Obesity Hypoventilation SyndromeCIBLENCT01748656
Target Volume in Noninvasive Positive Pressure Ventilation
A study testing IVAPS and AVAPS in people with Obesity Hypoventilation Syndrome, run by AGIR à Dom at 1 site in France.
Trial summary
Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined "ideal tidal volume" or "ideal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity Hypoventilation Syndrome
- What is being tested?
- IVAPS and AVAPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Feb 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with Obesity hypoventilation Syndrome (BMI≥ 30 kg/m2 and diurnal PaCO2 ≥ 45mmHg at diagnosis after exclusion of others causes of hypoventilation)
- 18 to 75 years old
- In stable state but treated by nocturnal NIPPV for more than 3 months and adherent to NIPPV (above 4h/night).
Who cannot join
- patient treated with additional long term Oxygen therapy
- Patient previously treated by AVAPS mode or IVAPS mode
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Noninvasive Positive Pressure Ventilation Devices Using Target Volume Modes in Obesity Hypoventilation Syndrome (OHS): A Pilot Randomized Crossover Controlled Trial
Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined "ideal tidal volume" or "ideal ventilation". However algorithms used to achieve these ideal targets are different among different commercialized devices and the relative efficacy from an algorithm compared to another remains unknown. The main objective is this study is to compare two commercialized NIPPV that have this option
Read the detailed description
RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).
- Conditions
- Obesity Hypoventilation Syndrome
- Being tested
- IVAPS, AVAPS
- Keywords
- Noninvasive ventilation, Obesity Hypoventilation Syndrome
- 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.
IVAPSDevice
IVAPS mode (RESMED Stelar 150) during 1 night
AVAPSDevice
AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night
| Study group | Role | What they receive |
|---|---|---|
| AVAPS | Active comparator | AVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night Receives: Device: IVAPS |
| IVAPS | Active comparator | IVAPS mode(STELAR 150-RESMED)1 night Receives: Device: AVAPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)
transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure.
Measured: 1 night
Secondary outcomes (6)
Mean transcutaneous CO2 pressure during REM Sleep
Measured: 1 Night
Mean nocturnal SpO2
Measured: 1 night
Awake arterial PaCO2 after 1 hour of NIPPV withdrawal
Measured: After 1 night
Micro-arousals/hour of sleep
Measured: 1 night
Sleep Quality assess by Visual analogic scale (100mm)
Measured: 1 night
Respiratory residual events detected by NIPPV built-in softwares
Measured: 1 Night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionFeb 2014
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed
- Responsible party
- Sponsor
- Investigators
- Jean Louis Pepin, MD PHD, Principal investigator, CHU Grenoble France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748656
- Sponsor's protocol ID
- 12-AGIR-02
- Acronym
- CIBLE
- Status last verified
- Dec 2012
- First submitted
- 11 Dec 2012
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Noninvasive Positive Pressure Ventilation Devices Using Target Volume Modes in Obesity Hypoventilation Syndrome (OHS): A Pilot Randomized Crossover Controlled Trial
- ClinicalTrials.gov ID
- NCT01748656
- Acronym / sponsor ID
- CIBLE / 12-AGIR-02
- Conditions
- Obesity Hypoventilation Syndrome
- Keywords
- Noninvasive ventilation, Obesity Hypoventilation Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Collaborators
- ResMed
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Dec 2012 (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.
Patients with OHS are efficiently managed with long term home-based nocturnal noninvasive positive pressure ventilation (NIPPV). Several NIPPV devices offer the feature of automatically adjusting pressure support (and/or respiratory back-up rate) on the basis of a pre-determined "ideal tidal volume" or "ideal ventilation". However algorithms used to achieve these ideal targets are different among different commercialized devices and the relative efficacy from an algorithm compared to another remains unknown. The main objective is this study is to compare two commercialized NIPPV that have this option
Detailed description
RESMED Stellar-150 (IVAPS mode)versus PHILIPS-RESPIRONICS A30 (AVAPS-mode).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVAPS | Active comparator | Device: IVAPSAVAPS mode(BIPAP-A30-PHILIPS-RESPIRONICS)1 night |
| IVAPS | Active comparator | Device: AVAPSIVAPS mode(STELAR 150-RESMED)1 night |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with Obesity hypoventilation Syndrome (BMI≥ 30 kg/m2 and diurnal PaCO2 ≥ 45mmHg at diagnosis after exclusion of others causes of hypoventilation)
- 18 to 75 years old
- In stable state but treated by nocturnal NIPPV for more than 3 months and adherent to NIPPV (above 4h/night).
Key exclusion criteria (2 listed)
- patient treated with additional long term Oxygen therapy
- Patient previously treated by AVAPS mode or IVAPS mode
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 |
|---|---|---|
| IVAPSIVAPS mode (RESMED Stelar 150) during 1 night | Device | AVAPS |
| AVAPSAVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night | Device | IVAPS |
Primary outcome
Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2)
Time frame: 1 night
transcutaneous CO2 pressure is measured overnight. It is a reliable estimation of arterial PaCO2 to monitor nocturnal ventilation in adults with chronic respiratory failure.
6 secondary outcomes
Mean transcutaneous CO2 pressure during REM Sleep
Time frame: 1 Night
Mean nocturnal SpO2
Time frame: 1 night
Awake arterial PaCO2 after 1 hour of NIPPV withdrawal
Time frame: After 1 night
Micro-arousals/hour of sleep
Time frame: 1 night
Sleep Quality assess by Visual analogic scale (100mm)
Time frame: 1 night
Respiratory residual events detected by NIPPV built-in softwares
Time frame: 1 Night
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 14 Mar 2014.
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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, MD PHD principal investigator
CHU Grenoble France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVAPS and AVAPS in people with Obesity Hypoventilation Syndrome, run by AGIR à Dom at 1 site 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 3 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 14 Mar 2014. 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 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?
Mean Nocturnal transcutaneous CO2 pressure (Mean nocturnal PtCO2) (time frame: 1 night). 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 14 Mar 2014.