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

Phase 4

• Conditions: Sleep Apnea Syndrome; Low Cardiovascular Risk

• Registration Number: NCT01796769
• Lead Sponsor: Fédération Française de Pneumologie

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Status Verified: 2014-09
• Primary Completion: 2014-09
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-05
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 936

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Subjective Sleepiness	inclusion and month 6	Sleepiness is assessed with Epworth Sleepiness 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
Cost analysis	month 6	Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use)
Fatigue	inclusion and month 6	Fatigue is assessed with Pichot Scale 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

Trial Locations

Locations (12)

Respiratory physician in private practice; 🇫🇷 Valence, France

General Hospital; 🇫🇷 St Avold, France

Dieulefit Santé Clinic; 🇫🇷 Dieulefit, France

Saint Vincent Clinic; 🇫🇷 Epernay, France

University Hospital; 🇫🇷 Rouen, France

University Hospital Calmette; 🇫🇷 Lille, France

La Louvière Clinic; 🇫🇷 Lille, France

Ambroise Paré Hospital; 🇫🇷 Marseille, France

Les Rieux Clinic; 🇫🇷 Nyons, France

Hospital Bichat Claude Bernard; 🇫🇷 Paris, France

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