Obstructive Sleep Apnea SyndromeNCT00875680
Efficacy of autoPPC for the Treatment of Obstructive Sleep Apnea Syndrome (OSAS)
A study testing autoPPC in people with Obstructive Sleep Apnea Syndrome, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche at 2 sites in France.
Trial summary
Obstructive Sleep Apnea Syndrome (OSAS) is a common condition that leads to daytime sleepiness and loss of vigilance and, in addition, increased risk of cardiovascular events. The most effective treatment consists in ventilation by mask with continuous positive airway pressure (CPAP), that prevents collapse of the… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- autoPPC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- May 2009to Jun 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with obstructive sleep apnea syndrome and indication for autoPPC
Who cannot join
- Patients with COPD, or evolutive heart disease Patients with evolutive cancer Patients already with PPC machine Patients simultaneously included in another clinical study.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 1 recruiting
- Recruiting
MEURICE
Poitiers, 86021
Jean Claude MEURICE, +33.5.49.44.43.87
- Active, not recruiting
Service explorations fonctionnelles - Hopital La Miletrie
Poitiers, 86021
About this study
Official title: Evaluation of the Efficacy of Autoadjusted Positive Pressure Devices for the Treatment of Obstructive Sleep Apnea Syndrome
Obstructive Sleep Apnea Syndrome (OSAS) is a common condition that leads to daytime sleepiness and loss of vigilance and, in addition, increased risk of cardiovascular events. The most effective treatment consists in ventilation by mask with continuous positive airway pressure (CPAP), that prevents collapse of the upper airway. However the degree of collapsibility of the pharynx may vary in relation to position, sleep stage, or alcohol or sedative consumption. Thus, CPAP treatment (invented in 1981) has evolved with the development of more sophisticated equipment that permits adapted variations in pressure levels (autoCPAP) with the objective adjusted pressure to avoid airways obstruction with minimal pressure.
Different models of autoCPAP function with different signals and event detection algorithms with different modes of reaction to events. These machines are marketed with CE certification, that guarantees electrical security, but there is to date, no requirement for pre-marketing clinical validation. Nonetheless inadequate treatment may leave patients at risk of accidents and cardiovascular events. These machines can be bench tested using test equipment that can measure with accuracy the response to simulated events, but the testing equipment cannot simulate the diversity of clinical situations, nor the residual level of microarousals that may persist. Thus these bench tests need to be supplemented by clinical studies. The investigators objective is to test the efficacy of these machines on residual sleep-related events during a one night autotitration polysomnography. We develop a prospective, multicentre, non randomised study with autotitration polysomnography only for one night. These clinical results will be compared with the results of bench tests in order to evaluate the pertinence of the bench tests and their eventual utility to simplify clinical evaluation. The perspective of developing a reliable testing protocol may eventually play a role in the certification of these machines.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- autoPPC
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autoPPCDevice
To test the efficacy of autoPPC machines on residual sleep-related events during a one night autotitration polysomnography.
| Study group | Role | What they receive |
|---|---|---|
| autoPPC | Experimental | Not described Receives: Device: autoPPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual sleep-related events .
Measured: One night of polysomnography
Secondary outcomes (1)
Tolerance and confort of the autoPPC machine
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2011
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
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, Daniel VEALE, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
- Investigators
- Jean Claude MEURICE, Pr, Principal investigator, Service explorations fonctionnelles. Hopital La miletrie . POITIERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875680
- Sponsor's protocol ID
- ANTADIR CMTS autoPPC 2009
- Status last verified
- Feb 2012
- First submitted
- 2 Apr 2009
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Autoadjusted Positive Pressure Devices for the Treatment of Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT00875680
- Acronym / sponsor ID
- ANTADIR CMTS autoPPC 2009
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Association Nationale pour les Traitements A Domicile, les Innovations et la RechercheUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2014 (estimated)
- First posted
- 3 Apr 2009 (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.
Obstructive Sleep Apnea Syndrome (OSAS) is a common condition that leads to daytime sleepiness and loss of vigilance and, in addition, increased risk of cardiovascular events. The most effective treatment consists in ventilation by mask with continuous positive airway pressure (CPAP), that prevents collapse of the upper airway. However the degree of collapsibility of the pharynx may vary in relation to position, sleep stage, or alcohol or sedative consumption. Thus, CPAP treatment (invented in 1981) has evolved with the development of more sophisticated equipment that permits adapted variations in pressure levels (autoCPAP) with the objective adjusted pressure to avoid airways obstruction with minimal pressure.
Different models of autoCPAP function with different signals and event detection algorithms with different modes of reaction to events. These machines are marketed with CE certification, that guarantees electrical security, but there is to date, no requirement for pre-marketing clinical validation. Nonetheless inadequate treatment may leave patients at risk of accidents and cardiovascular events. These machines can be bench tested using test equipment that can measure with accuracy the response to simulated events, but the testing equipment cannot simulate the diversity of clinical situations, nor the residual level of microarousals that may persist. Thus these bench tests need to be supplemented by clinical studies. The investigators objective is to test the efficacy of these machines on residual sleep-related events during a one night autotitration polysomnography. We develop a prospective, multicentre, non randomised study with autotitration polysomnography only for one night. These clinical results will be compared with the results of bench tests in order to evaluate the pertinence of the bench tests and their eventual utility to simplify clinical evaluation. The perspective of developing a reliable testing protocol may eventually play a role in the certification of these machines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autoPPC | Experimental | Device: autoPPC |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with obstructive sleep apnea syndrome and indication for autoPPC
Key exclusion criteria (1 listed)
- Patients with COPD, or evolutive heart disease Patients with evolutive cancer Patients already with PPC machine Patients simultaneously included in another clinical 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 |
|---|---|---|
| autoPPCTo test the efficacy of autoPPC machines on residual sleep-related events during a one night autotitration polysomnography. | Device | autoPPC |
Primary outcome
Residual sleep-related events .
Time frame: One night of polysomnography
1 secondary outcome
Tolerance and confort of the autoPPC machine
Time frame: one night
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2012.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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 Claude MEURICE, Pr principal investigator
Service explorations fonctionnelles. Hopital La miletrie . POITIERS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autoPPC in people with Obstructive Sleep Apnea Syndrome, run by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche 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 1 inclusion and 1 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 10 Feb 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Claude MEURICE, Pr (05 49 44 43 87, meurice@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual sleep-related events . (time frame: One night of polysomnography). 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 10 Feb 2012.