A Multicenter Study of Noninvasive Neuromodulation Treatment for Subjective Tinnitus

NCT06727175 | Completed

• 1 other identifier: SYSKY-2024-671-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjective Tinnitus

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Hamilton Anxiety Scale, HAMA

  0-7 days pre-therapy, 0-7 days post-therapy

• Hamilton depression scale, HAMD

  0-7 days pre-therapy, 0-7 days post-therapy

• Pittsburgh sleep quality index, PSQI

  0-7 days pre-therapy, 0-7 days post-therapy

Study Arms (2)

before non-invasive neuromodulation therapy

evaluation results before non-invasive neuroregulation therapy

Other: before any intervention

after non-invasive neuromodulation therapy

evaluation results after six-month non-invasive neuroregulation therapy

Behavioral: non-invasive neuromodulation therapy

Interventions

non-invasive neuromodulation therapy 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.

after non-invasive neuromodulation therapy

before any intervention OTHER

before any intervention

before non-invasive neuromodulation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Hyperacustic,
• Incomplete case data

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Tinnitus; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Haidi Yang, PhD

  SunYatSunU2H

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: January 1, 2018
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)