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A comparative study of the effect of trazodone, melatonin and trazodone/melatonine in the treatment of sleep disorders following traumatic brain injury

Protocol summary

Study aim
Determining and comparing the effects of trazodone and melatonin with trazodone/melatonin in the treatment of sleep disorders after traumatic brain injury
Design
A controlled, parallel-group, double-blind, randomized, phase 3 clinical trial on 48 patients. For randomization, patients referring to the clinic were randomly assigned to 3 groups of 16 patients by an intern, coded 1, 2, and 3.
Settings and conduct
Patients with a history of traumatic brain injury, who have referred to the specialized clinic of Taleghani Hospital in Kermanshah for follow-up of their traumatic brain injury problem and who have developed sleep disorders following TBI, will be included in the study if the patient is willing and meets the inclusion criteria. The patients will then be randomly assigned to three drug groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1. Being 18 years of age or older 2. Level of consciousness score (based on GCS) lower than thirteen 3. Suffering from severe or moderate brain injury Exclusion criteria 1. Having a sleep disorder before the brain injury 2. Presence of any neurological disease before the brain injury (other medical, psychiatric, environmental causes, alcoholism, pain, Parkinson's, dementia, depression, GERD, COPD, asthma, diabetes, heart disease and thyroid) 3. Inability of the patient to respond to the interviewer (having a vegetative state or severe consciousness deficits) 4. Receiving medication for insomnia disorder (except for the drug therapy group) 5. Lack of consent to enter the study
Intervention groups
The first intervention group will receive trazodone 25-100 mg, the second intervention group will receive melatonin 3-5 mg, and the third intervention group will receive trazodone 100-25 mg/melatonin 3-5 mg.
Main outcome variables
Level of sleepiness, severity of fatigue due to sleep disturbance, and severity of insomnia after concussion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241121063793N1
Registration date: 2024-12-28, 1403/10/08
Registration timing: prospective

Last update: 2024-12-28, 1403/10/08
Update count: 0
Registration date
2024-12-28, 1403/10/08
Registrant information
Name
saeed Gharooee Ahangar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 7663
Email address
saeedgharooeeahangar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-19, 1403/10/30
Expected recruitment end date
2025-02-18, 1403/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of trazodone, melatonin and trazodone/melatonine in the treatment of sleep disorders following traumatic brain injury
Public title
Comparative study of the effects of trazodone, melatonin, and trazodone/melatonin in the treatment of sleep disorders after traumatic brain injury: A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
GCS score (based on the GCS) below thirteen Suffered from severe or moderate concussion
Exclusion criteria:
Having a sleep disorder before the concussion Having any neurological disease before the brain injury (other medical, psychiatric, environmental causes, alcoholism, pain, Parkinson's, dementia, depression, GERD, COPD, asthma, diabetes, heart disease, and thyroid) Inability of the patient to respond to the interviewer (having a vegetative state or severe cognitive impairment) Receiving medication for insomnia (except for the drug therapy group) Lack of consent to enter the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients visiting the clinic are randomly assigned by an intern to treatments coded 1, 2, and 3.
Blinding (investigator's opinion)
Double blinded
Blinding description
Without any of the researchers or patients (double-blind design) being aware of the type of treatment, patients will be randomly assigned to three drug groups: trazodone, melatonin, and trazodone/melatonin.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Room No. 4, Deputy of Research and Technology Building, Kermanshah University of Medical Sciences, Building No. 2, Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Approval date
2023-10-15, 1402/07/23
Ethics committee reference number
IR.KUMS.MED.REC.1403.050

Health conditions studied

1

Description of health condition studied
Sleep disorders after a concussion
ICD-10 code
ICD-10
ICD-10 code description
اختلال خواب

Primary outcomes

1

Description
Changes in scores on the ESS, FSS, and ISI questionnaires
Timepoint
Start studying, one month later
Method of measurement
ESS, FSS, and ISI questionnaires

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: Every night, two hours before bedtime, take 25-100 mg of trazodone.
Category
Treatment - Drugs

2

Description
Second intervention group: Every night, two hours before bed, take 3-5 mg of melatonin.
Category
Treatment - Drugs

3

Description
Third intervention group: Every night, two hours before bedtime, trazodone 25-100 mg / melatonin 3-5 mg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Saeed Qarooee Ahangar
Street address
Ayatollah Taleghani Hospital, Shahid Beheshti Boulevard.
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3835 7663
Email
saeedgharooee@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus Jalili
Street address
Building No. 2, Deputy for Research and Technology, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 4185
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Saeed Qarooee Ahangar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Ayatollah Taleghani Hospital, Shahid Beheshti Boulevard.
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3835 7663
Email
saeedgharooee@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Saeed Qarooee Ahangar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Ayatollah Taleghani Hospital, Shahid Beheshti Boulevard.
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3835 7663
Email
saeedgharooee@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Saeed Qaroui Ahangar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Ayatollah Taleghani Hospital, Shahid Beheshti Boulevard.
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3835 7663
Email
saeedgharooee@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information available.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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