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

Primary Purpose

Sleep Apnea Syndromes, Atherosclerosis, Carotid Plaque

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oral appliance treatment
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Oral appliance intervention

    Without oral appliance intervention

    Arm Description

    Outcomes

    Primary Outcome Measures

    apnea hypopnea events 0 in Times
    apnea and hypopnea times per hour
    apnea hypopnea events 1 in Times
    apnea and hypopnea times per hour
    apnea hypopnea events 2 in Times
    apnea and hypopnea times per hour
    longest apnea time 0 in Seconds
    longest apnea or hypopnea time
    longest apnea time 1 in Seconds
    longest apnea or hypopnea time
    longest apnea time 2 in Seconds
    longest apnea or hypopnea time
    Blood oxygen saturation less than 90% of the total monitoring time percentage 0 in percentage
    Blood oxygen saturation less than 90% of the total monitoring time percentage
    Blood oxygen saturation less than 90% of the total monitoring time percentage 1 in percentage
    Blood oxygen saturation less than 90% of the total monitoring time percentage
    Blood oxygen saturation less than 90% of the total monitoring time percentage 2 in percentage
    Blood oxygen saturation less than 90% of the total monitoring time percentage
    lowest Oxygen Saturation 0 in percentage
    blood lowest oxygen saturation during the whole night
    lowest Oxygen Saturation 1 in percentage
    blood lowest oxygen saturation during the whole night
    lowest Oxygen Saturation 2 in percentage
    blood lowest oxygen saturation during the whole night
    atherosclerosis plaque thickness 0 in common carotid artery in milimetre
    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
    atherosclerosis plaque thickness 1 in common carotid artery in milimetre
    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
    atherosclerosis plaque length 0 in common carotid artery in milimetre
    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
    atherosclerosis plaque length 1 in common carotid artery in milimetre
    atherosclerosis plaque length is distance from the beginning to the end of a separate plaqu
    atherosclerosis plaque thickness 0 in internal carotid artery in milimetre
    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
    atherosclerosis plaque thickness 1 in internal carotid artery in milimetre
    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
    atherosclerosis plaque thickness 0 in carotid bulb in milimetre
    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
    atherosclerosis plaque thickness 1 in carotid bulb in milimetre
    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
    atherosclerosis plaque length 0 in internal carotid artery in milimetre
    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
    atherosclerosis plaque length 1 in internal carotid artery in milimetre
    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
    atherosclerosis plaque length 0 in carotid bolb in milimetre
    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
    atherosclerosis plaque length 1 in carotid bolb in milimetre
    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
    breath holding index 0 in percentage/seconds
    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.
    breath holding index 0 in percentage/seconds
    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.
    End systolic velocity of common carotid artery 0 in cm/s
    the velocity of common carotid artery at the end of systolic period
    End systolic velocity of common carotid artery 1 in cm/s
    the velocity of common carotid artery at the end of systolic period
    End systolic velocity of internal carotid artery 0 in cm/s
    the velocity of internal carotid artery at the end of systolic period
    End systolic velocity of internal carotid artery 1 in cm/s
    the velocity of internal carotid artery at the end of systolic period
    End systolic velocity of carotid bulb 0 in cm/s
    the velocity of carotid bulb at the end of systolic period
    End systolic velocity of carotid bulb 1 in cm/s
    the velocity of carotid bulb at the end of systolic period
    end diastolic velocity of common carotid artery 0 in cm/s
    the velocity of common carotid artery at the end of diastolic period
    end diastolic velocity of common carotid artery 1 in cm/s
    the velocity of common carotid artery at the end of diastolic period
    end diastolic velocity of internal carotid artery 0 in cm/s
    the velocity of internal carotid artery at the end of diastolic period
    end diastolic velocity of internal carotid artery 1 in cm/s
    the velocity of internal carotid artery at the end of diastolic period
    end diastolic velocity of carotid bulb 0 in cm/s
    the velocity of carotid bulb at the end of diastolic period
    end diastolic velocity of carotid bulb 1 in cm/s
    the velocity of carotid bulb at the end of diastolic period

    Secondary Outcome Measures

    Full Information

    First Posted
    July 18, 2018
    Last Updated
    July 21, 2020
    Sponsor
    Xuanwu Hospital, Beijing
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03665818
    Brief Title
    The Influence of Mandibular Advancement Device Treating OSAHS on Primary Prevention of Ischemic Stroke
    Official Title
    The Influence of Mandibular Advancement Device Treating OSAHS on Primary Prevention of Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 9, 2016 (Actual)
    Primary Completion Date
    September 1, 2018 (Actual)
    Study Completion Date
    December 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Xuanwu Hospital, Beijing

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Apnea Syndromes, Atherosclerosis, Carotid Plaque

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Oral appliance intervention
    Arm Type
    Experimental
    Arm Title
    Without oral appliance intervention
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    oral appliance treatment
    Intervention Description
    mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events
    Primary Outcome Measure Information:
    Title
    apnea hypopnea events 0 in Times
    Description
    apnea and hypopnea times per hour
    Time Frame
    initial time when patients are recruited
    Title
    apnea hypopnea events 1 in Times
    Description
    apnea and hypopnea times per hour
    Time Frame
    one month after oral appliance treatment
    Title
    apnea hypopnea events 2 in Times
    Description
    apnea and hypopnea times per hour
    Time Frame
    one and a half years after oral appliance treatment
    Title
    longest apnea time 0 in Seconds
    Description
    longest apnea or hypopnea time
    Time Frame
    initial time when patients are recruited
    Title
    longest apnea time 1 in Seconds
    Description
    longest apnea or hypopnea time
    Time Frame
    one month after oral appliance treatment
    Title
    longest apnea time 2 in Seconds
    Description
    longest apnea or hypopnea time
    Time Frame
    one and a half years after oral appliance treatment
    Title
    Blood oxygen saturation less than 90% of the total monitoring time percentage 0 in percentage
    Description
    Blood oxygen saturation less than 90% of the total monitoring time percentage
    Time Frame
    initial time when patients are recruited
    Title
    Blood oxygen saturation less than 90% of the total monitoring time percentage 1 in percentage
    Description
    Blood oxygen saturation less than 90% of the total monitoring time percentage
    Time Frame
    one month after oral appliance treatment
    Title
    Blood oxygen saturation less than 90% of the total monitoring time percentage 2 in percentage
    Description
    Blood oxygen saturation less than 90% of the total monitoring time percentage
    Time Frame
    one and a half years after oral appliance treatment
    Title
    lowest Oxygen Saturation 0 in percentage
    Description
    blood lowest oxygen saturation during the whole night
    Time Frame
    initial time when patients are recruited
    Title
    lowest Oxygen Saturation 1 in percentage
    Description
    blood lowest oxygen saturation during the whole night
    Time Frame
    one month after oral appliance treatment
    Title
    lowest Oxygen Saturation 2 in percentage
    Description
    blood lowest oxygen saturation during the whole night
    Time Frame
    one and a half years after oral appliance treatment
    Title
    atherosclerosis plaque thickness 0 in common carotid artery in milimetre
    Description
    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
    Time Frame
    initial time when patients are recruited
    Title
    atherosclerosis plaque thickness 1 in common carotid artery in milimetre
    Description
    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
    Time Frame
    one and a half years after oral appliance treatment
    Title
    atherosclerosis plaque length 0 in common carotid artery in milimetre
    Description
    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
    Time Frame
    initial time when patients are recruited
    Title
    atherosclerosis plaque length 1 in common carotid artery in milimetre
    Description
    atherosclerosis plaque length is distance from the beginning to the end of a separate plaqu
    Time Frame
    one and a half years after oral appliance treatment
    Title
    atherosclerosis plaque thickness 0 in internal carotid artery in milimetre
    Description
    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
    Time Frame
    initial time when patients are recruited
    Title
    atherosclerosis plaque thickness 1 in internal carotid artery in milimetre
    Description
    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
    Time Frame
    one and a half years after oral appliance treatment
    Title
    atherosclerosis plaque thickness 0 in carotid bulb in milimetre
    Description
    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
    Time Frame
    initial time when patients are recruited
    Title
    atherosclerosis plaque thickness 1 in carotid bulb in milimetre
    Description
    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media
    Time Frame
    one and a half years after oral appliance treatment
    Title
    atherosclerosis plaque length 0 in internal carotid artery in milimetre
    Description
    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
    Time Frame
    initial time when patients are recruited
    Title
    atherosclerosis plaque length 1 in internal carotid artery in milimetre
    Description
    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
    Time Frame
    one and a half years after oral appliance treatment
    Title
    atherosclerosis plaque length 0 in carotid bolb in milimetre
    Description
    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
    Time Frame
    initial time when patients are recruited
    Title
    atherosclerosis plaque length 1 in carotid bolb in milimetre
    Description
    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque
    Time Frame
    one and a half years after oral appliance treatment
    Title
    breath holding index 0 in percentage/seconds
    Description
    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.
    Time Frame
    initial time when patients are recruited
    Title
    breath holding index 0 in percentage/seconds
    Description
    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.
    Time Frame
    one and a half years after oral appliance treatment
    Title
    End systolic velocity of common carotid artery 0 in cm/s
    Description
    the velocity of common carotid artery at the end of systolic period
    Time Frame
    initial time when patients are recruited
    Title
    End systolic velocity of common carotid artery 1 in cm/s
    Description
    the velocity of common carotid artery at the end of systolic period
    Time Frame
    one and a half years after oral appliance treatment
    Title
    End systolic velocity of internal carotid artery 0 in cm/s
    Description
    the velocity of internal carotid artery at the end of systolic period
    Time Frame
    initial time when patients are recruited
    Title
    End systolic velocity of internal carotid artery 1 in cm/s
    Description
    the velocity of internal carotid artery at the end of systolic period
    Time Frame
    one and a half years after oral appliance treatment
    Title
    End systolic velocity of carotid bulb 0 in cm/s
    Description
    the velocity of carotid bulb at the end of systolic period
    Time Frame
    initial time when patients are recruited
    Title
    End systolic velocity of carotid bulb 1 in cm/s
    Description
    the velocity of carotid bulb at the end of systolic period
    Time Frame
    one and a half years after oral appliance treatment
    Title
    end diastolic velocity of common carotid artery 0 in cm/s
    Description
    the velocity of common carotid artery at the end of diastolic period
    Time Frame
    initial time when patients are recruited
    Title
    end diastolic velocity of common carotid artery 1 in cm/s
    Description
    the velocity of common carotid artery at the end of diastolic period
    Time Frame
    one and a half years after oral appliance treatment
    Title
    end diastolic velocity of internal carotid artery 0 in cm/s
    Description
    the velocity of internal carotid artery at the end of diastolic period
    Time Frame
    initial time when patients are recruited
    Title
    end diastolic velocity of internal carotid artery 1 in cm/s
    Description
    the velocity of internal carotid artery at the end of diastolic period
    Time Frame
    one and a half years after oral appliance treatment
    Title
    end diastolic velocity of carotid bulb 0 in cm/s
    Description
    the velocity of carotid bulb at the end of diastolic period
    Time Frame
    initial time when patients are recruited
    Title
    end diastolic velocity of carotid bulb 1 in cm/s
    Description
    the velocity of carotid bulb at the end of diastolic period
    Time Frame
    one and a half years after oral appliance treatment

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33415656
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    32720016
    Citation
    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.
    Results Reference
    derived

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

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