How hearing aids affect understanding speech in noisy places
Understanding Aided Speech Perception in Noise: Behavioral and Electrophysiological Measures
This project will test whether different hearing-aid directional settings help older adults with sensorineural hearing loss understand speech in noisy environments and whether simple spatial hearing measures predict who benefits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 121 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of South Florida Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06377215 on ClinicalTrials.gov |
What this trial studies
The protocol uses a between-group and within-subject repeated-measures design with three groups (young normal-hearing, older normal-hearing, and older hearing-impaired) and three aided conditions (omnidirectional, fixed directional, and variable directional). Participants complete clinical audiology tests, behavioral measures of spatial sensitivity (minimum audible angle, speech localization error, spatial release from masking) and neurophysiological recordings to estimate spatial segregation boundaries. Two experimental arms manipulate the masker: a fixed front masker or a diffuse masker presented from narrow or wide speaker arrays, and aided benefits are measured pre- and post-intervention using an open-source master hearing aid. Outcomes will relate individual spatial sensitivity measures to the cost or benefit produced by each directional processing scheme.
Who should consider this trial
Good fit: Ideal candidates are older adults (60–80 years) with bilateral, symmetric moderate sensorineural hearing loss within the study thresholds who can attend in-person testing and use the provided hearing aid fittings.
Not a fit: People with conductive or severe/profound hearing loss outside the study thresholds, those outside the required age ranges, or those unable to attend in-person visits are unlikely to benefit from these specific results.
Why it matters
Potential benefit: If successful, the findings could help clinicians match hearing-aid directional settings to patients' spatial hearing abilities to improve speech understanding in noise.
How similar studies have performed: Previous work has shown that directional processing can improve speech-in-noise performance, but using behavioral and neurophysiological spatial-sensitivity measures to predict individual aided benefit is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Target candidates for this study will be 38 young normal-hearing (YNH), 38 older normal-hearing (ONH), and 55 older hearing-impaired (OHI) subjects. Eligible NH listeners will have ≤20 dB HL at octave frequencies from 0.25 to 4 kHz and ≤30 dB HL up to 8 kHz. Eligible HI listeners will have bilateral (symmetric), moderate sensorineural hearing loss characterized by pure-tone thresholds between 35 to 50 dB HL from 0.25 to 2 kHz and 50 to 70 dB HL between 3 and 8 kHz. Age is restricted from 60 to 80 years for the older listening groups and from 18 to 35 for younger listeners. A balance of male and female participants will be recruited to assess sex as a biological variable in the data analyses. This age range for older listeners was chosen to be maximally inclusive of potential presbycusic participants, to promote generality of the results, and to facilitate uniform sampling within this age range. The investigators want to avoid the scientific need to stratify by age, which would make the scope of the project unmanageable given the constraints of this five-year award. The investigators have no evidence that lower or higher ages would affect aided intervention. Thus, inclusion of a larger age range would weaken the rigor of the investigation and complicate interpretation of the findings. The target range of hearing loss was chosen for similar reasons, reflecting the largest segment of older adults with hearing loss while avoiding the need to stratify by hearing loss to evaluate the stated hypotheses. Additional Inclusion Criteria for HI group: * Bilateral sensorineural hearing losses within the mild-to-moderately severe range as indicated by pure tone air- and bone-conduction audiometry and screening (Y-226 Hz, Type "A") tympanograms. * Candidates for hearing aids or experienced users. * Fluent speaker of English as speech testing will be in English. * MoCA (Montreal Cognitive Assessment; Nasreddine et al., 2005) score of \> 22. This cut point has been used frequently in investigations of aging and will better ensure that cognitive related problems will not restrict the abilities of subjects to perform the study tasks. Exclusion Criteria: Exclusion criteria include conditions for which one could anticipate that hearing or cognitive status might change markedly during the course of study. To hedge against such changes, participants will be excluded if they have undergone clinical management for any of the following in the past 12 months: * Head trauma * Traumatic brain injury * Epilepsy * Seizures * Other neurological disorders * Otologic surgical procedures * Actively fluctuating hearing loss * Acute Meniere's disease * Labyrinthitis * Conductive hearing loss * Use of ototoxic medications
Where this trial is running
Tampa, Florida
- USF Research Park BPB, 3802 Spectrum Boulevard, Suite 210C — Tampa, Florida, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.