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

Sleep Apnea, Obstructive Clinical Trial

— TELESAS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01226641
• Other study ID #: InitiativePS-TELESAS
• Status: Terminated
• Phase: N/A
• First received: October 20, 2010
• Last updated: January 16, 2013
• Start date: July 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2013
• Source: Initiative Pour la Sante
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: Conseil National de l'Ordre des MédecinsFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Telemedicine
CPAP treatment with telemedicine system
• Standard care
Standard care, including CPAP

Locations

Country	Name	City	State
France	Liberal Office	Boulogne Billancourt
France	Clermont Tonerre military hospital	Brest
France	Liberal Office	Chambery
France	Liberal Office	Grenoble
France	University Hospital	Grenoble
France	Liberal Office	Montigny les Metz
France	Liberal Office	Nancy
France	Cornouaille Hospital	Quimper
France	Montier Polyclinic	St Andre les Vergers
France	Hospitalor Hospital	St Avold
France	Liberal Office	St Jean de Maurienne
France	Liberal Office	St Martin les Boulogne
France	Liberal Office	StIsmier
France	Liberal Office	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Initiative Pour la Sante

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	CPAP compliance	the CPAP compliance is assessed in the two groups at week 16	week 16	Yes
Secondary	Sleepiness	Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups	weeks 1 and 16	Yes
Secondary	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	Yes
Secondary	Quality of Life	Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.	week 16	Yes
Secondary	Cardiovascular risk SCORE	The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.	Week 1	Yes
Secondary	Sleepiness	Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups	week 16	Yes
Secondary	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	Yes
Secondary	Quality of Life	Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.	week 1	Yes
Secondary	Cardiovascular risk SCORE	The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.	Week 16	Yes