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Completed

NCT Number: NCT06505473

Effects of Music Combined With CBT on Chronic Subjective Tinnitus

This study retrospectively analyzed the first and second visit data of chronic subjective tinnitus patients who received music combined with cognitive behavioral therapy in our hospital in recent years. Behavioral tests and tinnitus questionnaires, as well as sleep and depression scores, were used to analyze the therapeutic effects of this approach. EEG results were analyzed as a potential neurobiological marker to explore the neural mechanism of tinnitus symptom improvement.

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Key information

Conditions

Subjective Tinnitus Ear Diseases Hearing Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Sleep Disorder Sleep Wake Disorders Tinnitus

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

The subjects of this study were chronic subjective tinnitus patients and normal controls who were treated with music therapy combined with cognitive behavioral therapy (music-CBT) in the Department of Otolaryngology of Sun Yat-sen Memorial Hospital from December 2016 to March 2024 and who had completed re-examination. The pre- and post-music-CBT data of past patients who met our study conditions were collected for retrospective statistics. The complete sample data included medical history, pure tone audiometry, tinnitus matching, tinnitus questionnaires (Tinnitus Handicap Inventory, Visual Analog Scales, tinnitus Functional Index), sleep quality questionnaire (Pittsburgh Sleep Quality Index), and depression questionnaire (Hamilton Depression Scale -24 items). The resting state electroencephalogram (rs-EEG). Retrospective statistical analysis was conducted to determine the clinical efficacy and influencing factors of music-CBT for chronic subjective tinnitus at 3 months and long term. Finally, the neural mechanism of music-CBT for tinnitus treatment was analyzed based on rs-EEG results.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adults aged between 18 and 60
  • a total score of 18 or higher on THI
  • a constant tinnitus that can be matched
  • right-handed
  • no significant medical or psychiatric conditions

Exclusion criteria

  • intermittent, pulsating or objective tinnitus
  • central nervous system disease
  • cognitive impairment
  • other contraindications for EEG testing

Treatment and study plan

music-CBT

Behavioral

notched relaxation music combined with personalized CBT

Primary outcomes

  1. pure tone audiometry

    Time frame: the exact 1 day of the first visit

    The air conductivity threshold of pure tone audiometry across the frequency range of 500-4000Hz is referred to as the pure tone average (PTA) for the tested ear

  2. tinnitus loudness

    Time frame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months

    Tinnitus loudness was calculated by the matched intensity subtracting the pure tone threshold at that frequency.

  3. tinnitus handicap inventory (THI)

    Time frame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months

    There were 25 items in the THI scale, divided into three subscales (functional, emotional, and catastrophic), and response choices consisted of "no" (0 points), "sometimes" (2 points), and "yes" (4 points). A higher score of THI indicateed more severe tinnitus.

  4. tinnitus functional index (TFI)

    Time frame: the exact day of the first visit and review visit, within 3 - 4.5 months

    The TFI scale assessed tinnitus-related distress and severity. It contained 8 subscales. They were 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 worthes 100 points. The average score of all items was recorded as the total TFI score (0-100). A higher score of TFI indicateed more severe tinnitus.

  5. EEG functional connectivity and brain network characteristics

    Time frame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months

    EEG signals were used to explore the activation of brain regions and remodeling of poor connections in the postoperative outcomes of conductive hearing loss patients accompanied by with tinnitus. Power spectral density calculation, traceability analysis, functional connection, microstate, clustering coefficient, feature path length, feature path intermediation, and isocompatibility coefficient were collected and then analyzed.

Secondary outcomes

  1. visual analogue scale (VAS)

    Time frame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months

    VAS scaled from 0 to 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.

  2. Pittsburgh sleep quality index (PSQI)

    Time frame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months

    PSQI scale was compiled by Buysse et al in 1989 to assess the sleep quality of individuals in the last 1 month. The total score ranges from 0 to 21. A higher score indicates worse sleep quality in the past month.

  3. Hamilton Depression Scale -24 items (HAMD-24)

    Time frame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months

    The HAMD-24 was used to assess the degree of depression and emotional state in patients with chronic subjective tinnitus. The assessment included the emotional state and symptoms of autonomic nervous system disorders in the past week, and each question was scored according to the presence and severity of symptoms.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Effects of Music Combined With Cognitive Behavioral Therapy on Chronic Subjective Tinnitus and a Multi-Factor Analysis

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2024
Registry last updated
Aug 22, 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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