Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03665818
Recruitment Status : Active, not recruiting
First Posted : September 11, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ying Zhao, Xuanwu Hospital, Beijing

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Atherosclerosis Carotid Plaque Device: oral appliance treatment Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of Mandibular Advancement Device Treating OSAHS on Primary Prevention of Ischemic Stroke
Actual Study Start Date : July 9, 2016
Actual Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

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



Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Layout table for additonal information
Responsible Party: Ying Zhao, Director of the Department of Stomatology,Xuanwu Hospital, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03665818     History of Changes
Other Study ID Numbers: CSA-Z2015-06
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea Syndromes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases