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Активно (без набиране) Не е приложимо NCT06311045

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

Не е приложима фаза (напр. обсервационно)
Заболявания: Obstructive Sleep Apnea

Спонсор: NYU Langone Health

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Интервенции
N-acetylcysteine (NAC)
DIETARY_SUPPLEMENT
Placebo
DIETARY_SUPPLEMENT
Positive Airway Pressure (PAP) Therapy
PROCEDURE
Места на провеждане 1
САЩ (1)
NYU Langone Health
New York , New York
Технически детайли
Статус
Активно (без набиране)
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
55 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
07.05.2024
Крайна дата
01.05.2026
Регистрационен номер
NCT06311045
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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