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

This study has been terminated.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Syndrome
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014