Clinical trial NCT01796769: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sleep Apnea Syndrome
Low Cardiovascular Risk
Keywords: Obstructive Sleep Apnea Syndrome
Telemedicine
Patient Compliance
Lead sponsor: Fédération Française de Pneumologie
Sponsor class: OTHER
Collaborators: name: Federation of Medical Specialties
First posted: 2013-02-22
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline CPAP compliance at 6 months
timeFrame: day 0 and month 6
Secondary outcomes:
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: 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: University Hospital
city: Grenoble
country: France
facility: Respiratory physician in private practice
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: Saint Omer
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: 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 Saone
country: France
facility: Hospital Nord Ouest
Study officials:
affiliation: Functional Cardio-Respiratory Exploration Laboratory - University Hospital Grenoble - France
name: Jean Louis PEPIN, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References: