- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01796769
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
Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving Continuous Positive Airway Pressure (CPAP) Compliance in Low Cardiovascular Risk Sleep Apnea Patients
Targeted population:
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.
Study Overview
Status
Conditions
Detailed Description
Study procedures:
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Albertville, France, 73200
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Dominique LIGEONNET, MD
-
Annecy, France, 74000
- Recruiting
- Respiratory physician in private practice
-
Contact:
- François BON, MD
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Bordeaux, France, 33000
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Marc SAPENE, MD
-
Sub-Investigator:
- François PELLET, MD
-
Sub-Investigator:
- Laurent FALQUE, MD
-
Sub-Investigator:
- Vincent PUEL, MD
-
Sub-Investigator:
- Nathalie RAYMOND, MD
-
Sub-Investigator:
- Christophe SUREAU, MD
-
Cannes, France, 06401
- Recruiting
- General Hospital
-
Denain, France, 59225
- Recruiting
- General Hospital
-
Contact:
- Jean-Pierre GRIGNET, MD
-
Dieulefit, France, 26220
- Recruiting
- Dieulefit Santé Clinic
-
Contact:
- Frédéric HERENGT, MD
-
Echirolles, France, 38130
- Recruiting
- Respiratory physician in private practice
-
Contact:
- François ARBIB, MD
-
Sub-Investigator:
- Nathalie CHOURI, MD
-
Epernay, France, 51200
- Recruiting
- Saint Vincent Clinic
-
Contact:
- Eric BONGRAIN, MD
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Grenoble, France, 38000
- Recruiting
- University Hospital
-
Contact:
- Jean Louis PEPIN, Prof, PhD
-
Sub-Investigator:
- Patrick LEVY, Prof, PhD
-
Sub-Investigator:
- Natalia SIYANKO, MD
-
Sub-Investigator:
- Sandrine LAUNOIS, MD
-
Grenoble, France, 38100
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Janie GIREY-RANNAUD, MD
-
La Rochelle, France, 17000
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Frédéric LE GUILLOU, MD
-
Sub-Investigator:
- Claude GENDREAU, MD
-
Lille, France, 59000
- Recruiting
- University Hospital Calmette
-
Contact:
- Anne MALLART-VOISIN, MD
-
Sub-Investigator:
- Stéphanie FRY, MD
-
Lille, France, 59800
- Recruiting
- La Louvière Clinic
-
Contact:
- Thibaut GENTINA, MD
-
Sub-Investigator:
- Jean Marc DERNIS, MD
-
Sub-Investigator:
- Catherine LAMBLIN, MD
-
Sub-Investigator:
- Marc BURE, MD
-
Sub-Investigator:
- François CODRON, MD
-
Magny en Vexin, France, 95420
- Recruiting
- General Hospital
-
Contact:
- Sylvie NARES, MD
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Marseille, France, 13000
- Recruiting
- Ambroise Paré Hospital
-
Contact:
- Hervé PEGLIASCO, MD
-
Montigny les Metz, France, 57950
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Dominique MULLER, MD
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Montélimar, France, 26216
- Recruiting
- General Hospital
-
Contact:
- Dominique MARTINEAU, MD
-
Sub-Investigator:
- Gilbert SALARD, MD
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Nyons, France, 26110
- Recruiting
- Les Rieux Clinic
-
Contact:
- Gabrielle VOTTERO, MD
-
Sub-Investigator:
- Jorge Lucilo BENGOLEA, MD
-
Sub-Investigator:
- Valérie MAYER, MD
-
Sub-Investigator:
- Bernard PORSIN, MD
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Nîmes, France, 30900
- Recruiting
- Respiratory physician in private practice
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Contact:
- Olivier BENEZET, MD
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Paris, France, 75018
- Recruiting
- Hospital Bichat Claude Bernard
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Contact:
- Marie Pia D'ORTHO, Prof, PhD
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Reims, France, 51000
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Frédéric MASURE, MD
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Rouen, France, 76000
- Recruiting
- University Hospital
-
Contact:
- Jean François MUIR, Prof, PhD
-
Saint Etienne, France, 42100
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Dominique MOUNIER, MD
-
Saint Ismier, France, 38330
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Dominique BERTRAND, MD
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Saint Omer, France, 62500
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Philippe RICHARD, MD
-
Six Fours Les Plages, France, 83140
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Mireille PADOVANI, MD
-
Sub-Investigator:
- Gaël CHAIGNEAU, MD
-
St Avold, France, 57500
- Recruiting
- General Hospital
-
Contact:
- Christian KOLTES, MD
-
St Laurent du Var, France, 06700
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Guy BOYER, MD
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Toulon, France, 83000
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Mathieu LARROUSSE, MD
-
Sub-Investigator:
- Catherine PACCHIONI, MD
-
Sub-Investigator:
- Philippe SALLETTAZ, MD
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Valence, France, 26000
- Recruiting
- Respiratory physician in private practice
-
Contact:
- Yves GRILLET, MD
-
Sub-Investigator:
- Florence BOIS, MD
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Valenciennes, France, 59300
- Recruiting
- Tessier Clinic
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Contact:
- Bruno STACH, MD
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Villefranche Sur Saone, France, 69655
- Recruiting
- Hospital Nord Ouest
-
Contact:
- Lionel FALCHERO, MD
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 18 to 78 years
- 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:
- Known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Conventional
|
Usual CPAP treatment in sleep apnea patients
CPAP treatment with telemedicine system
|
ACTIVE_COMPARATOR: Telemedicine
|
Usual CPAP treatment in sleep apnea patients
CPAP treatment with telemedicine system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline CPAP compliance at 6 months
Time Frame: day 0 and month 6
|
CPAP compliance evolution by comparing baseline and 6 months measurements.
CPAP compliance is assessed at month 6 in the two groups.
|
day 0 and month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Sleepiness
Time Frame: inclusion and month 6
|
Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups
|
inclusion and month 6
|
Fatigue
Time Frame: inclusion and month 6
|
Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups
|
inclusion and month 6
|
Quality of Life
Time Frame: inclusion and month 6
|
Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups
|
inclusion and month 6
|
Health status
Time Frame: inclusion and month 6
|
Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups
|
inclusion and month 6
|
Cost analysis
Time Frame: month 6
|
Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use)
|
month 6
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jean Louis PEPIN, Prof, PhD, Functional Cardio-Respiratory Exploration Laboratory - University Hospital Grenoble - France
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-FFPO-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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