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The aim of this study is to determine the usefulness of a telemedicine system for the follow-up of OSA patients with a high cardiovascular risk. Our hypothesis is that the telemedicine system will enhance compliance and thus reduce self-measured blood pressure.
The obstructive sleep apnea syndrome (OSAS) corresponds to repeated epochs of complete or incomplete pharynx collapses occurring during sleep. The Continuous Positive Airway Pressure is the gold standard treatment for OSAS. It consists of air insufflation in upper airways with a pressure of about 5 to 15 cm of water with a facial or nasal mask. CPAP treatment reduces cardiovascular morbi-mortality.
OSAS is associated with cardiovascular mortality. A dose response effect exists between severity and arterial blood pressure. A recent meta-analysis has shown in unselected OSAS patients with or without hypertension, treated or non-treated for hypertension, CPAP reduces 24 h ambulatory blood pressure of approximately 2 mmHg. This decrease corresponds to a significant reduction in cardiovascular risk.
The aim of the present study is to include OSAS patients with a high cardiovascular risk and to measure the effect of CPAP on home measurements of arterial blood pressure. This controlled randomized trial will compare the effect CPAP on arterial blood pressure in a group with a telemedicine system versus a group with standard home care CPAP treatment.
An interim analysis will be carried out when 100 patients have been included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedecine | Experimental | CPAP treatment with telemedicine system |
|
| Standard Care | Active Comparator | Standard care, including CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Device | CPAP treatment with telemedicine system |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Home Arterial Blood Pressure | the primary outcome is assessed at weeks 1 and 16 for the both groups, moreover home arterial blood pressure is assessed each day, 2 times : morning and afternoon in the telemedicine group. | Home arterial Blood Pressure is assessed at week 1 |
| Home Arterial Blood Pressure | the primary outcome is assessed at weeks 1 and 16 for the both groups, moreover home arterial blood pressure is assessed each day, 2 times : morning and afternoon in the telemedicine group. | Home arterial Blood Pressure is assessed at week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| CPAP compliance | the CPAP compliance is assessed in the two groups at week 16 | week 16 |
| Sleepiness | Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Louis PEPIN, Prof, PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liberal Office | Boulogne-Billancourt | 92100 | France | |||
| Clermont Tonerre military hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25364081 | Derived | Mendelson M, Vivodtzev I, Tamisier R, Laplaud D, Dias-Domingos S, Baguet JP, Moreau L, Koltes C, Chavez L, De Lamberterie G, Herengt F, Levy P, Flore P, Pepin JL. CPAP treatment supported by telemedicine does not improve blood pressure in high cardiovascular risk OSA patients: a randomized, controlled trial. Sleep. 2014 Nov 1;37(11):1863-70. doi: 10.5665/sleep.4186. | |
| 24282316 |
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| Standard care |
| Device |
Standard care, including CPAP |
|
| weeks 1 and 16 |
| Physical Activity | Daily Physical Activity is assessed with an accelerometer (Sensewear Armband, Bodymedia) at weeks 1 and 16 in the two groups. Daily expenditure, steps number, daily METs are assessed. | week 1 |
| Quality of Life | Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups. | week 16 |
| Cardiovascular risk SCORE | The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups. | Week 1 |
| Sleepiness | Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups | week 16 |
| Physical Activity | Daily Physical Activity is assessed with an accelerometer (Sensewear Armband, Bodymedia) at weeks 1 and 16 in the two groups. Daily expenditure, steps number, daily METs are assessed. | week 16 |
| Quality of Life | Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups. | week 1 |
| Cardiovascular risk SCORE | The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups. | Week 16 |
| Brest |
| 29200 |
| France |
| Liberal Office | Chambéry | 73000 | France |
| Liberal Office | Grenoble | 38000 | France |
| University Hospital | Grenoble | 38000 | France |
| Liberal Office | Montigny-lès-Metz | 57950 | France |
| Liberal Office | Nancy | 54000 | France |
| Cornouaille Hospital | Quimper | 29107 | France |
| Liberal Office | Saint Martin Les Boulogne | 62280 | France |
| Montier Polyclinic | Saint-André-les-Vergers | 10120 | France |
| Hospitalor Hospital | Saint-Avold | 57500 | France |
| Liberal Office | Saint-Jean-de-Maurienne | 73300 | France |
| Liberal Office | StIsmier | 38330 | France |
| Liberal Office | Strasbourg | 67000 | France |
| Mendelson M, Tamisier R, Laplaud D, Dias-Domingos S, Baguet JP, Moreau L, Koltes C, Chavez L, de Lamberterie G, Herengt F, Levy P, Flore P, Pepin JL. Low physical activity is a determinant for elevated blood pressure in high cardiovascular risk obstructive sleep apnea. Respir Care. 2014 Aug;59(8):1218-27. doi: 10.4187/respcare.02948. |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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