The Influence of Mandibular Advancement Device Treating OSAHS on Primary Prevention of Ischemic Stroke
2020年7月21日 更新者：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.
調査の概要
詳細な説明
- 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.
研究の種類
介入
入学 (予想される)
100
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Oral appliance intervention
|
mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events
|
|
介入なし：Without oral appliance intervention
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
apnea hypopnea events 0 in Times
時間枠：initial time when patients are recruited
|
apnea and hypopnea times per hour
|
initial time when patients are recruited
|
|
apnea hypopnea events 1 in Times
時間枠：one month after oral appliance treatment
|
apnea and hypopnea times per hour
|
one month after oral appliance treatment
|
|
apnea hypopnea events 2 in Times
時間枠：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
時間枠：initial time when patients are recruited
|
longest apnea or hypopnea time
|
initial time when patients are recruited
|
|
longest apnea time 1 in Seconds
時間枠：one month after oral appliance treatment
|
longest apnea or hypopnea time
|
one month after oral appliance treatment
|
|
longest apnea time 2 in Seconds
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年7月9日
一次修了 (実際)
2018年9月1日
研究の完了 (実際)
2019年12月31日
試験登録日
最初に提出
2018年7月18日
QC基準を満たした最初の提出物
2018年9月7日
最初の投稿 (実際)
2018年9月11日
学習記録の更新
投稿された最後の更新 (実際)
2020年7月22日
QC基準を満たした最後の更新が送信されました
2020年7月21日
最終確認日
2020年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
睡眠時無呼吸症候群の臨床試験
-
University Hospital, Bonnわからない合併症 | 睡眠時無呼吸 (Apnea Hypopnea Index > 5/h として定義) | 頭蓋内動脈瘤のサイズ | 血圧の薬 | 合併症（くも膜下出血）ドイツ
oral appliance treatmentの臨床試験
-
Jiayuan SunZhouling (Shanghai) Medical Appliance Co., Ltd.募集
-
Washington State UniversityNational Institute on Drug Abuse (NIDA)完了
-
Reistone Biopharma Company Limited完了
-
Biomedical Development CorporationNational Heart, Lung, and Blood Institute (NHLBI); University of Kentuckyわからない
-
Federal University of the Valleys of Jequitinhonha...完了
-
University of Wisconsin, MadisonNational Institute on Aging (NIA)募集