Brain Mechanism and Outcome of Surgical Intervention of Conductive Hearing Loss.
- Conditions
- Conductive Hearing LossSurgeryTinnitus
- Interventions
- Other: surgery
- Registration Number
- NCT06535282
- Brief 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description follow-up surgery post-operative period test results
- Primary Outcome Measures
Name Time Method speech test 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
pure tone audiometry 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.
EEG activation 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 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.
- Secondary Outcome Measures
Name Time Method fNIRS activation 3-7 days before surgery, 1-12 months after surgery 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.
tinnitus function index scores 3-7 days before surgery, 1-12 months after surgery The total score of the TFI scale were collected before and after surgery for data analysis.
visual analogue scale 3-7 days before surgery, 1-12 months after surgery 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.
Trial Locations
- Locations (1)
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China