High Cardiovascular Risk, Sleep Apnea Syndromes
Conditions
Keywords
Obstructive Sleep Apnea Syndrome, Apnea, Sleep Apnea, Telemedicine, CPAP compliance
Brief summary
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.
Detailed 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.
Interventions
DEVICECPAP treatment
Usual CPAP treatment
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure evolution by comparing baseline and 6 months measurements | day 0 and month 6 | Systolic blood pressure is assessed at day 0 and month 6 in the two groups by home self-measured blood pressure (4 consecutive days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic blood pressure evolution by comparing baseline and 6 months | day 0 and month 6 | Diastolic blood pressure is assessed at day 0 and month 6 in the two groups |
| 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 |
| Objective CPAP compliance at 6 months | day 0 and month 6 | CPAP compliance assessed after 6 months 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 |
| Physical activity | inclusion and month 6 | Physical activity is assessed with actimetry 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) |
| 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 |
Countries
France
Contacts
Primary ContactJean Louis PEPIN, Prof, PhD
Outcome results
None listed