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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier:
NCT00875680
First received: April 2, 2009
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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 Intervention
Obstructive Sleep Apnea Syndrome
Device: autoPPC

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Autoadjusted Positive Pressure Devices for the Treatment of Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:

Primary Outcome Measures:
  • Residual sleep-related events . [ Time Frame: One night of polysomnography ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerance and confort of the autoPPC machine [ Time Frame: one night ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: May 2009
Estimated Study Completion Date: June 2014
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: autoPPC Device: autoPPC
To test the efficacy of autoPPC machines on residual sleep-related events during a one night autotitration polysomnography.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875680

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

Locations
France
Service explorations fonctionnelles - Hopital La Miletrie Active, not recruiting
Poitiers, France, 86021
MEURICE Recruiting
Poitiers, France, 86021
Contact: Jean Claude MEURICE    +33.5.49.44.43.87      
Sponsors and Collaborators
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Investigators
Principal Investigator: Jean Claude MEURICE, Pr Service explorations fonctionnelles. Hopital La miletrie . POITIERS
  More Information

No publications provided

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
Study First Received: April 2, 2009
Last Updated: February 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on July 22, 2014