TinnitusNCT06889259
Efficacy and Safety of CBT on Tinnitus
A study testing CBT based digital therapeutics and Conventional CBT in people with Tinnitus, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
Tinnitus, the perception of sound without external stimuli, affects 14% of the global population, posing a significant public health concern. This predominantly subjective condition often leads to psychological and physical distress, including anxiety, depression, and insomnia. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- CBT based digital therapeutics and Conventional CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjective tinnitus more than 3mo
- age over 19
- Pure tone audiometry < 60 decibel
- Tinnitus handicap inventory score > 18
Who cannot join
- Objective tinnitus
- Otitis, labyrinthitis
- Depression, Anxiety, Insomnia or other psychiatric disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Cognitive Behavioral Therapy, Tones Stimulator in Patients With Subjective Tinnitus: Prospective, Multi-center, Randomized, Single Blind (Subject), Parallel, Superiority, Confirmatory Trial
Tinnitus, the perception of sound without external stimuli, affects 14% of the global population, posing a significant public health concern. This predominantly subjective condition often leads to psychological and physical distress, including anxiety, depression, and insomnia. As tinnitus prevalence rises due to aging populations and increased noise exposure, the need for effective treatments grows urgent.
Current approaches include pharmacological interventions, sound therapy, and cognitive behavioral therapy (CBT), with CBT recognized as most effective for addressing psychological distress. However, traditional therapies face accessibility barriers such as frequent in-person sessions and high costs.
Read more
Digital therapeutics, particularly mobile applications, offer promising solutions by providing scalable, accessible interventions. These allow patients to engage in therapy conveniently, accessing real-time, personalized content. Despite advancements, research on digital therapeutics combining CBT and sound therapy for tinnitus remains limited.
This study aims to address this gap by evaluating the clinical efficacy of a mobile application delivering personalized CBT and sound stimulation compared to conventional CBT, potentially contributing to more accessible and effective tinnitus treatment options.
Read the detailed description
Tinnitus, characterized by the perception of sound without external stimuli, affects approximately 14% of the global population, posing a significant public health concern. This predominantly subjective condition often leads to psychological and physical distress, including anxiety, depression, and insomnia. Current approaches to managing tinnitus include pharmacological interventions, sound therapy, and cognitive behavioral therapy (CBT). Among these, CBT is recognized as one of the most effective methods for addressing the psychological distress associated with tinnitus. However, traditional CBT often faces accessibility barriers, such as the need for frequent in-person sessions and high costs. This limits its reach and effectiveness for many patients.Digital therapeutics, particularly mobile applications, offer promising solutions by providing scalable and accessible interventions. These platforms allow patients to engage in therapy conveniently, accessing real-time, personalized content. Despite advancements in digital therapeutics, research on combining CBT and sound therapy for tinnitus remains limited. This gap in research highlights the need for innovative, accessible treatments that can be tailored to individual patient needs.
This study aims to address this gap by evaluating the clinical efficacy of a mobile application that delivers personalized CBT and sound stimulation. The application, designed to provide tailored interventions, will be compared to conventional CBT methods. By leveraging the strengths of both CBT and sound therapy, this study seeks to contribute to the development of more accessible and effective tinnitus treatment options.
The study will employ a prospective, multicenter, randomized, single-blind (participant), parallel-design, superiority, confirmatory trial to assess the efficacy and safety of the mobile application. Participants will be randomly assigned to either the intervention group using the mobile application or the control group receiving conventional CBT educational materials. The primary outcome will be the change in Tinnitus Handicap Inventory (THI) scores from baseline to 6 weeks, with secondary outcomes including changes in THI subscales, Tinnitus Functional Index (TFI), Visual Analog Scale (VAS) for negative emotions and tinnitus discomfort, Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI).
The study's design and methodology are crucial for evaluating the effectiveness of the mobile application. By using a randomized controlled trial design, the study ensures that any observed effects can be attributed to the intervention rather than external factors. The use of standardized assessment tools like THI and TFI will provide a comprehensive understanding of the application's impact on tinnitus-related distress.
Furthermore, the study will assess the safety and tolerability of the mobile application, monitoring for any adverse events or side effects. This is essential for ensuring that the treatment is not only effective but also safe for widespread use.
- Conditions
- Tinnitus
- Being tested
- CBT based digital therapeutics, Conventional CBT
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT based digital therapeuticsBehavioural
The mobile-based digital therapeutic intervention integrated video education, thought record sheets, and sound therapy. This comprehensive treatment was administered five times weekly. The program consisted of a total of 30 sessions.
Conventional CBTBehavioural
The cognitive behavioral therapy program for tinnitus, based on a paper manual, was administered five times per week. The treatment regimen consisted of a total of 30 sessions,.
| Study group | Role | What they receive |
|---|---|---|
| CBT based digital therapeutics | Active comparator | CBT using digital therapeutics Receives: Behavioral: CBT based digital therapeutics |
| Conventional CBT | Sham comparator | Conventional CBT Receives: Behavioral: Conventional CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus handicap inventory
The Tinnitus Handicap Inventory is a widely used 25-item self-report questionnaire designed to assess the impact of tinnitus on an individual's daily life. It evaluates functional, emotional, and catastrophic effects of tinnitus, with scores ranging from 0 to 100. Higher score means worse outcome。
Measured: Baseline, 4weeks, 5weeks 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Jan 2024
- Primary completion31 Oct 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Multi-center, Randomized, single blind (subject), Parallel, Superiority, Confirmatory Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jae-Jun Song, Study director, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889259
- Sponsor's protocol ID
- 2023GR0400
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cognitive Behavioral Therapy, Tones Stimulator in Patients With Subjective Tinnitus: Prospective, Multi-center, Randomized, Single Blind (Subject), Parallel, Superiority, Confirmatory Trial
- ClinicalTrials.gov ID
- NCT06889259
- Acronym / sponsor ID
- 2023GR0400
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Mar 2025 (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.
Tinnitus, the perception of sound without external stimuli, affects 14% of the global population, posing a significant public health concern. This predominantly subjective condition often leads to psychological and physical distress, including anxiety, depression, and insomnia. As tinnitus prevalence rises due to aging populations and increased noise exposure, the need for effective treatments grows urgent.
Current approaches include pharmacological interventions, sound therapy, and cognitive behavioral therapy (CBT), with CBT recognized as most effective for addressing psychological distress. However, traditional therapies face accessibility barriers such as frequent in-person sessions and high costs.
Digital therapeutics, particularly mobile applications, offer promising solutions by providing scalable, accessible interventions. These allow patients to engage in therapy conveniently, accessing real-time, personalized content. Despite advancements, research on digital therapeutics combining CBT and sound therapy for tinnitus remains limited.
This study aims to address this gap by evaluating the clinical efficacy of a mobile application delivering personalized CBT and sound stimulation compared to conventional CBT, potentially contributing to more accessible and effective tinnitus treatment options.
Detailed description
Tinnitus, characterized by the perception of sound without external stimuli, affects approximately 14% of the global population, posing a significant public health concern. This predominantly subjective condition often leads to psychological and physical distress, including anxiety, depression, and insomnia. Current approaches to managing tinnitus include pharmacological interventions, sound therapy, and cognitive behavioral therapy (CBT). Among these, CBT is recognized as one of the most effective methods for addressing the psychological distress associated with tinnitus. However, traditional CBT often faces accessibility barriers, such as the need for frequent in-person sessions and high costs. This limits its reach and effectiveness for many patients.Digital therapeutics, particularly mobile applications, offer promising solutions by providing scalable and accessible interventions. These platforms allow patients to engage in therapy conveniently, accessing real-time, personalized content. Despite advancements in digital therapeutics, research on combining CBT and sound therapy for tinnitus remains limited. This gap in research highlights the need for innovative, accessible treatments that can be tailored to individual patient needs.
This study aims to address this gap by evaluating the clinical efficacy of a mobile application that delivers personalized CBT and sound stimulation. The application, designed to provide tailored interventions, will be compared to conventional CBT methods. By leveraging the strengths of both CBT and sound therapy, this study seeks to contribute to the development of more accessible and effective tinnitus treatment options.
The study will employ a prospective, multicenter, randomized, single-blind (participant), parallel-design, superiority, confirmatory trial to assess the efficacy and safety of the mobile application. Participants will be randomly assigned to either the intervention group using the mobile application or the control group receiving conventional CBT educational materials. The primary outcome will be the change in Tinnitus Handicap Inventory (THI) scores from baseline to 6 weeks, with secondary outcomes including changes in THI subscales, Tinnitus Functional Index (TFI), Visual Analog Scale (VAS) for negative emotions and tinnitus discomfort, Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI).
The study's design and methodology are crucial for evaluating the effectiveness of the mobile application. By using a randomized controlled trial design, the study ensures that any observed effects can be attributed to the intervention rather than external factors. The use of standardized assessment tools like THI and TFI will provide a comprehensive understanding of the application's impact on tinnitus-related distress.
Furthermore, the study will assess the safety and tolerability of the mobile application, monitoring for any adverse events or side effects. This is essential for ensuring that the treatment is not only effective but also safe for widespread use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Multi-center, Randomized, single blind (subject), Parallel, Superiority, Confirmatory Trial
| Arm | Type | Receives |
|---|---|---|
| CBT based digital therapeutics | Active comparator | Behavioral: CBT based digital therapeuticsCBT using digital therapeutics |
| Conventional CBT | Sham comparator | Behavioral: Conventional CBTConventional CBT |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjective tinnitus more than 3mo
- age over 19
- Pure tone audiometry < 60 decibel
- Tinnitus handicap inventory score > 18
Key exclusion criteria (4 listed)
- Objective tinnitus
- Otitis, labyrinthitis
- Depression, Anxiety, Insomnia or other psychiatric disorder
- Pregnancy
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 |
|---|---|---|
| CBT based digital therapeuticsThe mobile-based digital therapeutic intervention integrated video education, thought record sheets, and sound therapy. This comprehensive treatment was administered five times weekly. The program consisted of a total of 30 sessions. | Behavioural | CBT based digital therapeutics |
| Conventional CBTThe cognitive behavioral therapy program for tinnitus, based on a paper manual, was administered five times per week. The treatment regimen consisted of a total of 30 sessions,. | Behavioural | Conventional CBT |
Primary outcome
Tinnitus handicap inventory
Time frame: Baseline, 4weeks, 5weeks 6weeks
The Tinnitus Handicap Inventory is a widely used 25-item self-report questionnaire designed to assess the impact of tinnitus on an individual's daily life. It evaluates functional, emotional, and catastrophic effects of tinnitus, with scores ranging from 0 to 100. Higher score means worse outcome。
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 21 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Tinnitus
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A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
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Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
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Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
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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.
Jae-Jun Song study director
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT based digital therapeutics and Conventional CBT in people with Tinnitus, run by Korea University Guro Hospital at 1 site in South Korea.
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 4 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Tinnitus handicap inventory (time frame: Baseline, 4weeks, 5weeks 6weeks). 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 21 Mar 2025.