TELESAS: Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Telemedecine CPAP treatment with telemedicine system |
Device: Telemedicine
CPAP treatment with telemedicine system
|
| Active Comparator: Standard Care Standard care, including CPAP |
Device: Standard care
Standard care, including CPAP
|
Outcome Measures
Primary Outcome Measures
- Home Arterial Blood Pressure [Home arterial Blood Pressure is assessed at week 1]
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 [Home arterial Blood Pressure is assessed at week 16]
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.
Secondary Outcome Measures
- CPAP compliance [week 16]
the CPAP compliance is assessed in the two groups at week 16
- Sleepiness [weeks 1 and 16]
Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups
- Physical Activity [week 1]
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.
- Quality of Life [week 16]
Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.
- Cardiovascular risk SCORE [Week 1]
The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.
- Sleepiness [week 16]
Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups
- Physical Activity [week 16]
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.
- Quality of Life [week 1]
Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.
- Cardiovascular risk SCORE [Week 16]
The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 to 85 years old men and women
-
stable patient
-
BMI<40kg/m²
-
OSA patients diagnosed with polysomnography or polygraphy
-
SCORE>5% and/or cardiovascular disease pas history :
-
transient ischemic attack, stroke, cerebral haemorrhagy
-
myocardial infraction, angor, coronary revascularization, arteriopathy, aortic aneurism
Exclusion Criteria:
-
central sleep apnea syndrome
-
SCORE<5%
-
cardiac failure
-
past history of hypercapnic chronic respiratory failure
-
past history of severe or intercurrent pathology which can not allow the patient follow-up
-
Incapacitated patients in accordance with article L 1121-6 of the public health code
-
patients taking part in another clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Liberal Office | Boulogne Billancourt | France | 92100 | |
| 2 | Clermont Tonerre military hospital | Brest | France | 29200 | |
| 3 | Liberal Office | Chambery | France | 73000 | |
| 4 | Liberal Office | Grenoble | France | 38000 | |
| 5 | University Hospital | Grenoble | France | 38000 | |
| 6 | Liberal Office | Montigny les Metz | France | 57950 | |
| 7 | Liberal Office | Nancy | France | 54000 | |
| 8 | Cornouaille Hospital | Quimper | France | 29107 | |
| 9 | Montier Polyclinic | St Andre les Vergers | France | 10120 | |
| 10 | Hospitalor Hospital | St Avold | France | 57500 | |
| 11 | Liberal Office | St Jean de Maurienne | France | 73300 | |
| 12 | Liberal Office | St Martin les Boulogne | France | 62280 | |
| 13 | Liberal Office | StIsmier | France | 38330 | |
| 14 | Liberal Office | Strasbourg | France | 67000 |
Sponsors and Collaborators
- Initiative Pour la Sante
Investigators
- Principal Investigator: Jean Louis PEPIN, Prof, PhD, University Hospital, Grenoble
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- InitiativePS-TELESAS