Skip to main content
OpenTrials
Completed

NCT Number: NCT03665818

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea Syndromes Apnea Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Carotid Plaque Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral appliance treatment

Device

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

Primary outcomes

  1. apnea hypopnea events 0 in Times

    Time frame: initial time when patients are recruited

    apnea and hypopnea times per hour

  2. apnea hypopnea events 1 in Times

    Time frame: one month after oral appliance treatment

    apnea and hypopnea times per hour

  3. apnea hypopnea events 2 in Times

    Time frame: one and a half years after oral appliance treatment

    apnea and hypopnea times per hour

  4. longest apnea time 0 in Seconds

    Time frame: initial time when patients are recruited

    longest apnea or hypopnea time

  5. longest apnea time 1 in Seconds

    Time frame: one month after oral appliance treatment

    longest apnea or hypopnea time

  6. longest apnea time 2 in Seconds

    Time frame: one and a half years after oral appliance treatment

    longest apnea or hypopnea time

  7. Blood oxygen saturation less than 90% of the total monitoring time percentage 0 in percentage

    Time frame: initial time when patients are recruited

    Blood oxygen saturation less than 90% of the total monitoring time percentage

  8. Blood oxygen saturation less than 90% of the total monitoring time percentage 1 in percentage

    Time frame: one month after oral appliance treatment

    Blood oxygen saturation less than 90% of the total monitoring time percentage

  9. Blood oxygen saturation less than 90% of the total monitoring time percentage 2 in percentage

    Time frame: one and a half years after oral appliance treatment

    Blood oxygen saturation less than 90% of the total monitoring time percentage

  10. lowest Oxygen Saturation 0 in percentage

    Time frame: initial time when patients are recruited

    blood lowest oxygen saturation during the whole night

  11. lowest Oxygen Saturation 1 in percentage

    Time frame: one month after oral appliance treatment

    blood lowest oxygen saturation during the whole night

  12. lowest Oxygen Saturation 2 in percentage

    Time frame: one and a half years after oral appliance treatment

    blood lowest oxygen saturation during the whole night

  13. atherosclerosis plaque thickness 0 in common carotid artery in milimetre

    Time frame: initial time when patients are recruited

    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media

  14. atherosclerosis plaque thickness 1 in common carotid artery in milimetre

    Time frame: one and a half years after oral appliance treatment

    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media

  15. atherosclerosis plaque length 0 in common carotid artery in milimetre

    Time frame: initial time when patients are recruited

    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque

  16. atherosclerosis plaque length 1 in common carotid artery in milimetre

    Time frame: one and a half years after oral appliance treatment

    atherosclerosis plaque length is distance from the beginning to the end of a separate plaqu

  17. atherosclerosis plaque thickness 0 in internal carotid artery in milimetre

    Time frame: initial time when patients are recruited

    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media

  18. atherosclerosis plaque thickness 1 in internal carotid artery in milimetre

    Time frame: one and a half years after oral appliance treatment

    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media

  19. atherosclerosis plaque thickness 0 in carotid bulb in milimetre

    Time frame: initial time when patients are recruited

    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media

  20. atherosclerosis plaque thickness 1 in carotid bulb in milimetre

    Time frame: one and a half years after oral appliance treatment

    atherosclerosis plaque thickness is distance from the most convex point of plaque to carotid media

  21. atherosclerosis plaque length 0 in internal carotid artery in milimetre

    Time frame: initial time when patients are recruited

    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque

  22. atherosclerosis plaque length 1 in internal carotid artery in milimetre

    Time frame: one and a half years after oral appliance treatment

    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque

  23. atherosclerosis plaque length 0 in carotid bolb in milimetre

    Time frame: initial time when patients are recruited

    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque

  24. atherosclerosis plaque length 1 in carotid bolb in milimetre

    Time frame: one and a half years after oral appliance treatment

    atherosclerosis plaque length is distance from the beginning to the end of a separate plaque

  25. breath holding index 0 in percentage/seconds

    Time frame: initial time when patients are recruited

    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.

  26. breath holding index 0 in percentage/seconds

    Time frame: one and a half years after oral appliance treatment

    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.

  27. End systolic velocity of common carotid artery 0 in cm/s

    Time frame: initial time when patients are recruited

    the velocity of common carotid artery at the end of systolic period

  28. End systolic velocity of common carotid artery 1 in cm/s

    Time frame: one and a half years after oral appliance treatment

    the velocity of common carotid artery at the end of systolic period

  29. End systolic velocity of internal carotid artery 0 in cm/s

    Time frame: initial time when patients are recruited

    the velocity of internal carotid artery at the end of systolic period

  30. End systolic velocity of internal carotid artery 1 in cm/s

    Time frame: one and a half years after oral appliance treatment

    the velocity of internal carotid artery at the end of systolic period

  31. End systolic velocity of carotid bulb 0 in cm/s

    Time frame: initial time when patients are recruited

    the velocity of carotid bulb at the end of systolic period

  32. End systolic velocity of carotid bulb 1 in cm/s

    Time frame: one and a half years after oral appliance treatment

    the velocity of carotid bulb at the end of systolic period

  33. end diastolic velocity of common carotid artery 0 in cm/s

    Time frame: initial time when patients are recruited

    the velocity of common carotid artery at the end of diastolic period

  34. end diastolic velocity of common carotid artery 1 in cm/s

    Time frame: one and a half years after oral appliance treatment

    the velocity of common carotid artery at the end of diastolic period

  35. end diastolic velocity of internal carotid artery 0 in cm/s

    Time frame: initial time when patients are recruited

    the velocity of internal carotid artery at the end of diastolic period

  36. end diastolic velocity of internal carotid artery 1 in cm/s

    Time frame: one and a half years after oral appliance treatment

    the velocity of internal carotid artery at the end of diastolic period

  37. end diastolic velocity of carotid bulb 0 in cm/s

    Time frame: initial time when patients are recruited

    the velocity of carotid bulb at the end of diastolic period

  38. end diastolic velocity of carotid bulb 1 in cm/s

    Time frame: one and a half years after oral appliance treatment

    the velocity of carotid bulb at the end of diastolic period

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 11, 2018
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.