Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

The Influence of Mandibular Advancement Device Treating OSAHS on Primary Prevention of Ischemic Stroke

21 juli 2020 bijgewerkt door: Ying Zhao, Xuanwu Hospital, Beijing
  1. The purpose of this study is to detect the differences of carotid atherosclerosis severity between patients with or without OSAHS(Obstructive Sleep Apnea and Hypopnea Syndrome) in a cross-sectional study in a large sample.
  2. Then a longitudinal control study is conducted to observe the progress of the carotid atherosclerosis by vascular ultrasonography and the occurrence of cerebrovascular events after the intervention of the oral appliance for treating OSAHS，and finally explore the feasibility of using oral appliance to treat OSAHS in primary prevention of ischemic stroke.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

  1. the relevance of OSAHS and carotid atherosclerosis Patients are distributed questionnaire and recruited from neurology clinic，vascular ultrasonography clinic of Xuanwu Hospital if they match the inclusion criteria. After initial screening, carotid atherosclerosis patients with skeptical OSAHS are sent to sleep center for polysomnography examination to determine the severity of OSAHS. At least 50 patients for mild, moderate, severe OSAHS each are recruited for OSAHS Group. At least 100 patients without snoring from questionnaire and without OSAHS after PSG screening are recruited for non OSAHS Group. Vascular ultrasonography examination for carotid are done for the two groups. Data of carotid vascular plaque from two groups are collected. Statistics are done to detect differences of carotid atherosclerosis severity between patients with and without OSAHS, also the severity of OSAHS.
  2. the relevance of the progress of carotid atherosclerosis and oral appliances intervention for treating OSAHS All carotid atherosclerosis patients with OSAHS are from patients of the first study. If they consent the treatment of oral appliances, they are recruited into this second study. At least 100 patients are recruited. They are divided into 2 groups by randomized block design by Evidence-based Medicine Center of Xuanwu Hospital. One group is oral appliance intervention group, the other group is no intervention group. The intervention group patients accept oral appliance treatment, and no intervention group patients do not accept OSAHS treatment. The two groups both accept anti-hypertension treatment or anti-diabetes treatment, or anti-hyperlipidemia treatment according to their own situation in neurology clinic.

At timepoint of initial time, one month after oral appliance treatment, one and a half year after oral appliance treatment, the intervention group should accept PSG(Polysomnography) examination to monitor the treatment of OSAHS.

At timepoint of initial time, one month after oral appliance treatment, one and a half year after oral appliance treatment, the two groups should accept breath holding test to monitor the cerebral vascular reserve.

At timepoint of initial time, one and a half year after oral appliance treatment, the two groups should accept carotid vascular ultrasonography examination to monitor the progress of carotid atherosclerosis.

Cerebrovascular events and death are recorded from initial time. Statistics are done to detect the influence of treatment of OSAHS on carotid atherosclerosis.

Studietype

Ingrijpend

Inschrijving (Verwacht)

100

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • diagnosed with atherosclerosis by vascular ultrasonography
  • diagnosed with OSAHS by polysomnography

Exclusion Criteria:

  • patients who have stroke already
  • patients who can not wear oral appliances according to experiment requirements
  • patients who have bad periodontal condition or teeth number less than 20

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Oral appliance intervention
Apparaat: oral appliance treatment
mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events
Geen tussenkomst: Without oral appliance intervention

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
apnea hypopnea events 0 in Times
Tijdsspanne: initial time when patients are recruited
apnea and hypopnea times per hour
initial time when patients are recruited
apnea hypopnea events 1 in Times
Tijdsspanne: one month after oral appliance treatment
apnea and hypopnea times per hour
one month after oral appliance treatment
apnea hypopnea events 2 in Times
Tijdsspanne: one and a half years after oral appliance treatment
apnea and hypopnea times per hour
one and a half years after oral appliance treatment
longest apnea time 0 in Seconds
Tijdsspanne: initial time when patients are recruited
longest apnea or hypopnea time
initial time when patients are recruited
longest apnea time 1 in Seconds
Tijdsspanne: one month after oral appliance treatment
longest apnea or hypopnea time
one month after oral appliance treatment
longest apnea time 2 in Seconds
Tijdsspanne: one and a half years after oral appliance treatment
longest apnea or hypopnea time
one and a half years after oral appliance treatment
Blood oxygen saturation less than 90% of the total monitoring time percentage 0 in percentage
Tijdsspanne: initial time when patients are recruited
Blood oxygen saturation less than 90% of the total monitoring time percentage
initial time when patients are recruited
Blood oxygen saturation less than 90% of the total monitoring time percentage 1 in percentage
Tijdsspanne: one month after oral appliance treatment
Blood oxygen saturation less than 90% of the total monitoring time percentage
one month after oral appliance treatment
Blood oxygen saturation less than 90% of the total monitoring time percentage 2 in percentage
Tijdsspanne: one and a half years after oral appliance treatment
Blood oxygen saturation less than 90% of the total monitoring time percentage
one and a half years after oral appliance treatment
lowest Oxygen Saturation 0 in percentage
Tijdsspanne: initial time when patients are recruited
blood lowest oxygen saturation during the whole night
initial time when patients are recruited
lowest Oxygen Saturation 1 in percentage
Tijdsspanne: one month after oral appliance treatment
blood lowest oxygen saturation during the whole night
one month after oral appliance treatment
lowest Oxygen Saturation 2 in percentage
Tijdsspanne: one and a half years after oral appliance treatment
blood lowest oxygen saturation during the whole night
one and a half years after oral appliance treatment
atherosclerosis plaque thickness 0 in common carotid artery in milimetre
Tijdsspanne: initial time when patients are recruited
atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
initial time when patients are recruited
atherosclerosis plaque thickness 1 in common carotid artery in milimetre
Tijdsspanne: one and a half years after oral appliance treatment
atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
one and a half years after oral appliance treatment
atherosclerosis plaque length 0 in common carotid artery in milimetre
Tijdsspanne: initial time when patients are recruited
atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
initial time when patients are recruited
atherosclerosis plaque length 1 in common carotid artery in milimetre
Tijdsspanne: one and a half years after oral appliance treatment
atherosclerosis plaque length is distance from the beginning to the end of a separate plaqu
one and a half years after oral appliance treatment
atherosclerosis plaque thickness 0 in internal carotid artery in milimetre
Tijdsspanne: initial time when patients are recruited
atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
initial time when patients are recruited
atherosclerosis plaque thickness 1 in internal carotid artery in milimetre
Tijdsspanne: one and a half years after oral appliance treatment
atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
one and a half years after oral appliance treatment
atherosclerosis plaque thickness 0 in carotid bulb in milimetre
Tijdsspanne: initial time when patients are recruited
atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
initial time when patients are recruited
atherosclerosis plaque thickness 1 in carotid bulb in milimetre
Tijdsspanne: one and a half years after oral appliance treatment
atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
one and a half years after oral appliance treatment
atherosclerosis plaque length 0 in internal carotid artery in milimetre
Tijdsspanne: initial time when patients are recruited
atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
initial time when patients are recruited
atherosclerosis plaque length 1 in internal carotid artery in milimetre
Tijdsspanne: one and a half years after oral appliance treatment
atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
one and a half years after oral appliance treatment
atherosclerosis plaque length 0 in carotid bolb in milimetre
Tijdsspanne: initial time when patients are recruited
atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
initial time when patients are recruited
atherosclerosis plaque length 1 in carotid bolb in milimetre
Tijdsspanne: one and a half years after oral appliance treatment
atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
one and a half years after oral appliance treatment
breath holding index 0 in percentage/seconds
Tijdsspanne: initial time when patients are recruited
breath holding index = (v2-v1)/v2*100/t. v2 is average velocity of middle cerebral artery after breath holding, v1 is average velocity of middle cerebral artery before breath holding, t is time for breath holding.
initial time when patients are recruited
breath holding index 0 in percentage/seconds
Tijdsspanne: one and a half years after oral appliance treatment
breath holding index = (v2-v1)/v2*100/t. v2 is average velocity of middle cerebral artery after breath holding, v1 is average velocity of middle cerebral artery before breath holding, t is time for breath holding.
one and a half years after oral appliance treatment
End systolic velocity of common carotid artery 0 in cm/s
Tijdsspanne: initial time when patients are recruited
the velocity of common carotid artery at the end of systolic period
initial time when patients are recruited
End systolic velocity of common carotid artery 1 in cm/s
Tijdsspanne: one and a half years after oral appliance treatment
the velocity of common carotid artery at the end of systolic period
one and a half years after oral appliance treatment
End systolic velocity of internal carotid artery 0 in cm/s
Tijdsspanne: initial time when patients are recruited
the velocity of internal carotid artery at the end of systolic period
initial time when patients are recruited
End systolic velocity of internal carotid artery 1 in cm/s
Tijdsspanne: one and a half years after oral appliance treatment
the velocity of internal carotid artery at the end of systolic period
one and a half years after oral appliance treatment
End systolic velocity of carotid bulb 0 in cm/s
Tijdsspanne: initial time when patients are recruited
the velocity of carotid bulb at the end of systolic period
initial time when patients are recruited
End systolic velocity of carotid bulb 1 in cm/s
Tijdsspanne: one and a half years after oral appliance treatment
the velocity of carotid bulb at the end of systolic period
one and a half years after oral appliance treatment
end diastolic velocity of common carotid artery 0 in cm/s
Tijdsspanne: initial time when patients are recruited
the velocity of common carotid artery at the end of diastolic period
initial time when patients are recruited
end diastolic velocity of common carotid artery 1 in cm/s
Tijdsspanne: one and a half years after oral appliance treatment
the velocity of common carotid artery at the end of diastolic period
one and a half years after oral appliance treatment
end diastolic velocity of internal carotid artery 0 in cm/s
Tijdsspanne: initial time when patients are recruited
the velocity of internal carotid artery at the end of diastolic period
initial time when patients are recruited
end diastolic velocity of internal carotid artery 1 in cm/s
Tijdsspanne: one and a half years after oral appliance treatment
the velocity of internal carotid artery at the end of diastolic period
one and a half years after oral appliance treatment
end diastolic velocity of carotid bulb 0 in cm/s
Tijdsspanne: initial time when patients are recruited
the velocity of carotid bulb at the end of diastolic period
initial time when patients are recruited
end diastolic velocity of carotid bulb 1 in cm/s
Tijdsspanne: one and a half years after oral appliance treatment
the velocity of carotid bulb at the end of diastolic period
one and a half years after oral appliance treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Xuanwu Hospital, Beijing

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 juli 2016

Primaire voltooiing (Werkelijk)

1 september 2018

Studie voltooiing (Werkelijk)

31 december 2019

Studieregistratiedata

Eerst ingediend

18 juli 2018

Eerst ingediend dat voldeed aan de QC-criteria

7 september 2018

Eerst geplaatst (Werkelijk)

11 september 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juli 2020

Laatste update ingediend die voldeed aan QC-criteria

21 juli 2020

Laatst geverifieerd

1 juli 2020

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CSA-Z2015-06

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Slaapapneusyndromen

  • The Champ Foundation
    Children's Hospital of Philadelphia; The Cleveland Clinic
    Werving
    Pearson Syndrome Natural History Study
    Pearson-syndroom | Single Large Scale Mitochondrial DNA Deletion Syndromes (SLSMDS)
    Verenigde Staten

Klinische onderzoeken op oral appliance treatment

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Montenegro

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren