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Aspirin for Sleep Deprivation-Related Inflammation

Q: Are there any limitations to the number of participants for this investigation?

Affirmative. The information available on clinicaltrials.gov confirms that the study is actively looking for participants, having been posted on June 6th 2018 and recently updated in July 19th 2022. 66 patients are required to be recruited from a single medical centre.

Q: Is there historical precedence for this type of research?

Since 2005, the pharmaceutical industry has conducted extensive research into Aspirin. Abbott was the primary sponsor of its first trial in which 15480 people participated. Following this Phase 4 drug approval and 167 active studies being undertaken across 1398 cities and 57 countries today.

Q: Is this research available to those below the age of fifty?

This trial is only open to participants aged 18 to 65, however there are 79 studies for minors and 524 research projects available for those above the age of retirement.

Q: Are there currently any vacancies in the experiment for participants?

According to clinicaltrials.gov, this medical initiative is actively searching for suitable individuals, having initially been posted on June 6th 2018 and lastly updated on July 19th 2022.

Q: Could I potentially be eligible to partake in this clinical experiment?

This clinical trial is seeking 66 participants of legal age (18-65) suffering from inflammation. Those hoping to partake must meet the following requirements: male/female 18-65 years, BMI between 18.5 and 35 kg/m2, no significant discomfort during pre-menstruation or menstruation, <a href="https://www.withpower.com/clinical-trials/sleep">sleep</a> duration 7-9 hours verified by electronic sleep diary data for two weeks, habitual sleeping period beginning within one hour of 11:00pm in order to ensure normal entrainment as well as a negative toxicology screen including amphetamines, barbiturates, benzodiazepines cocaine opiates and methadone -

Q: To what conditions is Aspirin commonly prescribed?

Aspirin is most often prescribed for patients that have undergone a percutaneous coronary intervention (PCI). It also has other uses, such as reducing inflammation and alleviating neck <a href="https://www.withpower.com/clinical-trials/pain">pain</a> following dental treatments.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will investigate whether sleep deprivation leads to increased inflammation by disrupting newly discovered pathways that help the body resolve inflammation.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Inflammatory Resolution Markers

Secondary outcome measures

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

836 Previous Clinical Trials

13,010,164 Total Patients Enrolled

8 Trials studying Inflammation

5,497 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any limitations to the number of participants for this investigation?

"Affirmative. The information available on clinicaltrials.gov confirms that the study is actively looking for participants, having been posted on June 6th 2018 and recently updated in July 19th 2022. 66 patients are required to be recruited from a single medical centre."

Answered by AI

Is there historical precedence for this type of research?

"Since 2005, the pharmaceutical industry has conducted extensive research into Aspirin. Abbott was the primary sponsor of its first trial in which 15480 people participated. Following this Phase 4 drug approval and 167 active studies being undertaken across 1398 cities and 57 countries today."

Answered by AI

Is this research available to those below the age of fifty?

"This trial is only open to participants aged 18 to 65, however there are 79 studies for minors and 524 research projects available for those above the age of retirement."

Answered by AI

Are there currently any vacancies in the experiment for participants?

"According to clinicaltrials.gov, this medical initiative is actively searching for suitable individuals, having initially been posted on June 6th 2018 and lastly updated on July 19th 2022."

Answered by AI

Could I potentially be eligible to partake in this clinical experiment?

"This clinical trial is seeking 66 participants of legal age (18-65) suffering from inflammation. Those hoping to partake must meet the following requirements: male/female 18-65 years, BMI between 18.5 and 35 kg/m2, no significant discomfort during pre-menstruation or menstruation, sleep duration 7-9 hours verified by electronic sleep diary data for two weeks, habitual sleeping period beginning within one hour of 11:00pm in order to ensure normal entrainment as well as a negative toxicology screen including amphetamines, barbiturates, benzodiazepines cocaine opiates and methadone -"

Answered by AI

To what conditions is Aspirin commonly prescribed?

"Aspirin is most often prescribed for patients that have undergone a percutaneous coronary intervention (PCI). It also has other uses, such as reducing inflammation and alleviating neck pain following dental treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sleep and Inflammatory Resolution Pathway

Monika Haack 2018. "Sleep and Inflammatory Resolution Pathway". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03377543.

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