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RecruitingPoor Sleep QualityGut MicrobiomeGut Health

The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.

Eligible age

45+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

This study examines whether two continuous weeks of overnight active temperature regulation (via the Eight Sleep Pod) use affects gut microbiome composition, inflammation, and the body's daily temperature and blood pressure rhythms in postmenopausal women and age-matched men with self-reported poor sleep.

Sponsor: Eight Sleep Inc.

You may qualify if…

  • ✓ All of the following criteria, assessed via the Recruitment Survey and Health History Survey, must be met for an individual to be eligible to participate. Initially eligible individuals will complete a post-enrollment blood panel to confirm hsCRP values. The hsCRP value from the blood panel will influence the final inclusion decision on a case-by-case basis.
  • ✓ General \& Demographic
  • ✓ 45 years of age or older
  • ✓ Self-reported poor sleep quality: PSQI score greater than 5
  • ✓ Within 1.5 hours driving of the Greater Boston area
  • ✓ Have never used an Eight Sleep Pod (or similar device) ever
  • ✓ Health, Physiological, \& Logistics
  • ✓ Post-enrollment hsCRP ≤ 10 µg/mL at Preparation Period blood panel. If Preparation Period hsCRP \> 10 µg/mL: triggers clinical review on a case by case basis; hard exclusion applies only at \> 30 µg/mL

You may not qualify if…

  • ✕ 1.1 Study Equipment Compatibility
  • ✕ Unable or unwilling to swallow a standard-sized capsule (required for internal core temperature monitoring capsule)
  • ✕ Currently using a pacemaker or other electromagnetic medical implant (contraindicated with core temperature capsule)
  • ✕ MRI scheduled during the study period or within 1 week after study conclusion
  • ✕ Have or may have a CT scan planned during the study period
  • ✕ Allergic to nickel or aluminum
  • ✕ 1.2 Sample and Data Collection
  • ✕ Unable or unwilling to

Where it's recruiting

Massachusetts

Newton Center

Source: ClinicalTrials.gov · NCT07848594 · last updated 2026-10-26