A comparative analysis between the result of treatment with daily titrated Pap-therapy and nightly titrated Pap-therapy in OHS patient
Design
A clinical trial with parallel groups on 122 patients randomized by random numbers table.
Settings and conduct
Patients were randomly divided in two groups and treated with daily & nightly positive airway pressure (PAP) therapy. Participants were blinded. This study was done in Isfahan city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients known for obesity hypoventilation syndrome (OHS) with the age of 18 years old or more.
Exclusion criteria: Chronic obstructive pulmonary disease (COPD), Interstitial lung disease (ILD), Scoliosis
Intervention groups
Daily titrated positive airway pressure (PAP) therapy group and Nightly titrated airway pressure (PAP) therapy group
Main outcome variables
Evaluation and comparison of mean blood O2-saturation, Evaluation and comparison of mean score of ESS questionnaire, Evaluation and comparison of mean pressure of blood Co2
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170512033930N2
Registration date:2021-12-02, 1400/09/11
Registration timing:registered_while_recruiting
Last update:2021-12-02, 1400/09/11
Update count:0
Registration date
2021-12-02, 1400/09/11
Registrant information
Name
Forogh Soltaninejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3224 0059
Email address
f.soltaninejad@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative analysis between the result of treatment with daily titrated Pap-therapy and nightly titrated Pap-therapy in OHS patient
Public title
A comparison between the result of daily and nightly titrated Pap-therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obesity hypoventilation syndrome (OHS) patient
Adult older than 18
Patients without COPD
Patients without restrictive lung disease
Patients without problems of chest wall
BMI greater than 35
Paco2>45
Exclusion criteria:
Patients with known COPD
Scoliosis
Patients with known restrictive lung disease
Patient younger than 18
congestive heart failure (EF<40%)
Fev1/FVC< 70
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through block method. There are 8 blocks that each one have 4 members for night groups and 4 members for day groups. For better working EPI-INFO-7 software will be used.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
thics committee of Isfahan University of Medical Sciences
Street address
Shams Abadi street
City
Isfahan
Province
Isfehan
Postal code
8135613193
Approval date
2020-03-30, 1399/01/11
Ethics committee reference number
IR.MUI.MED.REC.1399.008
Health conditions studied
1
Description of health condition studied
Obesity Hypoventilation syndrome (OHS)
ICD-10 code
E66.2
ICD-10 code description
Extreme obesity with alveolar hypoventilation
Primary outcomes
1
Description
Co2 pressure (pco2)
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
By capnograph
2
Description
O2 saturation
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
By pulse oximeter
3
Description
Epworth Sleepiness Scale score
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
By Epworth Sleepiness Scale
Secondary outcomes
empty
Intervention groups
1
Description
Treatment with daily titrated positive airway pressure with Bipap or Cpap device manufactured by ResMed company for at least 4 hours in one day in a period of 12 weeks
Category
Treatment - Devices
2
Description
Treatment with nightly titrated positive airway pressure with Bipap or Cpap device manufactured by ResMed for at least 4 hours in one day in a period of 12 weeks
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Bamdad Medical Clinic Center
Full name of responsible person
Marzieh Ghasemi
Street address
Sheikh Mofid Ave
City
Isfahan
Province
Isfehan
Postal code
8156163161
Phone
+98 31 3521 4295
Email
ghasemi.md.67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Foroogh Soltaninejad
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
f.soltaninejad@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
Foroogh Soltaninejad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shams Abadi Ave.
City
Isfahan
Province
Isfehan
Postal code
8134654669
Phone
+98 31 3224 0059
Email
f.soltaninejad@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Foroogh Soltaninejad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shams Abadi Ave.
City
Isfahan
Province
Isfehan
Postal code
8134654669
Phone
+98 31 3224 0059
Email
f.soltaninejad@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Foroogh Soltaninejad
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shams Abadi Ave.
City
Isfahan
Province
Isfehan
Postal code
8134654669
Phone
+98 31 3224 0059
Email
f.soltaninejad@med.mui.ac.ir
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