Subjective TinnitusNCT06505473
Effects of Music Combined With CBT on Chronic Subjective Tinnitus
An observational study of Subjective Tinnitus and Sleep Disorder, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjective Tinnitus, Sleep Disorder
- What is being tested?
- music-CBT
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The participants involved in this study were patients admitted to Sun Yat-sen Memorial Hospital with chronic subjective tinnitus that had lasted for more than six months. They were all treated with Music-CBT for 3 months.
Who may be able to join
- 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
Who cannot join
- intermittent, pulsating or objective tinnitus
- central nervous system disease
- cognitive impairment
- other contraindications for EEG testing
About this study
Official title: Effects of Music Combined With Cognitive Behavioral Therapy on Chronic Subjective Tinnitus and a Multi-Factor Analysis
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.
Read the detailed description
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.
- Conditions
- Subjective Tinnitus, Sleep Disorder
- Being tested
- music-CBT
- Keywords
- chronic subjective tinnitus, music therapy, cognitive behavioral therapy, neural mechanism
- Medical subject headings
- Tinnitus, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music-CBTBehavioural
notched relaxation music combined with personalized CBT
| Study group | Role | What they receive |
|---|---|---|
| pre-operative results | pre-operative period test results, baseline data. Receives: Behavioral: music-CBT | |
| post-operative results | post-operative period test results, review data. | |
| healthy control | Subjects with no tinnitus and matched baseline information |
What is being measured
The primary outcome is the main question the study is designed to answer.
pure tone audiometry
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
Measured: the exact 1 day of the first visit
tinnitus loudness
Tinnitus loudness was calculated by the matched intensity subtracting the pure tone threshold at that frequency.
Measured: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
tinnitus handicap inventory (THI)
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.
Measured: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
tinnitus functional index (TFI)
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.
Measured: the exact day of the first visit and review visit, within 3 - 4.5 months
EEG functional connectivity and brain network characteristics
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.
Measured: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
Secondary outcomes (3)
visual analogue scale (VAS)
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.
Measured: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
Pittsburgh sleep quality index (PSQI)
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.
Measured: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
Hamilton Depression Scale -24 items (HAMD-24)
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.
Measured: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Dec 2016
- Primary completion31 Mar 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective TinnitusStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haidi Yang, master, Study director, SunYatSunU2H
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505473
- Sponsor's protocol ID
- SYSKY-2024-453-01
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Combined With Cognitive Behavioral Therapy on Chronic Subjective Tinnitus and a Multi-Factor Analysis
- ClinicalTrials.gov ID
- NCT06505473
- Acronym / sponsor ID
- SYSKY-2024-453-01
- Conditions
- Subjective Tinnitus, Sleep Disorder
- Keywords
- chronic subjective tinnitus, music therapy, cognitive behavioral therapy, neural mechanism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| pre-operative results | – | Behavioral: music-CBTpre-operative period test results, baseline data. |
| post-operative results | – | –post-operative period test results, review data. |
| healthy control | – | –Subjects with no tinnitus and matched baseline information |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants involved in this study were patients admitted to Sun Yat-sen Memorial Hospital with chronic subjective tinnitus that had lasted for more than six months. They were all treated with Music-CBT for 3 months.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- intermittent, pulsating or objective tinnitus
- central nervous system disease
- cognitive impairment
- other contraindications for EEG testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music-CBTnotched relaxation music combined with personalized CBT | Behavioural | pre-operative results |
Primary outcome
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
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.
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.
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.
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.
3 secondary outcomes
visual analogue scale (VAS)
Time frame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
Pittsburgh sleep quality index (PSQI)
Time frame: the exact 1 day of the first visit and review visit, within 3 - 4.5 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haidi Yang, master study director
SunYatSunU2H
Questions about this trial
What is this clinical trial studying?
An observational study of Subjective Tinnitus and Sleep Disorder, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pure tone audiometry (time frame: the exact 1 day of the first visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.