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

Fédération Française de Pneumologie

Status and phase: Unknown; Phase 4

Conditions: Sleep Apnea Syndromes; High Cardiovascular Risk

Treatments: Device: CPAP treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01505959

11-FFPO-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 936 estimated patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 to 78 years
• Men and women
• AHI > 30 / hour
• Patient with high cardiovascular score (>5% defined by European SCORE) or known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
• Patient affiliated to the National health insurance
• Willingness to use a telemonitoring system

Exclusion criteria

• Central sleep apnea syndrome
• Previous CPAP treatment with respiratory support for sleep respiratory trouble
• Cardiac failure with left ventricular ejection fraction lesser than 40%
• Hypercapnic chronic respiratory failure (daytime PaCO2 > 50 mmHg)
• Terminal disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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936 participants in 2 patient groups

Conventional

Experimental group

Treatment:

Device: CPAP treatment

Device: CPAP treatment

Telemedicine

Active Comparator group

Treatment:

Device: CPAP treatment

Device: CPAP treatment