NCT01090297

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: AGIR à Dom · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DEVICE	S8 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.
DEVICE	Somnosmart 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.
DEVICE	Remstar 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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-09-01
• Completion: 2012-11-01
• First posted: 2010-03-19
• Last updated: 2013-02-15

Locations

1 site across 1 country: France