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

Poitiers University Hospital

Status: Completed

Conditions: Obstructive Sleep Apnea Syndromes

Treatments: Device: Constant Continuous Positive Airway Pressure; Device: Automatic continuous Positive Airway Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT02749812

PREDIVARIUS

Details and patient eligibility

About

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.

Full 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

Enrollment: 800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

Constant Continuous Positive Airway Pressure

Experimental group

Treatment:

Device: Constant Continuous Positive Airway Pressure

automatic Continuous Positive Airway Pressure

Experimental group

Treatment:

Device: Automatic continuous Positive Airway Pressure