Obesity-Hypoventilation Syndrome (OHS)NIV-OHSNCT00603096
Use of Polysomnography for Non-Invasive Ventilation Settings' Optimization
A study testing GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare in people with Obesity-Hypoventilation Syndrome (OHS), run by Tyco Healthcare Group at 1 site in France.
Trial summary
The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obesity-Hypoventilation Syndrome (OHS)
- What is being tested?
- GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2006to Jun 2008
- 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
- Patient male or female, aged 20 to 75 years
- Patient with a OHS in stable condition, with a BMI> 32 kg/m2 and a PaCO2> 6 kPa in diurnal spontaneous breathing without other cause of alveolar hypoventilation
- Patient affiliated to a social security insurance
- Having given its written informed consent to participate to the study
Who cannot join
- Patients with inherent chronic obstructive pulmonary disease (COPD) with FEV1 on Forced Vital Capacity (FVC) ratio less than 70%
- Patients suffering from heart failure with periodic breathing
- Associated Neurological Diseases, evolving rapidly, leading to a dependency in daily activities
- Unbalanced Psychiatric Diseases
- Patients with a respiratory decompensation the month preceding the study
- Patients not autonomous in the use of the NIV
Show all 9Show fewer
- Pacemaker patients, constituting a contraindication to magnetic stimulation
- Sensitive subjects, in accordance with article L 1121-6 of the French Public Health Code
- Patients with long term by steroids or other anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
Maud Boucherie, CRA contact
France1 site, 1 recruiting
- Recruiting
Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires - CHU Grenoble
Grenoble, Cedex 9, 38043
Jean-Louis Pepin, Pr, JLPepin@chu-grenoble.fr
Jean-Christian Borel, JCBorel@chu-grenoble.fr
About this study
Official title: Interest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS)
The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.
Read the detailed description
Initiation of NIV treatment implies technical adjustments (choice of mask and ventilator), but also patient education by the nurses and medical staff. The settings are generally adjusted during the daytime in awake patients. The appropriateness of these settings is generally not optimal during sleep as many respiratory events (hypopnoea, apnea, leaks, desynchronization, and glottic closure) may occur under NIV then reducing the effectiveness of treatment. These nocturnal abnormalities are routinely evaluated by measuring their consequences, i.e. oxygen desaturation and the level of PaCO2 after wake up. Some teams are now proposing to better characterize what happens when using NIV during sleep using polysomnography (PSG). The precise characterization of residual events under treatment may allow optimizing ventilator settings.
- Conditions
- Obesity-Hypoventilation Syndrome (OHS)
- Being tested
- GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare
- 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.
GoodKnight 425ST - Mallinckrodt DF, Tyco HealthcareDevice
The aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients will benefit from a complete polysomnography under NIV Receives: Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare |
| 2 | Active comparator | settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas Receives: Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diurnal PaCO2
Measured: June 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJun 2006
- Primary completionJun 2008 (estimated)
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity-Hypoventilation Syndrome (OHS)Studies 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
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tyco Healthcare Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Louis pepin, Pr, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603096
- Sponsor's protocol ID
- 38/2006/2
- Other IDs
- Ethics Comittee ref.06-TYCO-1
- Acronym
- NIV-OHS
- Status last verified
- Jan 2008
- First submitted
- 15 Jan 2008
- Last updated
- 28 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Borel JC, Tamisier R, Gonzalez-Bermejo J, Baguet JP, Monneret D, Arnol N, Roux-Lombard P, Wuyam B, Levy P, Pepin JL. Noninvasive ventilation in mild obesity hypoventilation syndrome: a randomized controlled trial. Chest. 2012 Mar;141(3):692-702. doi: 10.1378/chest.10-2531. Epub 2011 Sep 1.
PubMed 21885724Borel JC, Roux-Lombard P, Tamisier R, Arnaud C, Monneret D, Arnol N, Baguet JP, Levy P, Pepin JL. Endothelial dysfunction and specific inflammation in obesity hypoventilation syndrome. PLoS One. 2009 Aug 24;4(8):e6733. doi: 10.1371/journal.pone.0006733.
PubMed 19701463
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Using Nocturnal Polysomnography for Non-Invasive Ventilation (NIV) Settings' Optimization in Obesity-Hypoventilation Syndrome (OHS)
- ClinicalTrials.gov ID
- NCT00603096
- Acronym / sponsor ID
- NIV-OHS / 38/2006/2
- Conditions
- Obesity-Hypoventilation Syndrome (OHS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tyco Healthcare GroupIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jun 2008 (estimated)
- Study completion
- Jun 2008 (estimated)
- First posted
- 28 Jan 2008 (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 aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV.
Detailed description
Initiation of NIV treatment implies technical adjustments (choice of mask and ventilator), but also patient education by the nurses and medical staff. The settings are generally adjusted during the daytime in awake patients. The appropriateness of these settings is generally not optimal during sleep as many respiratory events (hypopnoea, apnea, leaks, desynchronization, and glottic closure) may occur under NIV then reducing the effectiveness of treatment. These nocturnal abnormalities are routinely evaluated by measuring their consequences, i.e. oxygen desaturation and the level of PaCO2 after wake up. Some teams are now proposing to better characterize what happens when using NIV during sleep using polysomnography (PSG). The precise characterization of residual events under treatment may allow optimizing ventilator settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcarepatients will benefit from a complete polysomnography under NIV |
| 2 | Active comparator | Device: GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcaresettings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient male or female, aged 20 to 75 years
- Patient with a OHS in stable condition, with a BMI> 32 kg/m2 and a PaCO2> 6 kPa in diurnal spontaneous breathing without other cause of alveolar hypoventilation
- Patient affiliated to a social security insurance
- Having given its written informed consent to participate to the study
Key exclusion criteria (9 listed)
- Patients with inherent chronic obstructive pulmonary disease (COPD) with FEV1 on Forced Vital Capacity (FVC) ratio less than 70%
- Patients suffering from heart failure with periodic breathing
- Associated Neurological Diseases, evolving rapidly, leading to a dependency in daily activities
- Unbalanced Psychiatric Diseases
- Patients with a respiratory decompensation the month preceding the study
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 |
|---|---|---|
| GoodKnight 425ST - Mallinckrodt DF, Tyco HealthcareThe aim of this randomized controlled trial is comparing the improvement of diurnal PaCO2 in OHS patients after one month of NIV treatment depending upon the tools used for adjusting settings. In one arm settings will be adjusted using only nocturnal oxygen SaO2 and PaCO2 at awakening whereas in the other arm patients will benefit from a complete polysomnography under NIV. | Device | 1, 2 |
Primary outcome
Diurnal PaCO2
Time frame: June 2008
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2008.
- Derived from this study: PubMed 21885724Borel JC, Tamisier R, Gonzalez-Bermejo J, Baguet JP, Monneret D, Arnol N, Roux-Lombard P, Wuyam B, Levy P, Pepin JL. Noninvasive ventilation in mild obesity hypoventilation syndrome: a randomized controlled trial. Chest. 2012 Mar;141(3):692-702. doi: 10.1378/chest.10-2531. Epub 2011 Sep 1.
- Derived from this study: PubMed 19701463Borel JC, Roux-Lombard P, Tamisier R, Arnaud C, Monneret D, Arnol N, Baguet JP, Levy P, Pepin JL. Endothelial dysfunction and specific inflammation in obesity hypoventilation syndrome. PLoS One. 2009 Aug 24;4(8):e6733. doi: 10.1371/journal.pone.0006733.
Related trials for Obesity-Hypoventilation Syndrome (OHS)
Not yet recruiting
Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea
Obstructive Sleep Apnea, Obesity (BMI>30)
RecruitingObservational study
The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
Bronchial Asthma, Bronchiectasis
Not yet recruiting
The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Recruiting
Assessment of Breathing Pattern During NIV
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Not yet recruitingObservational study
Evaluation of Upper Extremity Functions in Obesity Hypoventilation Syndrome Patients
Obesity Hypoventilation Syndrome (OHS)
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.
Maud Boucherie, CRA contact
Jean-Louis pepin, Pr principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GoodKnight 425ST - Mallinckrodt DF, Tyco Healthcare in people with Obesity-Hypoventilation Syndrome (OHS), run by Tyco Healthcare Group 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Jan 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maud Boucherie, CRA (maud.boucherie@covidien.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diurnal PaCO2 (time frame: June 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00603096, which also lists 2 linked publications.
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 28 Jan 2008.