Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk (TELESAS)
This study has been terminated.
Sponsor:
Initiative Pour la Sante
Information provided by (Responsible Party):
Initiative Pour la Sante
ClinicalTrials.gov Identifier:
NCT01226641
First received: October 20, 2010
Last updated: January 16, 2013
Last verified: January 2013
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Purpose
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 | Intervention |
|---|---|
|
Sleep Apnea, Obstructive Obstructive Sleep Apnea Syndrome |
Device: Telemedicine Device: Standard care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk |
Resource links provided by NLM:
Further study details as provided by Initiative Pour la Sante:
Primary Outcome Measures:
- Home Arterial Blood Pressure [ Time Frame: Home arterial Blood Pressure is assessed at week 1 ] [ Designated as safety issue: Yes ]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 [ Time Frame: Home arterial Blood Pressure is assessed at week 16 ] [ Designated as safety issue: Yes ]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 [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]the CPAP compliance is assessed in the two groups at week 16
- Sleepiness [ Time Frame: weeks 1 and 16 ] [ Designated as safety issue: Yes ]Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups
- Physical Activity [ Time Frame: week 1 ] [ Designated as safety issue: Yes ]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 [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.
- Cardiovascular risk SCORE [ Time Frame: Week 1 ] [ Designated as safety issue: Yes ]The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.
- Sleepiness [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups
- Physical Activity [ Time Frame: week 16 ] [ Designated as safety issue: Yes ]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 [ Time Frame: week 1 ] [ Designated as safety issue: Yes ]Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.
- Cardiovascular risk SCORE [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.
| Enrollment: | 107 |
| Study Start Date: | July 2009 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226641
Locations
| France | |
| Liberal Office | |
| Boulogne Billancourt, France, 92100 | |
| Clermont Tonerre military hospital | |
| Brest, France, 29200 | |
| Liberal Office | |
| Chambery, France, 73000 | |
| Liberal Office | |
| Grenoble, France, 38000 | |
| University Hospital | |
| Grenoble, France, 38000 | |
| Liberal Office | |
| Montigny les Metz, France, 57950 | |
| Liberal Office | |
| Nancy, France, 54000 | |
| Cornouaille Hospital | |
| Quimper, France, 29107 | |
| Montier Polyclinic | |
| St Andre les Vergers, France, 10120 | |
| Hospitalor Hospital | |
| St Avold, France, 57500 | |
| Liberal Office | |
| St Jean de Maurienne, France, 73300 | |
| Liberal Office | |
| St Martin les Boulogne, France, 62280 | |
| Liberal Office | |
| StIsmier, France, 38330 | |
| Liberal Office | |
| Strasbourg, France, 67000 | |
Sponsors and Collaborators
Initiative Pour la Sante
Investigators
| Principal Investigator: | Jean Louis PEPIN, Prof, PhD | University Hospital, Grenoble |
More Information
No publications provided
| Responsible Party: | Initiative Pour la Sante |
| ClinicalTrials.gov Identifier: | NCT01226641 History of Changes |
| Other Study ID Numbers: | InitiativePS-TELESAS |
| Study First Received: | October 20, 2010 |
| Last Updated: | January 16, 2013 |
| Health Authority: | France: Direction Générale de la Santé France: Conseil National de l'Ordre des Médecins France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé |
Keywords provided by Initiative Pour la Sante:
|
Obstructive Sleep Apnea Syndrome SCORE Telemedicine Arterial blood pressure Daily physical activity |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013