Effects of N-acetylcysteine on Obstructive Sleep Apnea

Basis of Sex-specific Therapeutic Responses to Obstructive Sleep Apnea (OSA): a Trial of N-acetylcysteine (NAC) in Obstructive Sleep Apnea (OSA)

This study tests if taking N-acetylcysteine can help people with obstructive sleep apnea feel better while they use their breathing machines.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 206 (estimated)
• Ages: 55 Years to 75 Years
• Sex: All
• Sponsor: NYU Langone Health (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06311045 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of N-acetylcysteine (NAC) compared to a placebo in individuals with significant obstructive sleep apnea (OSA) who are undergoing positive airway pressure therapy. Over a period of four weeks, the study aims to assess whether NAC can induce sex-specific changes in oxidative stress, inflammation, and endothelial dysfunction in these patients. Participants will be monitored for their apnea-hypopnea index and other health metrics to evaluate the efficacy of the intervention.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with obstructive sleep apnea, exhibiting an apnea-hypopnea index of 15 events/hour or more, and not having diabetes.

Not a fit: Patients with a body mass index of 40 kg/m2 or higher, or those currently using diabetes medications, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option for improving health outcomes in patients with obstructive sleep apnea.

How similar studies have performed: While the specific use of NAC in this context may be novel, similar studies exploring antioxidant therapies for sleep apnea have shown promising results.

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

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Rashmi Nisha Aurora, MD — NYU Langone Health
• Study coordinator: Rashmi Nisha Aurora, MD

Conditions: Obstructive Sleep Apnea