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Sleep Apnea, ObstructiveTELESASNCT01226641

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

A study testing Telemedicine in people with Sleep Apnea, Obstructive and Obstructive Sleep Apnea Syndrome, run by Initiative Pour la Sante at 14 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Telemedicine
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
14 sitesFrance
Study dates
Jul 2009to Jan 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Liberal Office

    Boulogne-Billancourt, 92100

  • Clermont Tonerre military hospital

    Brest, 29200

  • Liberal Office

    Chambéry, 73000

  • Liberal Office

    Grenoble, 38000

  • University Hospital

    Grenoble, 38000

  • Liberal Office

    Montigny-lès-Metz, 57950

  • Liberal Office

    Nancy, 54000

  • Cornouaille Hospital

    Quimper, 29107

  • Liberal Office

    Saint Martin Les Boulogne, 62280

  • Montier Polyclinic

    Saint-André-les-Vergers, 10120

  • Hospitalor Hospital

    Saint-Avold, 57500

  • Liberal Office

    Saint-Jean-de-Maurienne, 73300

  • Liberal Office

    StIsmier, 38330

  • Liberal Office

    Strasbourg, 67000

Other trials in France

About this study

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.

Read the 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.

Being tested
Telemedicine, Standard care
Keywords
Obstructive Sleep Apnea Syndrome, SCORE, Telemedicine, Arterial blood pressure, Daily physical activity
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelemedicineDevice

    CPAP treatment with telemedicine system

  • Standard careDevice

    Standard care, including CPAP

Study groups in NCT01226641
Study groupRoleWhat they receive
TelemedecineExperimentalCPAP treatment with telemedicine system
Receives: Device: Telemedicine
Standard CareActive comparatorStandard care, including CPAP
Receives: Device: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Home arterial Blood Pressure is assessed at week 1

  2. 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.

    Measured: Home arterial Blood Pressure is assessed at week 16

Secondary outcomes (9)

  1. CPAP compliance

    the CPAP compliance is assessed in the two groups at week 16

    Measured: week 16

  2. Sleepiness

    Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups

    Measured: weeks 1 and 16

  3. 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.

    Measured: week 1

  4. Quality of Life

    Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.

    Measured: week 16

  5. Cardiovascular risk SCORE

    The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.

    Measured: Week 1

  6. Sleepiness

    Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups

    Measured: week 16

  7. 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.

    Measured: week 16

  8. Quality of Life

    Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.

    Measured: week 1

  9. Cardiovascular risk SCORE

    The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.

    Measured: Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2010 (estimated)
  2. Study startJul 2009
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01226641
Sponsor's protocol ID
InitiativePS-TELESAS
Acronym
TELESAS
Status last verified
Jan 2013
First submitted
20 Oct 2010
Last updated
17 Jan 2013
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 25364081

  • 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.

    PubMed 24282316

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine in people with Sleep Apnea, Obstructive and Obstructive Sleep Apnea Syndrome, run by Initiative Pour la Sante at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Home Arterial Blood Pressure (time frame: Home arterial Blood Pressure is assessed at week 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01226641, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.

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