NCT03665818

Brief Summary

  1. 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

2.1 years

First QC Date

July 18, 2018

Last Update Submit

July 21, 2020

Conditions

Sleep Apnea SyndromesAtherosclerosisCarotid Plaque

Outcome Measures

Primary Outcomes (38)

  • 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

Study Arms (2)

Oral appliance intervention

EXPERIMENTAL
Device: oral appliance treatment

Without oral appliance intervention

NO INTERVENTION

Interventions

oral appliance treatmentDEVICE

mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events

Oral appliance intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with atherosclerosis by vascular ultrasonography
  • diagnosed with OSAHS by polysomnography

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 33415656DERIVED

  • 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.

    PMID: 32720016DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesAtherosclerosis

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Department of Stomatology，Xuanwu Hospital

Study Record Dates

First Submitted

July 18, 2018

First Posted

September 11, 2018

Study Start

July 9, 2016

Primary Completion

September 1, 2018

Study Completion

December 31, 2019

Last Updated

July 22, 2020

Record last verified: 2020-07