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

Initiative Pour la Sante

Status: Terminated

Conditions: Sleep Apnea, Obstructive; Obstructive Sleep Apnea Syndrome

Treatments: Device: Telemedicine; Device: Standard care

Study type: Interventional

Funder types: Industry

Identifiers

NCT01226641

InitiativePS-TELESAS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Telemedecine

Experimental group

Description:

CPAP treatment with telemedicine system

Treatment:

Device: Telemedicine

Standard Care

Active Comparator group

Description:

Standard care, including CPAP

Treatment:

Device: Standard care