Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377215
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-02-09
Brief Title:
Understanding Aided Speech Perception in Noise
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
Understanding Aided Speech Perception in Noise Behavioral and Electrophysiological Measures
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss ARHL leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity One key component of the research design is to measure both behavioral and neurophysiological indices of an individuals spatial segregation boundary The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention
Detailed Description:
STUDY DESIGN
This is a between-group and within-subject repeated-measures design A detailed protocol visit schedule intervention methodology and battery of outcome measures will be used to assess audition spatial sensitivity and pre- and post-intervention of behavioral and neurophysiological indices of spatial segregation The study includes two control groups young normal-hearing YNH and older normal-hearing ONH and the test group older hearing-impaired OHI with three aided interventions omnidirectional processing fixed directional processing and variable directional processing There are two study arms Arm 1 tests spatial segregation in the presence of a fixed masker in front of the listener Arm 2 tests spatial segregation in the presence of a diffuse masker presented from three narrow or seven wide loudspeakers surrounding the frontal spatial hemisphere
DESCRIPTION OF THE PROTOCOL
All listeners receive an intake protocol consisting of standard clinical and laboratory measures of auditory function roughly two-hour visit The baseline measures include audiogram loudness discomfort levels LDLs middle ear status tympanometry acoustic reflex thresholds and words in noise Pre-treatment measures of spatial sensitivity are measured in a single two-hour visit Measures include the minimum audible angle MAA speech localization error and spatial release from masking The Pre-treatment measures of the spatial segregation boundary are conducted in a single two-hour visit Post-treatment measures OHI group only are counter balanced across three additional two-hour visits Pre- and post-treatment measures of the spatial segregation boundary include measures of a fixed spatial separation between target and masker speech and a roving moving target condition at multiple spatial separations spanning 0 to 90 in 15 steps
DELIVERY OF INTERVENTION
Hearing aid fitting The standard-of-care intervention for ARHL is amplification via hearing aids and this is the intervention to be used in this study The fitting procedures and any necessary troubleshooting or adjustments will follow the Auditory Neurosciences Technology Laboratory device Standard Operating Procedures dSOP manual for hearing aid fitting and counseling This manual is based upon guidelines of the American Speech-Language-Hearing Association and the American Academy of Audiology Devices are fit wirelessly using a clinical-style graphical user interface for device programming in conjunction with real-ear verification The audiologist Dr Secor will fit the OHI subjects with the hearing instruments prior to the experiments To avoid the possibility that independent amplitude compression at the two ears can reduce ILD cues aids will be fit with a linear prescription Because the sound levels in the experiments are in a restricted range near 65 dB the investigators will use NAL2 prescription for 65 dB input levels as verified using probe-microphone measures Verifit 2 Audioscan
Hearing aids In order to better generalize results and control for a wide array of potentially hidden digital processing effects by device manufacturers the investigators will use open-source research-grade devices made possible through the NIH-funded open Master Hearing Aid consortium openMHA The open-source hardware design includes behind-the-ear BTE receiver-in-the-canal RIC instruments Sonion wired to a multi-channel audio board Cape4all 16 kHz sampling attached to a portable main board Beaglebone Black Wireless The lightweight hardware is worn around the users neck Beamforming fixed or variable is accomplished in openMHA using a binaural minimum variance distortionless response MVDR algorithm that attempts to minimize any diffuse or spatially separated noise contributions from a target speech source
Hearing aid conditions In a within-subject design the OHI group will be tested per study arm in four device configurations 1 unaided 2 aided with omnidirectional microphones 3 aided with fixed directional processing and 4 aided with variable directional processing The fixed binaural beamformer has a relatively narrow spatial filter at the front whereas the variable binaural beamformer is steered to the speech direction in real time For the variable condition real time speech localization is based on a priori knowledge of where the speech is presented from instead of employing an adaptive speech locator as used in real devices This condition therefore represents the best achievable spatial filtering given perfect source localization and zero lag time between source localization and beam steering
SAMPLE SIZE AND DATA ANALYSIS METHODS
Power analyses Based on preliminary data and reports with similar analyses in the literature significant effect sizes are expected to have a minimum of ηp2 019 for repeated measures analysis of variance rmANOVA testing In Arm 1 computing sample size for the smallest possible effects ηp2 019 alpha 005 power 095 with moderate-to-strong correlation among repeated measures 075 indicates that 38 listeners per group are needed for each experiment 3 repeated measures GPower v3192 In Arm 2 the investigators will also use multiple regression to measure the relationship between spatial acuity and hearing aid benefit For a small-to-medium effect size f2 03 55 subjects are needed
Analytic plan Descriptive and graphical statistics will be used to summarize the data on all participants and appropriate transformations or non-parametric methods will be applied as necessary The investigators will use rmANOVAs to analyze the results from the behavioral data and cortical synchronization results at the group level Pearsons correlation coefficients will be Z-transformed Fisher before statistical analyses To protect against Type I error the principal analyses are designed to answer clearly stated major research hypotheses and are based on well-specified dependent variables All tests will be two-tailed at alpha005 with Holm-Bonferroni adjustment for multiple comparisons Where appropriate rmANOVAs will be used to measure group differences in our intake psychoacoustic measures and if the investigators observe statistical group differences they will be used as covariates
This is a between-group and within-subject repeated-measures design A detailed protocol visit schedule intervention methodology and battery of outcome measures will be used to assess audition spatial sensitivity and pre- and post-intervention of behavioral and neurophysiological indices of spatial segregation The study includes two control groups young normal-hearing YNH and older normal-hearing ONH and the test group older hearing-impaired OHI with three aided interventions omnidirectional processing fixed directional processing and variable directional processing There are two study arms Arm 1 tests spatial segregation in the presence of a fixed masker in front of the listener Arm 2 tests spatial segregation in the presence of a diffuse masker presented from three narrow or seven wide loudspeakers surrounding the frontal spatial hemisphere
DESCRIPTION OF THE PROTOCOL
All listeners receive an intake protocol consisting of standard clinical and laboratory measures of auditory function roughly two-hour visit The baseline measures include audiogram loudness discomfort levels LDLs middle ear status tympanometry acoustic reflex thresholds and words in noise Pre-treatment measures of spatial sensitivity are measured in a single two-hour visit Measures include the minimum audible angle MAA speech localization error and spatial release from masking The Pre-treatment measures of the spatial segregation boundary are conducted in a single two-hour visit Post-treatment measures OHI group only are counter balanced across three additional two-hour visits Pre- and post-treatment measures of the spatial segregation boundary include measures of a fixed spatial separation between target and masker speech and a roving moving target condition at multiple spatial separations spanning 0 to 90 in 15 steps
DELIVERY OF INTERVENTION
Hearing aid fitting The standard-of-care intervention for ARHL is amplification via hearing aids and this is the intervention to be used in this study The fitting procedures and any necessary troubleshooting or adjustments will follow the Auditory Neurosciences Technology Laboratory device Standard Operating Procedures dSOP manual for hearing aid fitting and counseling This manual is based upon guidelines of the American Speech-Language-Hearing Association and the American Academy of Audiology Devices are fit wirelessly using a clinical-style graphical user interface for device programming in conjunction with real-ear verification The audiologist Dr Secor will fit the OHI subjects with the hearing instruments prior to the experiments To avoid the possibility that independent amplitude compression at the two ears can reduce ILD cues aids will be fit with a linear prescription Because the sound levels in the experiments are in a restricted range near 65 dB the investigators will use NAL2 prescription for 65 dB input levels as verified using probe-microphone measures Verifit 2 Audioscan
Hearing aids In order to better generalize results and control for a wide array of potentially hidden digital processing effects by device manufacturers the investigators will use open-source research-grade devices made possible through the NIH-funded open Master Hearing Aid consortium openMHA The open-source hardware design includes behind-the-ear BTE receiver-in-the-canal RIC instruments Sonion wired to a multi-channel audio board Cape4all 16 kHz sampling attached to a portable main board Beaglebone Black Wireless The lightweight hardware is worn around the users neck Beamforming fixed or variable is accomplished in openMHA using a binaural minimum variance distortionless response MVDR algorithm that attempts to minimize any diffuse or spatially separated noise contributions from a target speech source
Hearing aid conditions In a within-subject design the OHI group will be tested per study arm in four device configurations 1 unaided 2 aided with omnidirectional microphones 3 aided with fixed directional processing and 4 aided with variable directional processing The fixed binaural beamformer has a relatively narrow spatial filter at the front whereas the variable binaural beamformer is steered to the speech direction in real time For the variable condition real time speech localization is based on a priori knowledge of where the speech is presented from instead of employing an adaptive speech locator as used in real devices This condition therefore represents the best achievable spatial filtering given perfect source localization and zero lag time between source localization and beam steering
SAMPLE SIZE AND DATA ANALYSIS METHODS
Power analyses Based on preliminary data and reports with similar analyses in the literature significant effect sizes are expected to have a minimum of ηp2 019 for repeated measures analysis of variance rmANOVA testing In Arm 1 computing sample size for the smallest possible effects ηp2 019 alpha 005 power 095 with moderate-to-strong correlation among repeated measures 075 indicates that 38 listeners per group are needed for each experiment 3 repeated measures GPower v3192 In Arm 2 the investigators will also use multiple regression to measure the relationship between spatial acuity and hearing aid benefit For a small-to-medium effect size f2 03 55 subjects are needed
Analytic plan Descriptive and graphical statistics will be used to summarize the data on all participants and appropriate transformations or non-parametric methods will be applied as necessary The investigators will use rmANOVAs to analyze the results from the behavioral data and cortical synchronization results at the group level Pearsons correlation coefficients will be Z-transformed Fisher before statistical analyses To protect against Type I error the principal analyses are designed to answer clearly stated major research hypotheses and are based on well-specified dependent variables All tests will be two-tailed at alpha005 with Holm-Bonferroni adjustment for multiple comparisons Where appropriate rmANOVAs will be used to measure group differences in our intake psychoacoustic measures and if the investigators observe statistical group differences they will be used as covariates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DC020514 | NIH | None | httpsreporternihgovquickSearchR01DC020514 |