Clinical trial NCT06727175: A Multicenter Study of Noninvasive Neuromodulation Treatment for Subjective Tinnitus
Official title: A Multi-center Efficacy Study of Noninvasive Neuromodulation in the Treatment of Subjective Tinnitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subjective Tinnitus
Keywords: non-invasive neuromodulation
Subjective tinnitus
clinical effect
sleep quality
anxiety
depression
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjective tinnitus patients and compliance with 6 months of noninvasive neuromodulation therapy, with complete two-assessment scale records.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: tinnitus loudness
timeFrame: 0-7 days pre-therapy, 0-7 days post-therapy
measure: tinnitus handicap inventory, THI
timeFrame: 0-7 days pre-therapy, 0-7 days post-therapy
measure: tinnitus functional index, TFI
timeFrame: 0-7 days pre-therapy, 0-7 days post-therapy
measure: visual analogue scale, VAS
timeFrame: 0-7 days pre-therapy, 0-7 days post-therapy
Secondary outcomes:
measure: Hamilton Anxiety Scale, HAMA
timeFrame: 0-7 days pre-therapy, 0-7 days post-therapy
measure: Hamilton depression scale, HAMD
timeFrame: 0-7 days pre-therapy, 0-7 days post-therapy
measure: Pittsburgh sleep quality index, PSQI
timeFrame: 0-7 days pre-therapy, 0-7 days post-therapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510000
state: Guangdong
Study officials:
affiliation: SunYatSunU2H
name: Haidi Yang, PhD
role: STUDY_DIRECTOR
References: