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Anti-oxidant

NAC for Obstructive Sleep Apnea

N/A

Waitlist Available

Led By Rashmi Nisha Aurora, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up final study visit (4 weeks post initiation of study therapy; up to month 6)

Awards & highlights

Study Summary

This trial is testing a supplement called N-acetylcysteine (NAC) for people with obstructive sleep apnea who are already using positive airway pressure therapy. The study aims to

Who is the study for?

This trial is for individuals with significant obstructive sleep apnea (OSA) who are already using standard treatment, positive airway pressure therapy (PAP). Participants should be interested in seeing if the supplement N-acetylcysteine (NAC) can reduce overnight oxidative stress and inflammation specific to their sex.Check my eligibility

What is being tested?

The study tests whether taking N-acetylcysteine (NAC) for four weeks has different effects on men and women with OSA, compared to a placebo. It's randomized, meaning participants are put into the NAC or placebo group by chance.See study design

What are the potential side effects?

Possible side effects of N-acetylcysteine may include nausea, vomiting, rash, and headache. Since it's being tested alongside standard PAP therapy which is generally safe, no additional side effects from PAP are expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ final study visit (4 weeks post initiation of study therapy; up to month 6)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~final study visit (4 weeks post initiation of study therapy; up to month 6)

This trial's timeline: 3 weeks for screening, Varies for treatment, and final study visit (4 weeks post initiation of study therapy; up to month 6) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Mean Change in Pre- to Post-Sleep GSH Levels

Percent Change in Overnight Levels of Glutathione (GSH)

Secondary outcome measures

8-Isoprostane Level

Epworth Sleepiness Scale (ESS) Score

Fatigue Severity Scale (FSS) Score

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment2 Interventions

Following run-in PAP therapy per standard clinical care for 12 weeks, participants randomized to the placebo arm will also receive placebo for four weeks while remaining on PAP therapy.

Group II: NACExperimental Treatment2 Interventions

Following run-in PAP therapy per standard clinical care for 12 weeks, participants randomized to the NAC arm will also receive the supplement N-acetylcysteine (NAC) for four weeks while remaining on PAP therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

N-acetylcysteine (NAC)

1998

Completed Phase 3

~780

Placebo

1995

Completed Phase 3

~2670

Positive Airway Pressure (PAP) Therapy

2020

N/A

~110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,303 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,841 Previous Clinical Trials

47,813,899 Total Patients Enrolled

Rashmi Nisha Aurora, MDPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

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

Is the research study open to individuals above the age of 45 years old?

"Eligible candidates for this research must fall within the age range of 55 to 75 years. There are no fewer than 45 investigations focused on minors under 18 and approximately 229 studies targeting individuals above the age of 65."

Answered by AI

What are the main goals being pursued in this research endeavor?

"The primary aim of this trial, to be evaluated from baseline through the final study visit (4 weeks after initiating the study therapy; potentially up to month 6), is focused on determining the mean change in pre- and post-sleep GSH levels. Secondary objectives encompass assessing TNFα-R2 levels measured via participant blood samples, Epworth Sleepiness Scale (ESS) scores utilizing an 8-item questionnaire gauging likelihood of daytime sleepiness during common activities, and plasma nitrate levels determined from participant blood samples."

Answered by AI

Which specific criteria determine the eligibility of individuals to participate in this research endeavor?

"Candidates must exhibit obstructive sleep apnea and fall within the age range of 55 to 75 in order to qualify for participation in this study. A total of 206 candidates will be accepted into this clinical trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC)

2024. "Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06311045.