The aim of our study was to evaluate the effect of melatonin tablet on subjective sleep quality in outpatient patients with clinically stable COPD. This randomized, double-blind, placebo-controlled study was done on 54 patients with confirmed moderate to severe COPD who had poor sleep quality (According to the Pittsburgh Sleep Quality Index, PSQI>5). Oxygenation according to pulse oximeter and rate of sleepiness on basis of ESS (Epworth Sleepiness scale) was also measured for all of the patients. None of the participants had a history of disease exacerbation 4 weeks prior to the study, obstructive sleep apnea, mental disorder, hypnotic-sedative medication, nocturnal oxygen therapy and shift work. Patients received 3 mg melatonin (N = 27 or placebo (N = 27), orally in a single dose, 1 h before bedtime for 30 consecutive days. At the end of the study pulmonary function test, pulse oximeter, ESS and PSQI was measured for all of the patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110237872N1
Registration date:2011-12-30, 1390/10/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-30, 1390/10/09
Registrant information
Name
abolhasan halvani
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 1623 4986
Email address
halvani@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences and Health Services
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of melatonin on subjective sleep quality in patients with chronic obstructive pulmonary disease
Public title
Effect of melatonin on subjective sleep quality in patients with chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 40 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences and Health Services
Street address
yazd,Bahonar square
City
yazd
Postal code
Approval date
2011-05-04, 1390/02/14
Ethics committee reference number
17196
Health conditions studied
1
Description of health condition studied
COPD
ICD-10 code
J44.8
ICD-10 code description
Other specified chronic obstructive pulmonary disease
Primary outcomes
1
Description
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 outcomes
1
Description
oxygenation
Timepoint
at the first of the study and one month after treatment1 month
Method of measurement
pulse oximeter
2
Description
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)
3
Description
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
Intervention groups
1
Description
intervention group: Case group received 3 mg melatonin tablet orally in a single dose, 1 h before bedtime for 30 consecutive days
Category
Treatment - Drugs
2
Description
control group :control group received placebo 1 h before bedtime
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Respratory Clinic of Shahid Sadughi Hospital
Full name of responsible person
Abolhasan Halvani
Street address
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
research deputy
Street address
Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Dr. Abolhasan Halvani
Position
assisstant professor
Other areas of specialty/work
Street address
No 7, Adab alley, Kashani Street
City
Yazd
Postal code
8916784538
Phone
+98 35 1623 4986
Fax
+98 35 1822 4100
Email
halvani@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
َDR Abolhasan halvani
Position
Assistant professor
Other areas of specialty/work
Street address
No 7, Adab alley, Kashani Street
City
yazd
Postal code
8916784538
Phone
+98 35 1623 4986
Fax
+98 35 1822 4100
Email
halvani@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Dr Abolhasan Halvani
Position
Assistant professor
Other areas of specialty/work
Street address
No 7, Adab alley, Kashani Street
City
Yazd
Postal code
8916784538
Phone
+98 35 1623 4986
Fax
+98 35 1822 4100
Email
halvani@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)