Conductive Hearing LossNCT06535282
Brain Mechanism and Outcome of Surgical Intervention of Conductive Hearing Loss.
A study testing surgery in people with Conductive Hearing Loss and Tinnitus, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and EEG data. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Conductive Hearing Loss, Tinnitus, Surgery
- What is being tested?
- surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2023
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged between 18 and 60 years;
- diagnosed with conductive hearing loss with tinnitus;
- treated with surgery;
- able to cooperate with all Chinese version evaluation;
- right-handed.
Who cannot join
- Pure tone audiometry indicates that the average pure tone hearing threshold (500Hz, 1kHz, 2kHz, 4kHz) is > 91dB HL;
- acoustic neuroma, nasopharyngeal carcinoma;
- hearing loss caused by noise or drugs.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: The Brain Network Mechanism and Outcome After Surgical Intervention of Conductive Hearing Loss Accompanied by Tinnitus.
This study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and EEG data.
Read the detailed description
This study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and EEG data. Including audiological assessment (pure tone audiometry, speech test), tinnitus assessment (tinnitus matching, tinnitus handicap inventory, tinnitus function index, visual analogue scale)and non-invasive brain imaging assessment (EEG, fNIRS).
- Conditions
- Conductive Hearing Loss, Tinnitus, Surgery
- Being tested
- surgery
- Keywords
- Conductive Hearing Loss, tinnitus, surgery, outcome, EEG, mechanism
- Medical subject headings
- Hearing Loss, Conductive, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryOther
Surgical treatment of conductive hearing loss with tinnitus
| Study group | Role | What they receive |
|---|---|---|
| baseline | No intervention | pre-operative period test results |
| follow-up | Other | post-operative period test results Receives: Other: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
pure tone audiometry
The air- conducted threshold, bone-conducted threshold and air- bone gap of each frequency of pure tone audiometry were used to compare pre - and post-operative hearing level.
Measured: 3-7 days before surgery, 1-12 months after surgery
speech test
Speech audiometry was mainly used to analyze the speech recognition rate of patients before and after surgery
Measured: 3-7 days before surgery, 1-12 months after surgery
EEG activation
EEG signals were used to explore the activation of brain regions and remodeling of poor connections in the postoperative outcomes of conductive hearing loss patients accompanied by with tinnitus. Power spectral density calculation, traceability analysis, functional connection, microstate, clustering coefficient, feature path length, feature path intermediation, and isocompatibility coefficient were collected and then analyzed.
Measured: 3-7 days before surgery, 1-12 months after surgery
tinnitus handicap inventory scores
The total score of the THI scale and the scores of the three subscales(functional, emotional, and catastrophic) were collected before and after surgery for data analysis.
Measured: 3-7 days before surgery, 1-12 months after surgery
Secondary outcomes (3)
tinnitus function index scores
The total score of the TFI scale were collected before and after surgery for data analysis.
Measured: 3-7 days before surgery, 1-12 months after surgery
visual analogue scale
The total score of the VAS were collected before and after surgery for data analysis. VAS scale 0-10. A score of 0 means that tinnitus has no impact on daily life, and a score of 10 means that tinnitus has an intolerable, fatal level of impact on daily life.
Measured: 3-7 days before surgery, 1-12 months after surgery
fNIRS activation
fNIRS signals were used to explore the activation of brain regions and remodeling of poor connections in the postoperative outcomes of conductive hearing loss patients accompanied by with tinnitus. Power spectral density calculation, traceability analysis, functional connection, microstate, clustering coefficient, feature path length, feature path intermediation, and isocompatibility coefficient were collected and then analyzed.
Measured: 3-7 days before surgery, 1-12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conductive Hearing LossStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535282
- Sponsor's protocol ID
- SYSKY-2024-328-01
- Status last verified
- Jul 2024
- First submitted
- 22 May 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Brain Network Mechanism and Outcome After Surgical Intervention of Conductive Hearing Loss Accompanied by Tinnitus.
- ClinicalTrials.gov ID
- NCT06535282
- Acronym / sponsor ID
- SYSKY-2024-328-01
- Conditions
- Conductive Hearing Loss, Tinnitus, Surgery
- Keywords
- Conductive Hearing Loss, tinnitus, surgery, outcome, EEG, mechanism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Aug 2024 (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.
This study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and EEG data.
Detailed description
This study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and EEG data. Including audiological assessment (pure tone audiometry, speech test), tinnitus assessment (tinnitus matching, tinnitus handicap inventory, tinnitus function index, visual analogue scale)and non-invasive brain imaging assessment (EEG, fNIRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| baseline | No intervention | –pre-operative period test results |
| follow-up | Other | Other: surgerypost-operative period test results |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged between 18 and 60 years;
- diagnosed with conductive hearing loss with tinnitus;
- treated with surgery;
- able to cooperate with all Chinese version evaluation;
- right-handed.
Key exclusion criteria (3 listed)
- Pure tone audiometry indicates that the average pure tone hearing threshold (500Hz, 1kHz, 2kHz, 4kHz) is > 91dB HL;
- acoustic neuroma, nasopharyngeal carcinoma;
- hearing loss caused by noise or drugs.
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 |
|---|---|---|
| surgerySurgical treatment of conductive hearing loss with tinnitus | Other | follow-up |
Primary outcome
pure tone audiometry
Time frame: 3-7 days before surgery, 1-12 months after surgery
The air- conducted threshold, bone-conducted threshold and air- bone gap of each frequency of pure tone audiometry were used to compare pre - and post-operative hearing level.
speech test
Time frame: 3-7 days before surgery, 1-12 months after surgery
Speech audiometry was mainly used to analyze the speech recognition rate of patients before and after surgery
EEG activation
Time frame: 3-7 days before surgery, 1-12 months after surgery
EEG signals were used to explore the activation of brain regions and remodeling of poor connections in the postoperative outcomes of conductive hearing loss patients accompanied by with tinnitus. Power spectral density calculation, traceability analysis, functional connection, microstate, clustering coefficient, feature path length, feature path intermediation, and isocompatibility coefficient were collected and then analyzed.
tinnitus handicap inventory scores
Time frame: 3-7 days before surgery, 1-12 months after surgery
The total score of the THI scale and the scores of the three subscales(functional, emotional, and catastrophic) were collected before and after surgery for data analysis.
3 secondary outcomes
tinnitus function index scores
Time frame: 3-7 days before surgery, 1-12 months after surgery
visual analogue scale
Time frame: 3-7 days before surgery, 1-12 months after surgery
fNIRS activation
Time frame: 3-7 days before surgery, 1-12 months after surgery
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 2 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Conductive Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
Recruiting
Evaluation of Flexible Conductive Hearing Aids
Conductive Hearing Loss
RecruitingObservational study
Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
Hearing Loss, Conductive, Hearing Loss, Mixed
Recruiting
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
Bone Conduction, Hearing Loss, Conductive
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery in people with Conductive Hearing Loss and Tinnitus, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 5 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 2 Aug 2024. 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?
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?
pure tone audiometry (time frame: 3-7 days before surgery, 1-12 months after surgery). The study lists 4 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 2 Aug 2024.