Aspirin for Sleep Deprivation-Related Inflammation

MH
JS
Overseen ByJennifer Scott-Sutherland, M.S.
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how aspirin affects inflammation related to sleep deprivation. It examines the pattern where people restrict sleep during the week and try to catch up over the weekend. Researchers aim to determine if aspirin can resolve inflammation caused by this sleep pattern. Participants may receive either aspirin or a placebo (a pill with no active ingredient) to compare effects. Ideal candidates should maintain a regular sleep schedule of 7-9 hours nightly and have no history of asthma or chronic health issues. As an Early Phase 1 trial, this research focuses on understanding how aspirin works in people, offering participants a chance to contribute to groundbreaking insights.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that low-dose aspirin is generally well-tolerated and can help reduce inflammation caused by insufficient sleep. In various studies, participants who took low-dose aspirin experienced less inflammation than those who took a placebo, a pill with no active ingredients. This suggests that aspirin might safely manage inflammation from lack of sleep. Additionally, low-dose aspirin is already widely used and approved for other health issues, supporting its safety. However, since this trial is in its early stages, researchers are still learning about its safety for this specific use.12345

Why are researchers excited about this trial's treatments?

Most treatments for sleep deprivation-related inflammation involve lifestyle changes, like improving sleep habits, or medications targeting inflammation directly. However, this trial is exploring the use of aspirin, a common anti-inflammatory medication, as a potential treatment. Researchers are excited about this approach because aspirin is well-known, widely available, and generally safe at low doses. The trial aims to uncover if a low-dose aspirin regimen can reduce inflammation caused by sleep deprivation, offering a simple and cost-effective solution compared to current options. If successful, this could provide an easily accessible treatment option for people struggling with sleep-related inflammation issues.

What evidence suggests that aspirin might be an effective treatment for sleep deprivation-related inflammation?

Research has shown that low-dose aspirin can reduce inflammation caused by insufficient sleep. In this trial, participants will join different arms to evaluate the effects of aspirin versus a placebo. Studies have found that taking aspirin before anticipated sleep loss can lower the body's inflammatory response. This suggests aspirin might help manage inflammation often associated with sleep deprivation. Specifically, findings indicate that, compared to a placebo, aspirin effectively reduced markers of inflammation in the body during sleep deprivation. These results suggest aspirin could benefit those dealing with inflammation related to lack of sleep.14678

Who Is on the Research Team?

MH

Monika Haack, PhD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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
See 2 more

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.
See 13 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Sleep Restriction/Non-Active PlaceboExperimental Treatment1 Intervention
Group II: Sleep Restriction/81mg Aspirin PillExperimental Treatment1 Intervention
Group III: Control Sleep/Non-Active Placebo or 81mg Aspirin PillExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials
872
Recruited
12,930,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39043348/
Effects of low-dose acetylsalicylic acid on the inflammatory ...Conclusion: This study shows that inflammatory responses to sleep restriction can be reduced by preemptive administration of low-dose ASA. This finding may open ...
Effects of low-dose acetylsalicylic acid on the inflammatory ...This study shows that inflammatory responses to sleep restriction can be reduced by preemptive administration of low-dose ASA. This finding may open new ...
Low-dose aspirin reduces inflammation caused by sleep lossResults show that compared with placebo, preemptive administration of low-dose aspirin during sleep restriction reduced pro-inflammatory ...
Low Aspirin Doses May Reduce Inflammation Due to ...Low aspirin doses can reduce pro-inflammatory responses to experimental sleep restriction in human participants.
NCT03377543 | Sleep and Inflammatory Resolution PathwayGoal of this project is to investigate whether increases in inflammation that result from common patterns of restricting sleep on week nights and catching up ...
Low-dose aspirin can reduce inflammatory responses to ...Results show that compared with placebo, preemptive administration of low-dose aspirin during sleep restriction reduced pro-inflammatory ...
Effects of low-dose acetylsalicylic acid on the inflammatory ...This study shows that inflammatory responses to sleep restriction can be reduced by preemptive administration of low-dose ASA. This finding may open new ...
Effects of low-dose acetylsalicylic acid on the inflammatory ...Effects of low-dose acetylsalicylic acid on the inflammatory response to experimental sleep restriction in healthy humans. July 2024; Brain ...
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