Comorbid insomnia and obstructive sleep apnea. Obstructive sleep apnea (adult) (pediatric)
Conditions
Interventions
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, on
Sponsors
Prescribing and rational use of medicine research center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Shahideh Amini
Tehran University of Medical Sciences
Outcome results
None listed