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Effect of melatonin on sleep in sulfur mustard exposed patients

Phase 4
Conditions
Disorders of initiating and maintaining sleep [insomnias]
Sleep Disorders.
Registration Number
IRCT2015092924267N1
Lead Sponsor
Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Male
Target Recruitment
30
Inclusion Criteria

•Inclusion criteria: Sulfur mustard-injured patients with mild [ Forced expiratory volume in 1 second (FEV1)=80% ] and moderate (50% = FEV1= 80%) lung damages which their sleep disorders were confirmed using polysomnography at sleep clinic of Baqiatallah University of Medical Sciences.
•Exclusion criteria: Cigarette smoking or a history of exposure to any other respiratory pollutants; History of rhinitis allergique or other allergic diseases before exposure to sulfur mustard; History of asthma, lung cancer and pulmonary tuberculosis; Acute infection at upper and lower respiratory system; History of drugs consumption that is associated with pulmonary complications; History of systemic diseases or other chronic abnormalities which are associated with lung problems (such as heart disorders, kidney diseases, hepatitis, cirrhosis)

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Sleep Quality. Timepoint: before treatment, 8 weeks after treatment. Method of measurement: Pittsburgh Sleep Quality Index.;Daytime Sleepiness. Timepoint: before treatment, 8 weeks after treatment. Method of measurement: Epworth Sleepiness Scale.;The risk of Obstructive Sleep Apnea. Timepoint: before treatment, 8 weeks after treatment. Method of measurement: STOP Bang Questionnaire.
Secondary Outcome Measures
NameTimeMethod
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