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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01505959
Other study ID # 11-FFPO-02
Secondary ID
Status Recruiting
Phase Phase 4
First received January 5, 2012
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: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: The Commission nationale de l’informatique et des libertés
Study type Interventional

Clinical Trial 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.


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.


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 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

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


Related Conditions & MeSH terms


Intervention

Device:
CPAP treatment
Usual CPAP treatment
CPAP treatment
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 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 St Omer
France Respiratory physician in private practice Toulon
France Respiratory physician in private practice Valence
France Tessier Clinic Valenciennes
France Hospital Nord Ouest Villefranche Sur Saône

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 Systolic blood pressure evolution by comparing baseline and 6 months measurements Systolic blood pressure is assessed at day 0 and month 6 in the two groups by home self-measured blood pressure (4 consecutive days) day 0 and month 6 Yes
Secondary Objective CPAP compliance at 6 months CPAP compliance assessed after 6 months in the two groups day 0 and month 6 Yes
Secondary Diastolic blood pressure evolution by comparing baseline and 6 months Diastolic blood pressure is assessed at day 0 and 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 Physical activity Physical activity is assessed with actimetry 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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