MedPath

Evaluation of melatonin on insomnia and daytime sleepiness associated with comisa

Phase 3
Recruiting
Conditions
Comorbid insomnia and obstructive sleep apnea.
Obstructive sleep apnea (adult) (pediatric)
G47.33
Registration Number
IRCT20220105053635N1
Lead Sponsor
Prescribing and rational use of medicine research center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
50
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

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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath