Determination of agomelatine effects on polysomnography parameters
Design
This study is a randomized, parallel-group and double-blind. Seventy patients with obstructive sleep apnea are randomly divided into intervention or control groups.
Settings and conduct
Place of study: Dr Masih Daneshvari Hospital
How to do the study: Seventy patients with obstructive sleep apnea are divided randomly into intervention or control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with age above 18 years old with obstructive sleep apnea that refer to the Sleep Clinic of Masih Daneshvari Hospital.
Exclusion criteria: Pregnancy, breastfeeding, neurological disease, use of stimulant drugs, allergy to agomelatine or formulation components, having stage 2 or 3 of liver failure, ciprofloxacin consumption, fluvoxamine consumption
Intervention groups
Patients in the intervention group receive 50mg agomelatine (Tadbir Kalay-e Jam Pharmaceutical company, Iran) one hour before sleep, for three nights and patients in the control group do not receive agomelatine.
Main outcome variables
Evaluating effects of agomelatine on sleep onset, sleep duration, sleep efficiency and sleep stages.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N26
Registration date:2021-06-13, 1400/03/23
Registration timing:prospective
Last update:2021-06-13, 1400/03/23
Update count:0
Registration date
2021-06-13, 1400/03/23
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-02, 1400/04/11
Expected recruitment end date
2022-01-01, 1400/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Agomelatine on polysomnography parameters in patients with obstructive sleep apnea
Public title
Evaluating the effect of Agomelatine in patients with obstructive sleep apnea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with age above 18 years old with obstructive sleep apnea that refer to the Sleep Clinic of Masih Daneshvari Hospital.
Exclusion criteria:
Pregnancy
Breastfeeding
Neurological disease (stroke, epilepsy, tumor, previously neurological manipulation)
Use of stimulant drugs
Allergy to Agomelatine or formulation components
Having stage 2 or 3 of liver failure
Ciprofloxacin consumption
Fluvoxamine consumption
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method and random number table was used in this study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Care provider and outcome assessor and data analyst are blind to the study groups until the end of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of School of Pharmacy and Nursing and Midwifery Shahid Beheshti University of Medi
Street address
3rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.280
Health conditions studied
1
Description of health condition studied
Obstructive sleep apnea
ICD-10 code
G47.33
ICD-10 code description
Obstructive sleep apnea (adult) (pediatric)
Primary outcomes
1
Description
The assessment of polysomnography parameters
Timepoint
The assessment of polysomnography parameters 2 days after agomelatine consumption
Method of measurement
With measurement of recorded criteria in the polysomnography test response
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group, receive two 25 mg agomelatine tablets of Tadbir Kalay-e Jam pharmaceutical company one hour before bedtime, two nights before sleep test and the night of sleep test.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group do not receive Agomelatine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farzaneh Dastan
Street address
Masih Daneshvari Hospital, Shahid Bahonar street (Niyavaran), Darabad