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
About this trial
This is an interventional treatment trial for Sleep Apnea Syndromes
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
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
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
Learn more about this trial
The Influence of Mandibular Advancement Device Treating OSAHS on Primary Prevention of Ischemic Stroke
We'll reach out to this number within 24 hrs