Phase
Condition
Sleep Apnea Syndromes
Treatment
N-acetylcysteine (NAC)
Placebo
Positive Airway Pressure (PAP) Therapy
Clinical Study ID
Ages 55-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Apnea-hypopnea index ≥15 events/hr on portable sleep monitoring
HbA1c <6.5%
Exclusion
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 previousthree months or HbA1c ≥6.5%;
Shift work (i.e., working hours that routinely cause sleep initiation after 1:00a.m.);
Another major sleep disorder (i.e., circadian rhythm disorder, any history ofnarcolepsy, concurrently diagnosed or medication-treated restless legs syndrome,concurrently diagnosed or medication-treated chronic insomnia with the exception ofantidepressant therapy);
Regular use (more than twice/week) of an opioid/narcotic, benzodiazepine, orprescription sleep medication other than antidepressants currently or within thelast month;
The use of N-acetylcysteine in any form (oral, intravenous, inhaled) in the lastseven days
The use of other over-the-counter antioxidant therapies including vitamin C orvitamin E in the preceding 10 days
History of reduced ejection fraction heart failure, or chronic cardiac arrhythmiarequiring medication or treatment;
Unstable or uncontrolled medical or psychiatric comorbidity requiringhospitalization 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 degenerativeneurological disease).
Pregnancy
Study Design
Connect with a study center
NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
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