Determining the effect of melatonin on sleep quality in patients with mild traumatic brain injury
Design
two arm parallel group double blinded randomised trial
Settings and conduct
Patients who are diagnosed with mTBI after hospitalization will be placed in one of three groups of 20 people A, B and C based on random blocks if they have sleep disorders and inclusion criteria.
For blinding, drugs (melatonin, clonazepam, and placebo) are packaged in separate but similar packages and labeled A, B, and C. Medications will be received and labeled by a third party. As a result, the prescriber (researcher) and the patient will be unaware of the type of drug in each package and will not know what drugs are in the three packages.
the way of priscription the drug for the melatonin group 3 mg melatonin tablets, for the clonazepam group, 1 mg clonazepam tablets and for the placebo group, one placebo is prescribed overnight. The duration of treatment for different groups will be 4 weeks.
The instruments used to assess patients will be a researcher-made demographic questionnaire and the Iranian questionnaire of Petersburg quality of sleep and App Worth questionnaire, which will be done at the beginning of the study, after the end of treatment, one month and three months after treatment (4 times).
Participants/Inclusion and exclusion criteria
mTBI patients in kashan referred to Shahid Beheshti Hospital in Kashan.
Intervention groups
For melatonin group, 3 mg melatonin tablets, for clonazepam group, 1 mg clonazepam tablets and for placebo group, one placebo is prescribed overnight.
Main outcome variables
sleep quality/ habitual sleep efficiency/ sleep latency/ sleep duration/ sleep disturbance/ use of sleeping medications/ daytime dysfunction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220504054738N1
Registration date:2023-03-08, 1401/12/17
Registration timing:prospective
Last update:2023-03-08, 1401/12/17
Update count:0
Registration date
2023-03-08, 1401/12/17
Registrant information
Name
seyede mahshad moosavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3464 5043
Email address
mahshad.m125@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin on sleep quality in patients with mild traumatic brain injury
Public title
The effect of melatonin on sleep quality in patients with mild traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not having a proved sleep disorder
History of mTBI during one past month
Not having allergy to both if the drugs
Not having hepatic failure
Not having respiratory problems or apnea and not consuming opiates
Not having cognitive disorders or dimentia
Age between 18 to 60
Exclusion criteria:
Cessation of therapy
Consuming other hypnotic drugs otherwise the ones ordered in this study
Manifestation of adverse drug reaction during the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method with blocks of equal and constant size (there will be 6 blocks, in each block two people from the intervention group, two people from the control group, two people from the routine treatment group) In order to create balance and comply with the condition of randomization in sampling and allocating the sample to each of the studied groups, it will be used. It is worth mentioning that the sample will be entered in each of the pre-designed blocks according to the time of entering the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, drugs (melatonin, clonazepam, and placebo) will be packaged in separate but similar packages and labeled A, B, and C. Medications will be received and labeled by a third party. As a result, the prescriber (researcher) and the patient will be unaware of the type of drug in each package and will not know what drugs are in the three packages
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in medical and dental school researches
Street address
Kashan.Qutb Ravandi Blvd.hekmat56.
City
کاشان
Province
Isfehan
Postal code
8715973474
Approval date
2023-01-08, 1401/10/18
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.198
Health conditions studied
1
Description of health condition studied
mild traumatic brain injury
ICD-10 code
S06.0X
ICD-10 code description
Concussion
Primary outcomes
1
Description
sleep quality
Timepoint
Measurements will be taken at the beginning of the study, after the end of treatment, one month and three months after treatment (4 times).
Method of measurement
The instruments used to examine patients will be a researcher-made demographic questionnaire and the Petersburg Sleep Quality index Questionnaire and Epworth Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 3 mg melatonin tablet from Razek Pharmaceutical Company is prescribed at night (one hour before bedtime).If there is no proper response in the melatonin group, the amount of drug will increase to 6 mg, provided there are no side effects. The duration of treatment for the intervention group will be 4 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: 1 mg clonazepam tablet from Sobhan Daru Pharmaceutical Company is prescribed overnight (one hour before bedtime). If there is no proper response in the clonazepam group, it will be increased to 2 mg provided there are no side effects. The duration of treatment for this group will be 4 weeks.
Category
Treatment - Drugs
3
Description
Control group: For the placebo group, one placebo is prescribed overnight (one hour before bedtime)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti hospital
Full name of responsible person
Aidin Omidvar
Street address
Qutb-e-Ravandi Boulevard
City
kashan
Province
Isfehan
Postal code
8715973474
Email
mahshad.m125@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Gholam Ali Hamidi
Street address
Qutb-e-Ravandi Boulevard
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 939 738 7292
Email
mahshad.m125@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Aidin Omidvar
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Qutb-e-Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5500 9999
Email
mahshad.m125@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Aidin Omidvar
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Qutb-e-Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
0983155009999
Email
aydineomidvar84@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Aidin Omidvar
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Qutb-e-Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
0983155009999
Email
aydineomidvar84@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The effect of melatonin on sleep quality in patients with mild traumatic brain injury
When the data will become available and for how long
till ten year after gathering of datum
To whom data/document is available
people who are introduced by research institutes, universities and prestigious scientific centers or from ethics committees.
Under which criteria data/document could be used
To conduct meta-analysis studies in the field of study
From where data/document is obtainable
Vice President of Technology and Research of Kashan School of Medical Sciences
What processes are involved for a request to access data/document
Sending a letter to the Deputy of Technology and Research of Kashan University of Medical Sciences.
Examination of the letter in the research and ethics committee of this vice president, approval of the request by this committee.
Send the data file to the requesting person.