Interest of Treatment of Obstructive Sleep Apnea Syndrome by Constant CPAP and Auto CPAP

NCT ID: NCT02749812

Last Updated: 2016-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-09-30

Brief Summary

The investigators propose a multicentric controlled randomized trial whose goal is to evaluate the possibility of a prediction of the efficiency of APAP (automatic continuous positive airway pressure) and constant CPAP (constant positive airway pressure) in 800 severe obstructive sleep apnea syndrome (OSAS) patients according to their profile of pressure variability.

Detailed Description

Multicenter open randomized clinical trial involving 800 patients with severe OSAS. After inclusion in the study, the patients will be proposed to initiate CPAP at home (ResMed S9 or PHILIPS PR1) using systematically an APAP mode between wide range of pressure variations (4 to 20 cm H2O) during the first 7day-period of time. After this first period of treatment, an analysis of the report will be released from the APAP in order evaluate the residual AHI, the duration of CPAP use and the amount of leaks in order to confirm CPAP efficiency and observance. Pressure parameters (efficient pressure and variability) will be collected. After randomization according to the further mode of ventilation to use (APAP vs constant CPAP), the patients will be treated at home for 3 months. In the constant CPAP group, efficient pressure will be determined as the P95 (ResMed) or the P90 (PHILIPS) as recommended by the manufacturers, while in the APAP group, the patients will be treated within the same range of pressure variations than during the first 7 day-period. Clinical and polygraphic evaluation will be done after 3 months of treatment, using the combined criteria previously described. In each group, results will be considered according to the efficient pressure value and its variability that were evaluated at the end of the first 7 day-period of treatment

Conditions

Obstructive Sleep Apnea Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Constant Continuous Positive Airway Pressure

Group Type: EXPERIMENTAL

Constant Continuous Positive Airway Pressure

Intervention Type: DEVICE

automatic Continuous Positive Airway Pressure

Group Type: EXPERIMENTAL

Automatic continuous Positive Airway Pressure

Intervention Type: DEVICE

Interventions

Constant Continuous Positive Airway Pressure

Intervention Type: DEVICE

Automatic continuous Positive Airway Pressure

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients > 18 with severe OSAS (AHI > 30/h)
• Patients naive of any previous OSAS treatment
• Written informed consent

Exclusion Criteria

Patients

• with more than 20% of central events at the initial polygraphic recording
• previously treated by CPAP
• previously treated for OSAS by any surgical procedure involving upper airways
• < 18
• with cardiac insufficiency
• with Chronic Obstructive Pulmonary Disease or obesity-hypoventilation syndrome
• without health insurance
• pregnant or lactating
• presumed uncooperativeness or legal incapacity

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PREDIVARIUS

Identifier Type: -

Identifier Source: org_study_id