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

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 Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: autoPPC

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean Claude MEURICE, Pr; Phone Number: 05 49 44 43 87; Email: meurice@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France, 86021
    • Recruiting
    • MEURICE
    • Contact: Jean Claude MEURICE; Phone Number: +33.5.49.44.43.87
  • Poitiers, France, 86021
    • Active, not recruiting
    • Service explorations fonctionnelles - Hopital La Miletrie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Residual sleep-related events .	One night of polysomnography

Secondary Outcome Measures

Outcome Measure	Time Frame
Tolerance and confort of the autoPPC machine	one night

Collaborators and Investigators

• Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
• Investigators: Principal Investigator: Jean Claude MEURICE, Pr, Service explorations fonctionnelles. Hopital La miletrie . POITIERS

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: April 2, 2009
• First Submitted That Met QC Criteria: April 2, 2009
• First Posted (Estimate): April 3, 2009

Study Record Updates

• Last Update Posted (Estimate): February 10, 2012
• Last Update Submitted That Met QC Criteria: February 9, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: ANTADIR CMTS autoPPC 2009