← Back to Search

Aspirin for Sleep Deprivation-Related Inflammation

Phase < 1
Waitlist Available
Led By Monika Haack, PhD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women and men between the ages 18-65 years
Be older than 18 years old
Must not have
Active infection/disease
Regular medication use other than oral contraceptives
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to sleep restriction, single measure in the morning

Summary

This trial is testing if a small amount of aspirin can reduce inflammation caused by irregular sleep patterns in healthy adults. The study focuses on people who restrict sleep for several days and then catch up later. Aspirin helps the body produce substances that turn off inflammation, which might be disrupted by these sleep patterns.

Who is the study for?
Adults aged 18-65 with a regular sleep pattern of 7-9 hours, starting around 11:00pm, and no significant pre-menstrual discomfort can join. They must not have asthma, high blood pressure, gastrointestinal issues, stroke history, NSAID allergies or intolerance, certain sleep disorders, be pregnant/nursing or taking specific supplements. A clean toxicology screen and BMI between 18.5-35 are required.
What is being tested?
The trial is testing if aspirin can help manage inflammation caused by disrupted sleep patterns like those from restricted weeknight sleep with weekend catch-up. Participants will either receive aspirin or a placebo to see if it affects inflammatory resolution pathways after such irregular sleep.
What are the potential side effects?
Aspirin may cause side effects including digestive system irritation (like stomach pain), increased bleeding risk due to its blood-thinning effect, allergic reactions in some people sensitive to NSAIDs and possibly other mild symptoms like nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any active infections or diseases.
Select...
I take medications regularly, but not oral contraceptives.
Select...
I have had stomach or esophagus problems, like ulcers or bleeding.
Select...
I or my close family member have had a stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to sleep restriction, single measure in the morning
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to sleep restriction, single measure in the morning for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Inflammatory Resolution Markers
Secondary study objectives
Inflammatory Markers

Trial Design

3Treatment groups
Experimental Treatment
Group I: Sleep Restriction/Non-Active PlaceboExperimental Treatment1 Intervention
Daily intake of pill at bedtime over 2-week period prior to and during the 11-day in-hospital stay
Group II: Sleep Restriction/81mg Aspirin PillExperimental Treatment1 Intervention
Daily intake of pill at bedtime over 2-week period prior to and during the 11-day in-hospital stay
Group III: Control Sleep/Non-Active Placebo or 81mg Aspirin PillExperimental Treatment2 Interventions
Daily intake of pill at bedtime over 2-week period prior to and during the 11-day in-hospital stay
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aspirin
2014
Completed Phase 4
~55580
Placebo
1995
Completed Phase 3
~2670

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for inflammation often target the reduction of pro-inflammatory signals and the enhancement of the body's natural resolution pathways. Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit cyclooxygenase enzymes (COX-1 and COX-2), reducing the production of prostaglandins that promote inflammation. Corticosteroids suppress multiple inflammatory genes by binding to glucocorticoid receptors, thereby reducing the production of inflammatory cytokines. Enhancing the body's natural production of endogenous inflammatory resolution mediators, such as lipoxins, resolvins, and protectins, is a novel approach that aims to actively resolve inflammation rather than merely suppress it. This matters for patients because it can potentially lead to more effective and sustained resolution of inflammation, reducing the risk of chronic inflammatory conditions and associated tissue damage.

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
861 Previous Clinical Trials
12,932,760 Total Patients Enrolled
9 Trials studying Inflammation
5,717 Patients Enrolled for Inflammation
Monika Haack, PhDPrincipal Investigator - Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
3 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT03377543 — Phase < 1
Inflammation Research Study Groups: Control Sleep/Non-Active Placebo or 81mg Aspirin Pill, Sleep Restriction/81mg Aspirin Pill, Sleep Restriction/Non-Active Placebo
Inflammation Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT03377543 — Phase < 1
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT03377543 — Phase < 1
~9 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top