Obesity Hypoventilation SyndromeBIO-OHSNCT01903135
Prevalence of Obesity Hypoventilation Syndrome
A study testing Blood test analysis in the clinical labs and Pneumologist consult to establish the diagnosis of OHS in people with Obesity Hypoventilation Syndrome, run by AGIR à Dom at 5 sites in France.
Trial summary
Rationale of the "BIO-OHS" study (Prevalence of Obesity Hypoventilation Syndrome): The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity Hypoventilation Syndrome
- What is being tested?
- Blood test analysis in the clinical labs and Pneumologist consult to establish the diagnosis of OHS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,004 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2013to Mar 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ans more
- BMI over 30 kg/M2
- Stable state (respiratory, metabolic and cardio-vascular) for the last 2 months
- Addressed to a clinical labs for a blood check-up whatever the prescription
Who cannot join
- No social security
- Non cooperative patient, as judged by the investigator
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Cabinet de Pneumologie Grenoble SUD
Échirolles
Laboratoire MEDIBIO Les Cedres
Échirolles
Hôpital Michallon, Laboratoire EFCR et Sommeil
Grenoble
Cabinet de Pneumologie Perpignan
Perpignan
Laboratoire d'analyses medicales de Thuir
Thuir
About this study
Official title: Prevalence of Obesity Hypoventilation Syndrome in Subjects With Obesity Referred to Clinical (Medical Analysis) Laboratories for Regular Follow-up
Rationale of the "BIO-OHS" study (Prevalence of Obesity Hypoventilation Syndrome):
The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Actually, this prevalence has been assessed in patients referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in patients already diagnosed with sleep apnea. The purpose of this study is to determine the prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical laboratories for regular follow-up medical analysis.
Read the detailed description
No additional description
- Conditions
- Obesity Hypoventilation Syndrome
- Being tested
- Blood test analysis in the clinical labs, Pneumologist consult to establish the diagnosis of OHS
- Keywords
- Obesity Hypoventilation Syndrome, Prevalence, Bicarbonate
- 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.
Blood test analysis in the clinical labsProcedure or surgery
for specific measurement of plasmatic bicarbonate
Pneumologist consult to establish the diagnosis of OHSProcedure or surgery
complete respiratory check-up: Arterial blood gases analysis, spirometry, anthropometry, polygraphy or polysomnography.
Medical history, previous treatments.
| Study group | Role | What they receive |
|---|---|---|
| [HCO3-] >= 27 mmol/L (Group 1) | Other | All obese patients with plasmatic[HCO3-] >= 27 mmol/L will be addressed to a pneumologist. The pneumology investigations will establish(or not) the diagnosis of OHS Receives: Procedure: Blood test analysis in the clinical labs; Procedure: Pneumologist consult to establish the diagnosis of OHS |
| [HCO3-]< 27mmol/L+pneumologist (Group 2) | Other | Among obese patients with serum [HCO3-]< 27 mmol/L, 300 randomized patients will be addressed to a pneumologist. The pneumology investigations will refute(or not)the diagnosis of OHS. Receives: Procedure: Blood test analysis in the clinical labs; Procedure: Pneumologist consult to establish the diagnosis of OHS |
| [HCO3-]< 27 mmol/L (Group 3) | Other | Obese patients with a [HCO3-]<27 mmol/L randomized to group 3 will receive usual medical follow-up (end of study) Receives: Procedure: Blood test analysis in the clinical labs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis.
OHS prevalence, validated by arterial blood gases analysis, will be assessed by the percentage of patients with OHS among all patients included in the study
Measured: From date of inclusion until the end of the study currently planned (up to 2 years)
Secondary outcomes (4)
Sensitivity and specificity of plasmatic [HCO3-] to detect OHS
A ROC curve will determine if the threshold of 27 mmol/L has the best diagnostic value.
Decision trees will show if the diagnostic value of plasmatic [HCO3-]could be optimized by a combination with other clinical parameters.
Measured: From date of inclusion to the end of the study currently planned (2 years)
Prevalence of metabolic and cardiovascular comorbidities in patients with OHS
Prevalence will be estimated by the percentage and the confidence interval. Prevalences of metabolic and cardiovascular comorbidities among patients with OHS and without OHS will be compared by a KHI-2 test or Fisher Exact depends on the theorical number.
Measured: From date of inclusion to the end of the study currently planned (2 years)
To determine which medical specialties referred patients with OHS to clinical labs
estimated by percentage
Measured: From date of inclusion to the end of the study currently planned (2 years)
Incidence of serious health events at 1 and 2-year follow-up
Cardiovascular, metabolic and respiratory events (measured by percentages in OHS group and non-OHS group) will be compared by logistic regressions.
Measured: From time of OHS diagnostic to 1 and 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2015
- Study completionMar 2015
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pepin, Pr, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903135
- Sponsor's protocol ID
- 13-AGIR-02
- Other IDs
- 2013-A00744-41
- Acronym
- BIO-OHS
- Status last verified
- Mar 2015
- First submitted
- 16 Jul 2013
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Obesity Hypoventilation Syndrome in Subjects With Obesity Referred to Clinical (Medical Analysis) Laboratories for Regular Follow-up
- ClinicalTrials.gov ID
- NCT01903135
- Acronym / sponsor ID
- BIO-OHS / 13-AGIR-02
- Conditions
- Obesity Hypoventilation Syndrome
- Keywords
- Obesity Hypoventilation Syndrome, Prevalence, Bicarbonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Jul 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.
Rationale of the "BIO-OHS" study (Prevalence of Obesity Hypoventilation Syndrome):
The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Actually, this prevalence has been assessed in patients referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in patients already diagnosed with sleep apnea. The purpose of this study is to determine the prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical laboratories for regular follow-up medical analysis.
Detailed description
No additional description
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| [HCO3-] >= 27 mmol/L (Group 1) | Other | Procedure: Blood test analysis in the clinical labs, Procedure: Pneumologist consult to establish the diagnosis of OHSAll obese patients with plasmatic[HCO3-] >= 27 mmol/L will be addressed to a pneumologist. The pneumology investigations will establish(or not) the diagnosis of OHS |
| [HCO3-]< 27mmol/L+pneumologist (Group 2) | Other | Procedure: Blood test analysis in the clinical labs, Procedure: Pneumologist consult to establish the diagnosis of OHSAmong obese patients with serum [HCO3-]< 27 mmol/L, 300 randomized patients will be addressed to a pneumologist. The pneumology investigations will refute(or not)the diagnosis of OHS. |
| [HCO3-]< 27 mmol/L (Group 3) | Other | Procedure: Blood test analysis in the clinical labsObese patients with a [HCO3-]<27 mmol/L randomized to group 3 will receive usual medical follow-up (end of study) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old ans more
- BMI over 30 kg/M2
- Stable state (respiratory, metabolic and cardio-vascular) for the last 2 months
- Addressed to a clinical labs for a blood check-up whatever the prescription
Key exclusion criteria (2 listed)
- No social security
- Non cooperative patient, as judged by the investigator
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 |
|---|---|---|
| Blood test analysis in the clinical labsfor specific measurement of plasmatic bicarbonate | Procedure or surgery | [HCO3-] >= 27 mmol/L (Group 1), [HCO3-]< 27 mmol/L (Group 3), [HCO3-]< 27mmol/L+pneumologist (Group 2) |
| Pneumologist consult to establish the diagnosis of OHScomplete respiratory check-up: Arterial blood gases analysis, spirometry, anthropometry, polygraphy or polysomnography. Medical history, previous treatments. | Procedure or surgery | [HCO3-] >= 27 mmol/L (Group 1), [HCO3-]< 27mmol/L+pneumologist (Group 2) |
Primary outcome
Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis.
Time frame: From date of inclusion until the end of the study currently planned (up to 2 years)
OHS prevalence, validated by arterial blood gases analysis, will be assessed by the percentage of patients with OHS among all patients included in the study
4 secondary outcomes
Sensitivity and specificity of plasmatic [HCO3-] to detect OHS
Time frame: From date of inclusion to the end of the study currently planned (2 years)
Prevalence of metabolic and cardiovascular comorbidities in patients with OHS
Time frame: From date of inclusion to the end of the study currently planned (2 years)
To determine which medical specialties referred patients with OHS to clinical labs
Time frame: From date of inclusion to the end of the study currently planned (2 years)
Incidence of serious health events at 1 and 2-year follow-up
Time frame: From time of OHS diagnostic to 1 and 2-year follow-up
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 1 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Louis Pepin, Pr, PhD principal investigator
University Hospital, Grenoble
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test analysis in the clinical labs and Pneumologist consult to establish the diagnosis of OHS in people with Obesity Hypoventilation Syndrome, run by AGIR à Dom at 5 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 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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?
Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis. (time frame: From date of inclusion until the end of the study currently planned (up to 2 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 1 Feb 2017.