The Influence of Mandibular Advancement Device Treating OSAHS on Primary Prevention of Ischemic Stroke
2020년 7월 21일 업데이트: 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.
연구 개요
상세 설명
- 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.
연구 유형
중재적
등록 (예상)
100
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Oral appliance intervention
|
mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events
|
|
간섭 없음: Without oral appliance intervention
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
apnea hypopnea events 0 in Times
기간: initial time when patients are recruited
|
apnea and hypopnea times per hour
|
initial time when patients are recruited
|
|
apnea hypopnea events 1 in Times
기간: one month after oral appliance treatment
|
apnea and hypopnea times per hour
|
one month after oral appliance treatment
|
|
apnea hypopnea events 2 in Times
기간: 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
기간: initial time when patients are recruited
|
longest apnea or hypopnea time
|
initial time when patients are recruited
|
|
longest apnea time 1 in Seconds
기간: one month after oral appliance treatment
|
longest apnea or hypopnea time
|
one month after oral appliance treatment
|
|
longest apnea time 2 in Seconds
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 7월 9일
기본 완료 (실제)
2018년 9월 1일
연구 완료 (실제)
2019년 12월 31일
연구 등록 날짜
최초 제출
2018년 7월 18일
QC 기준을 충족하는 최초 제출
2018년 9월 7일
처음 게시됨 (실제)
2018년 9월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 7월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 7월 21일
마지막으로 확인됨
2020년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .