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
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 936
- Locations
- 44
- Primary Endpoint
- Change from baseline CPAP compliance at 6 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 78 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change from baseline CPAP compliance at 6 months
Time Frame: 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 Outcomes
- Subjective Sleepiness(inclusion and month 6)
- Quality of Life(inclusion and month 6)
- Cost analysis(month 6)
- Fatigue(inclusion and month 6)
- Health status(inclusion and month 6)
Investigators
Jean Louis PEPIN
Professor, PhD, Hospital Grenoble France
Fédération Française de Pneumologie