Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk

Not Applicable

Terminated

• Conditions: Sleep Apnea, Obstructive; Obstructive Sleep Apnea Syndrome
• Interventions: Device: Telemedicine; Device: Standard care

• Registration Number: NCT01226641
• Lead Sponsor: Initiative Pour la Sante

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.

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 Timeline

• Study Start: 2009-07
• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-21
• Study First Posted: 2010-10-22
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-16
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedecine	Telemedicine	CPAP treatment with telemedicine system
Standard Care	Standard care	Standard care, including CPAP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
CPAP compliance	week 16	the CPAP compliance is assessed in the two groups at week 16
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.

Trial Locations

Locations (6)

University Hospital; 🇫🇷 Grenoble, France

Hospitalor Hospital; 🇫🇷 St Avold, France

Liberal Office; 🇫🇷 Strasbourg, France

Clermont Tonerre military hospital; 🇫🇷 Brest, France

Montier Polyclinic; 🇫🇷 St Andre les Vergers, France

Cornouaille Hospital; 🇫🇷 Quimper, France