Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving CPAP Compliance in Low Cardiovascular Risk Sleep Apnea Patients : OPTISAS 1 Study
NCT ID: NCT01796769
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 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.
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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 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional
Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
Usual CPAP treatment in sleep apnea patients
Telemedicine
Continuous Positive Airway Pressure (CPAP) in sleep apnea patients
CPAP treatment with telemedicine system
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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
Functional Cardio-Respiratory Exploration Laboratory - 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
University Hospital
Grenoble, , France
Respiratory physician in private practice
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
Jean Louis PEPIN, Prof, PhD
Role: primary
Janie GIREY-RANNAUD, MD
Role: primary
Frédéric LE GUILLOU, MD
Role: primary
Anne MALLART-VOISIN, 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-01
Identifier Type: -
Identifier Source: org_study_id
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