Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309264
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-03-05
Brief Title:
Comparing Hearing Aid Fitting Methods in Blast-exposed Veterans
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Benefits of Speech-based Audiometry and Low-gain Hearing Aids for Blast-exposed Veterans
Status:
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:
SBA
Brief Summary:
Since 2000 at least 250000 US Service members have experienced a blast-related mild traumatic brain injury A retrospective analysis of over 100000 post-911 Veterans shows that blast injury more than doubles the risk of a diagnosed auditory problem Many blast-exposed Veterans experience functional hearing difficulties FHDs problems in challenging listening environments despite clinically normal hearing as measured by the pure-tone audiogram VA audiologists have begun using low-gain hearing aids to treat FHDs but there are no concrete guidelines for this application given standard procedures rely on the pure-tone audiogram This study proposes a data-driven approach called speech-based audiometry SBA which optimizes hearing aid gains from a patients responses to speech stimuli in aided conditions This trial will assess the behavioral speech recognition in noise subjective listening difficulty and neurophysiological functional neuroimaging during a speech recognition task benefits of low-gain hearing aids programmed conventionally or with SBA among blast-exposed Veterans with FHDs
Detailed Description:
The present study is a randomized trial of low-gain hearing aids in blast-exposed Veterans with normal or near-normal audiometric hearing and self-reported functional hearing difficulties Hearing aids will be programmed using either conventional methods or a novel procedure called speech-based audiometry Participants will be randomized into different groups receiving conventional or speech-based programming Participants will be followed for a six-week intervention period and complete several outcome measures before during and after the intervention period Each group will be further divided at random into equal subgroups assigned to i use their hearing aid daily during the six-week intervention period or ii use their hearing aid only to complete the outcomes assessments The study will be broken into five periods
1 Prescreening screening and enrollment
2 Preparatory period
3 Baseline
4 Treatment first five weeks of hearing aid intervention
5 Follow-up final week of hearing aid intervention
Prescreening screening enrollment V0
Prescreening includes identification of potential participants via medical record search examination of patient rolls clinician referral or patient self-referral eg from study advertisements A prescreening phone call or in-person prescreening visit is scheduled for willing participants
At the time of the in-person prescreening or prescreening phone call a script will be used to learn if prospective participants meet basic eligibility criteria and are able to present for an in-person discussion of informed consent
After prescreening is completed potential participants meeting preliminary eligibility criteria will be scheduled for an initial study visit including informed consent procedures and if consent is obtained the following additional procedures
Participants will be screened for inclusion and exclusion criteria Screening includes performance of a routine audiological exam otoscopy tympanometry air- and bone-conduction pure-tone audiometry if a recent 6 months exam is not available in the medical record The subject also completes the following three questionnairesinterviews to determine eligibility which are not part of routine audiological care
1 Hearing Handicap Inventory for Adults HHIA The HHIA is a 25-item questionnaire that focuses on the emotional socialsituational and occupational effects of hearing loss
2 Mini-Mental State Exam MMSE The MMSE is an experimenter-led interview that assesses the global cognitive state of the subject including situational awareness memory language and sensorimotor function
3 Quantification of Cumulative Blast Exposure QCuBE The QCuBE is a semi-structured experimenter-led interview that measures number and severity of exposures to blast including date of exposure distance from explosion type of explosive and protective gear worn among other details The QCuBE also obtains a brief history of non-blast head traumas
If a subject is not eligible ie fails screening an explanation is provided to the subject along with a full debriefing of the study If a subject is eligible they are randomized and asked to complete the following additional questionnaires
4 Tinnitus Handicap Inventory THI The THI is a 25-item questionnaire that quantifies the impact of tinnitus on daily life
5 Demographic data form optional This form obtains information on the subjects sex ethnicity Hispanic or Latino not Hispanic or Latino and race for reporting to the study sponsor using standard definitions
Preparatory Period V1 V2
Two initial study visits will be conducted to prepare the subject for the hearing aid intervention At the first visit V1 the following procedures will be performed
1 Speech-based audiometry At the core of speech-based audiometry is the Open Speech Platform OSP an open-source hearing aid and speech processing platform with co-designed hardware and software elements For the proposed work the crucial component of OSP is a real-time master hearing aid a modular software environment that abstracts the details of a digital hearing aid processor eg block resampling sub-band filtering wide dynamic range compression and feedback cancellation That is the master hearing aid is a software simulation of a hearing aid that performs all the same functions eg sound amplification and compression The flexible nature of the master hearing aid allows any arbitrary hearing aid prescription to be simulated in real time The logic behind speech-based audiometry is as follows 1 there is a library of potential hearing aid prescriptions 1500 NAL-NL2 gain profiles determined by unsupervised clustering performed on a large library of pure-tone audiograms from patients with a range of hearing loss levels and configurations 2 there is also a library of speech stimuli eg audiobook excerpts that can be amplified with any prescription from the gain library in real time by OSP and presented to the patient over headphones 3 this facilitates a non-exhaustive search of the possible prescriptions based on a patients subjective ratings of speech amplified with different prescriptions 4 in practice this takes the form of a series of AB preference judgments made by the patient much as in fitting for eyeglasses do you prefer A or B 5 machine learning is used to select the A and B prescriptions for each presentation to optimize the search through the library of prescriptions for efficiency 6 the procedure terminates when the search is finished
2 Real ear measurement of realized gains The real ear aided response REAR of the master hearing aid is obtained for the gain settings selected during speech-based audiometry following standard clinical procedures
3 A hearing aid is ordered for the subject with preliminary gain settings established during speech-based audiometry or from the pure-tone audiogram depending on group assignment
At the second visit of the preparatory period V2 real ear verification of hearing aid gain prescription is performed That is the preliminary gain settings initially programmed into the hearing aids are based on a set of gain targets which may differ from the actual gains realized when the hearing aids are worn by the subject Thus REAR measurements are again obtained for soft moderate and loud inputs separately for each ear The hearing aid gains are manually adjusted by the fitting audiologist until the realized gains are within an acceptable range around the gain targets according to routine clinical standards For subjects assigned to the speech-based audiometry group the gain targets are the REAR measurements obtained during V1 For subjects assigned to the conventional fitting group the gain targets are the output of the NAL-NL2 prescriptive formula applied to the subjects pure-tone audiogram gains will be further adjusted based on the subjects subjective feedback typically between 5-10 dB additional insertion gain at some or all frequencies between 500 and 4000 Hz Once the final hearing aid gains are set the hearing aids are placed in a hearing aid test box and their gain responses for soft medium and loud sounds are recorded This will allow the study team to later use the hearing aid test box to verify that the hearing aid gains have not changed from prescribed settings Finally the subject will receive counseling from the fitting audiologist about how to use their hearing aids for the remainder of the study
Baseline Period V3 V4
Study outcome measures will be obtained at baseline ie before the daily use group has begun its six-week period of daily hearing aid usage The first visit of the baseline period V3 is an initial fMRI scan see description of outcome measures The fMRI scan session includes i metal screening ii counseling by a trained MRI technician about what to expect how to remain safe and how to trigger early termination of the MRI scan iii a practice session conducted outside the scanner iv familiarizing the subject with equipment to be used inside the scanner eg button box MR-compatible headphones and placing the subject inside the MRI scanner v acquisition of a T1 scout image and alignment of the MRI slices to be acquired in subsequent scans axial slices aligned with the anterior-posterior commissure vi acquisition of a high-resolution T1 anatomical scan and a gradient field mapping scan vii eight fMRI scans viii removal of the subject from the scanner and ix 5-10 minute observation of the subject during a cool off period
The second visit of the baseline period V4 is a baseline speech-in-noise evaluation including the modified Quick Speech-In-Noise mQuickSIN test and the Digits in Noise DIN test in aided and unaided conditions For subjects assigned to the daily hearing-aid-use group hearing aids are dispensed to the subject for daily use over the next six weeks of the study
Treatment Period V5-V9
Subjects complete weekly visits during the first five weeks of the six-week hearing aid intervention period V5-V9 At each visit the gain response of the subjects hearing aids will be verified in a hearing aid test box to ensure the final gain settings determined in V2 have not been altered For subjects assigned to the daily hearing aid use group the hearing aids data loggers will also be checked to determine the number of hours the subject used the hearing aid each day since the preceding visit The subject will complete the DIN as in V4
Follow-Up Period V10 V11
At the end of the final week of the six-week hearing aid intervention period subjects will complete two final visits V10 V11 at which baseline testing is repeated At V10 the subject completes a second fMRI scan with procedures just as in V3 At V11 the subject completes the same procedures as in V5-V9 with the following exceptions
1 The subject also performs the mQuickSIN as in V4
2 The subject completes the THI as in V0
3 Subjects in the daily use group complete the Abbreviated Profile of Hearing Aid Benefit APHAB The APHAB is a validated questionnaire that measures subjective levels of listening difficulty pre and post hearing aid fitting in persons with hearing loss
Once all the study procedures are completed the subject receives a full debriefing At the end of the debriefing a study audiologist assumes the responsibility for transitioning the subject back to routine clinical care
Instrumentation
Audiometric and speech-in-noise testing will be carried out in a double-walled sound-isolated audiometric chamber adjoined to a control room Audiometric testing will be carried out using typical audiology equipment A Madsen Astera2 or Grason-Stadler Audiostar Pro clinical audiometer calibrated to current standards ANSI S36-2010 will be used to deliver the pure-tone signals for threshold testing through Etymotic Research ER-3A insert earphones A Madsen Otoflex 100 Zodiac or Grasen-Stadler Tympstar Pro acoustic-immittance meter will be used for immittance measurements to verify normal middle ear function
For speech-based audiometry listeners will be seated comfortably in a sound-treated booth and wearing the same ER-3A earphones used in pure-tone audiometry The procedure is driven by prototype commercial software SpeechFit Nadi Inc Visual stimuli are displayed on a touchscreen monitor located in the sound booth The same touchscreen monitor is used to collect responses from the subject Acoustic stimuli are generated digitally by SpeechFit output through a digital-to-analog converter and pre-amplifier Motu M4 and amplified for presentation through ER-3A earphones The equipment used for sound presentation is calibrated in Audcal software Larson Davis Inc to the same standard as routine speech recognition testing on a clinical audiometer ANSI S36-2010 Calibration uses a Larson Davis 831C level meter and model AEC304 occluded ear simulator with calibrated 12-inch microphone
An Auricle Freefit or Audioscan Verifit2 real ear measurement system connected to a VA-furnished and networked PC with installations of Otosuite and NOAH software will be used to collect real ear measurements The same PC is used to program and order hearing aids
For fMRI testing speech stimuli will be presented over MR-compatible active noise cancelling headphones Optoacoustics Inc Amplification will be provided via the OSP master hearing aid running on the same PC used to generate and deliver the acoustic stimuli with overall and band-specific levels verified by ear-canal probe microphone In the aided condition REAR will be matched as closely as possible to that recorded from the participants fitted hearing aid The MRI scanner is a 3 Tesla Siemens Skyra equipped with a 32-channel Siemens head coil Philips SensaVue system for presentation of visual stimuli via MR-compatible LCD display and Cedrus Lumina control box to collect button presses Cedrus LS-LINE response box and trigger signals from the scanner Control of stimulus presentation is accomplished by custom MATLAB software running on a VA-owned PC that is permanently installed in the MRI control room
The mQuickSIN is administered using software furnished by Walter Reed National Military Medical Center with sounds presented through a free field speaker array The DIN is administered via custom Python software
For all speech-in-noise tests mQuickSIN DIN fMRI unaided speech will be delivered at a moderateconversational input level of 65 dB SPL
1 Prescreening screening and enrollment
2 Preparatory period
3 Baseline
4 Treatment first five weeks of hearing aid intervention
5 Follow-up final week of hearing aid intervention
Prescreening screening enrollment V0
Prescreening includes identification of potential participants via medical record search examination of patient rolls clinician referral or patient self-referral eg from study advertisements A prescreening phone call or in-person prescreening visit is scheduled for willing participants
At the time of the in-person prescreening or prescreening phone call a script will be used to learn if prospective participants meet basic eligibility criteria and are able to present for an in-person discussion of informed consent
After prescreening is completed potential participants meeting preliminary eligibility criteria will be scheduled for an initial study visit including informed consent procedures and if consent is obtained the following additional procedures
Participants will be screened for inclusion and exclusion criteria Screening includes performance of a routine audiological exam otoscopy tympanometry air- and bone-conduction pure-tone audiometry if a recent 6 months exam is not available in the medical record The subject also completes the following three questionnairesinterviews to determine eligibility which are not part of routine audiological care
1 Hearing Handicap Inventory for Adults HHIA The HHIA is a 25-item questionnaire that focuses on the emotional socialsituational and occupational effects of hearing loss
2 Mini-Mental State Exam MMSE The MMSE is an experimenter-led interview that assesses the global cognitive state of the subject including situational awareness memory language and sensorimotor function
3 Quantification of Cumulative Blast Exposure QCuBE The QCuBE is a semi-structured experimenter-led interview that measures number and severity of exposures to blast including date of exposure distance from explosion type of explosive and protective gear worn among other details The QCuBE also obtains a brief history of non-blast head traumas
If a subject is not eligible ie fails screening an explanation is provided to the subject along with a full debriefing of the study If a subject is eligible they are randomized and asked to complete the following additional questionnaires
4 Tinnitus Handicap Inventory THI The THI is a 25-item questionnaire that quantifies the impact of tinnitus on daily life
5 Demographic data form optional This form obtains information on the subjects sex ethnicity Hispanic or Latino not Hispanic or Latino and race for reporting to the study sponsor using standard definitions
Preparatory Period V1 V2
Two initial study visits will be conducted to prepare the subject for the hearing aid intervention At the first visit V1 the following procedures will be performed
1 Speech-based audiometry At the core of speech-based audiometry is the Open Speech Platform OSP an open-source hearing aid and speech processing platform with co-designed hardware and software elements For the proposed work the crucial component of OSP is a real-time master hearing aid a modular software environment that abstracts the details of a digital hearing aid processor eg block resampling sub-band filtering wide dynamic range compression and feedback cancellation That is the master hearing aid is a software simulation of a hearing aid that performs all the same functions eg sound amplification and compression The flexible nature of the master hearing aid allows any arbitrary hearing aid prescription to be simulated in real time The logic behind speech-based audiometry is as follows 1 there is a library of potential hearing aid prescriptions 1500 NAL-NL2 gain profiles determined by unsupervised clustering performed on a large library of pure-tone audiograms from patients with a range of hearing loss levels and configurations 2 there is also a library of speech stimuli eg audiobook excerpts that can be amplified with any prescription from the gain library in real time by OSP and presented to the patient over headphones 3 this facilitates a non-exhaustive search of the possible prescriptions based on a patients subjective ratings of speech amplified with different prescriptions 4 in practice this takes the form of a series of AB preference judgments made by the patient much as in fitting for eyeglasses do you prefer A or B 5 machine learning is used to select the A and B prescriptions for each presentation to optimize the search through the library of prescriptions for efficiency 6 the procedure terminates when the search is finished
2 Real ear measurement of realized gains The real ear aided response REAR of the master hearing aid is obtained for the gain settings selected during speech-based audiometry following standard clinical procedures
3 A hearing aid is ordered for the subject with preliminary gain settings established during speech-based audiometry or from the pure-tone audiogram depending on group assignment
At the second visit of the preparatory period V2 real ear verification of hearing aid gain prescription is performed That is the preliminary gain settings initially programmed into the hearing aids are based on a set of gain targets which may differ from the actual gains realized when the hearing aids are worn by the subject Thus REAR measurements are again obtained for soft moderate and loud inputs separately for each ear The hearing aid gains are manually adjusted by the fitting audiologist until the realized gains are within an acceptable range around the gain targets according to routine clinical standards For subjects assigned to the speech-based audiometry group the gain targets are the REAR measurements obtained during V1 For subjects assigned to the conventional fitting group the gain targets are the output of the NAL-NL2 prescriptive formula applied to the subjects pure-tone audiogram gains will be further adjusted based on the subjects subjective feedback typically between 5-10 dB additional insertion gain at some or all frequencies between 500 and 4000 Hz Once the final hearing aid gains are set the hearing aids are placed in a hearing aid test box and their gain responses for soft medium and loud sounds are recorded This will allow the study team to later use the hearing aid test box to verify that the hearing aid gains have not changed from prescribed settings Finally the subject will receive counseling from the fitting audiologist about how to use their hearing aids for the remainder of the study
Baseline Period V3 V4
Study outcome measures will be obtained at baseline ie before the daily use group has begun its six-week period of daily hearing aid usage The first visit of the baseline period V3 is an initial fMRI scan see description of outcome measures The fMRI scan session includes i metal screening ii counseling by a trained MRI technician about what to expect how to remain safe and how to trigger early termination of the MRI scan iii a practice session conducted outside the scanner iv familiarizing the subject with equipment to be used inside the scanner eg button box MR-compatible headphones and placing the subject inside the MRI scanner v acquisition of a T1 scout image and alignment of the MRI slices to be acquired in subsequent scans axial slices aligned with the anterior-posterior commissure vi acquisition of a high-resolution T1 anatomical scan and a gradient field mapping scan vii eight fMRI scans viii removal of the subject from the scanner and ix 5-10 minute observation of the subject during a cool off period
The second visit of the baseline period V4 is a baseline speech-in-noise evaluation including the modified Quick Speech-In-Noise mQuickSIN test and the Digits in Noise DIN test in aided and unaided conditions For subjects assigned to the daily hearing-aid-use group hearing aids are dispensed to the subject for daily use over the next six weeks of the study
Treatment Period V5-V9
Subjects complete weekly visits during the first five weeks of the six-week hearing aid intervention period V5-V9 At each visit the gain response of the subjects hearing aids will be verified in a hearing aid test box to ensure the final gain settings determined in V2 have not been altered For subjects assigned to the daily hearing aid use group the hearing aids data loggers will also be checked to determine the number of hours the subject used the hearing aid each day since the preceding visit The subject will complete the DIN as in V4
Follow-Up Period V10 V11
At the end of the final week of the six-week hearing aid intervention period subjects will complete two final visits V10 V11 at which baseline testing is repeated At V10 the subject completes a second fMRI scan with procedures just as in V3 At V11 the subject completes the same procedures as in V5-V9 with the following exceptions
1 The subject also performs the mQuickSIN as in V4
2 The subject completes the THI as in V0
3 Subjects in the daily use group complete the Abbreviated Profile of Hearing Aid Benefit APHAB The APHAB is a validated questionnaire that measures subjective levels of listening difficulty pre and post hearing aid fitting in persons with hearing loss
Once all the study procedures are completed the subject receives a full debriefing At the end of the debriefing a study audiologist assumes the responsibility for transitioning the subject back to routine clinical care
Instrumentation
Audiometric and speech-in-noise testing will be carried out in a double-walled sound-isolated audiometric chamber adjoined to a control room Audiometric testing will be carried out using typical audiology equipment A Madsen Astera2 or Grason-Stadler Audiostar Pro clinical audiometer calibrated to current standards ANSI S36-2010 will be used to deliver the pure-tone signals for threshold testing through Etymotic Research ER-3A insert earphones A Madsen Otoflex 100 Zodiac or Grasen-Stadler Tympstar Pro acoustic-immittance meter will be used for immittance measurements to verify normal middle ear function
For speech-based audiometry listeners will be seated comfortably in a sound-treated booth and wearing the same ER-3A earphones used in pure-tone audiometry The procedure is driven by prototype commercial software SpeechFit Nadi Inc Visual stimuli are displayed on a touchscreen monitor located in the sound booth The same touchscreen monitor is used to collect responses from the subject Acoustic stimuli are generated digitally by SpeechFit output through a digital-to-analog converter and pre-amplifier Motu M4 and amplified for presentation through ER-3A earphones The equipment used for sound presentation is calibrated in Audcal software Larson Davis Inc to the same standard as routine speech recognition testing on a clinical audiometer ANSI S36-2010 Calibration uses a Larson Davis 831C level meter and model AEC304 occluded ear simulator with calibrated 12-inch microphone
An Auricle Freefit or Audioscan Verifit2 real ear measurement system connected to a VA-furnished and networked PC with installations of Otosuite and NOAH software will be used to collect real ear measurements The same PC is used to program and order hearing aids
For fMRI testing speech stimuli will be presented over MR-compatible active noise cancelling headphones Optoacoustics Inc Amplification will be provided via the OSP master hearing aid running on the same PC used to generate and deliver the acoustic stimuli with overall and band-specific levels verified by ear-canal probe microphone In the aided condition REAR will be matched as closely as possible to that recorded from the participants fitted hearing aid The MRI scanner is a 3 Tesla Siemens Skyra equipped with a 32-channel Siemens head coil Philips SensaVue system for presentation of visual stimuli via MR-compatible LCD display and Cedrus Lumina control box to collect button presses Cedrus LS-LINE response box and trigger signals from the scanner Control of stimulus presentation is accomplished by custom MATLAB software running on a VA-owned PC that is permanently installed in the MRI control room
The mQuickSIN is administered using software furnished by Walter Reed National Military Medical Center with sounds presented through a free field speaker array The DIN is administered via custom Python software
For all speech-in-noise tests mQuickSIN DIN fMRI unaided speech will be delivered at a moderateconversational input level of 65 dB SPL
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I01RX005059 | NIH | None | httpsreporternihgovquickSearchI01RX005059 |