Efficacy of autoPPC for the Treatment of Obstructive Sleep Apnea Syndrome (OSAS)
Evaluation of the Efficacy of Autoadjusted Positive Pressure Devices for the Treatment of Obstructive Sleep Apnea Syndrome
1 other identifier
interventional
20
1 country
2
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFebruary 10, 2012
February 1, 2012
2.1 years
April 2, 2009
February 9, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Residual sleep-related events .
One night of polysomnography
Secondary Outcomes (1)
Tolerance and confort of the autoPPC machine
one night
Study Arms (1)
autoPPC
EXPERIMENTALInterventions
To test the efficacy of autoPPC machines on residual sleep-related events during a one night autotitration polysomnography.
Eligibility Criteria
You may qualify if:
- Patients with obstructive sleep apnea syndrome and indication for autoPPC
You may not qualify if:
- Patients with COPD, or evolutive heart disease Patients with evolutive cancer Patients already with PPC machine Patients simultaneously included in another clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
MEURICE
Poitiers, 86021, France
Service explorations fonctionnelles - Hopital La Miletrie
Poitiers, 86021, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Claude MEURICE, Pr
Service explorations fonctionnelles. Hopital La miletrie . POITIERS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor (co-investigator)
Study Record Dates
First Submitted
April 2, 2009
First Posted
April 3, 2009
Study Start
May 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2014
Last Updated
February 10, 2012
Record last verified: 2012-02