Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study

Phase 4

• Conditions: High Cardiovascular Risk; Sleep Apnea Syndromes
• Interventions: Device: CPAP treatment

• Registration Number: NCT01505959
• Lead Sponsor: Fédération Française de Pneumologie

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.

Study Timeline

• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-06
• Study First Posted: 2012-01-09
• Study Start: 2013-02
• 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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	CPAP treatment	-
Telemedicine	CPAP treatment	-

Primary Outcome Measures

Name	Time	Method
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 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
Health status	inclusion and month 6	Health status is assessed with EQ-5D questionnaire 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
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
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
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)

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

Ambroise Paré Hospital; 🇫🇷 Marseille, France

Les Rieux Clinic; 🇫🇷 Nyons, France

La Louvière Clinic; 🇫🇷 Lille, France

University Hospital Calmette; 🇫🇷 Lille, France

Hospital Bichat Claude Bernard; 🇫🇷 Paris, France

Tessier Clinic; 🇫🇷 Valenciennes, France

Hospital Nord Ouest; 🇫🇷 Villefranche Sur Saône, France