Low Cardiovascular Risk, Sleep Apnea Syndrome
Conditions
Keywords
Obstructive Sleep Apnea Syndrome, Telemedicine, Patient Compliance
Brief 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.
Interventions
DEVICEContinuous Positive Airway Pressure (CPAP) in sleep apnea patients
Usual CPAP treatment in sleep apnea patients
Sponsors
Federation of Medical Specialties
Fédération Française de Pneumologie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline CPAP compliance at 6 months | day 0 and month 6 | CPAP compliance evolution by comparing baseline and 6 months measurements. CPAP compliance is assessed at month 6 in the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Sleepiness | inclusion and month 6 | Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups |
| Fatigue | inclusion and month 6 | Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups |
| Quality of Life | inclusion and month 6 | Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups |
| Health status | inclusion and month 6 | Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups |
| Cost analysis | month 6 | Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use) |
Countries
France
Contacts
Primary ContactJean Louis PEPIN, Prof, PhD
Outcome results
None listed