COPD. Other specified chronic obstructive pulmonary disease
Conditions
Interventions
Intervention 1: intervention group: Case group received 3 mg melatonin tablet orally in a single dose, 1 h before bedtime for 30 consecutive days. Intervention 2: control group :control group receive
Treatment - Drugs
Placebo
intervention group: Case group received 3 mg melatonin tablet orally in a single dose, 1 h before bedtime for 30 consecutive days
control group :control group received placebo 1 h before bedtime
Sponsors
Shahid Sadoughi University of Medical Sciences and Health Services
Eligibility
Sex/Gender
All
Age
40 Years to 100 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria :COPD patients in stage 2-4 according to GOLD criteria with poor sleep quality (sleep quality more than 5 according to Pittsburgh Sleep Quality Index (PSQI)) Excusion criteria : history of COPD exacerbation during to previous 4 weeks , obstructive sleep apnea, mental disorder, or hypnotic-sedative medication, nocturnal oxygen therapy, and shift work
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality. Timepoint: at the first of the study and one month after the treatment. Method of measurement: According to the Pittsburgh Sleep Quality Index, PSQI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Oxygenation. Timepoint: at the first of the study and one month after treatment1 month. Method of measurement: pulse oximeter.;Daily sleepness. Timepoint: at the first of the study and one month after treatment1 month. Method of measurement: on basis of ESS (Epworth Sleepiness scale).;Pulmonary function test. Timepoint: at the first of the study and one month after treatment1 month. Method of measurement: FEV1 ,FVC,FEV1/FVC and FEF25-75. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Abolhasan Halvani
Shahid Sadoughi University of Medical Sciences and Health Services
Outcome results
None listed