A Multicenter Study of Noninvasive Neuromodulation Treatment for Subjective Tinnitus

A Multi-center Efficacy Study of Noninvasive Neuromodulation in the Treatment of Subjective Tinnitus

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.

Study Overview

• Status: Completed
• Conditions: Subjective Tinnitus
• Intervention / Treatment: Other: before any intervention; Behavioral: non-invasive neuromodulation therapy

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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
before non-invasive neuromodulation therapy; evaluation results before non-invasive neuroregulation therapy	Other: before any intervention; before any intervention
after non-invasive neuromodulation therapy; evaluation results after six-month non-invasive neuroregulation therapy	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tinnitus loudness	Taking 1dB as the step, parrticipants were asked to select the signal sound intensity consistent with their subjective tinnitus loudness, and the tinnitus loudness matching was completed after repeated testing. The difference between the matched intensity and the pure tone hearing threshold at this frequency was recorded as tinnitus loudness (dB SL).	0-7 days pre-therapy, 0-7 days post-therapy
tinnitus handicap inventory, THI	THI is divided into three sub-scales, namely functional, emotional and catastrophic. THI contains a total of 25 items, and each item is scored 4, 2 and 0 points according to "yes", "sometimes" and "no" respectively. After each item score was completed, the THI total score, THI functional total score (THI-F), THI affective total score (THI-E), and THI catastrophic total score (THI-C) were calculated for the specific patient. The severity of tinnitus was evaluated according to the total score: 1-16 points, grade 1 (slight); 18-36 points, grade 2 (mild); 38-56pointks, grade 3 (moderate); 58-76 points, level 4 (severe); Score 78-100, level 5 (catastrophic).	0-7 days pre-therapy, 0-7 days post-therapy
tinnitus functional index, TFI	The scale contains 8 subscales. They are denoted as TFI-I (Intrusiveness) and TFI-SC (Sense of) control), TFI-C (Cognition), TFI-S (Sleep), TFI-A (Auditory), TFI-R (Relaxation), TFI-Q (Quality of life), TFI-E (Emotional) distress); A total of 25 items are included. Each item is worth 100 points. The average score of all items is recorded as the total TFI score. The higher the score, the higher the pain and severity of the subject's tinnitus.	0-7 days pre-therapy, 0-7 days post-therapy
visual analogue scale, VAS	VAS was used to evaluate the impact of tinnitus on the daily life of patients with chronic subjective tinnitus. 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. VAS was used to evaluate subjective tinnitus loudness, annoyance, depression, and tinnitus control difficulty.	0-7 days pre-therapy, 0-7 days post-therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Anxiety Scale, HAMA	The scale contains 14 items, mainly involving two aspects of physical anxiety and mental anxiety. The scale is scored on a 0-4 scale on five scales: 0 for asymptomatic, 1 for mild, 2 for moderate, 3 for severe, and 4 for extremely severe.	0-7 days pre-therapy, 0-7 days post-therapy
Hamilton depression scale, HAMD	The study uses a 24-item version. Each item is scored on a 0-4 scale on a 5-point scale: 0 for asymptomatic, 1 for mild, 2 for moderate, 3 for severe, and 4 for extremely severe.	0-7 days pre-therapy, 0-7 days post-therapy
Pittsburgh sleep quality index, PSQI	The scale contains 24 items, which are divided into subjective sleep quality, sleep time, sleep latency, sleep efficiency, sleep disorders, sleep medication use and daily dysfunction, with a total of 7 components. Each component is rated 0-3 points. The total score ranges from 0 to 21. The higher the score, the worse the sleep quality in the past month. Among them, 0-5 points represent excellent sleep quality, 6-10 points represent good sleep quality, 11-15 points represent moderate sleep quality, 16-20 points indicate poor sleep quality, and 21 points indicate the worst sleep quality.	0-7 days pre-therapy, 0-7 days post-therapy

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Study Director: Haidi Yang, PhD, SunYatSunU2H

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: depression; anxiety; sleep quality; Subjective tinnitus; non-invasive neuromodulation; clinical effect
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Tinnitus
• Other Study ID Numbers: SYSKY-2024-671-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No