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IRCT20221023056278N1 IRCT 2023-06-03 NIMAD The study of the effects of melatonin on nocturnal blood pressure fluctuation in patients with obstructive sleep apnea The study of the effects of melatonin on nocturnal blood pressure fluctuation in patients with obstructive sleep apnea 2023-06-06 anticipated 60 Complete https://irct.ir/trial/69306 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be done in a simple way using a sealed envelope in which the name of the intervention group is written, Blinding description: In this study, the people who were invited to participate in the study and were classified into intervention groups after obtaining informed consent, as well as the person who analyzed the data collected during the study, did not aware about the prescribed medicine. 1-2 Obstructive sleep apnea. Intervention 1: Intervention group: Thirty participants will randomly assign to the melatonin group. Patients will receive 3 mg melatonin (time release) orally in a single dose or placebo, 1 h before bedtime. All measurements including PSG and laboratory assessments will conduct at baseline and after one month of melatonin therapy. Intervention 2: Control group: 30 participants are randomly placed in the control group. Patients will receive placebo orally in a single dose, 1 hour before bedtime. All measurements, including PSG and laboratory evaluations, were performed at baseline and after one month of placebo treatment. 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 further information
public Mohammad Rasoul Ghadami
Dolat abad, Farabi hospital
Kermanshah Iran (Islamic Republic of) 6719851451 +98 83 3826 5255 mr_ghadami@yahoo.com Kermanshah University of Medical Sciences scientific Mohammad Rasoul Ghadami
Dolat abad, Farabi hospital
Kermanshah Iran (Islamic Republic of) 6719851451 +98 83 3826 5255 mr_ghadami@yahoo.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 75 years Diagnosis of OSA [apnea-hypopnea index (AHI) ≥ 15] BP ≤ 180/110 mmHg 18 years 75 years Both Patients who have been hospitalized for cardiac or respiratory exacerbations less than 6 weeks prior to recruiting Those with autonomic nervous system diseases or endocrine disorders which might influence BP BP ≥ 180/110 mmHg Those unwilling to participate in the study. G47.33 Obstructive sleep apnea (adult) (pediatric) Treatment - Drugs Placebo Intervention group: Thirty participants will randomly assign to the melatonin group. Patients will receive 3 mg melatonin (time release) orally in a single dose or placebo, 1 h before bedtime. All measurements including PSG and laboratory assessments will conduct at baseline and after one month of melatonin therapy. Control group: 30 participants are randomly placed in the control group. Patients will receive placebo orally in a single dose, 1 hour before bedtime. All measurements, including PSG and laboratory evaluations, were performed at baseline and after one month of placebo treatment. Systolic and diastolic BP, serum ACE level and cortisol. Timepoint: Before and one month after the intervention. Method of measurement: Using polysomnography and laboratory evaluation. NIMAD Approved 2021-11-30 NIMAD Fatemi St., the beginning of Baath St Tehran Tehran Iran (Islamic Republic of)