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

Conditions: Poor Sleep Quality, Gut Microbiome, Gut Health, Inflammation, Circadian Rhythm, Circadian Clocks, Gut Microbiota, Women's Health, Gut-Brain Axis, Blood Pressure, Systemic Inflammatory Response

Sex: All

Ages: 45 Years – N/A

Healthy volunteers: Yes

Phase: NA

Enrollment: 100

Sponsor: Eight Sleep Inc.

Summary

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.

Eligibility Criteria

Inclusion Criteria: All Cohorts * 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 * 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 Weight ≥ 88 lbs * No MRI scheduled during the study period or within 1 week after study conclusion * No acute illness, injury, or dental procedure/cleaning within 3 months prior to study start * Non-smoker or previous infrequent (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07848594). StuddyBuddy aggregates publicly available trial information.