Sleep Apnea SyndromesNCT03665818
The Influence of Mandibular Advancement Device Treating OSAHS on Primary Prevention of Ischemic Stroke
A study testing oral appliance treatment in people with Sleep Apnea Syndromes and Atherosclerosis, run by Xuanwu Hospital, Beijing.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep Apnea Syndromes, Atherosclerosis, Carotid Plaque
- What is being tested?
- oral appliance treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 9 Jul 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed with atherosclerosis by vascular ultrasonography
- diagnosed with OSAHS by polysomnography
Who cannot join
- 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
About this study
- 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.
- 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.
Read the detailed description
- 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.
- Conditions
- Sleep Apnea Syndromes, Atherosclerosis, Carotid Plaque
- Being tested
- oral appliance treatment
- Medical subject headings
- Sleep Apnea Syndromes, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral appliance treatmentDevice
mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events
| Study group | Role | What they receive |
|---|---|---|
| Oral appliance intervention | Experimental | Not described Receives: Device: oral appliance treatment |
| Without oral appliance intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea hypopnea events 0 in Times
apnea and hypopnea times per hour
Measured: initial time when patients are recruited
apnea hypopnea events 1 in Times
apnea and hypopnea times per hour
Measured: one month after oral appliance treatment
apnea hypopnea events 2 in Times
apnea and hypopnea times per hour
Measured: one and a half years after oral appliance treatment
longest apnea time 0 in Seconds
longest apnea or hypopnea time
Measured: initial time when patients are recruited
longest apnea time 1 in Seconds
longest apnea or hypopnea time
Measured: one month after oral appliance treatment
longest apnea time 2 in Seconds
longest apnea or hypopnea time
Measured: 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
Measured: 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
Measured: 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
Measured: one and a half years after oral appliance treatment
lowest Oxygen Saturation 0 in percentage
blood lowest oxygen saturation during the whole night
Measured: initial time when patients are recruited
lowest Oxygen Saturation 1 in percentage
blood lowest oxygen saturation during the whole night
Measured: one month after oral appliance treatment
lowest Oxygen Saturation 2 in percentage
blood lowest oxygen saturation during the whole night
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: one and a half years after oral appliance treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start9 Jul 2016
- Primary completion1 Sep 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Zhao, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665818
- Sponsor's protocol ID
- CSA-Z2015-06
- Status last verified
- Jul 2020
- First submitted
- 18 Jul 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33415656Hao 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.
PubMed 32720016
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Mandibular Advancement Device Treating OSAHS on Primary Prevention of Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03665818
- Acronym / sponsor ID
- CSA-Z2015-06
- Conditions
- Sleep Apnea Syndromes, Atherosclerosis, Carotid Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 9 Jul 2016 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral appliance intervention | Experimental | Device: oral appliance treatment |
| Without oral appliance intervention | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed with atherosclerosis by vascular ultrasonography
- diagnosed with OSAHS by polysomnography
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral appliance treatmentmandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events | Device | Oral appliance intervention |
Primary outcome
apnea hypopnea events 0 in Times
Time frame: initial time when patients are recruited
apnea and hypopnea times per hour
apnea hypopnea events 1 in Times
Time frame: one month after oral appliance treatment
apnea and hypopnea times per hour
apnea hypopnea events 2 in Times
Time frame: one and a half years after oral appliance treatment
apnea and hypopnea times per hour
longest apnea time 0 in Seconds
Time frame: initial time when patients are recruited
longest apnea or hypopnea time
longest apnea time 1 in Seconds
Time frame: one month after oral appliance treatment
longest apnea or hypopnea time
longest apnea time 2 in Seconds
Time frame: one and a half years after oral appliance treatment
longest apnea or hypopnea time
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
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
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
lowest Oxygen Saturation 0 in percentage
Time frame: initial time when patients are recruited
blood lowest oxygen saturation during the whole night
lowest Oxygen Saturation 1 in percentage
Time frame: one month after oral appliance treatment
blood lowest oxygen saturation during the whole night
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Derived from this study: PubMed 33415656Qin 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.
- Derived from this study: PubMed 32720016Hao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing oral appliance treatment in people with Sleep Apnea Syndromes and Atherosclerosis, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
apnea hypopnea events 0 in Times (time frame: initial time when patients are recruited). The study lists 38 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665818, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.