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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06535282
Enrollment
26
Registered
2024-08-02
Start date
2018-01-01
Completion date
2023-12-31
Last updated
2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conductive Hearing Loss, Surgery, Tinnitus

Keywords

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

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).

Interventions

OTHERsurgery

Surgical treatment of conductive hearing loss with tinnitus

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
pure tone audiometry3-7 days before surgery, 1-12 months after surgeryThe 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.
speech test3-7 days before surgery, 1-12 months after surgerySpeech audiometry was mainly used to analyze the speech recognition rate of patients before and after surgery
EEG activation3-7 days before surgery, 1-12 months after surgeryEEG 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 scores3-7 days before surgery, 1-12 months after surgeryThe 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

MeasureTime frameDescription
visual analogue scale3-7 days before surgery, 1-12 months after surgeryThe 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.
fNIRS activation3-7 days before surgery, 1-12 months after surgeryfNIRS 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 scores3-7 days before surgery, 1-12 months after surgeryThe total score of the TFI scale were collected before and after surgery for data analysis.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026