Brain Mechanism and Outcome of Surgical Intervention of Conductive Hearing Loss.

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Tinnitus; Conductive Hearing Loss
• Intervention / Treatment: Other: surgery

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: baseline; pre-operative period test results
Other: follow-up; post-operative period test results	Other: surgery; Surgical treatment of conductive hearing loss with tinnitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	3-7 days before surgery, 1-12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tinnitus function index scores	The total score of the TFI scale were collected before and after surgery for data analysis.	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.	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.	3-7 days before surgery, 1-12 months after surgery

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: surgery; outcome; EEG; tinnitus; mechanism; Conductive Hearing Loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Tinnitus; Hearing Loss, Conductive
• Other Study ID Numbers: SYSKY-2024-328-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No