Obstructive Sleep Apnea Syndrome
Conditions
Keywords
Obstructive Sleep Apnea Syndrome, Blood pressure, Continuous Positive Airway Pressure
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.
Interventions
DEVICES8 Spirit 2
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.
DEVICESomnosmart 2
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.
DEVICERemstar Auto
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.
Sponsors
AGIR à Dom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical blood pressure | Before treatment, 4 months after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Pulse Wave Velocity | Before treatment, 4 months after treatment |
| 24 hours Blood Pressure measure | Before treatment, after 4 months of treatment |
Countries
France
Outcome results
None listed