RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-07

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06311045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Apnea-hypopnea index ≥15 events/hr on portable sleep monitoring * HbA1c \<6.5%	* 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

Inclusion Criteria

Exclusion Criteria

* Apnea-hypopnea index ≥15 events/hr on portable sleep monitoring
* HbA1c \<6.5%

* 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

Contacts and Locations

Study Contact

Rashmi Nisha Aurora, MD

CONTACT

443-513-6535

Rashmi.aurora@nyulangone.org

Ariana Budhu

CONTACT

646-501-0617

Ariana.budhu@nyulangone.org

Principal Investigator

Rashmi Nisha Aurora, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Rashmi Nisha Aurora, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-07

Study Completion Date2028-12

Study Record Updates

Study Start Date2024-05-07

Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

Obstructive Sleep Apnea