Hearing LossNCT05533840
Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
An observational study of Hearing Loss and Tinnitus, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Tinnitus, hearing loss and vertigo are the three major diseases of otology, affecting hundreds of millions of people in our country, and are major health problems. Ear structures and lesions are deeply embedded in the bone, and CT is the preferred examination technique. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Tinnitus, Vertigo
- What is being tested?
- ultra-high-resolution computed tomography exams
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- Sep 2022to Dec 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: * 50 healthy volunteers (100 ears) * otological patients 1450 cases (tinnitus>634 ears, hearing loss>634 ears, and vertigo>181 ears)
Who may be able to join
- Meet the ethical requirements of U-HRCT examination
- Can cooperate to complete U-HRCT examination
- There is no relevant medical history in the side ear scanned
- Due to tinnitus/deafness/peripheral vertigo/peripheral facial paralysis in the ENT department of our hospital
- Meet the ethical requirements of U-HRCT examination
- Can cooperate with the completion of U-HRCT examination
- Surgery in the ENT department of our hospital
- At least one follow-up or re-examination after discharge
Who cannot join
- Clinical symptoms related to middle and inner ear lesions, such as conduction deafness, sensorineural hearing loss, mixed deafness, vertigo, etc.
- Congenital inner ear malformation
- Diseases causing bone changes around the middle and inner ear, such as otitis media, tumors , otosclerosis, fibrous dysplasia, etc.
- history of previous ear surgery and trauma
- CT image artifacts or incomplete scan coverage
- incomplete clinical data
Show all 10Show fewer
- For patients with otological diseases
- History of previous ear surgery and trauma
- CT image artifacts or incomplete scanning coverage
- Incomplete clinical data
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Zhenchang Wang, +86-13501163497, cjr.wzhch@vip.163.com
Zhenchang Wang
About this study
Tinnitus, hearing loss and vertigo are the three major diseases of otology, affecting hundreds of millions of people in our country, and are major health problems. Ear structures and lesions are deeply embedded in the bone, and CT is the preferred examination technique. The key structures of the ear are small and the lesions are hidden. Spiral CT is "not visible" and "undiagnosed" due to insufficient spatial resolution. The ultra-high-resolution CT independently developed by our team has a spatial resolution of 50 μm, which is 6 times higher than that of high-end spiral CT, and solves the problem of "not showing" ear diseases. However, with the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable. It is urgent to carry out systematic research to create matching imaging plans, imaging anatomy standards and disease assessment standards to solve the problem of "undiagnosed". problem. This project plans to build an adult and pediatric imaging solution based on ultra-high-resolution CT to optimize image quality and radiation dose; comprehensively evaluate conduction, sensory, and surgical-related fine structures of the ear, and establish a new 0.1mm-scale image anatomy atlas; A prospective study conducted by the center analyzes the hidden pathological changes of tinnitus, deafness and vertigo, evaluates the diagnostic efficacy of ultra-high-resolution CT for the above diseases, and establishes new diagnostic criteria for lesion detection, symptom correlation, and efficacy evaluation. This project will bring new changes to the practice of otology clinical diagnosis and treatment
- Conditions
- Hearing Loss, Tinnitus, Vertigo
- Being tested
- ultra-high-resolution computed tomography exams
- Keywords
- Otology, Medical imaging, Tomography, X-ray, Diagnosis, Resolution
- Medical subject headings
- Hearing Loss, Tinnitus, Vertigo, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra-high-resolution computed tomography examsDiagnostic test
Participants in the age groups undergo ultra-high-resolution computed tomography exam
| Study group | Role | What they receive |
|---|---|---|
| Age under 18 | Participants under the age of 18 Receives: Diagnostic Test: ultra-high-resolution computed tomography exams | |
| Age 18-30 | Participants aged 18-30 Receives: Diagnostic Test: ultra-high-resolution computed tomography exams | |
| Age 31-40 | Participants aged 31-40 Receives: Diagnostic Test: ultra-high-resolution computed tomography exams | |
| Age 41-50 | Participants aged 41-50 Receives: Diagnostic Test: ultra-high-resolution computed tomography exams | |
| Age 51-60 | Participants aged 51-60 Receives: Diagnostic Test: ultra-high-resolution computed tomography exams | |
| Age ≥61 | Participants aged ≥61 Receives: Diagnostic Test: ultra-high-resolution computed tomography exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective and objective evaluation methods for CT image quality
Image quality (Likert score) and image noise will be combined to report the optimal image quality-noise combination
Measured: 2022.1-2024.12
Radiological anatomy of normal ears based on ultra-high resolution CT
diameters in milimeter
Measured: 2022.1-2024.12
Radiological anatomy of normal ears based on ultra-high resolution CT
angle in degree
Measured: 2022.1-2024.12
Quantitative diagnostic standard for ear diseases based on U-HRCT image
shape and position of conductive and senserineural hearing pathways
Measured: 2022.1-2024.12
Quantitative diagnostic standard for ear diseases based on U-HRCT image
size in milimeter of conductive and senserineural hearing pathways
Measured: 2022.1-2024.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tongren Hospital, Beijing Obstetrics and Gynecology Hospital
- Responsible party
- Principal investigator, Wang, Zhenchang, Beijing Friendship Hospital
- Investigators
- Zhenchang Wang, Prof., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533840
- Sponsor's protocol ID
- 2022-1-1111
- Status last verified
- Sep 2022
- First submitted
- 30 Aug 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The project team has not decided the ways to share the data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Application of a New Imaging System for Otology Based on Ultra-high Resolution CT
- ClinicalTrials.gov ID
- NCT05533840
- Acronym / sponsor ID
- 2022-1-1111
- Conditions
- Hearing Loss, Tinnitus, Vertigo
- Keywords
- Otology, Medical imaging, Tomography, X-ray, Diagnosis, Resolution
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing Tongren Hospital, Beijing Obstetrics and Gynecology Hospital
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Sep 2022 (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.
Tinnitus, hearing loss and vertigo are the three major diseases of otology, affecting hundreds of millions of people in our country, and are major health problems. Ear structures and lesions are deeply embedded in the bone, and CT is the preferred examination technique. The key structures of the ear are small and the lesions are hidden. Spiral CT is "not visible" and "undiagnosed" due to insufficient spatial resolution. The ultra-high-resolution CT independently developed by our team has a spatial resolution of 50 μm, which is 6 times higher than that of high-end spiral CT, and solves the problem of "not showing" ear diseases. However, with the transformation of imaging modes and the improvement of display capabilities, the imaging system of helical CT is no longer applicable. It is urgent to carry out systematic research to create matching imaging plans, imaging anatomy standards and disease assessment standards to solve the problem of "undiagnosed". problem. This project plans to build an adult and pediatric imaging solution based on ultra-high-resolution CT to optimize image quality and radiation dose; comprehensively evaluate conduction, sensory, and surgical-related fine structures of the ear, and establish a new 0.1mm-scale image anatomy atlas; A prospective study conducted by the center analyzes the hidden pathological changes of tinnitus, deafness and vertigo, evaluates the diagnostic efficacy of ultra-high-resolution CT for the above diseases, and establishes new diagnostic criteria for lesion detection, symptom correlation, and efficacy evaluation. This project will bring new changes to the practice of otology clinical diagnosis and treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Age under 18 | – | Diagnostic Test: ultra-high-resolution computed tomography examsParticipants under the age of 18 |
| Age 18-30 | – | Diagnostic Test: ultra-high-resolution computed tomography examsParticipants aged 18-30 |
| Age 31-40 | – | Diagnostic Test: ultra-high-resolution computed tomography examsParticipants aged 31-40 |
| Age 41-50 | – | Diagnostic Test: ultra-high-resolution computed tomography examsParticipants aged 41-50 |
| Age 51-60 | – | Diagnostic Test: ultra-high-resolution computed tomography examsParticipants aged 51-60 |
| Age ≥61 | – | Diagnostic Test: ultra-high-resolution computed tomography examsParticipants aged ≥61 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * 50 healthy volunteers (100 ears) * otological patients 1450 cases (tinnitus>634 ears, hearing loss>634 ears, and vertigo>181 ears)
Key inclusion criteria (8 listed)
- Due to tinnitus/deafness/peripheral vertigo/peripheral facial paralysis in the ENT department of our hospital
- Meet the ethical requirements of U-HRCT examination
- Can cooperate with the completion of U-HRCT examination
- Surgery in the ENT department of our hospital
- At least one follow-up or re-examination after discharge
Key exclusion criteria (10 listed)
- For patients with otological diseases
- History of previous ear surgery and trauma
- CT image artifacts or incomplete scanning coverage
- Incomplete clinical data
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 |
|---|---|---|
| ultra-high-resolution computed tomography examsParticipants in the age groups undergo ultra-high-resolution computed tomography exam | Diagnostic test | Age 18-30, Age 31-40, Age 41-50, Age 51-60, Age under 18, Age ≥61 |
Primary outcome
Subjective and objective evaluation methods for CT image quality
Time frame: 2022.1-2024.12
Image quality (Likert score) and image noise will be combined to report the optimal image quality-noise combination
Radiological anatomy of normal ears based on ultra-high resolution CT
Time frame: 2022.1-2024.12
diameters in milimeter
Radiological anatomy of normal ears based on ultra-high resolution CT
Time frame: 2022.1-2024.12
angle in degree
Quantitative diagnostic standard for ear diseases based on U-HRCT image
Time frame: 2022.1-2024.12
shape and position of conductive and senserineural hearing pathways
Quantitative diagnostic standard for ear diseases based on U-HRCT image
Time frame: 2022.1-2024.12
size in milimeter of conductive and senserineural hearing pathways
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Individual participant dataSharing planned: Undecided. The project team has not decided the ways to share the data.
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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.
Zhenchang Wang, Prof. principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Tinnitus, run by Beijing Friendship Hospital at 1 site in China.
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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pengfei Zhao, Prof. (+8613811048563, zhaopengf05@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective and objective evaluation methods for CT image quality (time frame: 2022.1-2024.12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2022.