Night Owl Sleep Study: The Effect of Sleep on Fecal Microbiota

Recruiting now · Not applicable

Conditions studied: Sleep

In brief

The goal of this clinical trial is to assess differences in the fecal microbiota and metabolome associated with insufficient and sufficient sleep, and to evaluate the response and recovery of the microbiota to changes in participant sleep profiles. Researchers will compare the effect of sleep intervention on both insufficient and sufficient sleepers to identify differences in fecal microbiota structure and function between cohorts during habitual sleep and during the sleep alteration intervention period.. Participants will be assigned to one of two cohorts based on their current sleep habits. Cohort 1 are participants who have insufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours more in bed per night. Cohort 2 are participants who have sufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours less in bed per night. The sleep intervention lasts for 14 days.

Key facts

Study ID

NCT07243574

Run by

Danisco

People needed

174

Starts

2025-09-17

Expected to finish

2027-02-01

Last updated by the study team

2026-08-07

Who can join

Age: 20 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men between 20 - 50 years of age and pre-menopausal women between 20 - 45 years of age (inclusive).
• Consistent schedule during daytime hours.
• BMI 18.5 - 35 kg/m2 (inclusive).
• Good physical and mental health as established by self-reported medical history.
• Willingness to maintain and record their general habits, eating, and activity/exercise pattern for the study period.
• Willingness to maintain and record the same time in bed they have during the workdays throughout the habitual workday sleep period.
• Able to alter sleeping time during the study intervention period as instructed.
• Willingness to maintain typical sleep hygiene patterns (e.g. sleep location, temperature, environment).
• 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.
• Completes all study procedures during the 14-day screening period to be eligible for the cohort specific criteria based on the sleep data collected during the screening period.
• Has regular bowel habits with bowel movements on at least 5 days a week.
• Pittsburgh Sleep Quality Index (PSQI) score ≤10. Note: If PSQI score is between 8 and 10, PI discretion needed to confirm eligibility based on self-report screening diaries and health \& lifestyle questionnaire.
• Cohort specific inclusion criteria:
• Cohort 1 (Insufficient Sleep)
• Participants must meet all general inclusion criteria PLUS:
• Sleep, on average, 5-7 hours per night on workdays, verified via participant self report during the screening period. Note: Oura ring data from the run-in period will be reviewed to confirm cohort based on PI/Sponsor discretion.
• Average KSS Score of 6-10 on workdays during the screening period. Note: Use standard rounding rules for averages with decimal places.
• Cohort 2 (Sufficient Sleep)
• Participants must meet all general inclusion criteria PLUS:
• Sleep, on average, 7-9 hours per night on workdays, verified via participant self-report during the screening period. Note: Oura ring data from the run-in period will be reviewed to confirm cohort based on PI/Sponsor discretion.
• Average KSS Score of 1-5 on workdays during screening period. Note: Use standard rounding rules for averages with decimal places.
• Exclusion:
• Any current diagnosed or self-reported sleep disorder, including but not limited to sleep apnea, habitual snoring (defined as loud, persistent snoring 3 or more nights per week), insomnia, narcolepsy, and parasomnias.
• Any current diagnosed or self-reported gastrointestinal disorder, including Crohn's disease, ulcerative colitis, celiac disease, IBS, or functional bowel disorder or chronic heart burn.

Where it is running

• Lindus Health — Boston, Massachusetts, United States (enrolling)
• Global Life Research Network — Miami, Florida, United States
• AccuMed — Garden City, New York, United States

Full record on ClinicalTrials.gov

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