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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665818
• Other study ID #: CSA-Z2015-06
• Status: Completed
• Phase: N/A
• Start date: July 9, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2020
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Plaque
• Sleep Apnea Syndromes

Intervention

Device:
• oral appliance treatment
mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	apnea hypopnea events 0 in Times	apnea and hypopnea times per hour	initial time when patients are recruited
Primary	apnea hypopnea events 1 in Times	apnea and hypopnea times per hour	one month after oral appliance treatment
Primary	apnea hypopnea events 2 in Times	apnea and hypopnea times per hour	one and a half years after oral appliance treatment
Primary	longest apnea time 0 in Seconds	longest apnea or hypopnea time	initial time when patients are recruited
Primary	longest apnea time 1 in Seconds	longest apnea or hypopnea time	one month after oral appliance treatment
Primary	longest apnea time 2 in Seconds	longest apnea or hypopnea time	one and a half years after oral appliance treatment
Primary	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
Primary	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
Primary	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
Primary	lowest Oxygen Saturation 0 in percentage	blood lowest oxygen saturation during the whole night	initial time when patients are recruited
Primary	lowest Oxygen Saturation 1 in percentage	blood lowest oxygen saturation during the whole night	one month after oral appliance treatment
Primary	lowest Oxygen Saturation 2 in percentage	blood lowest oxygen saturation during the whole night	one and a half years after oral appliance treatment
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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