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
1 other identifier
interventional
800
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2013
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
April 25, 2016
CompletedApril 25, 2016
April 1, 2016
2.7 years
April 11, 2016
April 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Constant Continuous Positive Airway Pressure
EXPERIMENTALautomatic Continuous Positive Airway Pressure
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Adult patients \> 18 with severe OSAS (AHI \> 30/h)
- Patients naive of any previous OSAS treatment
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2016
First Posted
April 25, 2016
Study Start
January 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
April 25, 2016
Record last verified: 2016-04