Obesity Hypoventilation Syndrome (OHS)NCT04835558
Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome
An observational study of Obesity Hypoventilation Syndrome (OHS), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 69 years
- Conditions the study is for
- Obesity Hypoventilation Syndrome (OHS)
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2018to 24 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Diagnosed with OHS
- Obese subjects (30 < body mass index < 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score < 3)
Who cannot join
- Severe respiratory disease
- Subjects with orthopeadic and/or neurologic disorders that could limit exercise tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome; Evaluation by Incremental Load Test
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.
Read the detailed description
In the literature, studies evaluating RME in subjects with OHS are limited. No study has been found to evaluate RME using the incremental load test in subjects with OHS. Accordingly, it was aimed to evaluate and compare respiratory muscle endurance in subjects with OHS and a control group, and to determine factors associated with respiratory muscle endurance.
- Conditions
- Obesity Hypoventilation Syndrome (OHS)
- Keywords
- Respiratory Muscle Endurance, Sleep, Fatigue, Quality of Life
- Medical subject headings
- Obesity Hypoventilation Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (7)
Mouth pressure measurements
Respiratory muscle strength was measured using mouth pressure measurements (Micro Medical MicroRPM).
Measured: 1 day
6 minute walk test
The 6 minute walk test was used to evaluate the functional exercise capacity of the subjects.
Measured: 1 day
Epworth Sleepiness Scale
Excessive daytime sleepiness was assessed with the Epworth Sleepiness Scale. A score of >10 accepted as daytime sleepiness.
Measured: 1 day
Pittsburg Sleep Quality Index
Sleep quality was assessed with the Pittsburg Sleep Quality Index. The total score were interpreted as follows: 0-5 indicated good sleep quality, > 5 indicated poor sleep quality, and >10 indicated the presence of a sleep disorder.
Measured: 1 day
Fatigue Severity Scale
Fatigue severity was assessed with the Fatigue Severity Scale. This seven-likert scale was used for each item and final score was accepted as mean value of the 9 items. The higher scores indicated higher fatigue severity.
Measured: 1 day
EQ-5D Health-Related Quality of Life Questionnaire
Quality of life was assessed with the EQ-5D Health-Related Quality of Life Questionnaire. The maximum score of 1 indicates the best health state, and higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status in which 100 indicates the best health status.
Measured: 1 day
Obesity and Weight Loss Quality of Life Instrument
Quality of life specific to obesity was assessed with the Obesity and Weight Loss Quality of Life Instrument. As the total score from the scale approaches 0, the quality of life decreases, and as it approaches 100, the quality of life increases.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start5 Feb 2018
- Primary completion5 Nov 2018
- Study completion24 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Hypoventilation Syndrome (OHS)Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goksen Kuran Aslan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835558
- Sponsor's protocol ID
- 29713
- Status last verified
- Apr 2021
- First submitted
- 28 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome; Evaluation by Incremental Load Test
- ClinicalTrials.gov ID
- NCT04835558
- Acronym / sponsor ID
- 29713
- Conditions
- Obesity Hypoventilation Syndrome (OHS)
- Keywords
- Respiratory Muscle Endurance, Sleep, Fatigue, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the literature, studies evaluating RME in subjects with OHS are limited. No study has been found to evaluate RME using the incremental load test in subjects with OHS. Accordingly, it was aimed to evaluate and compare respiratory muscle endurance in subjects with OHS and a control group, and to determine factors associated with respiratory muscle endurance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 24 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Diagnosed with OHS
- Obese subjects (30 < body mass index < 40 kg/m2) with low risk of obstructive sleep apnea (STOP-BANG score < 3)
Key exclusion criteria (2 listed)
- Severe respiratory disease
- Subjects with orthopeadic and/or neurologic disorders that could limit exercise tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incremental load test
Time frame: 1 day
Respiratory muscle endurance was evaluated by incremental load test. The incremental load test was performed using the electronic inspiratory loading device (PowerBreathe®-KHP2).
7 secondary outcomes
Mouth pressure measurements
Time frame: 1 day
6 minute walk test
Time frame: 1 day
Epworth Sleepiness Scale
Time frame: 1 day
Pittsburg Sleep Quality Index
Time frame: 1 day
Fatigue Severity Scale
Time frame: 1 day
EQ-5D Health-Related Quality of Life Questionnaire
Time frame: 1 day
Obesity and Weight Loss Quality of Life Instrument
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
Related trials for Obesity Hypoventilation Syndrome (OHS)
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Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea
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RecruitingObservational study
The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
Bronchial Asthma, Bronchiectasis
Not yet recruiting
The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
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Recruiting
Assessment of Breathing Pattern During NIV
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity Hypoventilation Syndrome (OHS), run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental load test (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.