The Effects of Melatonin in Sleep Disorders of Sarcoidosis Patients

Phase 3

• Conditions: Pulmonary Sarcoidosis.; Sarcoidosis of lung; D86.0

• Registration Number: IRCT20151227025726N25
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 May 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients with age above 18 years with pulmonary sarcoidosis and sleep-related disorders (Pittsburgh Sleep Quality Index equal or greater than 5) that refer to the Sarcoidosis Clinic of Masih Daneshvari Hospital.

Exclusion Criteria

Pregnancy
Breastfeeding
Neurological disease (stroke, epilepsy, tumor, previously neurologic manipulation)
Use of any sedative or hypnotic drugs (anti histamine drugs, benzodiazepines)
Use of stimulant drugs
Allergy to melatonin or formulation components
Having parasomnia
Shift work sleep disorder
Fluvoxamine consumption

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The assessment of sleep quality. Timepoint: The assessment of sleep quality at initiation of study and 3 month after melatonin consumption. Method of measurement: With the measurement of PSQI and GSDS questionnaire scores.;The assessment of daytime sleepiness. Timepoint: The assessment of daytime sleepiness at initiation of study and 3 month after melatonin consumption. Method of measurement: With the measurement of ESS questionnaire score.;The assessment of fatigue status. Timepoint: The assessment of fatigue status at initiation of study and 3 month after melatonin consumption. Method of measurement: With the measurement of FAS and PROMIS questionnaire scores.;The assessment of life quality. Timepoint: The assessment of life quality at initiation of study and 3 month after melatonin consumption. Method of measurement: With the measurement of SF-12 questionnaire score.

Secondary Outcome Measures

Name	Time	Method
The assessment of pulmonary function. Timepoint: The assessment of pulmonary function at initiation of study and 3 month after melatonin consumption. Method of measurement: With the spirometry method.