Obesity Hypoventilation SyndromeOVONCT01104610
Target Volume Mode Controlled Ventilator in Obesity Hypoventilation Syndrome
A study testing Breas Vivo 40 in people with Obesity Hypoventilation Syndrome, run by Breas Medical S.A.R.L. at 2 sites in France.
Trial summary
The purpose of this study is to investigate the evolution of daytime partial pressure of carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP) alone versus NIV-PSV. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obesity Hypoventilation Syndrome
- What is being tested?
- Breas Vivo 40
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- May 2009to May 2012
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from 20 to 75 years old.
- Body mass index > 32 kg/m2
- Nocturnal oxygen desaturation 5 mn ≤ 88% under CPAP,
- PaCO2 > 5,9 kPa in diurnal, spontaneous ventilation
Who cannot join
- Patients with COPD and VEMS/FVC < 65%
- Patients with CHF and periodic breathing (Ejection Fraction <40%)
- Patients with a recent respiratory decompensation in the month preceding inclusion
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU
Grenoble
GH Pitié-Salpétrière - Service de pneumologie et réanimation
Paris, 75651
About this study
Official title: Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure
The purpose of this study is to investigate the evolution of daytime partial pressure of carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP) alone versus NIV-PSV.
Read the detailed description
Compare the efficacy between 3 ventilation modes (CPAP, PSV and PSV with Target Volume) on patients with obesity hypoventilation syndrome already treated with CPAP but with persistent desaturations.
- Conditions
- Obesity Hypoventilation Syndrome
- Being tested
- Breas Vivo 40
- 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.
Breas Vivo 40Device
Also called Breas Vivo 40 target volume
The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume
| Study group | Role | What they receive |
|---|---|---|
| NIV-PSV without Target Volume | Active comparator | Pressure Support Non Invasive Ventilation without Target Volume Receives: Device: Breas Vivo 40 |
| NIV-PSV with Target Volume | Active comparator | Non Invasive Pressure Support Ventilation with Target Volume set Receives: Device: Breas Vivo 40 |
| NIV-CPAP | Active comparator | Pressure Support Ventilation in CPAP mode Receives: Device: Breas Vivo 40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone
Measured: 6 weeks
Secondary outcomes (8)
Evolution in dyspnea scores (BDI/TDI and Simon Score)
Measured: 6 weeks
Evolution of subjective and objective sleepness (Osler)
Measured: 6 weeks
Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test)
Measured: 6 weeks
Evolution of blood inflammation (IL6, TNFα et CRP)
Measured: 6 weeks
Evolution of insulin résistance
Measured: 6 weeks
Compliance (hours of treatment)
Measured: 6 weeks
Evolution of quality of ventilation (Leaks, asynchronism, others events)
Measured: 6 weeks
Sleep quality (PSG) between the 3 groups at 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Stopped by the sponsor
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Breas Medical S.A.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pepin, prof, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104610
- Sponsor's protocol ID
- OVO-2009
- Acronym
- OVO
- Status last verified
- Jul 2017
- First submitted
- 14 Apr 2010
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Volume With a Pressure Controlled Ventilator in Obesity Hypoventilation Syndrome With Persistent Oxygen Desaturations With Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT01104610
- Acronym / sponsor ID
- OVO / OVO-2009
- Conditions
- Obesity Hypoventilation Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Stopped by the sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Breas Medical S.A.R.L.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Apr 2010 (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.
The purpose of this study is to investigate the evolution of daytime partial pressure of carbon dioxide in the blood (PaCO2) after 6 weeks of noninvasive ventilation-pressure support ventilation (NIV-PSV) with target volume versus continuous positive airway pressure (CPAP) alone versus NIV-PSV.
Detailed description
Compare the efficacy between 3 ventilation modes (CPAP, PSV and PSV with Target Volume) on patients with obesity hypoventilation syndrome already treated with CPAP but with persistent desaturations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NIV-PSV without Target Volume | Active comparator | Device: Breas Vivo 40Pressure Support Non Invasive Ventilation without Target Volume |
| NIV-PSV with Target Volume | Active comparator | Device: Breas Vivo 40Non Invasive Pressure Support Ventilation with Target Volume set |
| NIV-CPAP | Active comparator | Device: Breas Vivo 40Pressure Support Ventilation in CPAP mode |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients from 20 to 75 years old.
- Body mass index > 32 kg/m2
- Nocturnal oxygen desaturation 5 mn ≤ 88% under CPAP,
- PaCO2 > 5,9 kPa in diurnal, spontaneous ventilation
Key exclusion criteria (3 listed)
- Patients with COPD and VEMS/FVC < 65%
- Patients with CHF and periodic breathing (Ejection Fraction <40%)
- Patients with a recent respiratory decompensation in the month preceding 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 |
|---|---|---|
| Breas Vivo 40Also: Breas Vivo 40 target volumeThe Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume | Device | NIV-CPAP, NIV-PSV with Target Volume, NIV-PSV without Target Volume |
Primary outcome
Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone
Time frame: 6 weeks
8 secondary outcomes
Evolution in dyspnea scores (BDI/TDI and Simon Score)
Time frame: 6 weeks
Evolution of subjective and objective sleepness (Osler)
Time frame: 6 weeks
Cardiovascular parameters on Arterial strength (pulse velocity) and Endothelial function (Post ischemic test)
Time frame: 6 weeks
Evolution of blood inflammation (IL6, TNFα et CRP)
Time frame: 6 weeks
Evolution of insulin résistance
Time frame: 6 weeks
Compliance (hours of treatment)
Time frame: 6 weeks
Evolution of quality of ventilation (Leaks, asynchronism, others events)
Time frame: 6 weeks
Sleep quality (PSG) between the 3 groups at 6 weeks
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
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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, prof principal investigator
University Hospital, Grenoble
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breas Vivo 40 in people with Obesity Hypoventilation Syndrome, run by Breas Medical S.A.R.L. at 2 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 3 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: withdrawn, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 withdrawn before enrolling participants, so there are no results.
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?
Evolution of daytime PaCO2 of NIV without target volume, with Target volume and with CPAP alone (time frame: 6 weeks). 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 13 Jul 2017.