Continuous Positive Airway Pressure (CPAP) Mode Impact on Clinical Blood Arterial Pressure

Study Overview
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Brief Summary
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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.

Official Title
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CPAP Treatment : Fixed Versus Auto-adjusting Mode Impact on Clinical Blood Arterial Pressure. Randomised, Controlled and Double Blinded Trial in SAOS Patients

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Device: S8 Spirit 2
* Device: Somnosmart 2
* Device: Remstar Auto


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fixed pressure<br> | Device: S8 Spirit 2<br>* 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.<br>Device: Somnosmart 2<br>* 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.<br>Device: Remstar Auto<br>* 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.<br>|
| Active Comparator: Auto-adjusting pressure<br> | Device: S8 Spirit 2<br>* 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.<br>Device: Somnosmart 2<br>* 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.<br>Device: Remstar Auto<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical blood pressure |  | Before treatment, 4 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse Wave Velocity |  | Before treatment, 4 months after treatment | 
| 24 hours Blood Pressure measure |  | Before treatment, after 4 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea Syndrome, Blood pressure, Continuous Positive Airway Pressure