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| Name | Class |
|---|---|
| Federation of Medical Specialties | OTHER |
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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Experimental |
| |
| Telemedicine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) in sleep apnea patients | Device | Usual CPAP treatment in sleep apnea patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Sleepiness | Sleepiness is assessed with Epworth Sleepiness Scale at inclusion and month 6 in the two groups | inclusion and month 6 |
| Fatigue | Fatigue is assessed with Pichot Scale at inclusion and month 6 in the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean Louis PEPIN, Prof, PhD | Contact | 0033476765516 | 65516 | JPepin@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean Louis PEPIN, Prof, PhD | Functional Cardio-Respiratory Exploration Laboratory - University Hospital Grenoble - France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory physician in private practice | Recruiting | Albertville | 73200 | France |
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| Continuous Positive Airway Pressure (CPAP) in sleep apnea patients | Device | CPAP treatment with telemedicine system |
|
| inclusion and month 6 |
| Quality of Life | Quality of life is assessed with SF-12 questionnaire at inclusion and month 6 in the two groups | inclusion and month 6 |
| Health status | Health status is assessed with EQ-5D questionnaire at inclusion and month 6 in the two groups | inclusion and month 6 |
| Cost analysis | Cost analysis will include all key resources associated with the telemonitoring intervention and related health (referrals, consultations, resource use) | month 6 |
| Respiratory physician in private practice | Recruiting | Annecy | 74000 | France |
|
| Respiratory physician in private practice | Recruiting | Bordeaux | 33000 | France |
|
| General Hospital | Recruiting | Cannes | 06401 | France |
|
| General Hospital | Recruiting | Denain | 59225 | France |
|
| Dieulefit Santé Clinic | Recruiting | Dieulefit | 26220 | France |
|
| Respiratory physician in private practice | Recruiting | Échirolles | 38130 | France |
|
| Saint Vincent Clinic | Recruiting | Épernay | 51200 | France |
|
| University Hospital | Recruiting | Grenoble | 38000 | France |
|
| Respiratory physician in private practice | Recruiting | Grenoble | 38100 | France |
|
| Respiratory physician in private practice | Recruiting | La Rochelle | 17000 | France |
|
| University Hospital Calmette | Recruiting | Lille | 59000 | France |
|
| La Louvière Clinic | Recruiting | Lille | 59800 | France |
|
| General Hospital | Recruiting | Magny-en-Vexin | 95420 | France |
|
| Ambroise Paré Hospital | Recruiting | Marseille | 13000 | France |
|
| General Hospital | Recruiting | Montélimar | 26216 | France |
|
| Respiratory physician in private practice | Recruiting | Montigny-lès-Metz | 57950 | France |
|
| Respiratory physician in private practice | Recruiting | Nîmes | 30900 | France |
|
| Les Rieux Clinic | Recruiting | Nyons | 26110 | France |
|
| Hospital Bichat Claude Bernard | Recruiting | Paris | 75018 | France |
|
| Respiratory physician in private practice | Recruiting | Reims | 51000 | France |
|
| University Hospital | Recruiting | Rouen | 76000 | France |
|
| General Hospital | Recruiting | Saint-Avold | 57500 | France |
|
| Respiratory physician in private practice | Recruiting | Saint-Etienne | 42100 | France |
|
| Respiratory physician in private practice | Recruiting | Saint-Ismier | 38330 | France |
|
| Respiratory physician in private practice | Recruiting | Saint-Laurent-du-Var | 06700 | France |
|
| Respiratory physician in private practice | Recruiting | Saint-Omer | 62500 | France |
|
| Respiratory physician in private practice | Recruiting | Six-Fours-les-Plages | 83140 | France |
|
| Respiratory physician in private practice | Recruiting | Toulon | 83000 | France |
|
| Respiratory physician in private practice | Recruiting | Valence | 26000 | France |
|
| Tessier Clinic | Recruiting | Valenciennes | 59300 | France |
|
| Hospital Nord Ouest | Recruiting | Villefranche-sur-Saône | 69655 | France |
|
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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