Study objectives : To determine effect of Zolpidem on sleep quality of Tehran firefighters.
The study design : Double Blind Randomized Controlled Crossover Trial
The study population : Firefighters of Tehran Fire and Safety Services Organization
Inclusion criteria : Firefighter of Tehran Fire and Safety Services Organization
with poor sleep quality (PSQI>5)
Exclusion criteria: Acute or chronic disease; Medication usage;Major stressor events during last 6 month
Sample size : 20
Interventions : Zolpidem (Tablet 10mg) bed time for 14 days as intervention & placebo (Wheat flour) bed time for 14 days as control.
Primary outcome : Overall sleep quality
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106076724N1
Registration date:2011-06-13, 1390/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-13, 1390/03/23
Registrant information
Name
Amir Hossein Naseri Esfahani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6640 5588
Email address
naseri_a@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of rsearch for Tehran University Of Medical sciences
Expected recruitment start date
2011-03-21, 1390/01/01
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 Zolpidem on sleep quality of Tehran firefighters
Public title
Effect of Zolpidem on sleep quality of Tehran firefighters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: firefighters of Tehran;
global score of Pittsburgh Sleep Quality Index > 5
EXclusion criteria: Any acute or chronic disease; Medication usage; Major stressor events during last 6 month.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tehran University Of Medical Sciences
Street address
On The Corner of Keshavarz Blvd. and Qods Street, Keshavarz Blvd., Vali-e-asr Square
City
Tehran
Postal code
1417653761
Approval date
2011-06-06, 1390/03/16
Ethics committee reference number
130/1253/D
Health conditions studied
1
Description of health condition studied
sleep quality disorders
ICD-10 code
G47
ICD-10 code description
sleep disorders
Primary outcomes
1
Description
sleep quality
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
1
Description
Problems has it been for each person to keep up enthusiasm to get things done
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention
Method of measurement
face to face interview & sleep data recorded by each person
2
Description
Time of going to bed
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention
Method of measurement
face to face interview & sleep data recorded by each person
3
Description
Time between going to bed and falling asleep
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention face
Method of measurement
face to face interview & sleep data recorded by each person
4
Description
Time of waking up
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention
Method of measurement
face to face interview & sleep data recorded by each person
5
Description
Hours of actual sleep (May be different than the number of hours each person spend in bed)
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention
Method of measurement
face to face interview & sleep data recorded by each person
6
Description
Number of more than 30 minutes trying to fall asleep
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention
Method of measurement
face to face interview & sleep data recorded by each person
7
Description
Number of waking up early morning or midnight
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention
Method of measurement
face to face interview & sleep data recorded by each person
8
Description
Number of daytime sleepiness
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention
Method of measurement
face to face interview & sleep data recorded by each person
9
Description
Other sleep problems
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention
Method of measurement
face to face interview & sleep data recorded by each person
10
Description
Medication usage for sleep
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention
Method of measurement
face to face interview & sleep data recorded by each person
11
Description
Self assessment about overall quality of his/her sleep
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention
Method of measurement
face to face interview & sleep data recorded by each person
12
Description
Morning sleepiness
Timepoint
before intervention, after Zolpidem intervention & after placebo intervention (all in 8 am)
Method of measurement
ESS Questionnaire
Intervention groups
1
Description
Intervention : Tablet Zolpidem (HEXAL®) 10 mg bedtime for 14 days
Category
Treatment - Drugs
2
Description
Control : Wheat flour in same appearance of Zolpidem 2 gr bedtime for 14 days (Placebo)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fire stations in Tehran
Full name of responsible person
Amir Hossein Naseri Esfahani , MD , Resident of Occupational Medicine
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Baharloo Hospital, Occupational Medicine Center
Full name of responsible person
Naseri Esfahani AH, MD, Resident of occupational Medicine
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Siences
Full name of responsible person
Akbar Fotouhi, vice chancellor for research
Street address
On The Corner of Keshavarz Blvd. & Qods Street, Keshavarz Blvd., Vali-e-asr Square, Sixth Floor
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Siences
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
Tehran University of Medical Siences
Full name of responsible person
Amir Hossein Naseri Esfahani
Position
MD, Resident Of Occupational Medicine
Other areas of specialty/work
Street address
Poorsina st., School of Medicine, Occupational Medicine Department
City
Tehran
Postal code
Phone
+98 21 6640 5588
Fax
+98 21 6640 5588
Email
occupationalmedicine@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Center for Research on Occupational Diseases, Tehran University of Medical Siences
Full name of responsible person
Ramin Mehrdad
Position
MD, MPH, Associate Professor of Occupational Medicine
Other areas of specialty/work
Street address
Poorsina St., School of Medicine, Occupational Medicine Department
City
Tehran
Postal code
Phone
+98 21 6640 5588
Fax
Email
mehrdadr@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Siences
Full name of responsible person
Amir Hossein Naseri Esfahani
Position
MD, Resident of occupational medicine
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 6640 5588
Fax
Email
occupationalmedicine@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)