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Sleep and Inflammatory Resolution Pathway

NCT03377543 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-03-24

No results posted yet for this study

Summary

Goal of this project is to investigate whether increases in inflammation that result from common patterns of restricting sleep on week nights and catching up on sleep over the weekend are caused by disruption in the newly discovered inflammatory resolution pathways. These pathways are crucial in the active termination of the inflammatory response, and their disruption may contribute to ongoing unresolved inflammation, which has been observed not only during periods of sleep restriction, but also after recovery sleep has been obtained. If the hypothesis is true, it is possible that increasing the body's natural production of endogenous, inflammatory resolution mediators may provide a non-behavioral strategy to limit the inflammatory consequences in those undergoing periods of sleep restriction with intermittent recovery sleep.

Conditions

  • Inflammatory Response
  • Inflammation
  • Sleep
  • Sleep Restriction

Interventions

DRUG

Aspirin

81mg aspirin pill daily at bedtime over a 25 day period

DRUG

Placebo

81mg non-active pill that looks like aspirin

Sponsors & Collaborators

Principal Investigators

  • Monika Haack, PhD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-06
Primary Completion
2025-12-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03377543 on ClinicalTrials.gov