Tinnitus, SubjectiveEEG-RCTNCT04449237
Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention
A study testing music therapy in people with Tinnitus, Subjective, run by Eye & ENT Hospital of Fudan University.
Trial summary
This project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- music therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 30 Jun 2023
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 years old, male or female;
- PTA (0.5,1,2kHz) ≤25dB HL;
- Tinnitus is a major problem faced by patients (except healthy volunteers);
- tinnitus course > for 3 months;
- Healthy, no history of other ear diseases, no history of hearing impairment;
- There are no other medical, psychological or social problems that need urgent treatment, and no other problems that interfere with tinnitus-related treatment;
- Voluntary tinnitus treatment, and have enough time to cooperate with treatment.
Who cannot join
- Pulsatile tinnitus;
- Acute tinnitus;
- Tinnitus is associated with severe hearing loss;
- Tinnitus accompanied by vertigo;
- Tinnitus accompanied by headache;
- Tinnitus is accompanied by somatic symptoms, such as neck pain and temporomandibular joint disorder;
- Post-traumatic tinnitus;
- Tinnitus is associated with serious psychiatric complications;
About this study
Official title: The Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention
This project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.
Read the detailed description
Tinnitus is one of the most common auditory disturbances in human. The treatment of tinnitus is always not effective, and the standardized treatment of tinnitus has been lacking. With the development of neuroimaging, neuroelectrophysiology and animal models of tinnitus, the central mechanism of tinnitus has been gradually revealed. The possible mechanisms of tinnitus are the increase of spontaneous discharge rate and synchronization of auditory central neurons caused by hearing deprivation, the change of brain topological structure, the reorganization of auditory cortex, and the disorder of limbic system and auditory central regulation of tinnitus patients. EEG, as an important means to study the cerebral cortex, has become an important technical support for the research on the central mechanism of tinnitus. Changes in activity in auditory brain areas associated with tinnitus have been observed using EEG/ERPs, and non-auditory brain areas such as the limbic system and frontal cortices have also been associated with tinnitus mechanisms. This project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.
- Conditions
- Tinnitus, Subjective
- Being tested
- music therapy
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyOther
music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.
| Study group | Role | What they receive |
|---|---|---|
| volunteer | Other | 40 volunteer will not accept any treatment Receives: Other: music therapy |
| patients with unmodified music group | Placebo comparator | 40 participants in this group will listen to music without any modification Receives: Other: music therapy |
| patients with modified tinnitus relieving music | Experimental | 40 participants in this group will listen to the music modified according to the matched dominant tinnitus pitch Receives: Other: music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
electroencephalogram evaluation
latency
Measured: From date of randomization, assessed every 3 month, up to 24 month
electroencephalogram evaluation
peak
Measured: From date of randomization, assessed every 3 month, up to 24 month
electroencephalogram evaluation
amplitude
Measured: From date of randomization, assessed every 3 month, up to 24 month
the loudness of tinnitus
estimated by auditory facility, recorded by unit of dB
Measured: From date of randomization, assessed every 3 month, up to 24 month
the frequency of tinnitus
estimated by auditory facility, recorded by unit of Hz
Measured: From date of randomization, assessed every 3 month, up to 24 month
minimum masking level
the minimum volume to masking tinnitus, recorded by unit of dB
Measured: From date of randomization, assessed every 3 month, up to 24 month
Tinnitus Handicapped Inventory
Tinnitus disability is divided into four levels, the first level:
0-16 points, no disability; Level 2:18-36, slightly disabled; Level 3:38-56, moderate disability; Level 4:58-100, severe disability.
Measured: From date of randomization, assessed every 3 month, up to 24 month
Hospital Anxiety and Distress Scale
0-7 are asymptomatic; 8 -10 respectively belong to suspicious existence; 11 -21 must exist.
Measured: From date of randomization, assessed every 3 month, up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449237
- Sponsor's protocol ID
- sunshan
- Acronym
- EEG-RCT
- Status last verified
- Jul 2020
- First submitted
- 16 Jun 2020
- Last updated
- 7 Jul 2020
- 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention
- ClinicalTrials.gov ID
- NCT04449237
- Acronym / sponsor ID
- EEG-RCT / sunshan
- Conditions
- Tinnitus, Subjective
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 26 Jun 2020 (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 project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.
Detailed description
Tinnitus is one of the most common auditory disturbances in human. The treatment of tinnitus is always not effective, and the standardized treatment of tinnitus has been lacking. With the development of neuroimaging, neuroelectrophysiology and animal models of tinnitus, the central mechanism of tinnitus has been gradually revealed. The possible mechanisms of tinnitus are the increase of spontaneous discharge rate and synchronization of auditory central neurons caused by hearing deprivation, the change of brain topological structure, the reorganization of auditory cortex, and the disorder of limbic system and auditory central regulation of tinnitus patients. EEG, as an important means to study the cerebral cortex, has become an important technical support for the research on the central mechanism of tinnitus. Changes in activity in auditory brain areas associated with tinnitus have been observed using EEG/ERPs, and non-auditory brain areas such as the limbic system and frontal cortices have also been associated with tinnitus mechanisms. This project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| volunteer | Other | Other: music therapy40 volunteer will not accept any treatment |
| patients with unmodified music group | Placebo comparator | Other: music therapy40 participants in this group will listen to music without any modification |
| patients with modified tinnitus relieving music | Experimental | Other: music therapy40 participants in this group will listen to the music modified according to the matched dominant tinnitus pitch |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-30 years old, male or female;
- PTA (0.5,1,2kHz) ≤25dB HL;
- Tinnitus is a major problem faced by patients (except healthy volunteers);
- tinnitus course > for 3 months;
- Healthy, no history of other ear diseases, no history of hearing impairment;
Key exclusion criteria (8 listed)
- Pulsatile tinnitus;
- Acute tinnitus;
- Tinnitus is associated with severe hearing loss;
- Tinnitus accompanied by vertigo;
- Tinnitus accompanied by headache;
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 therapymusic therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound. | Other | patients with modified tinnitus relieving music, patients with unmodified music group, volunteer |
Primary outcome
electroencephalogram evaluation
Time frame: From date of randomization, assessed every 3 month, up to 24 month
latency
electroencephalogram evaluation
Time frame: From date of randomization, assessed every 3 month, up to 24 month
peak
electroencephalogram evaluation
Time frame: From date of randomization, assessed every 3 month, up to 24 month
amplitude
the loudness of tinnitus
Time frame: From date of randomization, assessed every 3 month, up to 24 month
estimated by auditory facility, recorded by unit of dB
the frequency of tinnitus
Time frame: From date of randomization, assessed every 3 month, up to 24 month
estimated by auditory facility, recorded by unit of Hz
minimum masking level
Time frame: From date of randomization, assessed every 3 month, up to 24 month
the minimum volume to masking tinnitus, recorded by unit of dB
Tinnitus Handicapped Inventory
Time frame: From date of randomization, assessed every 3 month, up to 24 month
Tinnitus disability is divided into four levels, the first level: 0-16 points, no disability; Level 2:18-36, slightly disabled; Level 3:38-56, moderate disability; Level 4:58-100, severe disability.
Hospital Anxiety and Distress Scale
Time frame: From date of randomization, assessed every 3 month, up to 24 month
0-7 are asymptomatic; 8 -10 respectively belong to suspicious existence; 11 -21 must exist.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing music therapy in people with Tinnitus, Subjective, run by Eye & ENT Hospital of Fudan 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 7 inclusion and 8 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 7 Jul 2020. 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. 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?
Results are not available in the source record.
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?
electroencephalogram evaluation (time frame: From date of randomization, assessed every 3 month, up to 24 month). The study lists 8 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 7 Jul 2020.