Obesity Hypoventilation SyndromeNCT01757444
Non Invasive Ventilation : Efficacy of a New Ventilatory Mode in Patients With OHS
A study testing BiPAP - A40 and BiPAP - ST in people with Obesity Hypoventilation Syndrome, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 11 sites in France.
Trial summary
In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could offer potential advantages over fixed level pressure support, in particular, in patients with obesity hypoventilation syndrome (OHS). Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Obesity Hypoventilation Syndrome
- What is being tested?
- BiPAP - A40 and BiPAP - ST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 11 sitesFrance
- Study dates
- Jun 2013to Sep 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman, stable patient with obesity hypoventilation syndrome, naives of non invasive ventilation.
- PaCO2 ≥ 45 mmHg.
- PaO2 < 70 mmHg
- BMI ≥ 30Kg. m2
Who cannot join
- Chronic obstructive pulmonary disease
- Neuromuscular disease
- Scoliosis
- Cardiac insufficiency
- Significant psychiatric disease
- Sleep apnea syndrome with central apnea index > 10%
- Treatment with benzodiazepines at the inclusion
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Centre Hospitalier Universitaire d'Angers
Angers
Centre Hospitalier de Béziers
Béziers
Hôpital Haut- Lévêque
Bordeaux
Centre Hospitalier de Cannes
Cannes
Clinique du Parc
Castelnau-le-Lez
Hôpital du Bocage
Dijon
Hôpital Michallon
Grenoble
Hôpital Pitié-Salpêtrière
Paris
Hôpital La Milétrie
Poitiers
Hôpital de Bois Guillaume
Rouen
Hôpital Larrey
Toulouse
About this study
Official title: Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrome (OHS).
In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could offer potential advantages over fixed level pressure support, in particular, in patients with obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency while delivering the correct level of ventilation each user requires, whatever their body position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the initial titration of therapy, while providing long term comfort and assuring therapy compliance. However, studies on the physiologic and clinical effects have not yet been performed. The aim of our singled-blind randomised multicentre controlled trial is to prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange, symptoms, body composition, level of physical activity and health-related quality of life in OHS patients.
Read the detailed description
Efficacy on sleep quality, symptoms, physical activity and quality of life
- Conditions
- Obesity Hypoventilation Syndrome
- Being tested
- BiPAP - A40, BiPAP - ST
- 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.
BiPAP - A40Device
Patients receiving BiPAP AVAPS - AE ventilatory mode at home
BiPAP - STDevice
Patients receiving BiPAP- ST mode at home.
| Study group | Role | What they receive |
|---|---|---|
| BiPAP - A40 | Experimental | BiPAP with AVAPS AE mode Receives: Device: BiPAP - A40 |
| BiPAP- ST | Active comparator | Patients receiving BiPAP- ST at home Receives: Device: BiPAP - ST |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHANGE IN SLEEP QUALITY
Sleep stage, micro arousals, apnea/hypopnea index...
Measured: Day 1 and Day 61
Secondary outcomes (1)
CHANGE IN GAZ EXCHANGE
Measured: Day 1 and Day 61
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startJun 2013
- Primary completionSep 2018
- Study completionSep 2018
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DELRIEU Jacqueline, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Investigators
- Jean-François MUIR, Pr, Principal investigator, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757444
- Sponsor's protocol ID
- 2012 - A00731 - 42
- Other IDs
- EVAL CLIN - VENTILATEUR
- Status last verified
- Sep 2018
- First submitted
- 17 Dec 2012
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Benefits and Tolerance to a New Ventilatory Mode in Patients With Obesity Hypoventilation Syndrome (OHS).
- ClinicalTrials.gov ID
- NCT01757444
- Acronym / sponsor ID
- 2012 - A00731 - 42
- Conditions
- Obesity Hypoventilation Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la RechercheUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 31 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.
In 2012, it has announced the availability of the new ventilator (BiPAP- A40), which could offer potential advantages over fixed level pressure support, in particular, in patients with obesity hypoventilation syndrome (OHS). One of the key benefits of the BiPAP A40 is an innovative ventilation mode called AVAPS-AE, which automatically maintains airway patency while delivering the correct level of ventilation each user requires, whatever their body position or sleep stage. AVAPS-AE mode is also aimed to help the clinicians during the initial titration of therapy, while providing long term comfort and assuring therapy compliance. However, studies on the physiologic and clinical effects have not yet been performed. The aim of our singled-blind randomised multicentre controlled trial is to prospectively investigate the effects of BiPAP with the spontaneous/timed (S/T) or the AVAPS-AE ventilation mode over 8 weeks on sleep quality, ventilation pattern, gas exchange, symptoms, body composition, level of physical activity and health-related quality of life in OHS patients.
Detailed description
Efficacy on sleep quality, symptoms, physical activity and quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiPAP - A40 | Experimental | Device: BiPAP - A40BiPAP with AVAPS AE mode |
| BiPAP- ST | Active comparator | Device: BiPAP - STPatients receiving BiPAP- ST at home |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man or woman, stable patient with obesity hypoventilation syndrome, naives of non invasive ventilation.
- PaCO2 ≥ 45 mmHg.
- PaO2 < 70 mmHg
- BMI ≥ 30Kg. m2
Key exclusion criteria (7 listed)
- Chronic obstructive pulmonary disease
- Neuromuscular disease
- Scoliosis
- Cardiac insufficiency
- Significant psychiatric disease
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 |
|---|---|---|
| BiPAP - A40Patients receiving BiPAP AVAPS - AE ventilatory mode at home | Device | BiPAP - A40 |
| BiPAP - STPatients receiving BiPAP- ST mode at home. | Device | BiPAP- ST |
Primary outcome
CHANGE IN SLEEP QUALITY
Time frame: Day 1 and Day 61
Sleep stage, micro arousals, apnea/hypopnea index...
1 secondary outcome
CHANGE IN GAZ EXCHANGE
Time frame: Day 1 and Day 61
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 11 Sep 2018.
Related trials for Obesity Hypoventilation Syndrome
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Not yet recruiting
Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea
Obstructive Sleep Apnea, Obesity (BMI>30)
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
RecruitingObservational study
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
Childhood Obesity, Morbid Obesity
Not yet recruiting
Prevalence of Nocturnal Hypoventilation in Obese Subjects Fiited With Continuous Positive Airway Pressure for Obstructive Sleep Apnea / Hypopnea Syndrome
Nocturnal Hypoventilation, Obesity
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-François MUIR, Pr principal investigator
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiPAP - A40 and BiPAP - ST in people with Obesity Hypoventilation Syndrome, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 11 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: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
CHANGE IN SLEEP QUALITY (time frame: Day 1 and Day 61). 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 Sep 2018.