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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sleep Apnea Syndrome, Low Cardiovascular Risk

Intervention / Treatment
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* Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
* Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional<br> | Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients<br>* Usual CPAP treatment in sleep apnea patients<br>|
| Active Comparator: Telemedicine<br> | Device: Continuous Positive Airway Pressure (CPAP) in sleep apnea patients<br>* CPAP treatment with telemedicine system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline CPAP compliance at 6 months | CPAP compliance evolution by comparing baseline and 6 months measurements. CPAP compliance is assessed at month 6 in the two groups. | day 0 and month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Sleepiness | Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups | inclusion and month 6 | 
| Fatigue | Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups | inclusion and month 6 | 
| Quality of Life | Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups | inclusion and month 6 | 
| Health status | Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups | inclusion and month 6 | 
| Cost analysis | Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use) | month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea Syndrome, Telemedicine, Patient Compliance