Comparison of the effect of Melatonin and Clonazepam on the REM sleep behavior disorder of patients with Parkinson's disease, a double blind randomized trial
Comparison of the effect of Melatonin and Clonazepam on REM sleep quality in patients with Parkinson's disaese
Design
This study is a double-blind clinical trial.
Randomization method is a Simple Randomization.
30 people will be enrolled for each group. Patients were randomly divided into two groups, each receiving either melatonin or clonazepam.
Settings and conduct
Patients with Parkinson's disease who have REM sleep disorder based on results of a specific questionnaire or polysomnography, referred to the neurology clinic of Rouzbeh Hospital, enrolled in the study.
Informed consent will obtain from all patients before inclusion into the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with Parkinson's disease who have REM sleep disorder based on their history and questionnaire.
Exclusion criteria:
A history of drug sensitivity to clonazepam and either drug, ,
Hepatic failure
Respiratory disorders or apnea
Opioid use
Cognition disorder and dementia
Over 65 years Old.
Intervention groups
Participants were randomly divided into two groups of 30 patients.
30 patients treated with 3 mg of Melatonin and 30 patients treated with 1 mg of Clonazepam, along with pre-existing Parkinson's medication.
Both drugs are administered at night before bedtime. Melatonin starts at a dose of 3 mg and increases to 6 mg in the absence of appropriate response. Clonazepam is started at a dose of 0.5 mg and in the absence of appropriate response and no side effects after two weeks is increased to 1 mg .
Main outcome variables
Sleep quality
Daytime sleepiness
REM sleep disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170821035819N3
Registration date:2020-02-16, 1398/11/27
Registration timing:registered_while_recruiting
Last update:2020-02-16, 1398/11/27
Update count:0
Registration date
2020-02-16, 1398/11/27
Registrant information
Name
Vajiheh Aghamollaiy
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21554191515
Email address
v-aghamollaii@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Melatonin and Clonazepam on the REM sleep behavior disorder of patients with Parkinson's disease, a double blind randomized trial
Public title
Comparison of the effect of Melatonin and Clonazepam on the REM sleep behavior disorder of patients with Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Parkinson's who have REM sleep disorder based on history and questionnaire
Exclusion criteria:
Dementia
A history of drug sensitivity
Age
To 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Patients were randomly divided into two groups of 30 patients, one group will be treated with 3 mg of Melatonin and another group will be treated with 1 mg of Clonazepam. We referred "https://www.graphpad.com/quickcalcs/randomize2/" website for randomization, total sample size is 60 and were divided into two groups (A, B) each of them 30 patients. This is a randomized double blind study. The drugs (Melatonin and Clonazepam) are packaged in separate but similar packages and labeled A and B on them. As a result, the patient is unaware of the type of drug in each package, and the analyst is blind. Method of administration: For the A group, 3 mg of Melatonin tablets are administered overnight (before bedtime). For the B group, 1mg Clonazepom is given overnight (before bedtime).
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind study.
The drugs are divided into groups A and B by a third person and given to the researcher.
The researcher, participant and analyzer are unaware of the drug, until all data are fully analyzed.
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 Medicine - Tehran University of Medical Sciences
Street address
Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St.
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.094
Health conditions studied
1
Description of health condition studied
REM sleep behavior disorder of patients with Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Sleep quality
Timepoint
First time and After 1 month
Method of measurement
Pittsburgh sleep quality questionnaire
2
Description
Daytime sleepiness
Timepoint
First time and After 1 month
Method of measurement
Epworth sleepiness score questionnaire
3
Description
REM Sleep Disorder
Timepoint
First time and After 1 month
Method of measurement
REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with Parkinson's disease who have sleep disorder, Take 3 mg Melatonin, once a night before bedtime, for one month (This drug is manufactured by Tehran Chemie Company)
Category
Treatment - Drugs
2
Description
Control group: Patients with Parkinson's disease who have sleep disorders, Take 1 mg Clonazepam, once a night before bedtime, for one month (This drug is manufactured by Tehran Chemie Company)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital Neurology Clinic, Tehran University of Medical Sciences
Full name of responsible person
Dr Vajiheh Aghamolaiy
Street address
Tehran Province, Tehran, District 11, Karegar St, No. 606
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
vajiheh102@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad-Ali Sahraeian
Street address
6th Floor, Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Vajiheh Aghamollaii
Position
Assistant Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
South Kargar Sr
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
vajiheh102@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Vajiheh Aghamollaii
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kargar Sr
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
vajiheh102@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Vajiheh Aghamollaii
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kargar Sr
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 9151
Email
vajiheh102@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The Article will be publish in international journal and part of the data, such as information about the original outcome can shared without patients identification details.
When the data will become available and for how long
From 2020
To whom data/document is available
The Article will be available to everyone.
Under which criteria data/document could be used
Data will be made available to researchers, organizations and managers as needed.
From where data/document is obtainable
Dr Vajiheh Aghamollaii
What processes are involved for a request to access data/document
Reason for request and affiliation person who requested data