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

NCT06311045 | Active Not Recruiting

• 1 other identifier: 23-01469
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Percent Change in Overnight Levels of Glutathione (GSH)

  GSH measured using participant blood samples.

  Baseline, Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

• Mean Change in Pre- to Post-Sleep GSH Levels

  GSH measured using participant blood samples.

  Baseline

• Mean Change in Pre- to Post-Sleep GSH Levels

  GSH measured using participant blood samples.

  Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

Secondary Outcomes (26)

• Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG)

  Baseline

• Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG)

  Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

• 8-Isoprostane Level

  Baseline

• 8-Isoprostane Level

  Final Study Visit (4 Weeks post Initiation of Study Therapy; up to Month 6)

• Plasma Nitrate Level

  Baseline

Study Arms (2)

NAC

EXPERIMENTAL

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.

Dietary Supplement: N-acetylcysteine (NAC); Procedure: Positive Airway Pressure (PAP) Therapy

Placebo

EXPERIMENTAL

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.

Dietary Supplement: Placebo; Procedure: Positive Airway Pressure (PAP) Therapy

Interventions

N-acetylcysteine (NAC) DIETARY_SUPPLEMENT

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

NAC

Placebo DIETARY_SUPPLEMENT

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

Placebo

Positive Airway Pressure (PAP) Therapy PROCEDURE

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

NAC; Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Acetylcysteine; Therapeutics

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Rashmi Nisha Aurora, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: May 7, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. Requests should be directed to Rashmi.aurora@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request.

Locations

US (1)