The Influence of Mandibular Advancement Device Treating OSAHS on Primary Prevention of Ischemic Stroke
21 de julio de 2020 actualizado por: Ying Zhao, Xuanwu Hospital, Beijing
- 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.
- 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
- 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.
- 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.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
100
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Oral appliance intervention
|
mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events
|
|
Sin intervención: Without oral appliance intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
apnea hypopnea events 0 in Times
Periodo de tiempo: initial time when patients are recruited
|
apnea and hypopnea times per hour
|
initial time when patients are recruited
|
|
apnea hypopnea events 1 in Times
Periodo de tiempo: one month after oral appliance treatment
|
apnea and hypopnea times per hour
|
one month after oral appliance treatment
|
|
apnea hypopnea events 2 in Times
Periodo de tiempo: 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
Periodo de tiempo: initial time when patients are recruited
|
longest apnea or hypopnea time
|
initial time when patients are recruited
|
|
longest apnea time 1 in Seconds
Periodo de tiempo: one month after oral appliance treatment
|
longest apnea or hypopnea time
|
one month after oral appliance treatment
|
|
longest apnea time 2 in Seconds
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Qin L, Li N, Tong J, Hao Z, Wang L, Zhao Y. Impact of mandibular advancement device therapy on cerebrovascular reactivity in patients with carotid atherosclerosis combined with OSAHS. Sleep Breath. 2021 Sep;25(3):1543-1552. doi: 10.1007/s11325-020-02230-x. Epub 2021 Jan 7.
- Hao Z, Qin L, Tong J, Li N, Zhai Y, Zhao Y. The differences of carotid atherosclerosis among non-OSAHS and OSAHS patients of different severities: a cross-sectional study. Sleep Breath. 2021 Jun;25(2):639-648. doi: 10.1007/s11325-020-02145-7. Epub 2020 Jul 27.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
9 de julio de 2016
Finalización primaria (Actual)
1 de septiembre de 2018
Finalización del estudio (Actual)
31 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
18 de julio de 2018
Primero enviado que cumplió con los criterios de control de calidad
7 de septiembre de 2018
Publicado por primera vez (Actual)
11 de septiembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
21 de julio de 2020
Última verificación
1 de julio de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades de las vías respiratorias
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Apnea
- Trastornos de la respiración
- Trastornos del Sueño Intrínsecos
- Disomnias
- Trastornos del sueño y la vigilia
- Carrera
- Síndromes de apnea del sueño
- Accidente cerebrovascular isquémico
- Aterosclerosis
Otros números de identificación del estudio
- CSA-Z2015-06
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .