An interventional study of Sound Therapy 1 and Sound therapy 2 in Tinnitus and Hyperacusis, sponsored by Massachusetts Eye and Ear Infirmary. Withdrawn. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-12-24.
Sponsored by Massachusetts Eye and Ear Infirmary · Not applicable, Interventional, and Treatment
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.
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.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
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Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Closed-loop sound therapy. Weekly sessions over 6 weeks.
Behavioral: Sound Therapy 1
Placebo sound therapy. Weekly sessions over 6 weeks.
Behavioral: Sound therapy 2
Closed-loop sound therapy.
Placebo sound therapy.
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
The intensity of pulsated pure tones of 55 ms reported to be uncomfortably loud (test commonly employed in hearing aid fitting).
Time frame: 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.
Time frame: Pre-test / Post-test (6 weeks) / Follow-up (14 weeks)
No study locations are listed for this record.
This study is withdrawn, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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