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

This study is currently recruiting participants.
Verified September 2012 by Fédération Française de Pneumologie
Sponsor:
Collaborator:
Fédération des Spécialités Médicales
Information provided by (Responsible Party):
Jean Louis PEPIN, Fédération Française de Pneumologie
ClinicalTrials.gov Identifier:
NCT01505959
First received: January 5, 2012
Last updated: February 20, 2013
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Sleep Apnea Syndromes
High Cardiovascular Risk
 Device: CPAP treatment
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Fédération Française de Pneumologie:

Primary Outcome Measures:
  • Systolic blood pressure evolution by comparing baseline and 6 months measurements [ Time Frame: day 0 and month 6 ] [ Designated as safety issue: Yes ]
    Systolic blood pressure is assessed at day 0 and month 6 in the two groups by home self-measured blood pressure (4 consecutive days)


Secondary Outcome Measures:
  • Objective CPAP compliance at 6 months [ Time Frame: day 0 and month 6 ] [ Designated as safety issue: Yes ]
    CPAP compliance assessed after 6 months in the two groups

  • Diastolic blood pressure evolution by comparing baseline and 6 months [ Time Frame: day 0 and month 6 ] [ Designated as safety issue: Yes ]
    Diastolic blood pressure is assessed at day 0 and month 6 in the two groups

  • Subjective Sleepiness [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups

  • Fatigue [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups

  • Quality of Life [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups

  • Health status [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups

  • Physical activity [ Time Frame: inclusion and month 6 ] [ Designated as safety issue: Yes ]
    Physical activity is assessed with actimetry at inclusion and month 6 in the two groups

  • Cost analysis [ Time Frame: month 6 ] [ Designated as safety issue: Yes ]
    Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use)


Estimated Enrollment: 936
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional Device: CPAP treatment
Usual CPAP treatment
Active Comparator: Telemedicine Device: CPAP treatment
CPAP treatment with telemedicine system

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 to 75 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01505959

Contacts
Contact: Jean Louis PEPIN, Prof, PhD 0033476765516 JPepin@chu-grenoble.fr

Locations
France
Respiratory physician in private practice Recruiting
Albertville, France, 73200
Contact: Dominique LIGEONNET, MD            
Respiratory physician in private practice Recruiting
Bordeaux, France, 33000
Contact: Marc SAPENE, MD            
Respiratory physician in private practice Recruiting
Bordeaux, France, 33100
Contact: Laurent FALQUE, MD            
Sub-Investigator: Luc MARCAILLOU, MD            
General Hospital Recruiting
Cannes, France, 06401
Contact: Christophe PERRIN, MD            
Respiratory physician in private practice Recruiting
Cartelègue, France, 33390
Contact: Christophe SUREAU, MD            
General Hospital Recruiting
Denain, France, 59225
Contact: Jean-Pierre GRIGNET, MD            
Sub-Investigator: Nidal MOURAD AGHA, MD            
Respiratory physician in private practice Recruiting
Echirolles, France, 38130
Contact: Bruno LEPAULLE, MD            
Sub-Investigator: François ARBIB, MD            
Sub-Investigator: Michel JEANMART, MD            
Sub-Investigator: Nathalie CHOURI, MD            
Saint Vincent Clinic Recruiting
Epernay, France, 51200
Contact: Eric BONGRAIN, MD            
Respiratory physician in private practice Recruiting
Epernay, France, 51200
Contact: Michel CARBONNELLE, MD            
Respiratory physician in private practice Recruiting
Forbach, France, 57600
Contact: Martine CLAUSSNER, MD            
University Hospital Recruiting
Grenoble, France, 38000
Contact: Jean-Louis PEPIN, Prof, PhD            
Sub-Investigator: Patrick LEVY, Prof, PhD            
Sub-Investigator: Renaud TAMISIER, MD            
Sub-Investigator: Natalia SIYANKO, MD            
Respiratory physician in private practice Recruiting
Grenoble, France, 38000
Contact: Janie GIREY-RANNAUD, MD            
Respiratory physician in private practice Recruiting
Hagondange, France, 57300
Contact: Jean-Marc ZORDAN, MD            
Respiratory physician in private practice Recruiting
La Rochelle, France, 17000
Contact: Claude GENDREAU, MD            
Respiratory physician in private practice Recruiting
La Rochelle, France, 17000
Contact: Frédéric LE GUILLOU, MD            
Respiratory physician in private practice Recruiting
La Varenne Saint-Hilaire, France, 94210
Contact: Jean-Pierre L'HUILLIER, MD            
University Hospital Calmette Recruiting
Lille, France, 59000
Contact: Anne MALLART-VOISIN, MD            
General Hospital Recruiting
Magny en Vexin, France, 95420
Contact: Sylvie NARES, MD            
Ambroise Paré Hospital Recruiting
Marseille, France, 13000
Contact: Hervé PEGLIASCO, MD            
Respiratory physician in private practice Recruiting
Montgeron, France, 91230
Contact: Marie-Pascale SCHULLER, MD            
Respiratory physician in private practice Recruiting
Montigny les Metz, France, 57950
Contact: Mohammed BOUKHANA, MD            
Respiratory physician in private practice Recruiting
Nancy, France, 54100
Contact: Laurent MOREAU, MD            
Les Rieux Clinic Recruiting
Nyons, France, 26110
Contact: Gabrielle VOTTERO, MD            
Sub-Investigator: Jorge Lucilo BENGOLEA, MD            
Sub-Investigator: Dominique MARTINEAU, MD            
Sub-Investigator: Olivier ROQUE D'ORBCASTEL, MD            
Sub-Investigator: Valérie MAYER, MD            
Sub-Investigator: Bernard PORSIN, MD            
Respiratory physician in private practice Recruiting
Nîmes, France, 30900
Contact: Olivier BENEZET, MD            
Hospital Bichat Claude Bernard Recruiting
Paris, France, 75018
Contact: Marie-Pia D'ORTHO, Prof, PhD            
Respiratory physician in private practice Recruiting
Reims, France, 51000
Contact: Frédéric MASURE, MD            
University Hospital Recruiting
Rouen, France, 76000
Contact: Jean-François MUIR, Prof, PhD            
Cardiological Hospital Recruiting
Saint Denis, France, 93200
Contact: Georges DENNEWALD, MD            
Respiratory physician in private practice Recruiting
Saint Etienne, France, 42100
Contact: Dominique MOUNIER, MD            
General Hospital Saintonge Recruiting
Saintes, France, 17108
Contact: Thierry BEYSENS, MD            
Respiratory physician in private practice Recruiting
Six Fours Les Plages, France, 83140
Contact: Mireille PADOVANI, MD            
Sub-Investigator: Gaël CHAIGNEAU, MD            
General Hospital Recruiting
St Avold, France, 57500
Contact: Christian KOLTES, MD            
Respiratory physician in private practice Recruiting
St Laurent du Var, France, 06700
Contact: Guy BOYER, MD            
Respiratory physician in private practice Recruiting
St Omer, France, 62500
Contact: Philippe RICHARD, MD            
Respiratory physician in private practice Recruiting
Toulon, France, 83000
Contact: Mathieu LARROUSSE, MD            
Sub-Investigator: Bernard TEROL, MD            
Sub-Investigator: Catherine PACCHIONI, MD            
Sub-Investigator: Philippe SALLETTAZ, MD            
Respiratory physician in private practice Recruiting
Toulon, France, 83000
Contact: Brigitte MULLER, MD            
Respiratory physician in private practice Recruiting
Valence, France, 26000
Contact: Yves GRILLET, MD            
Sub-Investigator: Florence BOIS, MD            
Tessier Clinic Recruiting
Valenciennes, France, 59300
Contact: Bruno STACH, MD            
Respiratory physician in private practice Recruiting
Vandoeuvre Les Nancy, France, 54500
Contact: Bruno MOUGET, MD            
Hospital Nord Ouest Recruiting
Villefranche Sur Saône, France, 69655
Contact: Lionel FALCHERO, MD            
Sponsors and Collaborators
Fédération Française de Pneumologie
Fédération des Spécialités Médicales
Investigators
Principal Investigator: Jean Louis PEPIN, Prof, PhD University Hospital, Grenoble, France
  More Information

No publications provided

Responsible Party: Jean Louis PEPIN, Professor, PhD, Hospital Grenoble France, Fédération Française de Pneumologie
ClinicalTrials.gov Identifier: NCT01505959     History of Changes
Other Study ID Numbers: 11-FFPO-02
Study First Received: January 5, 2012
Last Updated: February 20, 2013
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

Keywords provided by Fédération Française de Pneumologie:
Obstructive Sleep Apnea Syndrome
Apnea
Sleep Apnea
Telemedicine
CPAP compliance

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013