Aspirin for Sleep Deprivation-Related Inflammation

Overseen By Jennifer Scott-Sutherland, M.S.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: NSAIDs, Cold/cough remedies

Disqualifiers: Diabetes, Hypertension, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking regular medications, except for oral contraceptives, to participate in this trial. Additionally, you should not have taken NSAIDs or cold/cough remedies in the last month, or dietary supplements with DHA/EPA-derived fatty acids in the last three months.

Is aspirin effective in reducing inflammation related to sleep deprivation?

The research suggests that sleep deprivation can have complex effects on inflammation, sometimes reducing certain inflammatory markers. While aspirin is known for its anti-inflammatory properties, the studies provided do not directly address its effectiveness for sleep deprivation-related inflammation. ^{1 2 3 4 5}

Is aspirin generally safe for humans?

Aspirin is generally safe for humans, but it can disrupt sleep by increasing awakenings and reducing sleep efficiency. It may also lower body temperature slightly and suppress melatonin, which could affect sleep patterns. ^{6 7 8 9 10}

How does the placebo treatment for sleep deprivation-related inflammation differ from other treatments?

The placebo treatment, often used as a control in clinical trials, does not contain active ingredients and is used to compare the effects of the actual drug being tested. Unlike active treatments, it does not directly address inflammation or sleep deprivation but helps researchers understand the true effects of the drug being studied. ^{1 3 4 11 12}

Research Team

Monika Haack, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

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.

Inclusion Criteria

Body mass index (BMI) between 18.5 and 35 kg/m2

For female participants: No significant discomfort during pre-menses/menses

Daily sleep duration between 7-9 hours, verified by electronic sleep diary data for two weeks

Exclusion Criteria

I take medications regularly, but not oral contraceptives.

I haven't taken fish oil or similar supplements in the last 3 months.

I haven't taken NSAIDs or cold/cough medicine in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment

Participants take a daily pill (placebo or 81mg aspirin) at bedtime over a 2-week period prior to the in-hospital stay

2 weeks

In-hospital Treatment

Participants undergo three 11-day in-hospital stays with control sleep or sleep restriction-recovery patterns, combined with continued daily pill intake

11 days per stay

Follow-up

Participants are monitored for changes in inflammatory markers after treatment

4 weeks

Treatment Details

Interventions

• Aspirin
• Placebo

Trial Overview 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.

Participant Groups

Group I: Sleep Restriction/Non-Active Placebo Experimental Treatment 1 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 Pill Experimental Treatment 1 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 Pill Experimental Treatment 2 Interventions

Daily intake of pill at bedtime over 2-week period prior to and during the 11-day in-hospital stay

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Differential effects of an experimental model of prolonged sleep disturbance on inflammation in healthy females and males. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Normative variation in self-reported sleep quality and sleep debt is associated with stimulated pro-inflammatory cytokine production. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Sleep deprivation attenuates inflammatory responses and ischemic cell death. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Childhood adversity is associated with heightened inflammation after sleep loss. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The dual effect of paradoxical sleep deprivation on murine immune functions. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Nonsteroidal anti-inflammatory drugs affect normal sleep patterns in humans. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Aspirin and nonfebrile waking oral temperature in healthy men and women: links with SWS changes? [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Sleep deprivation in the rat: XVII. Effect of aspirin on elevated body temperature. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Nonsteroidal anti-inflammatory drugs alter body temperature and suppress melatonin in humans. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Salicylates and sulfasalazine, but not glucocorticoids, inhibit leukocyte accumulation by an adenosine-dependent mechanism that is independent of inhibition of prostaglandin synthesis and p105 of NFkappaB. [2019]

11. Ireland pubmed.ncbi.nlm.nih.gov

Novel environment influences the effect of paradoxical sleep deprivation upon brain and peripheral cytokine gene expression. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Immunization with a heat-killed bacterium, Mycobacterium vaccae NCTC 11659, prevents the development of cortical hyperarousal and a PTSD-like sleep phenotype after sleep disruption and acute stress in mice. [2021]