Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06117254
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-10-30
Brief Title:
Hearing Aids for Veterans With Functional Hearing Difficulties
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Evaluating Device-based Rehabilitation for Veterans With Functional Hearing Difficulties A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Every year approximately 100000 Veterans seek help at VA Audiology clinics for hearing and communication difficulties only to learn that they have normal hearing sensitivity Unfortunately there are very few established options to improve hearing and listening for these patients To address this need audiologists are increasingly prescribing hearing aids set to provide a small amount of amplification Patients may benefit from the amplification or from modern hearing aid features such as noise reduction technology and the ability to stream sounds from a desired sound source directly to their ears thus reducing the background noise This project will help to determine if prescribing hearing aids to patients without hearing loss is in fact beneficial and if so why It will also help to determine if some patients benefit more from hearing aids than others so that in the future rehabilitation strategies can be better targeted toward individuals
Detailed Description:
At least 10 of Veterans seeking help in VA audiology clinics have clinically normal audiograms a figure that broadly confirms a recent prevalence study indicating that 336 of current active-duty military Service Members are at risk of hearing and communication deficits despite having normal-hearing thresholds While a considerable amount of research effort over the past 20 years has been devoted to understanding the potential causes for hearing difficulties in patients with normal hearing sensitivity comparatively little research effort has been devoted to rehabilitation and improvement of function for these patients This predicament has left audiologists and other medical professionals with very few evidence-based options to provide care for the large segment of help-seeking Veterans struggling with functional hearing difficulties Currently audiologic standard of care SOC for these patients involves reassurance of normal hearing and providing general communication tips though evidence suggests that many patients are unsatisfied with this approach and request further testing and rehabilitation options To help address patient concerns many VA audiologists are now prescribing hearing aids though there is very little data on whether these devices improve functional outcomes for patients with self-reported hearing difficulties and normal hearing sensitivity Therefore the purpose of this study is to compare the efficacy of device-based rehabilitation options with current standard of care for Veterans with self-reported hearing and communication problems and to identify subgroups in the sample that may benefit differently depending upon patient-specific characteristics and needs The general hypothesis is that most Veterans with hearing difficulties and normal audiograms will benefit from device-based auditory rehabilitation as reflected by decreases in perceived hearing handicap However the amount of benefit will vary according to patient-specific characteristics including auditory psychological and cognitive factors in combination with the type and severity of auditory dysfunction experienced by the patient
All study participants will be Veterans with normal to near-normal pure-tone sensitivity but with moderate to severe perceived hearing handicap who are interested in seeking professional help Participants will be interviewed to gather data regarding their hearing difficulties including the context and impacts of difficulties as well as goals for auditory rehabilitation Next participants will undergo assessments of peripheral and central auditory system function including electrophysiological and behavioral measures and cognitive and psychological status assessed using established NIH Toolbox measures Participant medical charts will be reviewed to gather data on comorbid conditions and previous exposures known to be risk factors for developing auditory processing difficulties These data will be compiled to provide an estimate of the distribution of characteristics likely to impact auditory function and response to intervention among Veterans seeking help for functional hearing difficulties Participants will then be randomized into one of following three intervention arms 1 SOC 2 SOC hearing aids or 3 SOC hearing aids with remote microphone Outcomes will be measured at two- and six-months post-intervention The primary outcome measure is the Hearing Handicap Inventory for Adults Secondary outcome measures are aimed at identifying the underlying mechanisms and potential mediators that influence whether and how participants receive benefit from hearing devices These will include measures of speech understanding in quiet and noise objective and subjective listening effort electrophysiological measures of neural responses to sound and interviews to learn more about participants perceptions of the intervention Interaction effects will be estimated between treatment arm and patient characteristics to identify key moderating factors that influence the degree and direction of benefit associated with different treatment strategies This information can then be used to inform both clinical decision making for individual patients and the design of future intervention studies
All study participants will be Veterans with normal to near-normal pure-tone sensitivity but with moderate to severe perceived hearing handicap who are interested in seeking professional help Participants will be interviewed to gather data regarding their hearing difficulties including the context and impacts of difficulties as well as goals for auditory rehabilitation Next participants will undergo assessments of peripheral and central auditory system function including electrophysiological and behavioral measures and cognitive and psychological status assessed using established NIH Toolbox measures Participant medical charts will be reviewed to gather data on comorbid conditions and previous exposures known to be risk factors for developing auditory processing difficulties These data will be compiled to provide an estimate of the distribution of characteristics likely to impact auditory function and response to intervention among Veterans seeking help for functional hearing difficulties Participants will then be randomized into one of following three intervention arms 1 SOC 2 SOC hearing aids or 3 SOC hearing aids with remote microphone Outcomes will be measured at two- and six-months post-intervention The primary outcome measure is the Hearing Handicap Inventory for Adults Secondary outcome measures are aimed at identifying the underlying mechanisms and potential mediators that influence whether and how participants receive benefit from hearing devices These will include measures of speech understanding in quiet and noise objective and subjective listening effort electrophysiological measures of neural responses to sound and interviews to learn more about participants perceptions of the intervention Interaction effects will be estimated between treatment arm and patient characteristics to identify key moderating factors that influence the degree and direction of benefit associated with different treatment strategies This information can then be used to inform both clinical decision making for individual patients and the design of future intervention studies
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