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NCT Number: NCT06535282

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

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, 510000, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SURGERY

Other

Surgical treatment of conductive hearing loss with tinnitus

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

  1. tinnitus function index scores

    Time frame: 3-7 days before surgery, 1-12 months after surgery

    The total score of the TFI scale were collected before and after surgery for data analysis.

  2. visual analogue scale

    Time frame: 3-7 days before surgery, 1-12 months after surgery

    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. fNIRS activation

    Time frame: 3-7 days before surgery, 1-12 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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