Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome
1 other identifier
observational
60
1 country
1
Brief Summary
Obesity hypoventilation syndrome (OHS) is defined as a combination of obesity \[body mass index (BMI) ≥30 kg/m2\], chronic daytime hypercapnia (PaCO2 \>45 mm Hg), and sleep-apnea in the absence of other known causes of hypercapnia. Respiratory system compliance decreases and resistance increases in OHS. This causes increase in work of breathing and oxygen cost of breathing, which may result in respiratory muscle fatigue. Increase in respiratory workload and increase in resistance to respiration is expected to decrease in respiratory muscle endurance (RME) in subjects with OHS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2019
CompletedFirst Submitted
Initial submission to the registry
March 28, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedApril 8, 2021
April 1, 2021
9 months
March 28, 2021
April 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incremental load test
Respiratory muscle endurance was evaluated by incremental load test. The incremental load test was performed using the electronic inspiratory loading device (PowerBreathe®-KHP2).
1 day
Secondary Outcomes (7)
Mouth pressure measurements
1 day
6 minute walk test
1 day
Epworth Sleepiness Scale
1 day
Pittsburg Sleep Quality Index
1 day
Fatigue Severity Scale
1 day
- +2 more secondary outcomes
Study Arms (3)
Group I
Subjects with obesity hypoventilation sydrome (30 \< body mass index \< 40 kg/m2)
Group II
Subjects with obesity hypoventilation sydrome (body mass index \> 40 kg/m2)
Control Group
Age and sex-matched obese subjects (30 \< body mass index \< 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \< 3)
Eligibility Criteria
All subjects who had polysomnography performed in the sleep laboratory and were diagnosed with OHS were screened. Age and sex-matched obese subjects (30 \< body mass index \< 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \< 3) included in the study as the control group.
You may qualify if:
- Diagnosed with OHS
- Obese subjects (30 \< body mass index \< 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score \< 3)
You may not qualify if:
- Severe respiratory disease
- Subjects with orthopeadic and/or neurologic disorders that could limit exercise tests
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
March 28, 2021
First Posted
April 8, 2021
Study Start
February 5, 2018
Primary Completion
November 5, 2018
Study Completion
January 24, 2019
Last Updated
April 8, 2021
Record last verified: 2021-04