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IRCT20190602043791N1 IRCT 2019-11-12 Tehran University of Medical Sciences lidocaine-prilocaine cream effect on comfortably of CPAP mask Effect of lidocaine-prilocaine cream on comfortably of CPAP mask in patients who undergone PAP-titration due to obstructive sleep apnea 2019-11-21 anticipated 23 Complete https://irct.ir/trial/43103 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomized block randomization was performed by the StatsDirect program with seed 10, number 69 and random block size between 2 and 4 and treatment number 3. A B C code is required for each group. At night the technician (blind to AB groups) contact the code holder who is blind to each of the groups (CAB), to be informed for titration in order to use the gel in 1 or 2 or he should not use the gel. It should be explained that in Group C no gel 1 or 2 is used, it is not possible to blind technicians and patients in this group. The technician and the patient are blind to the type of material used. Gel 1 is a mixture of lidocaine prilocaine and 2 is lubricants, Blinding description: A B C code is required for each group. At night the technician (blind to AB groups) contact the code holder who is blind to each of the groups (CAB), to be informed for titration in order to use the gel in 1 or 2 or he should not use the gel. It should be explained that in Group C no gel 1 or 2 is used, it is not possible to blind technicians and patients in this group. The technician and the patient are blind to the type of material used. Gel 1 is a mixture of lidocaine prilocaine and 2 is lubricants. 3 Obstructive sleep apnea. Intervention group: Patients who candidates for CPAP titration due to obstructive sleep apnea. Yes - There is a plan to make this available What will be shared: Part of data would be accessible When: In time of publishing the results To whom: Researchers in the field of sleep medicine Conditions: For helping to treat sleep disorders Where to obtain: ِDr Reza Erfanian rezakhoravimd@gmail.com How to obtain: At end of the project by email Comments:
public Reza Erfanian Azimzadeh Khosravi
Sa'adi Shomali Street, Darwazeh Doulat, the new building of Amir Alam Hospital
Tehran Iran (Islamic Republic of) 1145755811 +98 21 6670 6106 rezakhosravimd@gmail.com Tehran University of Medical Sciences scientific Reza Erfanian Azimzadeh Khosravi
Sa'adi Shomali Street, Darwazeh Doulat, the new building of Amir Alam Hospital
Tehran Iran (Islamic Republic of) 1145755811 +98 21 6670 6106 rezakhosravimd@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who refeered to Bharlou and Imam Khomeyni hospital for CPAP titration due to obstructive sleep apnea 18 years no limit Both Cardiac arrhythmia, Anti arrhythmic drug class III consumption, seizure, Methemoglobinemia, allergy to anesthesia solution, absence of informed consent G47.33 G47.33 Treatment - Devices Intervention group: Patients who candidates for CPAP titration due to obstructive sleep apnea Comfortably of CPAP mask usage. Timepoint: Two times, immediately after putting CPAP mask and 15 minutes after applying gel. Method of measurement: Visual analogue scale. Tehran University of Medical Sciences Approved 2019-09-21 Vice-Chancellor in Research Affairs- Tehran University of Medical Sciences Baharloo Hospital, Behdari St, Railway Sq, and Tehran, Iran Tehran Tehran Iran (Islamic Republic of)