TinnitusNCT07302373
Closed-loop Rehabilitation for Hyperactive Hearing
A study testing Sound Therapy 1 and Sound therapy 2 in people with Tinnitus and Hyperacusis, run by Massachusetts Eye and Ear Infirmary.
Trial summary
There are no widely available treatments for the underserved populations with tinnitus, hyperacusis, and hearing-in-noise deficits. Left unmanaged, these disorders can lead to a wide range of negative psychosocial and emotional sequelae including anxiety, depression, fear, and social isolation. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Tinnitus, Hyperacusis
- What is being tested?
- Sound Therapy 1 and Sound therapy 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2022to 21 Sep 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Normal audiometric thresholds
- Subjects with tinnitus will have self-reported chronic tinnitus that has persisted for the duration of at least 6 months
- Subjects with hyperacusis will have a clinical diagnosis of hyperacusis and/or self-reported sound tolerance complaints that have persisted for the duration of at least 6 months
Who cannot join
- Conductive hearing loss (as assessed by audiologist)
- Active otologic disease (as assessed by audiologist)
- Significant cognitive decline (Montreal Cognitive Assessment score > 25)
About this study
Official title: Harnessing Endogenous Brain Plasticity Systems for the Recalibration of Pathological Auditory Percepts
There are no widely available treatments for the underserved populations with tinnitus, hyperacusis, and hearing-in-noise deficits. Left unmanaged, these disorders can lead to a wide range of negative psychosocial and emotional sequelae including anxiety, depression, fear, and social isolation. The proposed research will investigate a novel closed-loop sound therapy designed to address the mutual basis of these disorders.
Read the detailed description
Upwards of 700 million people are projected to require rehabilitative services for hearing disorders by the year 2050 (Chadha, Kamenov, \& Cieza, 2021). Many will suffer not from what is inaudible but from the presence of insuppressible sound. Individuals may be overwhelmed by phantom sounds that do not exist external to the auditory system (tinnitus) (Henry, Dennis, \& Schechter, 2005). Moderate intensity sounds may have malformed percepts that induce loudness, annoyance, fear, or pain (hyperacusis) (Tyler et al., 2014). Sounds may also appear engulfed by other noises in the environment (Plack, Barker, \& Prendergast, 2014). These hearing disorders are co-morbid with one another with roughly 80% of tinnitus patients reporting reduced sound level tolerance (Anari et al., 1999). Hyperacusis, tinnitus, and hearing-in-noise deficits are common chronic disorders within middle-aged/older adults but can also affect younger ages, with noise exposure history and traumatic brain injuries as key predictors. The outlined hearing disorders are complicated and heterogeneous making them challenging to treat. Consequently, despite a clear demand for rehabilitative services, there are no widely accepted nor effective treatments available (Baguley and Hoare, 2018). The result of this is typified in tinnitus patients, of whom 84.8% have never attempted any form of remedy (Bhatt, Lin, \& Bhattacharyya, 2016).
We propose a therapeutic strategy that is founded upon the most beneficial aspects of previously conducted randomized controlled trials (RCTs). Namely, the therapy will employ a closed-loop system. The research capitalizes on promising findings from current studies in animal models, seeking to take advantage of the neuroscience principles thought to operationalize paired plasticity. The therapy is entirely non-invasive, posing minimal risk to the patient, and is translatable to widely available hardware. The research will use a "gold-standard" randomized, double-blinded, placebo-controlled clinical trial to objectively evaluate its worth.
- Conditions
- Tinnitus, Hyperacusis
- Being tested
- Sound Therapy 1, Sound therapy 2
- Medical subject headings
- Tinnitus, Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound Therapy 1Behavioural
Closed-loop sound therapy.
Sound therapy 2Behavioural
Placebo sound therapy.
| Study group | Role | What they receive |
|---|---|---|
| Sound Therapy Group 1 | Experimental | Closed-loop sound therapy. Weekly sessions over 6 weeks. Receives: Behavioral: Sound Therapy 1 |
| Sound Therapy Group 2 | Placebo comparator | Placebo sound therapy. Weekly sessions over 6 weeks. Receives: Behavioral: Sound therapy 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Score on the Tinnitus Reaction Questionnaire
Measured: Pre-test / Post-test (6 weeks) / Follow-up (14 weeks)
Reduction in Loudness Discomfort Levels
The intensity of pulsated pure tones of 55 ms reported to be uncomfortably loud (test commonly employed in hearing aid fitting).
Measured: Pre-test / Post-test (6 weeks) / Follow-up (14 weeks)
Change in Speech Recognition in Noise Performance Accuracy
Keyword recognition accuracy for sentences in noise will be assessed with a clinical test, the QuickSiN. Signal to noise ratios vary from 25 to 0 dB in 5 dB steps.
Measured: Pre-test / Post-test (6 weeks) / Follow-up (14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start21 Sep 2022 (estimated)
- Primary completion21 Sep 2023 (estimated)
- Study completion21 Sep 2023 (estimated)
Why it stopped: Funding for this study ended prior to enrollment of any participants.
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Brandon Polley, Massachusetts Eye and Ear Infirmary
- Investigators
- Daniel B Polley, Ph.D., Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302373
- Sponsor's protocol ID
- pending_102121
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Endogenous Brain Plasticity Systems for the Recalibration of Pathological Auditory Percepts
- ClinicalTrials.gov ID
- NCT07302373
- Acronym / sponsor ID
- pending_102121
- Conditions
- Tinnitus, Hyperacusis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding for this study ended prior to enrollment of any participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- 21 Sep 2022 (estimated)
- Primary completion
- 21 Sep 2023 (estimated)
- Study completion
- 21 Sep 2023 (estimated)
- First posted
- 24 Dec 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.
There are no widely available treatments for the underserved populations with tinnitus, hyperacusis, and hearing-in-noise deficits. Left unmanaged, these disorders can lead to a wide range of negative psychosocial and emotional sequelae including anxiety, depression, fear, and social isolation. The proposed research will investigate a novel closed-loop sound therapy designed to address the mutual basis of these disorders.
Detailed description
Upwards of 700 million people are projected to require rehabilitative services for hearing disorders by the year 2050 (Chadha, Kamenov, \& Cieza, 2021). Many will suffer not from what is inaudible but from the presence of insuppressible sound. Individuals may be overwhelmed by phantom sounds that do not exist external to the auditory system (tinnitus) (Henry, Dennis, \& Schechter, 2005). Moderate intensity sounds may have malformed percepts that induce loudness, annoyance, fear, or pain (hyperacusis) (Tyler et al., 2014). Sounds may also appear engulfed by other noises in the environment (Plack, Barker, \& Prendergast, 2014). These hearing disorders are co-morbid with one another with roughly 80% of tinnitus patients reporting reduced sound level tolerance (Anari et al., 1999). Hyperacusis, tinnitus, and hearing-in-noise deficits are common chronic disorders within middle-aged/older adults but can also affect younger ages, with noise exposure history and traumatic brain injuries as key predictors. The outlined hearing disorders are complicated and heterogeneous making them challenging to treat. Consequently, despite a clear demand for rehabilitative services, there are no widely accepted nor effective treatments available (Baguley and Hoare, 2018). The result of this is typified in tinnitus patients, of whom 84.8% have never attempted any form of remedy (Bhatt, Lin, \& Bhattacharyya, 2016).
We propose a therapeutic strategy that is founded upon the most beneficial aspects of previously conducted randomized controlled trials (RCTs). Namely, the therapy will employ a closed-loop system. The research capitalizes on promising findings from current studies in animal models, seeking to take advantage of the neuroscience principles thought to operationalize paired plasticity. The therapy is entirely non-invasive, posing minimal risk to the patient, and is translatable to widely available hardware. The research will use a "gold-standard" randomized, double-blinded, placebo-controlled clinical trial to objectively evaluate its worth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sound Therapy Group 1 | Experimental | Behavioral: Sound Therapy 1Closed-loop sound therapy. Weekly sessions over 6 weeks. |
| Sound Therapy Group 2 | Placebo comparator | Behavioral: Sound therapy 2Placebo sound therapy. Weekly sessions over 6 weeks. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Normal audiometric thresholds
- Subjects with tinnitus will have self-reported chronic tinnitus that has persisted for the duration of at least 6 months
- Subjects with hyperacusis will have a clinical diagnosis of hyperacusis and/or self-reported sound tolerance complaints that have persisted for the duration of at least 6 months
Key exclusion criteria (3 listed)
- Conductive hearing loss (as assessed by audiologist)
- Active otologic disease (as assessed by audiologist)
- Significant cognitive decline (Montreal Cognitive Assessment score > 25)
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 |
|---|---|---|
| Sound Therapy 1Closed-loop sound therapy. | Behavioural | Sound Therapy Group 1 |
| Sound therapy 2Placebo sound therapy. | Behavioural | Sound Therapy Group 2 |
Primary outcome
Change in Score on the Tinnitus Reaction Questionnaire
Time frame: Pre-test / Post-test (6 weeks) / Follow-up (14 weeks)
Reduction in Loudness Discomfort Levels
Time frame: Pre-test / Post-test (6 weeks) / Follow-up (14 weeks)
The intensity of pulsated pure tones of 55 ms reported to be uncomfortably loud (test commonly employed in hearing aid fitting).
Change in Speech Recognition in Noise Performance Accuracy
Time frame: Pre-test / Post-test (6 weeks) / Follow-up (14 weeks)
Keyword recognition accuracy for sentences in noise will be assessed with a clinical test, the QuickSiN. Signal to noise ratios vary from 25 to 0 dB in 5 dB steps.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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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.
Daniel B Polley, Ph.D. principal investigator
Massachusetts Eye and Ear Infirmary
Questions about this trial
What is this clinical trial studying?
A study testing Sound Therapy 1 and Sound therapy 2 in people with Tinnitus and Hyperacusis, run by Massachusetts Eye and Ear Infirmary.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 24 Dec 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Score on the Tinnitus Reaction Questionnaire (time frame: Pre-test / Post-test (6 weeks) / Follow-up (14 weeks)). The study lists 3 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 24 Dec 2025.