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

NYU Langone Health

Status: Enrolling

Conditions: Obstructive Sleep Apnea

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06311045

23-01469

Details and patient eligibility

About

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.

Enrollment: 206 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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206 participants in 2 patient groups

NAC

Experimental group

Description:

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.

Treatment:

Dietary Supplement: N-acetylcysteine (NAC)

Procedure: Positive Airway Pressure (PAP) Therapy

Placebo

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Procedure: Positive Airway Pressure (PAP) Therapy