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

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.

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea Syndrome; Sleep Apnea, Obstructive
• Intervention / Treatment: Device: Telemedicine; Device: Standard care

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 Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Boulogne Billancourt, France, 92100
    • Liberal Office
  • Brest, France, 29200
    • Clermont Tonerre military hospital
  • 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
    • Liberal Office
  • Quimper, France, 29107
    • Cornouaille Hospital
  • St Andre les Vergers, France, 10120
    • Montier Polyclinic
  • St Avold, France, 57500
    • Hospitalor Hospital
  • St Jean de Maurienne, France, 73300
    • Liberal Office
  • St Martin les Boulogne, France, 62280
    • Liberal Office
  • StIsmier, France, 38330
    • Liberal Office
  • Strasbourg, France, 67000
    • Liberal Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Initiative Pour la Sante
• Investigators: Principal Investigator: Jean Louis PEPIN, Prof, PhD, University Hospital, Grenoble

Publications and helpful links

General Publications

• Mendelson M, Vivodtzev I, Tamisier R, Laplaud D, Dias-Domingos S, Baguet JP, Moreau L, Koltes C, Chavez L, De Lamberterie G, Herengt F, Levy P, Flore P, Pepin JL. CPAP treatment supported by telemedicine does not improve blood pressure in high cardiovascular risk OSA patients: a randomized, controlled trial. Sleep. 2014 Nov 1;37(11):1863-70. doi: 10.5665/sleep.4186.
• Mendelson M, Tamisier R, Laplaud D, Dias-Domingos S, Baguet JP, Moreau L, Koltes C, Chavez L, de Lamberterie G, Herengt F, Levy P, Flore P, Pepin JL. Low physical activity is a determinant for elevated blood pressure in high cardiovascular risk obstructive sleep apnea. Respir Care. 2014 Aug;59(8):1218-27. doi: 10.4187/respcare.02948.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 20, 2010
• First Submitted That Met QC Criteria: October 21, 2010
• First Posted (Estimate): October 22, 2010

Study Record Updates

• Last Update Posted (Estimate): January 17, 2013
• Last Update Submitted That Met QC Criteria: January 16, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Telemedicine; Obstructive Sleep Apnea Syndrome; SCORE; Arterial blood pressure; Daily physical activity
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: InitiativePS-TELESAS