Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Federation of Medical Specialties | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Targeted population:
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.
Study procedures:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Experimental |
| |
| Telemedicine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP treatment | Device | Usual CPAP treatment |
| |
| CPAP treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure evolution by comparing baseline and 6 months measurements | Systolic blood pressure is assessed at day 0 and month 6 in the two groups by home self-measured blood pressure (4 consecutive days) | day 0 and month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective CPAP compliance at 6 months | CPAP compliance assessed after 6 months in the two groups | day 0 and month 6 |
| Diastolic blood pressure evolution by comparing baseline and 6 months | Diastolic blood pressure is assessed at day 0 and month 6 in the two groups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean Louis PEPIN, Prof, PhD | Contact | 0033476765516 | JPepin@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean Louis PEPIN, Prof, PhD | University Hospital, Grenoble, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory physician in private practice | Recruiting | Albertville | 73200 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
CPAP treatment with telemedicine system |
|
| day 0 and month 6 |
| 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 | 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 |
| Physical activity | Physical activity is assessed with actimetry 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 |
|
| Respiratory physician in private practice | Recruiting | Grenoble | 38000 | France |
|
| University Hospital | Recruiting | Grenoble | 38000 | 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 |
| D001049 | Apnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
Not provided
Not provided