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

NCT ID: NCT06311045

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-07
• Study Completion Date: 2028-12-31

Brief 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

NAC

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.

Group Type: EXPERIMENTAL

N-acetylcysteine (NAC)

Intervention Type: DIETARY_SUPPLEMENT

Participants will take two NAC 600mg capsules daily for four weeks.

Positive Airway Pressure (PAP) Therapy

Intervention Type: PROCEDURE

All participants will receive PAP therapy per standard of care for OSA.

Placebo

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 Type: EXPERIMENTAL

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants will take two placebo 600mg capsules daily for four weeks.

Positive Airway Pressure (PAP) Therapy

Intervention Type: PROCEDURE

All participants will receive PAP therapy per standard of care for OSA.

Interventions

N-acetylcysteine (NAC)

Participants will take two NAC 600mg capsules daily for four weeks.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Participants will take two placebo 600mg capsules daily for four weeks.

Intervention Type: DIETARY_SUPPLEMENT

Positive Airway Pressure (PAP) Therapy

All participants will receive PAP therapy per standard of care for OSA.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Apnea-hypopnea index ≥15 events/hr on portable sleep monitoring
• HbA1c <6.5%

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 previous three months or HbA1c ≥6.5%;
• Shift work (i.e., working hours that routinely cause sleep initiation after 1:00 a.m.);
• Another major sleep disorder (i.e., circadian rhythm disorder, any history of narcolepsy, concurrently diagnosed or medication-treated restless legs syndrome, concurrently diagnosed or medication-treated chronic insomnia with the exception of antidepressant therapy);
• Regular use (more than twice/week) of an opioid/narcotic, benzodiazepine, or prescription sleep medication other than antidepressants currently or within the last month;
• The use of N-acetylcysteine in any form (oral, intravenous, inhaled) in the last seven days
• The use of other over-the-counter antioxidant therapies including vitamin C or vitamin E in the preceding 10 days
• History of reduced ejection fraction heart failure, or chronic cardiac arrhythmia requiring medication or treatment;
• Unstable or uncontrolled medical or psychiatric comorbidity requiring hospitalization 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 degenerative neurological disease).
• Pregnancy

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rashmi Nisha Aurora, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rashmi Nisha Aurora, MD

Role: CONTACT

Rashmi.aurora@nyulangone.org

443-513-6535

Ariana Budhu

Role: CONTACT

Ariana.budhu@nyulangone.org

646-501-0617

Other Identifiers

23-01469

Identifier Type: -

Identifier Source: org_study_id