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

Sleep Apnea Syndromes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01505959
• Other study ID #: 11-FFPO-02
• 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

• Apnea
• High Cardiovascular Risk
• Sleep Apnea Syndromes

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