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

NCT ID: NCT06535282

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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Conductive Hearing Loss Tinnitus Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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baseline

pre-operative period test results

Group Type NO_INTERVENTION

No interventions assigned to this group

follow-up

post-operative period test results

Group Type OTHER

surgery

Intervention Type OTHER

Surgical treatment of conductive hearing loss with tinnitus

Interventions

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surgery

Surgical treatment of conductive hearing loss with tinnitus

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SYSKY-2024-328-01

Identifier Type: -

Identifier Source: org_study_id

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