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A Multicenter Study of Noninvasive Neuromodulation Treatment for Subjective Tinnitus

NCT ID: NCT06727175

Last Updated: 2024-12-10

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

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-07-31

Brief Summary

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The purpose of this study is to find out the scientific and effectiveness of non-invasive neuromodulation therapy for subjective tinnitus and further guide the clinical response to tinnitus problems. This study collects the case data of subjective tinnitus patients who received non-invasive neuromodulation treatment for statistical analysis. The complete data included pure tone audiometry, tinnitus assessment, mood assessments, and sleep quality assessment. Paired T-tests are suppoesed to be conducted to analyze the clinical efficacy of non-invasive neuromodulation therapy for subjective tinnitus and its specific effect on improving mood and sleep.

Detailed Description

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The purpose of this study is to find out the scientific and effectiveness of non-invasive neuromodulation therapy for subjective tinnitus and further guide the clinical response to tinnitus problems. This study collects the case data of subjective tinnitus patients who received non-invasive neuromodulation treatment for statistical analysis. The complete data included pure tone audiometry, tinnitus assessment (tinnitus matching, Tinnitus Handicap Inventory, Tinnitus Function Index, Visual analog Scales), mood assessments (Hamilton Anxiety Scale, Hamilton Depression Scale), and sleep quality assessment (Pittsburgh Sleep Index Scale). Paired T-tests are suppoesed to be conducted to analyze the clinical efficacy of non-invasive neuromodulation therapy for subjective tinnitus and its specific effect on improving mood and sleep.

Conditions

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Subjective Tinnitus

Keywords

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non-invasive neuromodulation Subjective tinnitus clinical effect sleep quality anxiety depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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before non-invasive neuromodulation therapy

evaluation results before non-invasive neuroregulation therapy

before any intervention

Intervention Type OTHER

before any intervention

after non-invasive neuromodulation therapy

evaluation results after six-month non-invasive neuroregulation therapy

non-invasive neuromodulation therapy

Intervention Type BEHAVIORAL

Patients with subjective tinnitus were treated using non-invasive neuroregulation therapy. That is, to generate personalized, non-invasive acoustically stimulated neuroregulation regimens for six montns. Each participant was treated three times a day (morning, noon and bedtime) for 30 minutes each time.

Interventions

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non-invasive neuromodulation therapy

Patients with subjective tinnitus were treated using non-invasive neuroregulation therapy. That is, to generate personalized, non-invasive acoustically stimulated neuroregulation regimens for six montns. Each participant was treated three times a day (morning, noon and bedtime) for 30 minutes each time.

Intervention Type BEHAVIORAL

before any intervention

before any intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥18yrs,
* Diagnosed as subjective tinnitus,
* THI≥38,
* Chinese, can cooperate with all Chinese version evaluation,
* Right-handed,
* No major neurological disease or other

Exclusion Criteria

* Hyperacustic,
* Incomplete case data
Minimum Eligible Age

18 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

Principal Investigators

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Haidi Yang, PhD

Role: STUDY_DIRECTOR

SunYatSunU2H

Locations

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Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510000

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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SYSKY-2024-671-01

Identifier Type: -

Identifier Source: org_study_id