Clinical trial NCT01226641: Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk
Official title: Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Obstructive Sleep Apnea Syndrome
Keywords: Obstructive Sleep Apnea Syndrome
SCORE
Telemedicine
Arterial blood pressure
Daily physical activity
Lead sponsor: Initiative Pour la Sante
Sponsor class: INDUSTRY
First posted: 2010-10-22
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Home Arterial Blood Pressure
timeFrame: Home arterial Blood Pressure is assessed at week 1
measure: Home Arterial Blood Pressure
timeFrame: Home arterial Blood Pressure is assessed at week 16
Secondary outcomes:
measure: CPAP compliance
timeFrame: week 16
measure: Sleepiness
timeFrame: weeks 1 and 16
measure: Physical Activity
timeFrame: week 1
measure: Quality of Life
timeFrame: week 16
measure: Cardiovascular risk SCORE
timeFrame: Week 1
measure: Sleepiness
timeFrame: week 16
measure: Physical Activity
timeFrame: week 16
measure: Quality of Life
timeFrame: week 1
measure: Cardiovascular risk SCORE
timeFrame: Week 16
Other outcomes:
Locations:
city: Boulogne Billancourt
country: France
facility: Liberal Office
city: Brest
country: France
facility: Clermont Tonerre military hospital
city: Chambery
country: France
facility: Liberal Office
city: Grenoble
country: France
facility: Liberal Office
city: Grenoble
country: France
facility: University Hospital
city: Montigny les Metz
country: France
facility: Liberal Office
city: Nancy
country: France
facility: Liberal Office
city: Quimper
country: France
facility: Cornouaille Hospital
city: St Andre les Vergers
country: France
facility: Montier Polyclinic
city: St Avold
country: France
facility: Hospitalor Hospital
city: St Jean de Maurienne
country: France
facility: Liberal Office
city: St Martin les Boulogne
country: France
facility: Liberal Office
city: StIsmier
country: France
facility: Liberal Office
city: Strasbourg
country: France
facility: Liberal Office
Study officials:
affiliation: University Hospital, Grenoble
name: Jean Louis PEPIN, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.