Clinical trial NCT01505959: Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study
Official title: Blood Pressure Reduction Induced by Continuous Positive Airway Pressure (CPAP) in Sleep Apnea Patients at High Cardiovascular Risk : A Randomized Controlled Trial Comparing Usual CPAP Care Versus a Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sleep Apnea Syndromes
High Cardiovascular Risk
Keywords: Obstructive Sleep Apnea Syndrome
Apnea
Sleep Apnea
Telemedicine
CPAP compliance
Lead sponsor: Fédération Française de Pneumologie
Sponsor class: OTHER
Collaborators: name: Federation of Medical Specialties
First posted: 2012-01-09
Enrollment: 936
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic blood pressure evolution by comparing baseline and 6 months measurements
timeFrame: day 0 and month 6
Secondary outcomes:
measure: Objective CPAP compliance at 6 months
timeFrame: day 0 and month 6
measure: Diastolic blood pressure evolution by comparing baseline and 6 months
timeFrame: day 0 and month 6
measure: Subjective Sleepiness
timeFrame: inclusion and month 6
measure: Fatigue
timeFrame: inclusion and month 6
measure: Quality of Life
timeFrame: inclusion and month 6
measure: Health status
timeFrame: inclusion and month 6
measure: Physical activity
timeFrame: inclusion and month 6
measure: Cost analysis
timeFrame: month 6
Other outcomes:
Locations:
city: Albertville
country: France
facility: Respiratory physician in private practice
city: Annecy
country: France
facility: Respiratory physician in private practice
city: Bordeaux
country: France
facility: Respiratory physician in private practice
city: Cannes
country: France
facility: General Hospital
city: Denain
country: France
facility: General Hospital
city: Dieulefit
country: France
facility: Dieulefit Santé Clinic
city: Echirolles
country: France
facility: Respiratory physician in private practice
city: Epernay
country: France
facility: Saint Vincent Clinic
city: Grenoble
country: France
facility: Respiratory physician in private practice
city: Grenoble
country: France
facility: University Hospital
city: La Rochelle
country: France
facility: Respiratory physician in private practice
city: Lille
country: France
facility: University Hospital Calmette
city: Lille
country: France
facility: La Louvière Clinic
city: Magny en Vexin
country: France
facility: General Hospital
city: Marseille
country: France
facility: Ambroise Paré Hospital
city: Montigny les Metz
country: France
facility: Respiratory physician in private practice
city: Montélimar
country: France
facility: General Hospital
city: Nyons
country: France
facility: Les Rieux Clinic
city: Nîmes
country: France
facility: Respiratory physician in private practice
city: Paris
country: France
facility: Hospital Bichat Claude Bernard
city: Reims
country: France
facility: Respiratory physician in private practice
city: Rouen
country: France
facility: University Hospital
city: Saint Etienne
country: France
facility: Respiratory physician in private practice
city: Saint Ismier
country: France
facility: Respiratory physician in private practice
city: Six Fours Les Plages
country: France
facility: Respiratory physician in private practice
city: St Avold
country: France
facility: General Hospital
city: St Laurent du Var
country: France
facility: Respiratory physician in private practice
city: St Omer
country: France
facility: Respiratory physician in private practice
city: Toulon
country: France
facility: Respiratory physician in private practice
city: Valence
country: France
facility: Respiratory physician in private practice
city: Valenciennes
country: France
facility: Tessier Clinic
city: Villefranche Sur Saône
country: France
facility: Hospital Nord Ouest
Study officials:
affiliation: University Hospital, Grenoble, France
name: Jean Louis PEPIN, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References: