve health outcomes in those with inadequate or poor sleep.
Who can participate
Age range20 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Men between 20 - 50 years of age and pre-menopausal women between 20 - 45 years of age (inclusive).
✓. Consistent schedule during daytime hours.
✓. Body Mass Index (BMI) 18.5 - 35 kg/m2 (inclusive).
✓. Good physical and mental health as established by self-reported medical history and evaluated by a study investigator.
✓. Willingness to maintain and record their general habits, eating, and daily activity/exercise pattern for the study period.
✓. Willingness to maintain their current pattern of alcohol consumption for the duration of the study.
✓. Willing and able to participate fully in all aspects of the study and complete all study procedures, including providing signed informed consent.
Exclusion criteria
✕. Ever diagnosed with or self-reports a sleep disorder, including sleep apnea, habitual snoring (defined as loud, persistent snoring 3 or more nights per week), insomnia, narcolepsy, or parasomnias.
✕. Extreme chronotypes, those who regularly go to sleep prior to 8:00pm.
✕. Any current diagnosed or self-reported gastrointestinal disorder, including Crohn's disease, ulcerative colitis, celiac disease, IBS, or functional bowel disorder or chronic heartburn.
What they're measuring
1
Microbiome characterization of the short sleeper population
Timeframe: baseline through day 10 of the study period.
2
Comparison of natural short sleeper microbiomes to participants from the night owl study.
Timeframe: From baseline through day 10 of the study period.
✕. Regularly wakes up during the night 5 or more times per night for a cumulative amount of 30 minutes as observed via self-report during the screening period, per PI discretion.
✕. Currently taking medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.
✕. Have taken in the last 3 months medications (including over-the-counter medications) or dietary supplements that, in the investigator's opinion, may affect the participants' microbiome or sleep.
✕. Recent history (past year) of alcohol abuse or dependence. Defined as regularly drinking more than 12 drinks for females and more than 20 drinks for males per week and based on PI discretion.