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

Last updated: April 22, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Treatment

N-acetylcysteine (NAC)

Placebo

Positive Airway Pressure (PAP) Therapy

Clinical Study ID

NCT06311045
23-01469
  • Ages 55-75
  • All Genders

Study Summary

This is a randomized controlled trial (RCT) of 4 weeks of study supplement N-acetylcysteine (NAC) versus placebo in persons with significant obstructive sleep apnea (OSA) who are receiving positive airway pressure therapy (PAP), the standard of care therapy. The purpose of the study is to determine if NAC is associated with sex-specific changes in overnight oxidative stress, inflammation, as well as endothelial dysfunction in persons with OSA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Apnea-hypopnea index ≥15 events/hr on portable sleep monitoring

  • HbA1c <6.5%

Exclusion

Exclusion Criteria:

  • Body mass index (BMI) ≥40 kg/m2;

  • Diagnosis of diabetes mellitus, defined as the use of any diabetes medication (including glucagon like peptide [GLP]-1 agonists) currently or in the previousthree months or HbA1c ≥6.5%;

  • Shift work (i.e., working hours that routinely cause sleep initiation after 1:00a.m.);

  • Another major sleep disorder (i.e., circadian rhythm disorder, any history ofnarcolepsy, concurrently diagnosed or medication-treated restless legs syndrome,concurrently diagnosed or medication-treated chronic insomnia with the exception ofantidepressant therapy);

  • Regular use (more than twice/week) of an opioid/narcotic, benzodiazepine, orprescription sleep medication other than antidepressants currently or within thelast month;

  • The use of N-acetylcysteine in any form (oral, intravenous, inhaled) in the lastseven days

  • The use of other over-the-counter antioxidant therapies including vitamin C orvitamin E in the preceding 10 days

  • History of reduced ejection fraction heart failure, or chronic cardiac arrhythmiarequiring medication or treatment;

  • Unstable or uncontrolled medical or psychiatric comorbidity requiringhospitalization or change in medication during the previous three months;

  • Use of biologics or immune modulators in the last year;

  • Use of systemic steroids during the previous three months;

  • Current tobacco smoking;

  • Inability to sign informed consent;

  • Currently use of positive airway pressure therapy or another OSA treatment (e.g.,hypoglossal nerve stimulator, oral device);

  • Recent history of alcoholism or drug abuse (within the last three months)

  • Neurological condition that requires ongoing pharmacological therapy (e.g.,Parkinson's disease, Alzheimer's dementia, multiple sclerosis, other degenerativeneurological disease).

  • Pregnancy

Study Design

Total Participants: 206
Treatment Group(s): 3
Primary Treatment: N-acetylcysteine (NAC)
Phase:
Study Start date:
May 07, 2024
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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