Investigating the effects of melatonin on nocturnal blood pressure fluctuations in patients with obstructive sleep apnea
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase one and two on 60 patients.
Settings and conduct
Sixty participants will randomly assign to the melatonin or placebo group by 1:1 ratio. Patients will receive 3 mg melatonin orally in a single dose or placebo, 1 h before bedtime. All measurements including polysomnography and laboratory assessments will conduct at baseline and after one month of melatonin therapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria will as follows: (1) age between 18 and 75 years; (2) Diagnosis of OSA [apnea-hypopnea index (AHI) ≥ 15]; and (3) BP ≤ 180/110 mmHg. Exclusion criteria are (1) patients who have been hospitalized for cardiac or respiratory exacerbations less than 6 weeks prior to recruiting; (2) those with autonomic nervous system diseases or endocrine disorders which might influence BP; (3) BP ≥ 180/110 mmHg; and (4) those unwilling to participate in the study.
Intervention groups
Intervention group: receiving 3 mg of melatonin as a single dose one hour before sleep
Control group: receiving placebo as a single dose one hour before sleep
Main outcome variables
Polysomnography assessment; blood samples will analyze for serum ACE level and cortisol.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221023056278N1
Registration date:2023-06-03, 1402/03/13
Registration timing:prospective
Last update:2023-06-03, 1402/03/13
Update count:0
Registration date
2023-06-03, 1402/03/13
Registrant information
Name
Mohammad Rasoul Ghadami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 5255
Email address
mr_ghadami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-06, 1402/03/16
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effects of melatonin on nocturnal blood pressure fluctuation in patients with obstructive sleep apnea
Public title
The study of the effects of melatonin on nocturnal blood pressure fluctuation in patients with obstructive sleep apnea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 75 years
Diagnosis of OSA [apnea-hypopnea index (AHI) ≥ 15]
BP ≤ 180/110 mmHg
Exclusion criteria:
Patients who have been hospitalized for cardiac or respiratory exacerbations less than 6 weeks prior to recruiting
Those with autonomic nervous system diseases or endocrine disorders which might influence BP
BP ≥ 180/110 mmHg
Those unwilling to participate in the study.
Age
From 18 years old to 75 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done in a simple way using a sealed envelope in which the name of the intervention group is written.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the people who were invited to participate in the study and were classified into intervention groups after obtaining informed consent, as well as the person who analyzed the data collected during the study, did not aware about the prescribed medicine.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
NIMAD
Street address
Fatemi St., the beginning of Baath St
City
Tehran
Province
Tehran
Postal code
1419693211
Approval date
2021-11-30, 1400/09/09
Ethics committee reference number
IR.NIMAD.REC.1400.163
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
Systolic and diastolic BP, serum ACE level and cortisol
Timepoint
Before and one month after the intervention
Method of measurement
Using polysomnography and laboratory evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Thirty participants will randomly assign to the melatonin group. Patients will receive 3 mg melatonin (time release) orally in a single dose or placebo, 1 h before bedtime. All measurements including PSG and laboratory assessments will conduct at baseline and after one month of melatonin therapy.
Category
Treatment - Drugs
2
Description
Control group: 30 participants are randomly placed in the control group. Patients will receive placebo orally in a single dose, 1 hour before bedtime. All measurements, including PSG and laboratory evaluations, were performed at baseline and after one month of placebo treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sleep Disorders Research Center
Full name of responsible person
Dr. Habibolah Khazaie
Street address
Dolat abad, Farabi hospital
City
Kermanshah
Province
Kermanshah
Postal code
6719851451
Phone
+98 83 3826 5255
Fax
+98 83 3826 5255
Email
hakhazaie@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
NIMAD
Full name of responsible person
Dr. Younes Panahi
Street address
Fatemi St., the beginning of Baath St
City
Tehran
Province
Tehran
Postal code
1419693211
Phone
+98 21 6690 0920
Email
nimadiran@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
NIMAD
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
Mohammad Rasoul Ghadami
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Dolat abad, Farabi hospital
City
Kermanshah
Province
Kermanshah
Postal code
6719851451
Phone
+98 83 3826 5255
Email
mr_ghadami@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Rasoul Ghadami
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Dolat abad, Farabi hospital
City
Kermanshah
Province
Kermanshah
Postal code
6719851451
Phone
+98 83 3826 5255
Email
mr_ghadami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Rasoul Ghadami
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Dolat abad, Farabi hospital
City
Kermanshah
Province
Kermanshah
Postal code
6719851451
Phone
+98 83 3826 5255
Email
mr_ghadami@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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
Undecided - It is not yet known if there will be a plan to make this available