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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
936
Usual CPAP treatment in sleep apnea patients
CPAP treatment with telemedicine system
Respiratory physician in private practice
Albertville, France
RECRUITINGRespiratory physician in private practice
Annecy, France
RECRUITINGRespiratory physician in private practice
Bordeaux, France
RECRUITINGGeneral Hospital
Cannes, France
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.
Time frame: day 0 and month 6
Subjective Sleepiness
Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups
Time frame: inclusion and month 6
Fatigue
Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups
Time frame: 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
Time frame: inclusion and month 6
Health status
Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups
Time frame: 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)
Time frame: month 6
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General Hospital
Denain, France
RECRUITINGDieulefit Santé Clinic
Dieulefit, France
RECRUITINGRespiratory physician in private practice
Échirolles, France
RECRUITINGSaint Vincent Clinic
Épernay, France
RECRUITINGUniversity Hospital
Grenoble, France
RECRUITINGRespiratory physician in private practice
Grenoble, France
RECRUITING...and 22 more locations