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Closed-loop Rehabilitation for Hyperactive Hearing

Harnessing Endogenous Brain Plasticity Systems for the Recalibration of Pathological Auditory Percepts

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07302373
Enrollment
0
Registered
2025-12-24
Start date
2022-09-21
Completion date
2023-09-21
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperacusis, Tinnitus

Brief 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. 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.

Interventions

BEHAVIORALSound Therapy 1

Closed-loop sound therapy.

BEHAVIORALSound therapy 2

Placebo sound therapy.

Sponsors

Massachusetts Eye and Ear Infirmary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Conductive hearing loss (as assessed by audiologist) * Active otologic disease (as assessed by audiologist) * Significant cognitive decline (Montreal Cognitive Assessment score \> 25)

Design outcomes

Primary

MeasureTime frameDescription
Change in Score on the Tinnitus Reaction QuestionnairePre-test / Post-test (6 weeks) / Follow-up (14 weeks)
Reduction in Loudness Discomfort LevelsPre-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 AccuracyPre-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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026