Tinnitus, SubjectiveNCT03716544
Efficacy of Amplification With Hearing Aids for Tinnitus Relief
A study testing Amplification with hearing aid and Customized music in people with Tinnitus, Subjective and Hearing Impairment, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study evaluates the treatment efficacy of tinnitus in people with mild hearing loss. One-third of participants will use hearing aid, one-third of participants will use customized music, while the other one-third participants will receive no treatment (waiting list control). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinnitus, Subjective, Hearing Impairment
- What is being tested?
- Amplification with hearing aid and Customized music
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2018to 31 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or above
- can provide written informed consent
- have a diagnosis of subjective tinnitus, i.e., the tinnitus can only be heard by the patient and there is no acoustic source
- a tinnitus duration of more than one year
- have pure-tone average between 20 and 40 dB HL
- have bilateral symmetrical hearing loss (i.e. difference less than 15 dB)
- have at least a medium level of distress caused by tinnitus as indicated with total scores above 30 on the TQ-CH
- are committed to complete the 12-month follow-up
Who cannot join
- objective tinnitus, i.e. tinnitus produced by an internal acoustic source activating the cochlea and can be heard by another person
- received other forms of tinnitus treatments within three months before the baseline assessment session
- any history suggestive of psychiatric illness
- psychological distress or depression as indicated with total scores at or above 15 on the Cantonese HADS
- current hearing aid users
- inability to complete the study as revealed by the medical reports
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Amplification With Hearing Aids for Tinnitus Relief: a Randomized Controlled Trial
This study evaluates the treatment efficacy of tinnitus in people with mild hearing loss. One-third of participants will use hearing aid, one-third of participants will use customized music, while the other one-third participants will receive no treatment (waiting list control).
Read the detailed description
Acoustic stimulation could induce plastic changes in the auditory cortex, and tinnitus mechanisms have been viewed as a negative consequence of neural plasticity in the central nervous system after peripheral aggression. Cortical changes (neural activity in the deafferented cortical area was reduced but the adjacent frequencies of the hearing loss region activated more extensive cortical areas) occur after sensorineural hearing loss, while exposure to an acoustically enriched environment or using hearing aids may minimize or reverse the plastic tonotopic map changes in the auditory cortex. The use of hearing aids in tinnitus management for people with significant hearing loss will always be associated with an improvement in hearing handicap and quality of life, and that complicates the interpretation of how much hearing aids specifically affect tinnitus. Thus studies on tinnitus patients with mild hearing loss could be illuminating, and this population will be targeted in the present study.
- Conditions
- Tinnitus, Subjective, Hearing Impairment
- Being tested
- Amplification with hearing aid, Customized music
- Keywords
- Tinnitus, Hearing Loss, Amplification, Sound Therapy
- Medical subject headings
- Tinnitus, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplification with hearing aidDevice
Also called Hearing aid group
Use of hearing aids
Customized musicDevice
Customized music delivered via an iPod
| Study group | Role | What they receive |
|---|---|---|
| Waiting list control group | No intervention | There will be no treatment for 12 months. |
| Hearing aid group | Experimental | Participants will receive amplification with hearing aids. Bilateral open-fit hearing aids will be fitted. Participants will be required to use the hearing aids for at least 2 hours daily for 12 months. Receives: Device: Amplification with hearing aid |
| Customized music group | Active comparator | Customized music according to participants hearing level will be made available in an iPod. The iPod will deliver ear-specific therapeutic sound for asymmetrical hearing profile. Participants will have to listen to the therapeutic sound at a comfortable volume for two hours daily for 12 months. Receives: Device: Customized music |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Tinnitus Functional Index (Chinese version) (TFI-CH)
TFI-CH is a 25-item self-administered questionnaire which assesses eight domains of tinnitus impact: intrusiveness; sense of control; cognitive; sleep; auditory; relaxation; quality of life (QoL); emotion. The total TFI score ranges 0 - 100, the higher score is indicative of greater problem with tinnitus.
Measured: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Secondary outcomes (5)
The Tinnitus Questionnaire (Chinese version) (TQ-CH) scores
The TQ-CH is a 52-item questionnaire which assesses five dimensions of tinnitus complaint: emotional distress; auditory perceptual difficulties; intrusiveness; sleep disturbance; and somatic complaints. The total TQ score ranges 0 - 104, the higher score is indicative of greater problem with tinnitus.
Measured: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
The Tinnitus Handicap Inventory (Chinese version) (THI-CH) scores
The THI-CH is a reliable 25-item self-administered Chinese QoL tool that quantifies the impact of tinnitus on daily living. The total THI score ranges 0 - 100, the higher score is indicative of greater tinnitus handicap.
Measured: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Self-rated Visual Analogue Scale (VAS) on tinnitus loudness
The subjects will be asked to rate the perceived loudness of their tinnitus on VAS, with "inaudible" (scale rating value = 0) and "very loud" (scale rating value = 100) as reference points for the ends of the scale. The higher rating is indicative of louder tinnitus.
Measured: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Tinnitus loudness matches at the tinnitus frequency and at 1000 Hz
Tinnitus loudness matches will be done according to Vernon and Meikle's procedure
Measured: Change from baseline values at 3 months, 6 months and 12 months after the first day of treatment will be measured.
The Chinese Hospital Anxiety and Depression Scale (HADS)
The Chinese HADS is a 14-item questionnaire that consists of two subscales that measure anxiety and depression. It serves as an outcome measure targeting psychological and mental health effects.
Measured: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Nov 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tinnitus, SubjectiveStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, KAM Chi Shan Anna, Education University of Hong Kong
- Investigators
- Anna CS KAM, AuD, Principal investigator, The Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716544
- Sponsor's protocol ID
- RGC18100117
- Status last verified
- Mar 2024
- First submitted
- 17 Oct 2018
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kam ACS. Efficacy of Amplification for Tinnitus Relief in People With Mild Hearing Loss. J Speech Lang Hear Res. 2024 Feb 12;67(2):606-617. doi: 10.1044/2023_JSLHR-23-00031. Epub 2024 Jan 25.
PubMed 38271299
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Amplification With Hearing Aids for Tinnitus Relief: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03716544
- Acronym / sponsor ID
- RGC18100117
- Conditions
- Tinnitus, Subjective, Hearing Impairment
- Keywords
- Tinnitus, Hearing Loss, Amplification, Sound Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 23 Oct 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 evaluates the treatment efficacy of tinnitus in people with mild hearing loss. One-third of participants will use hearing aid, one-third of participants will use customized music, while the other one-third participants will receive no treatment (waiting list control).
Detailed description
Acoustic stimulation could induce plastic changes in the auditory cortex, and tinnitus mechanisms have been viewed as a negative consequence of neural plasticity in the central nervous system after peripheral aggression. Cortical changes (neural activity in the deafferented cortical area was reduced but the adjacent frequencies of the hearing loss region activated more extensive cortical areas) occur after sensorineural hearing loss, while exposure to an acoustically enriched environment or using hearing aids may minimize or reverse the plastic tonotopic map changes in the auditory cortex. The use of hearing aids in tinnitus management for people with significant hearing loss will always be associated with an improvement in hearing handicap and quality of life, and that complicates the interpretation of how much hearing aids specifically affect tinnitus. Thus studies on tinnitus patients with mild hearing loss could be illuminating, and this population will be targeted in the present study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Waiting list control group | No intervention | –There will be no treatment for 12 months. |
| Hearing aid group | Experimental | Device: Amplification with hearing aidParticipants will receive amplification with hearing aids. Bilateral open-fit hearing aids will be fitted. Participants will be required to use the hearing aids for at least 2 hours daily for 12 months. |
| Customized music group | Active comparator | Device: Customized musicCustomized music according to participants hearing level will be made available in an iPod. The iPod will deliver ear-specific therapeutic sound for asymmetrical hearing profile. Participants will have to listen to the therapeutic sound at a comfortable volume for two hours daily for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years old or above
- can provide written informed consent
- have a diagnosis of subjective tinnitus, i.e., the tinnitus can only be heard by the patient and there is no acoustic source
- a tinnitus duration of more than one year
- have pure-tone average between 20 and 40 dB HL
Key exclusion criteria (6 listed)
- objective tinnitus, i.e. tinnitus produced by an internal acoustic source activating the cochlea and can be heard by another person
- received other forms of tinnitus treatments within three months before the baseline assessment session
- any history suggestive of psychiatric illness
- psychological distress or depression as indicated with total scores at or above 15 on the Cantonese HADS
- current hearing aid users
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 |
|---|---|---|
| Amplification with hearing aidAlso: Hearing aid groupUse of hearing aids | Device | Hearing aid group |
| Customized musicCustomized music delivered via an iPod | Device | Customized music group |
Primary outcome
The Tinnitus Functional Index (Chinese version) (TFI-CH)
Time frame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
TFI-CH is a 25-item self-administered questionnaire which assesses eight domains of tinnitus impact: intrusiveness; sense of control; cognitive; sleep; auditory; relaxation; quality of life (QoL); emotion. The total TFI score ranges 0 - 100, the higher score is indicative of greater problem with tinnitus.
5 secondary outcomes
The Tinnitus Questionnaire (Chinese version) (TQ-CH) scores
Time frame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
The Tinnitus Handicap Inventory (Chinese version) (THI-CH) scores
Time frame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Self-rated Visual Analogue Scale (VAS) on tinnitus loudness
Time frame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Tinnitus loudness matches at the tinnitus frequency and at 1000 Hz
Time frame: Change from baseline values at 3 months, 6 months and 12 months after the first day of treatment will be measured.
The Chinese Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
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 4 Mar 2024.
- Derived from this study: PubMed 38271299Kam ACS. Efficacy of Amplification for Tinnitus Relief in People With Mild Hearing Loss. J Speech Lang Hear Res. 2024 Feb 12;67(2):606-617. doi: 10.1044/2023_JSLHR-23-00031. Epub 2024 Jan 25.
- 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.
Anna CS KAM, AuD principal investigator
The Education University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amplification with hearing aid and Customized music in people with Tinnitus, Subjective and Hearing Impairment, run by Education University of Hong Kong at 1 site in Hong Kong.
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: finished, as of the sponsor's last update on 4 Mar 2024. 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 Hong Kong. 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?
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?
The Tinnitus Functional Index (Chinese version) (TFI-CH) (time frame: Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.). 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 NCT03716544, which also lists 1 linked publication.
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 4 Mar 2024.