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

21 lipca 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

  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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

100

Faza

  • Nie dotyczy

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Oral appliance intervention
Urządzenie: oral appliance treatment
mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events
Brak interwencji: Without oral appliance intervention

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
apnea hypopnea events 0 in Times
Ramy czasowe: initial time when patients are recruited
apnea and hypopnea times per hour
initial time when patients are recruited
apnea hypopnea events 1 in Times
Ramy czasowe: one month after oral appliance treatment
apnea and hypopnea times per hour
one month after oral appliance treatment
apnea hypopnea events 2 in Times
Ramy czasowe: 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
Ramy czasowe: initial time when patients are recruited
longest apnea or hypopnea time
initial time when patients are recruited
longest apnea time 1 in Seconds
Ramy czasowe: one month after oral appliance treatment
longest apnea or hypopnea time
one month after oral appliance treatment
longest apnea time 2 in Seconds
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Xuanwu Hospital, Beijing

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

9 lipca 2016

Zakończenie podstawowe (Rzeczywisty)

1 września 2018

Ukończenie studiów (Rzeczywisty)

31 grudnia 2019

Daty rejestracji na studia

Pierwszy przesłany

18 lipca 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 września 2018

Pierwszy wysłany (Rzeczywisty)

11 września 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 lipca 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 lipca 2020

Ostatnia weryfikacja

1 lipca 2020

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CSA-Z2015-06

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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