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IRCT20190602043791N2 IRCT 2021-02-11 Tehran University of Medical Sciences Comparison of hypopharyngeal collapse pattern by DISE maneuver before and after hyoidothyroid suspension surgery in comparison with control DISE Comparison of hypopharyngeal collapse pattern by DISE maneuver before and after hyoidothyroid suspension surgery in comparison with control in patients with obstructive sleep apnea 2021-02-28 anticipated 48 Complete https://irct.ir/trial/53365 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization type is blocked randomization. Foursquare blocks of intervention group (A) and control (B) are defined on cards 1-6 (AABB, ABAB, ABBA, BBAA, BABA, BAAB), the cards are placed inside the envelope. Then the cards are selected randomly and then the random string is created from the sequence of selected cards. Patients in the intervention and control group are included in the study according to this sequence, Blinding description: The patient does not know whether he is in the intervention or control group, and the outcome assessor does not know whether hyoido-thyroid suspension has been performed for the patient or not. N/A Obstructive sleep apnea. Intervention 1: Intervention group: obstructive apnea patients candidate for palatal suspension surgery who, after the end of pharyngeal surgery, the surgeon also performs hyoid suspension in patients in this group. Intervention 2: Control group: patients with obstructive sleep apnea who are candidates for palatal suspension surgery, but after pharyngeal surgery, the surgeon does not perform hyoid suspension in patients in this group. 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 more information
public Reza Erfanian Azimzadeh Khosravi
Amir Alam hospital ENT clinic, North Sadi St., Enghelsb Ave.
Tehran Iran (Islamic Republic of) 141765371 +98 21 6670 6106 rezakhosravimd@gmail.com Tehran University of Medical Sciences scientific Reza Erfanian Azimzadeh Khosravi
Amir Alam hospital ENT clinic, North Sadi St., Enghelsb Ave.
Tehran Iran (Islamic Republic of) 1145755811 +98 21 6670 6106 rezakhosravimd@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) AHI>5 in polysomnography with complaint of obstructive sleep apnea symptoms 18 years 55 years Both BMI>35 past history of neck or OSA surgeries metabolic or cardiovascular diseases cooperative disinclination G47.33 Obstructive sleep apnea (adult) (pediatric) Treatment - Surgery Treatment - Surgery Intervention group: obstructive apnea patients candidate for palatal suspension surgery who, after the end of pharyngeal surgery, the surgeon also performs hyoid suspension in patients in this group. Control group: patients with obstructive sleep apnea who are candidates for palatal suspension surgery, but after pharyngeal surgery, the surgeon does not perform hyoid suspension in patients in this group. Hypopnea apnea ratio index(AHI). Timepoint: Before the study and two months after surgery. Method of measurement: Polysomnography test. Intensity of snoring. Timepoint: Before the study and two months after surgery. Method of measurement: Visual Analogue Scale. Tehran University of Medical Sciences Approved 2020-12-07 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Vice Chancellor for Research and Technology, Ghods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)