protocolSection identificationModule nctId: NCT06311045, orgStudyIdInfo id: 23-01469, briefTitle: Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: 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., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 206, type: ESTIMATED, armsInterventionsModule interventions name: N-acetylcysteine (NAC), interventions name: Placebo, interventions name: Positive Airway Pressure (PAP) Therapy, outcomesModule primaryOutcomes measure: Percent Change in Overnight Levels of Glutathione (GSH), primaryOutcomes measure: Mean Change in Pre- to Post-Sleep GSH Levels, primaryOutcomes measure: Mean Change in Pre- to Post-Sleep GSH Levels, secondaryOutcomes measure: Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG), secondaryOutcomes measure: Ratio of GSH to oxidized GSH (GSSG) (GSH:GSSG), secondaryOutcomes measure: 8-Isoprostane Level, secondaryOutcomes measure: 8-Isoprostane Level, secondaryOutcomes measure: Plasma Nitrate Level, secondaryOutcomes measure: Plasma Nitrate Level, secondaryOutcomes measure: Plasma Nitrite Level, secondaryOutcomes measure: Plasma Nitrite Level, secondaryOutcomes measure: Organic Nitrite Level, secondaryOutcomes measure: Organic Nitrite Level, secondaryOutcomes measure: Interleukin 6 (IL-6) Level, secondaryOutcomes measure: Interleukin 6 (IL-6) Level, secondaryOutcomes measure: Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level, secondaryOutcomes measure: Tumor Necrosis Factor-alpha (TNFα) Receptor-1 (TNFα-R1) Level, secondaryOutcomes measure: Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level, secondaryOutcomes measure: Tumor Necrosis Factor-alpha (TNFα) Receptor-2 (TNFα-R2) Level, secondaryOutcomes measure: Reactive Hyperemia Index (RHI) Score, secondaryOutcomes measure: Reactive Hyperemia Index (RHI) Score, secondaryOutcomes measure: Epworth Sleepiness Scale (ESS) Score, secondaryOutcomes measure: Epworth Sleepiness Scale (ESS) Score, secondaryOutcomes measure: Insomnia Severity Index (ISI) Score, secondaryOutcomes measure: Insomnia Severity Index (ISI) Score, secondaryOutcomes measure: Fatigue Severity Scale (FSS) Score, secondaryOutcomes measure: Fatigue Severity Scale (FSS) Score, secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI) Score, secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI) Score, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False