Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

16. januar 2013 opdateret af: Initiative Pour la Sante
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

107

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Boulogne Billancourt, Frankrig, 92100
        • Liberal Office
      • Brest, Frankrig, 29200
        • Clermont Tonerre military hospital
      • Chambery, Frankrig, 73000
        • Liberal Office
      • Grenoble, Frankrig, 38000
        • University Hospital
      • Grenoble, Frankrig, 38000
        • Liberal Office
      • Montigny les Metz, Frankrig, 57950
        • Liberal Office
      • Nancy, Frankrig, 54000
        • Liberal Office
      • Quimper, Frankrig, 29107
        • Cornouaille Hospital
      • St Andre les Vergers, Frankrig, 10120
        • Montier Polyclinic
      • St Avold, Frankrig, 57500
        • Hospitalor Hospital
      • St Jean de Maurienne, Frankrig, 73300
        • Liberal Office
      • St Martin les Boulogne, Frankrig, 62280
        • Liberal Office
      • StIsmier, Frankrig, 38330
        • Liberal Office
      • Strasbourg, Frankrig, 67000
        • Liberal Office

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Telemedecine
CPAP treatment with telemedicine system
Enhed: Telemedicine
CPAP treatment with telemedicine system
Aktiv komparator: Standard Care
Standard care, including CPAP
Enhed: Standard care
Standard care, including CPAP

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Home Arterial Blood Pressure
Tidsramme: Home arterial Blood Pressure is assessed at week 1
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
Tidsramme: Home arterial Blood Pressure is assessed at week 16
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CPAP compliance
Tidsramme: week 16
the CPAP compliance is assessed in the two groups at week 16
week 16
Sleepiness
Tidsramme: weeks 1 and 16
Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups
weeks 1 and 16
Physical Activity
Tidsramme: week 1
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.
week 1
Quality of Life
Tidsramme: week 16
Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.
week 16
Cardiovascular risk SCORE
Tidsramme: Week 1
The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.
Week 1
Sleepiness
Tidsramme: week 16
Sleepiness is assessed with Epworth Sleepiness Scale at weeks 1 and 16 for the two groups
week 16
Physical Activity
Tidsramme: week 16
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.
week 16
Quality of Life
Tidsramme: week 1
Quality of life is assessed with SF-12 questionnaire at weeks 1 and 16 in the two groups.
week 1
Cardiovascular risk SCORE
Tidsramme: Week 16
The cardiovascular risk SCORE is assessed at weeks 1 and 16 in the two groups.
Week 16

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Initiative Pour la Sante

Efterforskere

  • Ledende efterforsker: Jean Louis PEPIN, Prof, PhD, University Hospital, Grenoble

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2009

Primær færdiggørelse (Faktiske)

1. januar 2012

Studieafslutning (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først indsendt

20. oktober 2010

Først indsendt, der opfyldte QC-kriterier

21. oktober 2010

Først opslået (Skøn)

22. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • InitiativePS-TELESAS

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Obstruktivt søvnapnøsyndrom

Kliniske forsøg med Telemedicine

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Estonia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner