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Efficacy of autoPPC for the Treatment of Obstructive Sleep Apnea Syndrome (OSAS)

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ClinicalTrials.gov Identifier: NCT00875680
Recruitment Status : Unknown
Verified February 2012 by Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire.
Recruitment status was:  Recruiting
First Posted : April 3, 2009
Last Update Posted : February 10, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Syndrome Device: autoPPC

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Autoadjusted Positive Pressure Devices for the Treatment of Obstructive Sleep Apnea Syndrome
Study Start Date : May 2009
Primary Completion Date : June 2011
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: autoPPC Device: autoPPC
To test the efficacy of autoPPC machines on residual sleep-related events during a one night autotitration polysomnography.

Outcome Measures

Primary Outcome Measures :
  1. Residual sleep-related events . [ Time Frame: One night of polysomnography ]

Secondary Outcome Measures :
  1. Tolerance and confort of the autoPPC machine [ Time Frame: one night ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with obstructive sleep apnea syndrome and indication for autoPPC

Exclusion Criteria:

  • Patients with COPD, or evolutive heart disease Patients with evolutive cancer Patients already with PPC machine Patients simultaneously included in another clinical study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875680

Contact: Jean Claude MEURICE, Pr 05 49 44 43 87 meurice@chu-poitiers.fr

MEURICE Recruiting
Poitiers, France, 86021
Contact: Jean Claude MEURICE    +      
Service explorations fonctionnelles - Hopital La Miletrie Active, not recruiting
Poitiers, France, 86021
Sponsors and Collaborators
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Principal Investigator: Jean Claude MEURICE, Pr Service explorations fonctionnelles. Hopital La miletrie . POITIERS
More Information

Responsible Party: Daniel VEALE, Doctor (co-investigator), Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier: NCT00875680     History of Changes
Other Study ID Numbers: ANTADIR CMTS autoPPC 2009
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases