Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study
NCT ID: NCT01505959
Last Updated: 2014-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
936 participants
INTERVENTIONAL
2013-02-28
2014-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional
CPAP treatment
Usual CPAP treatment
Telemedicine
CPAP treatment
CPAP treatment with telemedicine system
Interventions
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CPAP treatment
Usual CPAP treatment
CPAP treatment
CPAP treatment with telemedicine system
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
78 Years
ALL
No
Sponsors
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Federation of Medical Specialties
OTHER
Fédération Française de Pneumologie
OTHER
Responsible Party
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Jean Louis PEPIN
Professor, PhD, Hospital Grenoble France
Principal Investigators
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Jean Louis PEPIN, Prof, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble, France
Locations
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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
Échirolles, , France
Saint Vincent Clinic
Épernay, , France
Respiratory physician in private practice
Grenoble, , France
University Hospital
Grenoble, , France
Respiratory physician in private practice
La Rochelle, , France
University Hospital Calmette
Lille, , France
La Louvière Clinic
Lille, , France
General Hospital
Magny-en-Vexin, , France
Ambroise Paré Hospital
Marseille, , France
General Hospital
Montélimar, , France
Respiratory physician in private practice
Montigny-lès-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
General Hospital
Saint-Avold, , France
Respiratory physician in private practice
Saint-Etienne, , France
Respiratory physician in private practice
Saint-Ismier, , France
Respiratory physician in private practice
Saint-Laurent-du-Var, , France
Respiratory physician in private practice
Saint-Omer, , France
Respiratory physician in private practice
Six-Fours-les-Plages, , 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, , France
Countries
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Central Contacts
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Facility Contacts
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Dominique LIGEONNET, MD
Role: primary
François BON, MD
Role: primary
Marc SAPENE, MD
Role: primary
Christophe PERRIN, MD
Role: primary
Jean-Pierre GRIGNET, MD
Role: primary
Frédéric HERENGT, MD
Role: primary
François ARBIB, MD
Role: primary
Eric BONGRAIN, MD
Role: primary
Janie GIREY-RANNAUD, MD
Role: primary
Jean-Louis PEPIN, Prof, PhD
Role: primary
Frédéric LE GUILLOU, MD
Role: primary
Anne MALLART, MD
Role: primary
Thibaut GENTINA, MD
Role: primary
Sylvie NARES, MD
Role: primary
Hervé PEGLIASCO, MD
Role: primary
Dominique MARTINEAU, MD
Role: primary
Dominique MULLER, MD
Role: primary
Olivier BENEZET, MD
Role: primary
Gabrielle VOTTERO, MD
Role: primary
Marie-Pia D'ORTHO, Prof, PhD
Role: primary
Frédéric MASURE, MD
Role: primary
Jean-François MUIR, Prof, PhD
Role: primary
Christian KOLTES, MD
Role: primary
Dominique MOUNIER, MD
Role: primary
Dominique BERTRAND, MD
Role: primary
Guy BOYER, MD
Role: primary
Philippe RICHARD, MD
Role: primary
Mireille PADOVANI, MD
Role: primary
Mathieu LARROUSSE, MD
Role: primary
Yves GRILLET, MD
Role: primary
Bruno STACH, MD
Role: primary
Lionel FALCHERO, MD
Role: primary
Other Identifiers
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11-FFPO-02
Identifier Type: -
Identifier Source: org_study_id
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