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IRCT20240407061441N1 IRCT 2024-04-18 Shahid Beheshti University of Medical Sciences Efficacy of Nortriptyline in treating OSA Efficacy of Nortriptyline in treating OSA: Randomized, placebo-controlled, double-blind clinical trial. 2024-04-13 anticipated 24 Complete https://irct.ir/trial/76291 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: The participant does not know which treatment group he is in. The Care Provider and Outcomes Assessor do not know about the treatment performed. 3 Obstructive Sleep Apnea. Intervention 1: Intervention group: Patients are treated with Nortriptyline 25 mg for one month, and then undergo polysomnography. Intervention 2: Control group: Patients are treated with a placebo for one month and then undergo polysomnography. Yes - There is a plan to make this available What will be shared: Demographic data, drug/placebo consumption and study results will be published without mentioning the names of individuals. When: Access period will start six months after the publication of the results. To whom: Executives and collaborators of the project and research centers Conditions: The data must not be published publicly. Where to obtain: Chronic Disease Research Center, Dr. Fateme Mohammadi How to obtain: Sending an email to Dr. Fateme Mohammadi --> Review and approval by Dr. Fateme Mohammadi --> Sending information Comments:
public Fateme Mohammadi
sleep Lab, Masih Daneshvari Hospital, Dar-abad, Niavaran
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 3816 fatemeh.Mohammadi.inloo@gmail.com Shahid Beheshti University of Medical Sciences scientific Fateme Mohammadi
Sleep Lab, Masih Daneshvari Hospital, Dar-Abad, Niavaran
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 3816 fatemeh.Mohammadi.inloo@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) ≥18 years of age at the time of informed consent PSG criteria: AHI of >5; ≤ 25% central or mixed apneas; and PLM arousal index ≤15 Escale of sleepiness symptom score ≥10 PAP intolerance or current PAP refusal BMI between 18.5 and 30 kg/m2 for men, or 32 kg/m2 for women 18 years no limit Both Narcolepsy, restless leg syndrome, REM sleep behavior disorder Insomnia disorder or use of sedative-hypnotics or other medication to treat or avoid insomnia symptoms, shift disorder or night shift craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy Clinically significant cardiac disease, e.g., ventricular arrhythmia, untreated or unstable coronary artery disease, cardiac failure Metabolic, renal, pulmonary disease, and uncontrolled HTN Neuromuscular disorder (e.g., motor neuron disease, muscular dystrophy or myopathy, myasthenic syndrome); epilepsy; Parkinson's, Alzheimer's, or another neurodegenerative disease Central neural system stimulant or suppressant drugs G47.33 Obstructive sleep apnea (adult) (pediatric) Treatment - Drugs Placebo Intervention group: Patients are treated with Nortriptyline 25 mg for one month, and then undergo polysomnography. Control group: Patients are treated with a placebo for one month and then undergo polysomnography. Apnea-Hypopnea Index. Timepoint: after one month of medication consumption. Method of measurement: Polysomnography. Sleepiness Scale. Timepoint: after one month of medication consumption. Method of measurement: Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2024-03-05 Ethics Committee of Masih Daneshvari Teaching, Research, and Treatment Center for Tuberculosis and P Floor 7, Emam Hasan Building, Masih Daneshvari Hospital, Daar-Abad, Niavaran Tehran Tehran Iran (Islamic Republic of)