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IRCT20220607055095N2 IRCT 2023-07-19 Tehran University of Medical Sciences study of medium term effects of Trazodone and Atomoxetine combination in obstructive sleep apnea pilot study of medium term effects of Trazodone and Atomoxetine combination on the number of apnea and apnea-hypopnea sleep index in obstructive sleep apnea patients 2023-07-23 anticipated 18 Complete https://irct.ir/trial/71277 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2-3 obstructive sleep apnea. Intervention group: All patients are treated with a combination of atomoxetine and trazodone for one month, and then undergo polysomnography.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Arezu Najafi
Tehran, Railway Square, Behadari St., Baharlo Hospital, Occupational Sleep Disorders Research Center
Tehran Iran (Islamic Republic of) 1339973111 +98 21 5546 0184 najafeeaz.inbox@gmail.com Tehran University of Medical Sciences scientific Arezu Najafi
Tehran, Railway Square, Behadari St., Baharlo Hospital, Occupational Sleep Disorders Research Center
Tehran Iran (Islamic Republic of) 1339973111 +98 21 5546 0184 najafeeaz@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Definite diagnosis of obstructive sleep apnea with AHI>15 in polysomnography lack of compliance treatment with CPAP or BIPAP either the patient is unwilling to have surgery or they are not candidates for surgery in the opinion of the expert 21 years 65 years Both commodities' existence (excluding controlled blood pressure, hyperlipidemia and diabetes) Taking any medication that leads to changes in the physiology of breathing, sleep / wake and muscles Taking any medication that leads to changes in the physiology of breathing, sleeping / waking and muscles any underlying cardiac disease, such as arrhythmia Inability to sleep in supine position Hypersensitivity to lidocaine, atomoxetine or trazodone Pregnancy History of seizures, Panic disorder, Hyperventilation syndrome, Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder any hepatic disease or failure G47.33 Obstructive sleep apnea (adult) (pediatric) Treatment - Drugs Intervention group: All patients are treated with a combination of atomoxetine and trazodone for one month, and then undergo polysomnography. Apnea-hypopnea index. Timepoint: after on month medication consumption. Method of measurement: Polysomnography. Minimum O2 saturation. Timepoint: once. Method of measurement: pulse oxymetry. Tehran University of Medical Sciences Approved 2023-06-20 Ethics committee of Tehran University of medical sciences Imam Khomeini Hospital Complex ,Dr. Gharib Street ,Keshavarz Boulevard ,Tehran Tehran Tehran Iran (Islamic Republic of)