Clinical Trial

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

Recruiting
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Summary
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-05 -> 2026-11 2026-08-08
minor Completion pushed: 2026-07 -> 2027-02 2026-08-08
Trial Details
NCT Number NCT07243574
Lead Sponsor Danisco
Conditions Sleep
Enrollment 174 participants
Start Date 2025-09-17
Primary Completion 2026-11 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-07