Actively Recruiting
Night Owl Sleep Study: The Effect of Sleep on Fecal Microbiota
Led by Danisco · Updated on 2026-04-23
174
Participants Needed
3
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Night Owl Sleep Study: The Effect of Sleep on Fecal Microbiota
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men between 20 and 50 years old and pre-menopausal women between 20 and 45 years old
- Consistent schedule during daytime hours
- Body mass index (BMI) between 18.5 and 35 kg/m2
- Good physical and mental health based on self-reported medical history
- Willingness to maintain and record usual habits, eating, and exercise patterns during the study
- Willingness to maintain and record habitual workday time in bed during the screening period
- Able to change sleeping time as instructed during the intervention
- Willingness to maintain typical sleep hygiene (sleep location, temperature, environment)
- Willingness to keep current alcohol consumption pattern during the study
- Willing and able to complete all study procedures and provide signed informed consent
- Completion of all study procedures during the 14-day screening period
- Regular bowel habits with bowel movements at least 5 days per week
- Pittsburgh Sleep Quality Index (PSQI) score of 10 or less, with additional review if score is between 8 and 10
- Cohort 1 (Insufficient Sleep): average 5-7 hours sleep on workdays and average KSS score 6-10 during screening
- Cohort 2 (Sufficient Sleep): average 7-9 hours sleep on workdays and average KSS score 1-5 during screening
You will not qualify if you...
- Any diagnosed or self-reported sleep disorder including sleep apnea, habitual snoring, insomnia, narcolepsy, or parasomnias
- Any diagnosed or self-reported gastrointestinal disorder such as Crohn's disease, ulcerative colitis, celiac disease, IBS, functional bowel disorder, or chronic heartburn
- Regularly waking 5 or more times per night for a total of 30 minutes or more during screening
- Taking medications or dietary supplements that may affect microbiome or sleep currently or within the past 3 months
- Neurodegenerative diseases including multiple sclerosis, Parkinson's disease, Alzheimer's disease, or dementia
- Recent smoking, vaping, or nicotine use within the past month
- History of alcohol abuse or dependence in the past year
- Drug abuse or dependence including recreational marijuana use
- Binge drinking 4+ drinks for women or 5+ drinks for men on 2 or more occasions in the past month
- Diagnosed neuropsychiatric disorders or symptoms affecting sleep such as anxiety, depression, bipolar disorder, or schizophrenia
- Use of systemic antibiotics in past 3 months; topical antibiotics allowed
- Use of probiotic supplements or proton pump inhibitors in past 2 weeks
- Pregnant, breastfeeding, or planning pregnancy
- Personal life stress or sleep challenges causing disruption
- Planned overnight or cross-time zone travel during study
- Females with perimenopausal or menopausal symptoms or diagnosis
- Conditions or symptoms disrupting sleep such as hyperthyroidism, restless legs, night sweats, or allergic rhinitis
- Extreme chronotypes with very early or late sleep times for respective cohorts
- Shift workers or varying work schedules with overnight shifts
- Any other medical or personal condition that may bias or confound results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Global Life Research Network
Miami, Florida, United States, 33155
Not Yet Recruiting
2
Lindus Health
Boston, Massachusetts, United States, 02111
Actively Recruiting
3
AccuMed
Garden City, New York, United States, 11530
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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