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

October 20, 2010
January 16, 2013
July 2009
January 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01226641 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 cardiovasular risk SCORE is assessed at weeks 1 and 16 in the two grooups.
  • 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 cardiovasular risk SCORE is assessed at weeks 1 and 16 in the two grooups.
Not Provided
Not Provided
 
Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk
Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sleep Apnea, Obstructive
  • Obstructive Sleep Apnea Syndrome
  • Device: Telemedicine
    CPAP treatment with telemedicine system
  • Device: Standard care
    Standard care, including CPAP
  • Experimental: Telemedecine
    CPAP treatment with telemedicine system
    Intervention: Device: Telemedicine
  • Active Comparator: Standard Care
    Standard care, including CPAP
    Intervention: Device: Standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
107
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01226641
InitiativePS-TELESAS
Yes
Initiative Pour la Sante
Initiative Pour la Sante
Not Provided
Principal Investigator: Jean Louis PEPIN, Prof, PhD University Hospital, Grenoble
Initiative Pour la Sante
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP