What side effects are associated with this type of intervention?

Common treatments for inflammation, such as NSAIDs (e.g., ibuprofen, naproxen) and glucocorticoids (e.g., prednisone), are associated with several side effects. NSAIDs can cause gastrointestinal issues like ulcers and bleeding, renal impairment, and cardiovascular risks. Glucocorticoids may lead to side effects such as weight gain, osteoporosis, hypertension, diabetes, and increased susceptibility to infections. Treatments that enhance the body's natural production of inflammatory resolution mediators are still under investigation, but they aim to minimize these side effects by promoting the body's own mechanisms to resolve inflammation without prolonged drug use.

What prior FDA approvals exist?

FDA-approved treatments for inflammation include various classes of drugs such as nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and biologics. NSAIDs like ibuprofen and naproxen reduce inflammation by inhibiting cyclooxygenase enzymes. Corticosteroids, such as prednisone, suppress multiple inflammatory pathways. Biologics, including TNF-alpha inhibitors (e.g., infliximab, adalimumab) and interleukin inhibitors (e.g., secukinumab, ustekinumab), target specific cytokines involved in the inflammatory process. While these treatments are effective, they do not specifically enhance the body's natural production of inflammatory resolution mediators, which is a novel approach currently under investigation.

What other types of research exist?

Promising novel alternatives for inflammation treatment in 2024 include: <ol> <li>Tacrolimus: Used in combination with methylprednisolone pulse therapy, it has shown improved survival rates in patients with acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF).</li> <li>Hemoperfusion with Polymyxin-B Immobilized Fiber: This therapy has demonstrated improved oxygenation and survival rates in AE-IPF patients by potentially removing cytokines contributing to lung injury.</li> <li>TNF Inhibitors: For conditions like psoriatic arthritis, TNF inhibitors such as infliximab, adalimumab, and etanercept are recommended for patients not responding to conventional DMARDs.</li> <li>Secukinumab and Ustekinumab: These biologic agents are used for patients with peripheral arthritis who do not respond to TNF inhibitors, offering targeted anti-inflammatory effects.</li> </ol>

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Aspirin for Sleep Deprivation-Related Inflammation

Q: What is the mechanism of action of this treatment?

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.

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.

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I take medications regularly, but not oral contraceptives.

Select...

I have had stomach or esophagus problems, like ulcers or bleeding.

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I or my close family member have had a stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to sleep restriction, single measure in the morning

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

0 / 5Eligibility criteria met

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.