Clinical trial NCT02749812: Interest of Treatment of Obstructive Sleep Apnea Syndrome by Constant CPAP and Auto CPAP
Official title: Beneficial Effects of Obstructive Sleep Apnea Syndrome (OSAS) Treatment by Automatic Continuous Positive Airway Pressure (APAP) vs Constant Continuous Positive Airway Pressure (Constant CPAP) According to the Level of the Efficient Pressure and Its Variability. A Multicentric Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndromes
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: A combined score that takes into account the residual apnea hypopnea index (AHI) under CPAP associated with the value of the Epworth score after 3 months of treatment.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: