Basis of Sex-specific Therapeutic Responses to Obstructive Sleep Apnea (OSA): a Trial of N-acetylcysteine (NAC) in Obstructive Sleep Apnea (OSA)
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 75
Healthy Volunteers: f
View:
• Apnea-hypopnea index ≥15 events/hr on portable sleep monitoring
• HbA1c \<6.5%
Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Rashmi Nisha Aurora, MD
Rashmi.aurora@nyulangone.org
443-513-6535
Backup
Ariana Budhu
Ariana.budhu@nyulangone.org
646-501-0617
Time Frame
Start Date: 2024-05-07
Estimated Completion Date: 2028-12
Participants
Target number of participants: 206
Treatments
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)