Closed-loop Rehabilitation for Hyperactive Hearing

NCT07302373 | Withdrawn

• 1 other identifier: pending_102121
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tinnitus; Hyperacusis

Outcome Measures

Primary Outcomes (3)

• Change in Score on the Tinnitus Reaction Questionnaire

  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).

  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.

  Pre-test / Post-test (6 weeks) / Follow-up (14 weeks)

Study Arms (2)

Sound Therapy Group 1

EXPERIMENTAL

Closed-loop sound therapy. Weekly sessions over 6 weeks.

Behavioral: Sound Therapy 1

Sound Therapy Group 2

PLACEBO COMPARATOR

Placebo sound therapy. Weekly sessions over 6 weeks.

Behavioral: Sound therapy 2

Interventions

Sound Therapy 1 BEHAVIORAL

Closed-loop sound therapy.

Sound Therapy Group 1

Sound therapy 2 BEHAVIORAL

Placebo sound therapy.

Sound Therapy Group 2

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

MeSH Terms

Conditions

Tinnitus; Hyperacusis

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel B Polley, Ph.D.

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniel Polley, Professor in Department of Otology and Laryngology, Massachusetts Eye and Ear Infirmary

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: September 21, 2022
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: December 24, 2025

Record last verified: 2025-12