NCT01796769

Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving CPAP Compliance in Low Cardiovascular Risk Sleep Apnea Patients : OPTISAS 1 Study

Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving Continuous Positive Airway Pressure (CPAP) Compliance in Low Cardiovascular Risk Sleep Apnea Patients

• 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 low cardiovascular risk newly treated by CPAP Hypothesis: Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP care. Main goal: To compare 6-months CPAP compliance when Sleep Apnea patients at low 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 oximetry, 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 200 patients will be included.

Conditions

• Sleep Apnea Syndrome
• Low Cardiovascular Risk

Interventions

Type	Name	Description
DEVICE	Continuous Positive Airway Pressure (CPAP) in sleep apnea patients	Usual CPAP treatment in sleep apnea patients
DEVICE	Continuous Positive Airway Pressure (CPAP) in sleep apnea patients	CPAP treatment with telemedicine system

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2013-02-22
• Last updated: 2014-09-05

Locations

32 sites across 1 country: France