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Anti-oxidant

N-acetylcysteine for Obstructive Sleep Apnea

N/A

Recruiting

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)

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change in Pre- to Post-Sleep GSH Levels

Percent Change in Overnight Levels of Glutathione (GSH)

Secondary study objectives

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)

2020

Completed Phase 3

~870

Positive Airway Pressure (PAP) Therapy

2020

N/A

~140