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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral appliance intervention | Experimental |
| |
| Without oral appliance intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral appliance treatment | Device | mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events |
|
| Measure | Description | Time Frame |
|---|---|---|
| apnea hypopnea events 0 in Times | apnea and hypopnea times per hour | initial time when patients are recruited |
| apnea hypopnea events 1 in Times | apnea and hypopnea times per hour | one month after oral appliance treatment |
| apnea hypopnea events 2 in Times | apnea and hypopnea times per hour | one and a half years after oral appliance treatment |
| longest apnea time 0 in Seconds | longest apnea or hypopnea time | initial time when patients are recruited |
| longest apnea time 1 in Seconds | longest apnea or hypopnea time | one month after oral appliance treatment |
| longest apnea time 2 in Seconds | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33415656 | Derived | 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. | |
| 32720016 | Derived | 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. |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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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 | 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 | blood lowest oxygen saturation during the whole night | initial time when patients are recruited |
| lowest Oxygen Saturation 1 in percentage | blood lowest oxygen saturation during the whole night | one month after oral appliance treatment |
| lowest Oxygen Saturation 2 in percentage | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | the velocity of carotid bulb at the end of diastolic period | one and a half years after oral appliance treatment |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |