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NCT Number: NCT06727175

A Multicenter Study of Noninvasive Neuromodulation Treatment for 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.

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Key information

Conditions

Subjective Tinnitus Anxiety Disorders Behavior Behavioral Symptoms Depression Dyssomnias Ear Diseases Hearing Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Tinnitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

before any intervention

Other

before any intervention

Primary outcomes

  1. tinnitus loudness

    Time frame: 0-7 days pre-therapy, 0-7 days post-therapy

    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).

  2. tinnitus handicap inventory, THI

    Time frame: 0-7 days pre-therapy, 0-7 days post-therapy

    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).

  3. tinnitus functional index, TFI

    Time frame: 0-7 days pre-therapy, 0-7 days post-therapy

    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.

  4. visual analogue scale, VAS

    Time frame: 0-7 days pre-therapy, 0-7 days post-therapy

    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.

Secondary outcomes

  1. Hamilton Anxiety Scale, HAMA

    Time frame: 0-7 days pre-therapy, 0-7 days post-therapy

    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.

  2. Hamilton depression scale, HAMD

    Time frame: 0-7 days pre-therapy, 0-7 days post-therapy

    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.

  3. Pittsburgh sleep quality index, PSQI

    Time frame: 0-7 days pre-therapy, 0-7 days post-therapy

    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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2024
Registry last updated
Dec 10, 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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