NCT01226641

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

Geographic Reach
1 country

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

2.5 years

First QC Date

October 20, 2010

Last Update Submit

January 16, 2013

Conditions

Sleep Apnea, ObstructiveObstructive Sleep Apnea Syndrome

Keywords

Obstructive Sleep Apnea SyndromeSCORETelemedicineArterial blood pressureDaily physical activity

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (9)

  • CPAP compliance

    week 16

  • Sleepiness

    weeks 1 and 16

  • Physical Activity

    week 1

  • Quality of Life

    week 16

  • Cardiovascular risk SCORE

    Week 1

  • +4 more secondary outcomes

Study Arms (2)

Telemedecine

EXPERIMENTAL

CPAP treatment with telemedicine system

Device: Telemedicine

Standard Care

ACTIVE COMPARATOR

Standard care, including CPAP

Device: Standard care

Interventions

TelemedicineDEVICE

CPAP treatment with telemedicine system

Telemedecine
Standard careDEVICE

Standard care, including CPAP

Standard Care

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Liberal Office

Boulogne-Billancourt, 92100, France

Location

Clermont Tonerre military hospital

Brest, 29200, France

Location

Liberal Office

Chambéry, 73000, France

Location

Liberal Office

Grenoble, 38000, France

Location

University Hospital

Grenoble, 38000, France

Location

Liberal Office

Montigny-lès-Metz, 57950, France

Location

Liberal Office

Nancy, 54000, France

Location

Cornouaille Hospital

Quimper, 29107, France

Location

Liberal Office

Saint Martin Les Boulogne, 62280, France

Location

Montier Polyclinic

Saint-André-les-Vergers, 10120, France

Location

Hospitalor Hospital

Saint-Avold, 57500, France

Location

Liberal Office

Saint-Jean-de-Maurienne, 73300, France

Location

Liberal Office

StIsmier, 38330, France

Location

Liberal Office

Strasbourg, 67000, France

Location

Related Publications (2)

  • 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.

    PMID: 25364081DERIVED

  • 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.

    PMID: 24282316DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jean Louis PEPIN, Prof, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 22, 2010

Study Start

July 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

FR(14)