Clinical trial NCT01090297: Continuous Positive Airway Pressure (CPAP) Mode Impact on Clinical Blood Arterial Pressure
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
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Obstructive Sleep Apnea Syndrome
Blood pressure
Continuous Positive Airway Pressure
Lead sponsor: AGIR à Dom
Sponsor class: OTHER
First posted: 2010-03-19
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Clinical blood pressure
timeFrame: Before treatment, 4 months after treatment
Secondary outcomes:
measure: Pulse Wave Velocity
timeFrame: Before treatment, 4 months after treatment
measure: 24 hours Blood Pressure measure
timeFrame: Before treatment, after 4 months of treatment
Other outcomes:
Locations:
city: Meylan
country: France
facility: AGIR à Dom
Study officials:
References:
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.