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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01796769
Other study ID # 11-FFPO-01
Secondary ID
Status Recruiting
Phase Phase 4
First received February 15, 2013
Last updated September 4, 2014
Start date February 2013
Est. completion date December 2014

Study information

Verified date September 2014
Source Fédération Française de Pneumologie
Contact Jean Louis PEPIN, Prof, PhD
Phone 0033476765516
Email JPepin@chu-grenoble.fr
Is FDA regulated No
Health authority France: Ansm - French Health Products Safety AgencyFrance: The Commission nationale de l’informatique et des libertés
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 936
Est. completion date December 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 78 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
Usual CPAP treatment in sleep apnea patients
Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
CPAP treatment with telemedicine system

Locations

Country Name City State
France Respiratory physician in private practice Albertville
France Respiratory physician in private practice Annecy
France Respiratory physician in private practice Bordeaux
France General Hospital Cannes
France General Hospital Denain
France Dieulefit Santé Clinic Dieulefit
France Respiratory physician in private practice Echirolles
France Saint Vincent Clinic Epernay
France Respiratory physician in private practice Grenoble
France University Hospital Grenoble
France Respiratory physician in private practice La Rochelle
France La Louvière Clinic Lille
France University Hospital Calmette Lille
France General Hospital Magny en Vexin
France Ambroise Paré Hospital Marseille
France General Hospital Montélimar
France Respiratory physician in private practice Montigny les Metz
France Respiratory physician in private practice Nîmes
France Les Rieux Clinic Nyons
France Hospital Bichat Claude Bernard Paris
France Respiratory physician in private practice Reims
France University Hospital Rouen
France Respiratory physician in private practice Saint Etienne
France Respiratory physician in private practice Saint Ismier
France Respiratory physician in private practice Saint Omer
France Respiratory physician in private practice Six Fours Les Plages
France General Hospital St Avold
France Respiratory physician in private practice St Laurent du Var
France Respiratory physician in private practice Toulon
France Respiratory physician in private practice Valence
France Tessier Clinic Valenciennes
France Hospital Nord Ouest Villefranche Sur Saone

Sponsors (2)

Lead Sponsor Collaborator
Fédération Française de Pneumologie Fédération des Spécialités Médicales

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline CPAP compliance at 6 months CPAP compliance evolution by comparing baseline and 6 months measurements. CPAP compliance is assessed at month 6 in the two groups. day 0 and month 6 Yes
Secondary Subjective Sleepiness Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups inclusion and month 6 Yes
Secondary Fatigue Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups inclusion and month 6 Yes
Secondary Quality of Life Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups inclusion and month 6 Yes
Secondary Health status Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups inclusion and month 6 Yes
Secondary Cost analysis Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use) month 6 Yes
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