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Clinical Trials/NCT06535282
NCT06535282
Completed
Not Applicable

The Brain Network Mechanism and Outcome After Surgical Intervention of Conductive Hearing Loss Accompanied by Tinnitus.

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 site in 1 country26 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Conductive Hearing Loss
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Enrollment
26
Locations
1
Primary Endpoint
speech test
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

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.

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.

Secondary Outcomes

  • fNIRS activation(3-7 days before surgery, 1-12 months after surgery)
  • tinnitus function index scores(3-7 days before surgery, 1-12 months after surgery)
  • visual analogue scale(3-7 days before surgery, 1-12 months after surgery)

Study Sites (1)

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