Investigating the effect of non-invasive ventilation on the heart rate variability in patients with obesity hypoventilation syndrome
Design
One-blind, clinical trial, 30 patients with obesity hypoventilation syndrome
Settings and conduct
Patients referring to Bamdad respiration research center, if they detect obesity hypoventilation syndrome and fill out the informed consent card and have criteria for entering the study, are monitored and cardiac heart rate data are collected for each patient separately. At least Three months after treatment, patients will again undergo Holtermonitoring and data on heart changes will be collected. Then, the results of Holtermonitoring before and after treatment, will be analyzed by appropriate statistical software.
Participants/Inclusion and exclusion criteria
Entry requirements include recent diagnoses of obesity-induced hypoventilation, provided that hypoventilations are not caused by renal failure, hypothyroidism, central hypoventilation.
Conditions for not admitting to the study include those who do not complete the informed consent.
Intervention groups
The intervention group includes patients who have recently been diagnosed with obesity hypoventilation syndrome and are undergoing heart rate changes through Holter monitoring before and after treatment with noninvasive ventilation
Main outcome variables
Early diagnosis of cardiac complications due to Hypoventilation syndrome; Statistical analysis of the relationship between heart rate variability and ventilation functions.
General information
Reason for update
Acronym
Heart Rate Variability
IRCT registration information
IRCT registration number:IRCT20171219037964N1
Registration date:2019-03-15, 1397/12/24
Registration timing:registered_while_recruiting
Last update:2019-03-15, 1397/12/24
Update count:0
Registration date
2019-03-15, 1397/12/24
Registrant information
Name
Babak Amra
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
amra@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2019-04-19, 1398/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Heart Rate Variability changes by Non Invasive Ventilation in Obesity Hypoventilation Syndrome
Public title
The effect of noninvasive ventilation on heart rate variability in patients with obesity hypoventilation syndrome
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with obesity hypoventilation syndrome
Exclusion criteria:
Central hypoventilation
renal failure
Hypothyroidism
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Each patient is included in the study individually and after diagnosis, without informing other patients
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
faculty of medicine, Isfahan university of medical sciences,Hezarjerib avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-03-08, 1395/12/18
Ethics committee reference number
IR.MUI.REC.1396.3.185
Health conditions studied
1
Description of health condition studied
Obesity Hypoventilation Syndrome
ICD-10 code
E66.2
ICD-10 code description
Morbid (severe) obesity with alveolar hypoventilation
Primary outcomes
1
Description
Heart Rate Variability
Timepoint
Before treatment, and at least 3 months after using noninvasive ventilation
Method of measurement
Holter monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Patients after the diagnosis of hypoventilation syndrome of obesity and, if there are criteria for entry into the study, are subjected to the study of the change in heart rate by Holtermonitoring. After receiving at least three months of non-invasive ventilation therapy, they will be re-evaluated for heart rate variability and the data will be compared with each other.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Bamdad Respiratory Research Center
Full name of responsible person
Babak Amra
Street address
No. 11, Sheikh-e-mofid street, North Sheikh-e-sadoogh avenue
City
Isfahan
Province
Isfehan
Postal code
8146111111
Phone
+98 31 3663 7177
Email
amra@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Faculty of medicine, Isfahan university of medical sciences, Hezarjerib avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Babak Amra
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Respiratory Disease_Sleep
Street address
Faculty of medicine, Isfahan university of medical sciences, Hezarjerib avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
amra@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Amra
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Respiratory disease_Sleep
Street address
Faculty of medicine, Isfahan university of medical sciences, Hezarjerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
amra@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Amra
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Respiratory disease_ sleep
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hezarjerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
amra@med.mui.ac.ir
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 data is available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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