Hearing Aids for Central Auditory Processing Disorder
(SBA Trial)
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
Must not be taking: Auditory medications
Disqualifiers: Conductive hearing impairment, Chronic disease, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
Since 2000, at least 250,000 U.S. Service members have experienced a blast-related mild traumatic brain injury. A retrospective analysis of over 100,000 post-9/11 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 patient's 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.
Will I have to stop taking my current medications?
The trial excludes participants who use medication that might affect the auditory system or their ability to perform the experimental tasks, so you may need to stop certain medications. It's best to discuss your specific medications with the trial team to see if they are affected.
What data supports the effectiveness of the treatment Phonak Lumina P90, Phonak Audeo Lumity 90, Phonak Lumina P90 for Central Auditory Processing Disorder?
Research shows that using similar devices, like the Phonak EduLink FM, helps children with auditory processing disorders improve their ability to understand speech in noisy environments, leading to better academic performance and social interactions. This suggests that hearing aids like the Phonak Lumina P90 and Phonak Audeo Lumity 90 could also be beneficial for similar conditions.12345
How does the Phonak Lumina P90 treatment differ from other treatments for Central Auditory Processing Disorder?
The Phonak Lumina P90 hearing aids are unique because they are specifically designed to improve hearing clarity and speech understanding, which may help address the auditory processing challenges in Central Auditory Processing Disorder. Unlike other treatments that might focus on medication or therapy, these hearing aids provide a direct technological solution to enhance auditory input.678910
Eligibility Criteria
This trial is for blast-exposed Veterans who have trouble hearing in noisy places but have normal hearing tests. They should not already be using a low-gain hearing aid and must be able to complete speech recognition tasks and undergo neuroimaging.Inclusion Criteria
All subjects must score 20 or higher on the Hearing Handicap Inventory for Adults (HHIA)
A score of at least 25 on the Mini Mental State Exam
Human subjects will be male or female Veterans selected without regard to race or ethnic background
See 6 more
Exclusion Criteria
I have hearing loss not caused by nerve damage.
I cannot perform the tasks required in the study.
Experience with hearing aids prior to the study
See 2 more
Trial Timeline
Prescreening, Screening, and Enrollment
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person), 1 call (virtual)
Preparatory Period
Participants undergo speech-based audiometry and real ear measurement to prepare for hearing aid intervention
2 weeks
2 visits (in-person)
Baseline
Baseline outcome measures are obtained, including fMRI scan and speech-in-noise evaluation
1 week
2 visits (in-person)
Treatment
Participants receive hearing aid intervention with weekly visits for gain verification and outcome assessments
5 weeks
5 visits (in-person)
Follow-up
Participants complete final outcome assessments, including fMRI scan and speech-in-noise evaluation
1 week
2 visits (in-person)
Treatment Details
Interventions
- Phonak Lumina P90 (Behavioural Intervention)
Trial OverviewThe study compares two ways of fitting low-gain hearing aids: the usual method based on pure-tone audiograms, and a new data-driven approach using patient responses to speech in noise. It measures how well participants recognize speech with background noise and their brain activity during these tasks.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Speech-based hearing aid fittingExperimental Treatment1 Intervention
Half of the study participants receive a hearing aid with gain settings determined via speech-based audiometry. Other hearing aid features such as noise reduction and directional microphones are disabled. Of this group of subjects, half are assigned to use the hearing aid daily for six weeks, while the remainder are followed for the same six-week period but use their hearing aids only to complete outcomes testing.
Group II: Audiogram-based hearing aid fittingActive Control1 Intervention
Half of the study participants receive a hearing aid with gain settings determined by applying the NAL-NL2 prescriptive formula to the pure-tone audiogram. Other hearing aid features such as noise reduction and directional microphones are disabled. Of this group of subjects, half are assigned to use the hearing aid daily for six weeks, while the remainder are followed for the same six-week period but use their hearing aids only to complete outcomes testing.
Phonak Lumina P90 is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Phonak Audeo Lumity 90 for:
- Mild to profound sensorineural hearing loss
- Functional hearing difficulties (FHDs)
🇪🇺 Approved in European Union as Phonak Lumina P90 for:
- Mild to profound sensorineural hearing loss
🇨🇦 Approved in Canada as Phonak Audeo Lumity 90 for:
- Mild to profound sensorineural hearing loss
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, CA
VA Greater Los Angeles Healthcare System, Sepulveda, CASepulveda, CA
VA Loma Linda Healthcare System, Loma Linda, CALoma Linda, CA
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Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
University of California, San DiegoCollaborator
NADI Inc.Collaborator
References
Effects of speech in noise and dichotic listening intervention programs on central auditory processing disorders. [2019]Twenty children with central auditory processing disorders [(C)APD] were subjected to a structured intervention program of listening skills in quiet and in noise. Their performance was compared to that of a control group of 10 children with (C)APD with no special treatment. Pretests were conducted in quiet and in degraded listening conditions (speech noise and competing speech). The (C)APD management approach was integrative and included top-down and bottom-up strategies. It focused on environmental modifications, remediation techniques, and compensatory strategies. Training was conducted with monosyllabic and polysyllabic words, sentences and phrases in quiet and in noise. Comparisons of pre- and post-management measures indicated increase in speech recognition performance in background noise and competing speech for the treatment group. This improvement was exhibited for both ears. A significant difference between ears was found with the left ear showing improvement in both the short and the long versions of competing sentence tests and the right ear performing better in the long competing sentences only following intervention. No changes were documented for the control group. These findings add to a growing body of literature suggesting that interactive auditory training can improve listening skills.
Bone-anchored hearing aid surgery in older adults: implant loss and skin reactions. [2022]We evaluated the clinical outcome measures of fixture loss and skin reactions in older-adult users of percutaneous bone-anchored hearing aids (BAHAs).
Multiple benefits of personal FM system use by children with auditory processing disorder (APD). [2015]Children with auditory processing disorders (APD) were fitted with Phonak EduLink FM devices for home and classroom use. Baseline measures of the children with APD, prior to FM use, documented significantly lower speech-perception scores, evidence of decreased academic performance, and psychosocial problems in comparison to an age- and gender-matched control group. Repeated measures during the school year demonstrated speech-perception improvement in noisy classroom environments as well as significant academic and psychosocial benefits. Compared with the control group, the children with APD showed greater speech-perception advantage with FM technology. Notably, after prolonged FM use, even unaided (no FM device) speech-perception performance was improved in the children with APD, suggesting the possibility of fundamentally enhanced auditory system function.
Auditory Training Effects on the Listening Skills of Children With Auditory Processing Disorder. [2015]Children with auditory processing disorder (APD) typically present with "listening difficulties,"' including problems understanding speech in noisy environments. The authors examined, in a group of such children, whether a 12-week computer-based auditory training program with speech material improved the perception of speech-in-noise test performance, and functional listening skills as assessed by parental and teacher listening and communication questionnaires. The authors hypothesized that after the intervention, (1) trained children would show greater improvements in speech-in-noise perception than untrained controls; (2) this improvement would correlate with improvements in observer-rated behaviors; and (3) the improvement would be maintained for at least 3 months after the end of training.
Auditory Localization and Spatial Release From Masking in Children With Suspected Auditory Processing Disorder. [2020]We sought to investigate whether children referred to our audiology clinic with a complaint of listening difficulty, that is, suspected of auditory processing disorder (APD), have difficulties localizing sounds in noise and whether they have reduced benefit from spatial release from masking.
Neuroprotective potential of ionotropic glutamate receptor antagonists. [2023]From the therapeutic point of view, the real challenge is not only to improve the symptoms, but to interfere with the pathomechanism of the disease. That is why a considerable interest has recently been devoted to developing glutamate receptor antagonists (mainly of the NMDA type) for acute and chronic neurodegeneration. Developing such a treatment that slows down the progression of the disease is extremely time and cost consuming. At present there is consensus that competitive NMDA receptor antagonists will not find therapeutic applications, in contrast to agents acting at the glycine(B) site, or channel blockers. Recently, at least seven glycine(B) antagonists (e.g. ACEA 1021, GV-150526, GV-196771A, ZD-9379, MRZ 2/576) and over 10 NMDA channel blockers (e.g. Remacemide, ARL-15896AR, HU-211, ADCI, CNS-5161, Neramexane-MRZ 2/579) have been under development, most of them as neuroprotective agents for acute (stroke, trauma) or chronic insult (e.g. Huntington's or Alzheimer's disease). Several substances selective for NR2B NMDA receptor subtypes such as eliprodil, CP-101606 and Ro-25-6981 have been claimed to have a good neuroprotective profile. This presentation is an attempt to critically review preclinical and scarce clinical experience in the development of new NMDA receptor antagonists as neuroprotective agents according to the following scheme: rational, preclinical findings in animal models and finally clinical experience if available. The general impression is that NMDA receptor antagonists may find use in chronic type of neurodegeneration while AMPA antagonists seem to show better promise in acute insult.
NS1209/SPD 502, A Novel Selective AMPA Antagonist for Stroke, Neuropathic Pain or Epilepsy? Drug Development Lessons Learned. [2018]Preclinical Research The selective AMPA (α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist, NS1209 (also known as SPD 502) has been explored in several research and development campaigns since its selection as a lead drug candidate in the early 1990s by the Danish biotechnology company, NeuroSearch. The compound was successively tested in animal models of stroke, neuropathic pain and epilepsy. The preclinical data to support development for the treatment of stroke were incomplete, as the compound was administered after the stroke episode, and did not protect subcortical areas of the brain. Preclinical data for neuropathic pain and epilepsy appeared more promising, but the design of the Phase IIa studies in both indications was suboptimal, and an exploratory study in neuropathic pain, like one in refractory epilepsy gave inconclusive results. Preclinical data in pain models were much less convincing than reported by the authors in abstract and discussion sections. Due to a long preclinical sequential testing phase and insufficiently powered clinical trials, NS 1209 disappeared from the CNS development pipeline, while its patent protection exclusivity was markedly reduced due to the unfortunate slow speed in development-a phenomenon far from unusual in CNS drug discovery. NeuroSearch ceased operations as an R&D entity in 2012 and its R & D portfolio was transferred to Teva Pharmaceuticals and to a spin off, Saniona A/S. Based on an in-depth case analysis of the development of NS 1209, a number of recommendations are given to reduce chances of failure during clinical development of neuropathic pain compounds and, more generally, of CNS compounds. Drug Dev Res 78 : 75-80, 2017. © 2017 Wiley Periodicals, Inc.
Efficacy and safety of single- and repeated-selurampanel dosing for 2 weeks in patients with chronic subjective tinnitus: Results of a randomized, double-blind, placebo-controlled, cross-over, proof-of-concept phase IIa study. [2021]To evaluate efficacy and safety of BGG492 (selurampanel; an orally active, competitive AMPA glutamate receptor antagonist) in patients with moderate-to-catastrophic chronic subjective tinnitus. Study (NCT01302873) enrolled patients with subjective tinnitus based on THI severity grade 3, 4 or 5 (moderate, severe or catastrophic), and those with chronic (>6 and
NMDA receptor channel antagonism by dizocilpine (MK-801) impairs performance of rats in aversively motivated complex maze tasks. [2019]To determine the involvement of the N-methyl-D-aspartate (NMDA) receptor in shock-motivated complex maze performance, the drug dizocilpine (DIZO; a.k.a. MK-801) was administered a) to naive, 3-month-old male F-344 rats prior to acquisition (AQ) in the 14-unit T-maze (Experiment 1), and b) to well-trained 11-month-old male F-344 rats prior to testing in a delayed-matching-to-sample (DMTS) task in the detour maze (Experiment 2). For Experiment 1, rats first were pretrained in a straight runway on one-way active avoidance (13/15 correct avoidances) for a maximum of 30 trials. On the following day, either DIZO 0.025 (n = 8), 0.05 (n = 8), 0.1 (n = 8), mg/kg, or saline (SAL; n = 15) was administered subcutaneously (SC) 20 min prior to 15 AQ trials in the shock-motivated 14-unit T-maze. The highest dose disrupted all measures of maze performance including errors, alternation errors, runtime, shock duration and frequency, but also produced marked motor ataxia. The 0.05-mg/kg group displayed significant impairment in AQ of this task but only on the cognitive measures, errors and alternation errors, and the 0.025-mg/kg group was impaired on the alternation measure only. One week later, the 15 SAL rats were divided into 2 groups and tested on retention with either SAL or 0.05 mg/kg DIZO. No effects on maze performance were observed. For Experiment 2, after receiving extensive pretraining in the shock-motivated detour maze, 7 rats were exposed to a novel sequence of 4 problems (P) during each of 7 daily sessions. Performance was evaluated 20 min after SC injection of either DIZO--0.025, 0.05, 0.125 mg/kg, or SAL. The 0.125-mg/kg dose caused extreme motor ataxia which precluded testing during that session. The 0.05-mg/kg but not the 0.025-mg/kg dose significantly disrupted performance on both error and trials to criterion measures. Both problem and interaction effects were significant. Disruption was most evident on two specific problems, those involving a side change from the first to second detour. Also, rats had more difficulty switching sides from problem to problem (few errors on P-1 and most on P-4), suggesting proactive interference effects. In sum, DIZO was observed to significantly disrupt performance in both mazes in a dose-related manner similar to effects observed in previous studies following administration of the anticholinergic drug scopolamine. For the 14-unit T-maze, the present results simulate age-related deficits previously found in acquisition of that task.
A placebo-controlled add-on trial of the Ampakine, CX516, for cognitive deficits in schizophrenia. [2018]AMPA-receptor-positive modulators (Ampakines) facilitate learning and memory in animal models and in preliminary trials in human subjects. CX516 is the first Ampakine to be studied for cognitive enhancement in schizophrenia. Stable schizophrenia patients treated with clozapine (n=52), olanzapine (n=40), or risperidone (n=13) were randomly assigned to add-on treatment with CX516 900 mg three times daily or placebo for 4 weeks. Subjects were assessed with a cognitive battery at baseline, week 4, and at 4-week follow-up. Clinical scales and safety monitoring were also performed. The primary endpoint was the change from baseline in a composite cognitive score at week 4 for the intent-to-treat sample. Additional analyses examined change in symptom rating scores and examined drug effects on patients treated with clozapine separately from patients treated with either olanzapine or risperidone. A total of 105 patients were randomized and 95 (90%) completed the 4-week trial. Patients treated with CX516 did not differ from placebo in change from baseline on the composite cognitive score, or on any cognitive test at weeks 4 or 8. The between groups effect size at week 4 for the cognitive composite score was -0.19 for clozapine-treated patients and 0.24 for patients treated with olanzapine or risperidone. The placebo group improved more on the PANSS total score than the CX516 group; no other clinical rating differed between treatment groups. CX516 was associated with fatigue, insomnia and epigastric discomfort compared to placebo, but was generally well tolerated. CX516 was not effective for cognition or for symptoms of schizophrenia when added to clozapine, olanzapine, or risperidone.