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

1. 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.
2. 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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Atherosclerosis; Carotid Plaque
• Intervention / Treatment: Device: oral appliance treatment

Detailed Description

1. 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.
2. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral appliance intervention	Device: oral appliance treatment; mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events
No Intervention: Without oral appliance intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Stroke; Sleep Apnea Syndromes; Ischemic Stroke; Atherosclerosis
• Other Study ID Numbers: CSA-Z2015-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No