TinnitusNCT03764826
Study on the Effect of Sound Therapy on Chronic Primary Tinnitus
A study testing CAABT and TMT in people with Tinnitus, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This study is to compare the effect of Cochleural Alternating Acoustic Beam Therapy(CAABT) and tinnitus masking therapy(TMT) on chronic primary tinnitus.Half of participants will receive CAABT, while the other half will receive TMT. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- CAABT and TMT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 8 Dec 2019
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 18-75 years
- Tinnitus undergone for more than 6 months
- Continuous attack, single tone dominated, annoying tinnitus
- Able to cooperate with auditory function test and psychoacoustic test
- The main tinnitus frequency is from 125Hz to 8000Hz
- Willing to use the equipment daily during the test
- Willing and able to follow up regularly
- Ability to read and write Chinese, able to understand and complete questionnaires
Who cannot join
- Secondary tinnitus
- Pure tone audiometry shows conduction deafness or mixed deafness
- Tinnitus main frequency threshold >60dB
- Receiving treatment for other tinnitus
- MRI contraindications
- Feeling uncomfortable with the treatment equipment or not being accepted
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100031
Shu-Sheng Gong, MD
Zhen-Chang Wang, MD, 010-63138217, cjr.wzhch@vip.163.com
About this study
This study is to compare the effect of Cochleural Alternating Acoustic Beam Therapy(CAABT) and tinnitus masking therapy(TMT) on chronic primary tinnitus.Half of participants will receive CAABT, while the other half will receive TMT.
Read the detailed description
The patients with tinnitus will be collected with medical history, ear examination ,auditory function test and questionnaire survey.100 cases of chronic primary tinnitus will be selected as the research object.This study will be developed in the form of a blind randomized clinical trial.The study subjects will be divided into 2 groups by randomized method, with 50 cases in each group. Psychological acoustic test, Resting-state function magnetic resonance imaging（RS-fMRI) will be conducted.For 6 months, the patients will be treated with Cochleural Alternating Acoustic Beam Therapy（CAABT）and tinnitus masking therapy（TMT） respectively, followed by questionnaire survey, psychological acoustics test and RS-fMRI. The THI,VAS score, RS-fMRI ReHo value and low-frequency wave amplitude (ALFF) before and after the treatment will be compared. For those cases with poor results, the exchanged treatment will be performed for 6 months, followed by questionnaire survey, psychoacoustic test, RS-fMRI, and comparison of THI, VAS score, ReHo value and ALFF before and after treatment.All cases will be followed up for 1 year, and questionnaire survey will be conducted again.
- Conditions
- Tinnitus
- Being tested
- CAABT, TMT
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAABTDevice
The sound generators with CAABT will be used 15 min each session, three times a day
TMTDevice
The sound generators with TMT will be used 15 min each session, three times a day
| Study group | Role | What they receive |
|---|---|---|
| CAABT | Experimental | CAABT(Cochleural Alternating Acoustic Beam Therapy) is an innovative tinnitus intervention which based on neural science and cochlear plastic research and aimed to reprogram the central auditory system to neutralize the discordant responses of the dysfunctioning cochlea via acoustic beaming stimuli. Receives: Device: CAABT |
| TMT | Active comparator | TMT(tinnitus masking therapy) is a traditional tinnitus intervention. The masking sound is mainly white noise, and the intensity just covers tinnitus. Receives: Device: TMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory ( THI)
Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Tinnitus Handicap Inventory scale.
Efficacy evaluation criteria: (1) cure: THI score was reduced to less than 16 points;(2) significant effect: THI score decreased by more than 17 points;(3) invalid: THI score value decreased < 17 points or even increased.Efficiency is the sum of cure and effect.
Measured: baseline, 2 months, 4 months, 6 months
Resting-state function magnetic resonance imaging(RS-fMRI) Regional homogeneity(ReHo) value
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ReHo value
Measured: baseline, 6 months
Resting-state function magnetic resonance imaging(RS-fMRI) low-frequency wave amplitude (ALFF)
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ALFF
Measured: baseline, 6 months
Visual Analogue Scale(VAS)
Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Visual Analogue Scale(VAS).
The number 0 to 10 indicates the severity of symptoms, "0" means no symptoms, and "10" means the most severe
Measured: baseline, 2 months, 4 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Dec 2018
- Primary completion8 Jun 2019 (estimated)
- Study completion8 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-sheng Gong, Beijing Friendship Hospital
- Investigators
- Shu-Sheng Gong, MD, Study director, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764826
- Sponsor's protocol ID
- 2018-P2-182-01
- Status last verified
- Dec 2018
- First submitted
- 30 Nov 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available within 6 months of study completion
Publications
Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus executive summary. Otolaryngol Head Neck Surg. 2014 Oct;151(4):533-41. doi: 10.1177/0194599814547475.
PubMed 25274374Liu C, Lv H, Jiang T, Xie J, He L, Wang G, Liu J, Wang Z, Gong S. The Cochleural Alternating Acoustic Beam Therapy (CAABT): A pre-clinical trial. Am J Otolaryngol. 2018 Jul-Aug;39(4):401-409. doi: 10.1016/j.amjoto.2018.04.002. Epub 2018 Apr 3.
PubMed 29655489
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Sound Therapy on Chronic Primary Tinnitus
- ClinicalTrials.gov ID
- NCT03764826
- Acronym / sponsor ID
- 2018-P2-182-01
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 8 Jun 2019 (estimated)
- Study completion
- 8 Dec 2019 (estimated)
- First posted
- 5 Dec 2018 (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 is to compare the effect of Cochleural Alternating Acoustic Beam Therapy(CAABT) and tinnitus masking therapy(TMT) on chronic primary tinnitus.Half of participants will receive CAABT, while the other half will receive TMT.
Detailed description
The patients with tinnitus will be collected with medical history, ear examination ,auditory function test and questionnaire survey.100 cases of chronic primary tinnitus will be selected as the research object.This study will be developed in the form of a blind randomized clinical trial.The study subjects will be divided into 2 groups by randomized method, with 50 cases in each group. Psychological acoustic test, Resting-state function magnetic resonance imaging（RS-fMRI) will be conducted.For 6 months, the patients will be treated with Cochleural Alternating Acoustic Beam Therapy（CAABT）and tinnitus masking therapy（TMT） respectively, followed by questionnaire survey, psychological acoustics test and RS-fMRI. The THI,VAS score, RS-fMRI ReHo value and low-frequency wave amplitude (ALFF) before and after the treatment will be compared. For those cases with poor results, the exchanged treatment will be performed for 6 months, followed by questionnaire survey, psychoacoustic test, RS-fMRI, and comparison of THI, VAS score, ReHo value and ALFF before and after treatment.All cases will be followed up for 1 year, and questionnaire survey will be conducted again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAABT | Experimental | Device: CAABTCAABT(Cochleural Alternating Acoustic Beam Therapy) is an innovative tinnitus intervention which based on neural science and cochlear plastic research and aimed to reprogram the central auditory system to neutralize the discordant responses of the dysfunctioning cochlea via acoustic beaming stimuli. |
| TMT | Active comparator | Device: TMTTMT(tinnitus masking therapy) is a traditional tinnitus intervention. The masking sound is mainly white noise, and the intensity just covers tinnitus. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages between 18-75 years
- Tinnitus undergone for more than 6 months
- Continuous attack, single tone dominated, annoying tinnitus
- Able to cooperate with auditory function test and psychoacoustic test
- The main tinnitus frequency is from 125Hz to 8000Hz
Key exclusion criteria (6 listed)
- Secondary tinnitus
- Pure tone audiometry shows conduction deafness or mixed deafness
- Tinnitus main frequency threshold >60dB
- Receiving treatment for other tinnitus
- MRI contraindications
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 |
|---|---|---|
| CAABTThe sound generators with CAABT will be used 15 min each session, three times a day | Device | CAABT |
| TMTThe sound generators with TMT will be used 15 min each session, three times a day | Device | TMT |
Primary outcome
Tinnitus Handicap Inventory ( THI)
Time frame: baseline, 2 months, 4 months, 6 months
Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Tinnitus Handicap Inventory scale. Efficacy evaluation criteria: (1) cure: THI score was reduced to less than 16 points;(2) significant effect: THI score decreased by more than 17 points;(3) invalid: THI score value decreased < 17 points or even increased.Efficiency is the sum of cure and effect.
Resting-state function magnetic resonance imaging(RS-fMRI) Regional homogeneity(ReHo) value
Time frame: baseline, 6 months
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ReHo value
Resting-state function magnetic resonance imaging(RS-fMRI) low-frequency wave amplitude (ALFF)
Time frame: baseline, 6 months
Change from Baseline in Tinnitus Subjective Measures at 6 months: RS-fMRI ALFF
Visual Analogue Scale(VAS)
Time frame: baseline, 2 months, 4 months, 6 months
Change from Baseline in Tinnitus Subjective Measures at 2 months, 4 months, 6 months: Visual Analogue Scale(VAS). The number 0 to 10 indicates the severity of symptoms, "0" means no symptoms, and "10" means the most severe
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Results publication: PubMed 25274374Tunkel DE, Bauer CA, Sun GH, Rosenfeld RM, Chandrasekhar SS, Cunningham ER Jr, Archer SM, Blakley BW, Carter JM, Granieri EC, Henry JA, Hollingsworth D, Khan FA, Mitchell S, Monfared A, Newman CW, Omole FS, Phillips CD, Robinson SK, Taw MB, Tyler RS, Waguespack R, Whamond EJ. Clinical practice guideline: tinnitus executive summary. Otolaryngol Head Neck Surg. 2014 Oct;151(4):533-41. doi: 10.1177/0194599814547475.
- Results publication: PubMed 29655489Liu C, Lv H, Jiang T, Xie J, He L, Wang G, Liu J, Wang Z, Gong S. The Cochleural Alternating Acoustic Beam Therapy (CAABT): A pre-clinical trial. Am J Otolaryngol. 2018 Jul-Aug;39(4):401-409. doi: 10.1016/j.amjoto.2018.04.002. Epub 2018 Apr 3.
- Individual participant dataSharing planned: Yes. Data will be made available within 6 months of study completion
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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.
Shu-Sheng Gong, MD study director
Beijing Friendship 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 CAABT and TMT in people with Tinnitus, run by Beijing Friendship Hospital at 1 site in China.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Dec 2018. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Sheng Gong, MD (13911068366, 50228354@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory ( THI) (time frame: baseline, 2 months, 4 months, 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03764826, which also lists 2 linked publications.
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 11 Dec 2018.