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

NCT06535282 | Completed

• 1 other identifier: SYSKY-2024-328-01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Conductive Hearing Loss; Tinnitus; Surgery

Keywords

Conductive Hearing Loss; tinnitus; surgery; outcome; EEG; mechanism

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

• fNIRS activation

  3-7 days before surgery, 1-12 months after surgery

Study Arms (2)

baseline

NO INTERVENTION

pre-operative period test results

follow-up

OTHER

post-operative period test results

Other: surgery

Interventions

surgery OTHER

Surgical treatment of conductive hearing loss with tinnitus

follow-up

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Hearing Loss, Conductive; Tinnitus

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: August 2, 2024
• Study Start: January 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)