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

Fédération Française de Pneumologie

Status and phase: Unknown; Phase 4

Conditions: Sleep Apnea Syndrome; Low Cardiovascular Risk

Treatments: Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients

Study type: Interventional

Funder types: Other

Identifiers

NCT01796769

11-FFPO-01

Details and patient eligibility

About

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.

Full 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.

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 low cardiovascular score (<5% defined by European SCORE)
• Patient affiliated to the national health insurance
• Willingness to use a telemonitoring system

Exclusion criteria

• Known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
• Central sleep apnea syndrome
• Previous CPAP treatment with respiratory support for sleep respiratory trouble
• Cardiac failure
• 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: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients

Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients

Telemedicine

Active Comparator group

Treatment:

Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients

Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients