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
1 other identifier
interventional
936
1 country
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2013
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 15, 2013
CompletedFirst Posted
Study publicly available on registry
February 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 5, 2014
September 1, 2014
1.6 years
February 15, 2013
September 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline CPAP compliance at 6 months
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 Outcomes (5)
Subjective Sleepiness
inclusion and month 6
Fatigue
inclusion and month 6
Quality of Life
inclusion and month 6
Health status
inclusion and month 6
Cost analysis
month 6
Study Arms (2)
Conventional
EXPERIMENTALTelemedicine
ACTIVE COMPARATORInterventions
Usual CPAP treatment in sleep apnea patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Respiratory physician in private practice
Albertville, 73200, France
Respiratory physician in private practice
Annecy, 74000, France
Respiratory physician in private practice
Bordeaux, 33000, France
General Hospital
Cannes, 06401, France
General Hospital
Denain, 59225, France
Dieulefit Santé Clinic
Dieulefit, 26220, France
Respiratory physician in private practice
Échirolles, 38130, France
Saint Vincent Clinic
Épernay, 51200, France
University Hospital
Grenoble, 38000, France
Respiratory physician in private practice
Grenoble, 38100, France
Respiratory physician in private practice
La Rochelle, 17000, France
University Hospital Calmette
Lille, 59000, France
La Louvière Clinic
Lille, 59800, France
General Hospital
Magny-en-Vexin, 95420, France
Ambroise Paré Hospital
Marseille, 13000, France
General Hospital
Montélimar, 26216, France
Respiratory physician in private practice
Montigny-lès-Metz, 57950, France
Respiratory physician in private practice
Nîmes, 30900, France
Les Rieux Clinic
Nyons, 26110, France
Hospital Bichat Claude Bernard
Paris, 75018, France
Respiratory physician in private practice
Reims, 51000, France
University Hospital
Rouen, 76000, France
General Hospital
Saint-Avold, 57500, France
Respiratory physician in private practice
Saint-Etienne, 42100, France
Respiratory physician in private practice
Saint-Ismier, 38330, France
Respiratory physician in private practice
Saint-Laurent-du-Var, 06700, France
Respiratory physician in private practice
Saint-Omer, 62500, France
Respiratory physician in private practice
Six-Fours-les-Plages, 83140, France
Respiratory physician in private practice
Toulon, 83000, France
Respiratory physician in private practice
Valence, 26000, France
Tessier Clinic
Valenciennes, 59300, France
Hospital Nord Ouest
Villefranche-sur-Saône, 69655, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Louis PEPIN, Prof, PhD
Functional Cardio-Respiratory Exploration Laboratory - University Hospital Grenoble - France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, PhD, Hospital Grenoble France
Study Record Dates
First Submitted
February 15, 2013
First Posted
February 22, 2013
Study Start
February 1, 2013
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
September 5, 2014
Record last verified: 2014-09