Obesity-hypoventilation SyndromeNCT02021448
Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -
A study testing Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS) in people with Obesity-hypoventilation Syndrome and Nocturnal Alveolar Hypoventilation, run by University Hospital, Strasbourg, France at 6 sites in France.
Trial summary
Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity-hypoventilation Syndrome, Nocturnal Alveolar Hypoventilation
- What is being tested?
- Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 6 sitesFrance
- Study dates
- Dec 2013to Jun 2022
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese volunteer Subject (BMI> 30 kg/m2)
- Adults of either sex
- Social security affiliation
- Written informed consent
Who cannot join
- Confirmed OHS at baseline defined by a daytime hypercapnia with PaCO2> 45mmHg
- Any cause of chronic respiratory failure other than obesity such as COPD, chest deformation, phrenic nerve paralysis, pulmonary fibrosis, neuromuscular disease, a history of mutilating thoracic surgery ...
- Obstructive ventilatory defect with FEV1/ FVC <70% post-bronchodilator
- Long term oxygen therapy, noninvasive ventilation, continuous positive airway pressure
- Any serious illness involving life-threatening within 3 years after inclusion
- Drug or alcohol abuse
- Pregnancy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Angers
Angers, 49000
CHU Brest
Brest, 29609
CH Cannes
Cannes, 06400
CHU Grenoble
Grenoble, 38043
CHU Reims
Reims, 51100
CHU Strasbourg
Strasbourg, 67091
About this study
Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects
- Being tested
- Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS)
- Keywords
- OHS
- Medical subject headings
- Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS)Other
Polygraphy/Polysomnography,Blood sampling, EKG,Lung function testing,Arterial blood gases,Thoracic radiography,Six-minute walk test,Respiratory questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Obesity: BMI > 30 kg/m2 | Other | Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS) Polygraphy/Polysomnography, Blood sampling, EKG, Lung function testing, Arterial blood gases, Thoracic radiography, Six-minute walk test, Respiratory questionnaires Receives: Other: Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of obesity-hypoventilation syndrome
partial pressure of carbon dioxide in the arterial blood > 45mmHg
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJan 2022
- Study completionJun 2022
Why it stopped: difficulty in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity-hypoventilation SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KESSLER Romain, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021448
- Sponsor's protocol ID
- 5059
- Status last verified
- Jul 2022
- First submitted
- 29 Aug 2013
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Obesity-hypoventilation Syndrome (OHS) Among Obese Subjects- ETUDE COHYPOB -
- ClinicalTrials.gov ID
- NCT02021448
- Acronym / sponsor ID
- 5059
- Keywords
- OHS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in recruiting
- Enrolment
- 188 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 27 Dec 2013 (estimated)
- 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.
Investigate whether the course of an isolated nocturnal alveolar hypoventilation can predict the future occurrence of obesity-hypoventilation syndrome (OHS) in obese subjects
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obesity: BMI > 30 kg/m2 | Other | Other: Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS)Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS) Polygraphy/Polysomnography, Blood sampling, EKG, Lung function testing, Arterial blood gases, Thoracic radiography, Six-minute walk test, Respiratory questionnaires |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Obese volunteer Subject (BMI> 30 kg/m2)
- Adults of either sex
- Social security affiliation
- Written informed consent
Key exclusion criteria (7 listed)
- Confirmed OHS at baseline defined by a daytime hypercapnia with PaCO2> 45mmHg
- Any cause of chronic respiratory failure other than obesity such as COPD, chest deformation, phrenic nerve paralysis, pulmonary fibrosis, neuromuscular disease, a history of mutilating thoracic surgery ...
- Obstructive ventilatory defect with FEV1/ FVC <70% post-bronchodilator
- Long term oxygen therapy, noninvasive ventilation, continuous positive airway pressure
- Any serious illness involving life-threatening within 3 years after inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS)Polygraphy/Polysomnography,Blood sampling, EKG,Lung function testing,Arterial blood gases,Thoracic radiography,Six-minute walk test,Respiratory questionnaires | Other | Obesity: BMI > 30 kg/m2 |
Primary outcome
Occurrence of obesity-hypoventilation syndrome
Time frame: 3 years
partial pressure of carbon dioxide in the arterial blood > 45mmHg
Results and safety
The study was stopped early (reason given: difficulty in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
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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.
KESSLER Romain, MD principal investigator
University Hospital, Strasbourg, France
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS) in people with Obesity-hypoventilation Syndrome and Nocturnal Alveolar Hypoventilation, run by University Hospital, Strasbourg, France at 6 sites in France.
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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 was stopped early (reason given: difficulty in recruiting). Results are not available in the source record.
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?
Occurrence of obesity-hypoventilation syndrome (time frame: 3 years). 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 11 Jul 2022.