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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndromes
• Intervention / Treatment: Device: Constant Continuous Positive Airway Pressure; Device: Automatic continuous Positive Airway Pressure

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

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Constant Continuous Positive Airway Pressure	Device: Constant Continuous Positive Airway Pressure
Experimental: automatic Continuous Positive Airway Pressure	Device: Automatic continuous Positive Airway Pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The main objective of this study is to evaluate the ability to predict the mode of CPAP to use (APAP vs constant CPAP) in the treatment of OSAS patients, according to their own level of efficient pressure and its variability obtained on CPAP report after the first 7 days of use in an initial and systematic APAP mode. This prediction will be evaluated by using the association of the residual AHI value under CPAP and the Epworth score value obtained after 3 months of treatment, in each group of CPAP mode (constant vs APAP) used during the study. This combined criteria will be used according an ordinal scale with six levels of severity. It will be evaluated in each group (constant CPAP vs APAP) according to the level of P90 or P95 and the degree of pressure variability obtained during the first 7 day-period of use.	3 months

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 20, 2016
• First Posted (Estimate): April 25, 2016

Study Record Updates

• Last Update Posted (Estimate): April 25, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: April 1, 2016

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: PREDIVARIUS