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

21. juli 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

  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

Intervensjonell

Registrering (Forventet)

100

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Oral appliance intervention
Enhet: oral appliance treatment
mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events
Ingen inngripen: Without oral appliance intervention

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
apnea hypopnea events 0 in Times
Tidsramme: initial time when patients are recruited
apnea and hypopnea times per hour
initial time when patients are recruited
apnea hypopnea events 1 in Times
Tidsramme: one month after oral appliance treatment
apnea and hypopnea times per hour
one month after oral appliance treatment
apnea hypopnea events 2 in Times
Tidsramme: 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
Tidsramme: initial time when patients are recruited
longest apnea or hypopnea time
initial time when patients are recruited
longest apnea time 1 in Seconds
Tidsramme: one month after oral appliance treatment
longest apnea or hypopnea time
one month after oral appliance treatment
longest apnea time 2 in Seconds
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Xuanwu Hospital, Beijing

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. juli 2016

Primær fullføring (Faktiske)

1. september 2018

Studiet fullført (Faktiske)

31. desember 2019

Datoer for studieregistrering

Først innsendt

18. juli 2018

Først innsendt som oppfylte QC-kriteriene

7. september 2018

Først lagt ut (Faktiske)

11. september 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juli 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2020

Sist bekreftet

1. juli 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CSA-Z2015-06

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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