Determination of melatonin effects in the improvement of sarcoidosis patients with sleep disorders
Design
This study is a randomized, parallel-group, and double-blind. One hundred patients with sarcoidosis and sleep-related disorders are randomly divided into intervention or control groups.
Settings and conduct
Place of study: Dr Masih Daneshvari Hospital
How to do the study: One hundred of patients with pulmonary sarcoidosis and sleep-related disorders, are divided randomly into two intervention or control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with age above 18 years with pulmonary sarcoidosis and sleep-related disorders (Pittsburgh Sleep Quality Index equal or greater than 5) that refer to the Sarcoidosis Clinic of Masih Daneshvari Hospital
Exclusion criteria:
.Pregnancy
. Breastfeeding
. Neurological disease (stroke, epilepsy, tumor, previously neurologic manipulation)
. Use of any sedative or hypnotic drugs (anti histamine drugs, benzodiazepines)
. Use of stimulant drugs
. Allergy to melatonin or formulation components
. Having parasomnia
. Shift work sleep disorder
. Fluvoxamine consumption
Intervention groups
Patients in the intervention group receive 3 mg melatonin (Razak Pharmaceutical company, Iran) one hour before sleep, for three months.
Patients in the control group do not receive melatonin.
Main outcome variables
Sleep quality
Daytime sleepiness
Quality of life
Fatigue status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N25
Registration date:2021-05-19, 1400/02/29
Registration timing:prospective
Last update:2021-05-19, 1400/02/29
Update count:0
Registration date
2021-05-19, 1400/02/29
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
2021-06-22, 1400/04/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Efficacy of Melatonin in Sleep Disorders of Sarcoidosis Patients
Public title
The Effects of Melatonin in Sleep Disorders of Sarcoidosis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with age above 18 years with pulmonary sarcoidosis and sleep-related disorders (Pittsburgh Sleep Quality Index equal or greater than 5) that refer to the Sarcoidosis Clinic of Masih Daneshvari Hospital.
Exclusion criteria:
Pregnancy
Breastfeeding
Neurological disease (stroke, epilepsy, tumor, previously neurologic manipulation)
Use of any sedative or hypnotic drugs (anti histamine drugs, benzodiazepines)
Use of stimulant drugs
Allergy to melatonin or formulation components
Having parasomnia
Shift work sleep disorder
Fluvoxamine consumption
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method was used in this study. Twenty-five blocks including four patients generated with online website (www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, two patients will be assigned to melatonin group and two patients will be assigned to control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Investigator, outcome assessors, 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
3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2021-02-14, 1399/11/26
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.339
Health conditions studied
1
Description of health condition studied
Pulmonary Sarcoidosis
ICD-10 code
D86.0
ICD-10 code description
Sarcoidosis of lung
Primary outcomes
1
Description
The assessment of sleep quality
Timepoint
The assessment of sleep quality at initiation of study and 3 month after melatonin consumption
Method of measurement
With the measurement of PSQI and GSDS questionnaire scores
2
Description
The assessment of daytime sleepiness
Timepoint
The assessment of daytime sleepiness at initiation of study and 3 month after melatonin consumption
Method of measurement
With the measurement of ESS questionnaire score
3
Description
The assessment of fatigue status
Timepoint
The assessment of fatigue status at initiation of study and 3 month after melatonin consumption
Method of measurement
With the measurement of FAS and PROMIS questionnaire scores
4
Description
The assessment of life quality
Timepoint
The assessment of life quality at initiation of study and 3 month after melatonin consumption
Method of measurement
With the measurement of SF-12 questionnaire score
Secondary outcomes
1
Description
The assessment of pulmonary function
Timepoint
The assessment of pulmonary function at initiation of study and 3 month after melatonin consumption
Method of measurement
With the spirometry method
Intervention groups
1
Description
Intervention group: Patients in the intervention group receive melatonin 3 mg for Razak pharmaceutical company, one hour before sleep for one month.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group do not receive melatonin.
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