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

Part of paid clinical trials in Miami, Florida.

Sponsor
Danisco
Study ID
NCT07243574
Status
Recruiting
Apply to this trial

Conditions

  • Sleep

Eligibility Criteria

Sex
ALL
Age
20 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Increase sleep by 90 minutes — BEHAVIORAL
    For 14 days, participants will increase their nightly sleep by 90 minutes.
  • Decrease sleep by 90 minutes — BEHAVIORAL
    For 14 days, participants will decrease their nightly sleep by 90 minutes.

Study Details

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 Dates

Start date
Sep 17, 2025
Status verified
Nov 2025
Primary completion
May 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
174 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Cohort 1
    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.
  • Active Comparator: Cohort 2
    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.

Primary Outcome Measure

Differences in the fecal microbiota of individuals with sufficient and insufficient sleep. [ Time Frame: From Day 1 to Day 28 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Global Life Research NetworkMiamiFlorida33155
Emily Lozano
[email protected]
(786) 558-8892
Lindus HealthBostonMassachusetts02111
Patient Recruitment Coordinator
[email protected]
833-711-1429
Peter Polos, MD, PhD (PRINCIPAL_INVESTIGATOR)
AccuMedGarden CityNew York11530
Leanne Cossu
[email protected]
516-746-2190

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By research site
Global Life Research Network· Miami, FLLindus Health· Boston, MAAccuMed· Garden City, NY

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