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

Evaluation of the effect of melatonin tablet administration on insomnia and daytime sleepiness in patients with COMISA

A clinical trial with placebo control, parallel groups, double bind, randomized, phase 3 on 50 patients. randomization will prepared with online randomization generator

This clinical trial will be performed as a single-center trial in Emam Khomeini sleep clinic in Tehran. Patients in the melatonin group will receive 10 mg of melatonin 30-60 minutes before sleep with CPAP. In the placebo group, patients will receive the placebo tablets similar to melatonin tablets with CPAP 30-60 minutes before sleep with CPAP at night for one month.

Age: 18-65 years old Moderate- severe OSA (AHI ≥ 15 times per hour) Using CPAP for at least one month PSQI questionnaire score ≥ 5 Severe pulmonary disease ( life expectancy less than 6 months) Severe heart disease ( life expectance less than 6 months) Severe neurologic disease ( example: dementia, Parkinson's disease) Major psychiatric disorder ( drug users, bipolar disorder, psychiatric disease in 3 months ago Using drugs that 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

In the melatonin group, patients receive one 10 mg melatonin tablet, 30-60 minutes before sleep as long as using CPAP. In the control group, patients receive one placebo tablet before sleep for one month.

Change from baseline in PSQI; ESS; ISI; FOSQ-10 questionnaire in melatonin group in comparison with placebo

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.

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

All of the individual participant data collected during the trial, after deidentification

Immediately after publication. No end date.

Anyone who wishes to access the data.

Any purpose.

Data are available indefinitely at (link to be included)

Data are available indefinitely at (link to be included)