Continuous Positive Airway Pressure (CPAP) Mode Impact on Clinical Blood Arterial Pressure (AgirSASadom)
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
S8 Spirit 2
Somnosmart 2
Remstar Auto
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring Obstructive Sleep Apnea Syndrome, Blood pressure, Continuous Positive Airway Pressure
Eligibility Criteria
Inclusion Criteria:
- age between 18 and 80 years
- patients who gave written informed consent
- patients who subscribed a social insurance
- SAOS patients who need CPAP treatment.
Exclusion Criteria:
- cardiac failure known and treated
- central Apnea syndrome
- patients who stopped CPAP treatment in the previous year
- pregnant women
- patients under guardianship
- imprisoned patients, patients in hospital
- patients included in an other clinical study
Sites / Locations
- AGIR à Dom
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fixed pressure
Auto-adjusting pressure
Arm Description
Outcomes
Primary Outcome Measures
Clinical blood pressure
Secondary Outcome Measures
Pulse Wave Velocity
24 hours Blood Pressure measure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01090297
Brief Title
Continuous Positive Airway Pressure (CPAP) Mode Impact on Clinical Blood Arterial Pressure
Acronym
AgirSASadom
Official Title
CPAP Treatment : Fixed Versus Auto-adjusting Mode Impact on Clinical Blood Arterial Pressure. Randomised, Controlled and Double Blinded Trial in SAOS Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AGIR à Dom
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: Continuous positive airway pressure (CPAP) is the first line therapy for obstructive sleep apnea syndrome (OSAS). Two positive airway pressure (PAP) modalities can be used: Fixed pressure, in which the effective pressure is set and kept constant all night, and auto CPAP devices where the positive pressure changes during the night depend on patient's requirements.
Hypothesis: Pressure variations associated with autoCPAP functioning can lead to sleep fragmentation and alterations in sleep structure. This can limit blood pressure dipping during sleep and then impact clinical blood pressure reduction.
Main objective: To compare in a randomized controlled trial 4 months clinical blood pressure (BP) evolution depending on CPAP mode: fixed pressure versus autoCPAP. Secondary outcomes: Evolution of arterial stiffness, biological parameters, quality of life and symptoms.
Methods: Patients will be randomised depending on CPAP mode. Baseline and 4 months evaluation will include: 24-h ambulatory blood pressure monitoring, clinical BP measurements and carotid-to-femoral pulse wave velocity (PWV). Patients will also complete quality of life and symptoms questionnaires.
2 interim analysis will be carried out when 150 and 220 patients respectively will have completed the study. The Peto's method will be used to correct the p-values.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
Obstructive Sleep Apnea Syndrome, Blood pressure, Continuous Positive Airway Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
322 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fixed pressure
Arm Type
Active Comparator
Arm Title
Auto-adjusting pressure
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
S8 Spirit 2
Intervention Description
3 types of Continuous Positive Airway Pressure (CPAP) device: S8 Spirit 2, Somnosmart 2, Remstar Auto.
These 3 types of CPAP can be set in both mode of pressure.
Intervention Type
Device
Intervention Name(s)
Somnosmart 2
Intervention Description
3 types of Continuous Positive Airway Pressure (CPAP) device: S8 Spirit 2, Somnosmart 2, Remstar Auto.
These 3 types of CPAP can be set in both mode of pressure.
Intervention Type
Device
Intervention Name(s)
Remstar Auto
Intervention Description
3 types of Continuous Positive Airway Pressure (CPAP) device: S8 Spirit 2, Somnosmart 2, Remstar Auto.
These 3 types of CPAP can be set in both mode of pressure.
Primary Outcome Measure Information:
Title
Clinical blood pressure
Time Frame
Before treatment, 4 months after treatment
Secondary Outcome Measure Information:
Title
Pulse Wave Velocity
Time Frame
Before treatment, 4 months after treatment
Title
24 hours Blood Pressure measure
Time Frame
Before treatment, after 4 months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 18 and 80 years
patients who gave written informed consent
patients who subscribed a social insurance
SAOS patients who need CPAP treatment.
Exclusion Criteria:
cardiac failure known and treated
central Apnea syndrome
patients who stopped CPAP treatment in the previous year
pregnant women
patients under guardianship
imprisoned patients, patients in hospital
patients included in an other clinical study
Facility Information:
Facility Name
AGIR à Dom
City
Meylan
ZIP/Postal Code
38240
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
27091542
Citation
Pepin JL, Tamisier R, Baguet JP, Lepaulle B, Arbib F, Arnol N, Timsit JF, Levy P. Fixed-pressure CPAP versus auto-adjusting CPAP: comparison of efficacy on blood pressure in obstructive sleep apnoea, a randomised clinical trial. Thorax. 2016 Aug;71(8):726-33. doi: 10.1136/thoraxjnl-2015-207700. Epub 2016 Apr 18.
Results Reference
derived
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Continuous Positive Airway Pressure (CPAP) Mode Impact on Clinical Blood Arterial Pressure
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