NCT01505959

Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study

Blood Pressure Reduction Induced by Continuous Positive Airway Pressure (CPAP) in Sleep Apnea Patients at High Cardiovascular Risk : A Randomized Controlled Trial Comparing Usual CPAP Care Versus a Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 936 (estimated)
• Sponsor: Fédération Française de Pneumologie · Academic / Other
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

Targeted population: Sleep apnea patients at high cardiovascular risk newly treated by CPAP Hypothesis: Improvement in blood pressure after 6 months of CPAP treatment might be greater in the telemonitoring arm compared to usual CPAP care. Main goal: To compare 6-months blood pressure reduction when Sleep Apnea patients at high cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.

Detailed description

Study procedures: The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of home self-measured blood pressure, oximetry, physical activity recorded by actigraphy, CPAP compliance, side effects and residual events. Secured data transmission to medical staff computers and secured websites will allow easy telemonitoring. Automatic algorithms have been built-up for early adjustment of CPAP treatment in case of side effects, leaks and persistent residual events. An interim analysis will be performed when 300 patients will be included.

Conditions

• Sleep Apnea Syndromes
• High Cardiovascular Risk

Interventions

Type	Name	Description
DEVICE	CPAP treatment	Usual CPAP treatment
DEVICE	CPAP treatment	CPAP treatment with telemedicine system

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2012-01-09
• Last updated: 2014-09-05

Locations

32 sites across 1 country: France