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IRCT20220105053635N1 IRCT 2022-04-19 Prescribing and rational use of medicine research center Evaluation of melatonin on insomnia and daytime sleepiness associated with comisa Comorbid Insomnia with Obstructive Sleep Apnea (COMISA) Evaluation of effect of melatonin tablet administration or placebo on insomnia and daytime sleepiness in patients with obstructive sleep apnea and insomnia (COMISA) treated with continuous positive airway pressure: A randomized double-blind placebo-controlled trial 2022-04-21 anticipated 50 Complete https://irct.ir/trial/62651 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will enter one of the two rows of the trial in a one-to-one ratio (1: 1). Allocation will be done by permuted block randomization method. The size of 4 blocks will be selected. The allocation in each block will be simple randomization. Randomization will be done centrally and before the start of the study by a person who has no direct role in the entry of participants with a random number table. People who include patients in the study will not know the order of assignment. The order of allocation will be hidden from the researchers by thick, tightly packed dark envelopes. The medicine is given to patients by researchers. The drugs and placebo are provided to the researchers in the form of packages containing the study drug and the placebo for one month. The drugs are provided to researchers in packages of the same shape and only after determining the order of treatment. There is an expiration date on the package. If the expiration date of the package is less than 5 months at the time of entry into the study, the package will be returned to the allocation officer and the package with the appropriate expiration date will be given to the researcher in the same way. In the event of a serious adverse event for the participant, unblinding will be performed immediately for both the participant and the researcher. In the event of a severe adverse event in more than 12.5% ​​of participants (at least 7), unblinding will be performed for the researcher for all participants, and if the adverse event is due to melatonin use and is unexpected for melatonin, It will be done for all participants as well, Blinding description: The study will be double-blind which means the patients and researchers who include patients in the study will not know the order of assignment. The order of allocation will be hidden from the researchers by thick, tightly packed dark envelopes. 3 Comorbid insomnia and obstructive sleep apnea. Intervention 1: Intervention group: 10 mg melatonin tablets, one tablet before sleep for 30 days. The tablets were supplied from the jalinus factory. Intervention 2: Control group: placebo tablets, one tablet before sleep for 30 days. The tablets supplied from jalinus factory. Yes - There is a plan to make this available What will be shared: All of the individual participant data collected during the trial, after deidentification When: Immediately after publication. No end date. To whom: Anyone who wishes to access the data. Conditions: Any purpose. Where to obtain: Data are available indefinitely at (link to be included) How to obtain: Data are available indefinitely at (link to be included) Comments:
public Dr. Shahideh Amini
16 azar
Tehran Iran (Islamic Republic of) ۱۴۱۷۶۱۴۴۱۱ 00982164120 aminishahideh@gmail.com Tehran University of Medical Sciences scientific Dr. Shahideh Amini
16 azar
Tehran Iran (Islamic Republic of) ۱۴۱۷۶۱۴۴۱۱ 00982164120 aminishahideh@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age: 18-65 years old Moderate- severe OSA ( apnea -hypopnea index ≥ 15 times per hours) Using CPAP for a minimum duration of one month PSQI questionnaire point should be ≥5 The patient declares his / her commitment to strictly follow the study instructions, participate in visits and take interventions. 18 years 65 years Both Severe pulmonary disease ( life expectancy less than 6 months) Severe heart disease ( life expectance less than 6 months) Severe neurologic disease ( example: dementia, Parkinson disease) Major psychiatric disorder ( drug users, bipolar disorder, psychiatric disease in 3 months ago Using drugs which interfere with sleeping and breathing Known allergic reactions to melatonin according to past allergic history Pregnancy or lactation Hypothyroidism Narcolepsy Restless leg syndrome Shift workers G47.33 Obstructive sleep apnea (adult) (pediatric) Treatment - Drugs Placebo Intervention group: 10 mg melatonin tablets, one tablet before sleep for 30 days. The tablets were supplied from the jalinus factory Control group: placebo tablets, one tablet before sleep for 30 days. The tablets supplied from jalinus factory Change from baseline in PSQI questionnaire score in melatonin group in comparison with placebo group. Timepoint: Measurement of PSQI questionnaire score at the baseline and one month after initiation of treatment. Method of measurement: PSQI questionnaire. Change from baseline in ESS questionnaire score in melatonin group in comparison with placebo group. Timepoint: Measurement of ESS questionnaire score at the baseline and one month after initiation of treatment. Method of measurement: ESS questionnaire. Change from baseline in ISI questionnaire score in melatonin group in comparison with the placebo group. Timepoint: Measurement of ISI questionnaire score at the baseline and one month after initiation of treatment. Method of measurement: ISI questionnaire. Change from baseline in FOSQ-10 questionnaire score in melatonin group in comparison with the placebo group. Timepoint: Measurement ofFOSQ-10 questionnaire score at the baseline and one month after initiation of treatment. Method of measurement: FOSQ-10 questionnaire. Change from baseline in CPAP uses duration in hours in melatonin group in comparison with placebo. Timepoint: CPAP uses duration in hours at the baseline and one month after intervention. Method of measurement: CPAP device information. Change from baseline in CPAP uses duration in number of nights in one month in melatonin group in comparison with placebo. Timepoint: change from baseline in CPAP uses duration in number of nights in melatonin group in comparison with placebo. Method of measurement: CPAP device information. Prescribing and rational use of medicine research center Approved 2021-12-11 Ethics committee of drug sciences of Tehran University of Medical Sciences Qods ave. Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)