Pulmonary Sarcoidosis. Sarcoidosis of lung
Conditions
Interventions
Intervention 1: Intervention group: Patients receive 3 mg of melatonin one hour before bedtime for three months. Intervention 2: Control group: Patients do not use melatonin before going to bed.
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: People over 18 years old People with pulmonary sarcoidosis and concomitant sleep disorder (PSQI = 3) Have signed the consent to participate in the study
Exclusion criteria
Exclusion criteria: Pregnancy Breastfeeding History of central nervous system disease (stroke, epilepsy, tumor, history of neurological manipulation) Taking any sedative-hypnotic drugs (antihistamines, benzodiazepines) Taking stimulant drugs Allergy to melatonin or formulation components Having parasomnias Shift work sleep disorder Taking fluvoxamine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of sleepiness during the day. Timepoint: At the start and end of the study. Method of measurement: ESS criteria.;Fatigue state. Timepoint: At the start and end of the study. Method of measurement: FAS and PROMIS criteria.;Quality of Life. Timepoint: At the start and end of the study. Method of measurement: SF-12 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function of patients. Timepoint: At the start and end of the study. Method of measurement: Spirometry. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSahar Yousefian
Shahid Beheshti University of Medical Sciences
Outcome results
None listed