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IRCT20220201053905N1 IRCT 2022-06-08 Tehran University of Medical Sciences Evaluating the effect of Atomoxetine and Oxybutynin combination on the number of apnea in obstructive sleep apnea patients referring to the sleep clinics of Tehran University of Medical Sciences Evaluating the effect of Atomoxetine and Oxybutynin combination on the number of apnea in obstructive sleep apnea patients 2022-04-04 anticipated 18 Complete https://irct.ir/trial/61665 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: block-randomization, each block includes 4 persons: We will pick up 4 persons and put them in one of the placebo or intervention group in regard to the gender composition. Thus, We will pick 4 other persons up and put them in two groups in a same way. This block-randomization continues until all 18 persons been put in a group, Blinding description: patients, nurses and patient's relatives would not aware of what the drug exactly is. So the participant would not find out that the prescribed compound is whether Ato-Oxy or placebo. It leads the participant to imagine the placebo's effect equal to Ato-Oxy's, so at the end of the study, the placebo effect could be ruled out. 3 Obstructive Sleep Apnea. Intervention 1: Intervention group: This group will consume Oxybutynin-Atomoxetine combination during the first night of study, then they would consume placebo(Vitamin C) at least 1 weak later. Intervention 2: Control group: This group will consume placebo(Vitamin C) during the first night of study, then they would consume Oxybutynin-Atomoxetine combination at least 1 weak later. Yes - There is a plan to make this available What will be shared: The demographic data, drug/placebo consumption before intervention and defined outcomes will be evaluated. All data will be published without noticing the participants' names. When: The data will become available in 18 months later. To whom: The participants' data is secured and available just for primary researcher(s), collaborators and the research centers the study is going to conducted in. Conditions: The data must not be published publicly. Where to obtain: Iranian Center of Neurological Research, Dr Hamed AmiriFard How to obtain: To send email to Dr. AmiriFard or other researchers and clarifying the request and it's purpose --> To review admissibility of the request by the researchers --> Final approval by Dr. AmiriFard --> To send the data for requester in a week to a month after the request. Comments:
public Hamed AmiriFard
Fourth Floor, Iranian Center of Neurological Research Building, Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2398 dr.amirifard@gmail.com Tehran University of Medical Sciences scientific Hamed AmiriFard
Fourth Floor, Iranian Center of Neurological Research Building, Imam Khomeini Hospital, Keshavarz Blvd., Tehran, Iran.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2398 dr.amirifard@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) established OSA diagnosis in the past medical history with AHI more than 20 in the last polysomnography(if accessible) age between 21 and 65 years old noncompliant for CPAP or BiPAP not indicated for surgical treatment, according to the sleep specialist. or the situation that the patient doesn't tend to surgical treatment 21 years 65 years Both the existence of any other disorders(except controlled HTN, Hyperlipidemia and Diabetes) the consumption of any drug resulting in changes in ventilation physiology, sleep/awake cycle and the muscles; such as methocarbamol, tramadol, TCAs, SSRIs, SNRIs, ventilation stimulants and depressants, hypnotics, CNS stimulants, central sleep apnea, and etc. Claustrophobia Inability for being in supine position Allergy to any of lidocaine, atomoxetine, oxybutynin, vitamin C the existence of any underlying heart diseases such as arrhythmias the consumption of psychiatric drugs such as atomoxetine or any other drug that is prescribed for medical care and could not be withdrawn while the experiment night. for women: pregnancy the history of seizure, panic disorder, hyperventilation syndrome, ADHD, ASD Any disease that exacerbates by antimuscarinic drugs such as urinary retention, BPH, severe ulcerative colitis, glaucoma, myasthenia gravis G47.33 Obstructive sleep apnea (adult) (pediatric) Treatment - Drugs Placebo Intervention group: This group will consume Oxybutynin-Atomoxetine combination during the first night of study, then they would consume placebo(Vitamin C) at least 1 weak later. Control group: This group will consume placebo(Vitamin C) during the first night of study, then they would consume Oxybutynin-Atomoxetine combination at least 1 weak later. AHI(Apnea-Hypopnea index): Number of apnea plus hypopnea during a night sleep per hour. Timepoint: Just after intervention. Method of measurement: Polysomnography records. Tehran University of Medical Sciences Approved 2022-04-03 Ethics committee of Tehran University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)