Hearing Aids for Central Auditory Processing Disorder

(SBA Trial)

Recruiting at 2 trial locations

Overseen By Akai R McKinley, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Auditory medications

Disqualifiers: Conductive hearing impairment, Chronic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 5 weeks

80 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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.

Research Team

Jonathan Venezia, PhD

Principal Investigator

VA Loma Linda Healthcare System, Loma Linda, CA

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

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

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

Trial Overview The 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

Group I: Speech-based hearing aid fitting Experimental Treatment 1 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 fitting Active Control 1 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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

NADI Inc.

Collaborator

Trials

1

Recruited

80+

Findings from Research

A structured intervention program for 20 children with central auditory processing disorders (C)APD significantly improved their speech recognition in noisy environments compared to a control group of 10 untreated children, indicating the efficacy of the training.

The training, which included various listening exercises in both quiet and noisy conditions, led to notable improvements in performance for both ears, with specific enhancements observed in the left ear for competing sentence tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of speech in noise and dichotic listening intervention programs on central auditory processing disorders. Putter-Katz, H., Adi-Bensaid, L., Feldman, I., et al.[2019]

In a study of 224 older adults who received bone-anchored hearing aids (BAHAs), the implant loss rate was 6.5% over an average follow-up of 39 months, which is comparable to rates seen in the general population.

Severe skin reactions occurred in 16.9% of implants, but the overall outcomes were favorable, with low risks of complications and no infections leading to implant loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone-anchored hearing aid surgery in older adults: implant loss and skin reactions. de Wolf, MJ., Hol, MK., Mylanus, EA., et al.[2022]

Children with auditory processing disorders (APD) showed significant improvements in speech perception and academic performance after using Phonak EduLink FM devices, compared to a control group.

Prolonged use of FM devices not only enhanced speech perception in noisy environments but also led to improved performance even without the devices, indicating potential long-term benefits for the auditory system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple benefits of personal FM system use by children with auditory processing disorder (APD). Johnston, KN., John, AB., Kreisman, NV., et al.[2015]

A 12-week computer-based auditory training program significantly improved speech-in-noise perception and functional listening skills in children with auditory processing disorder (APD), with effect sizes ranging from 0.76 to 1.7.

The improvements in speech-in-noise performance were maintained for at least 3 months after the training, indicating the long-term efficacy of the intervention in enhancing auditory processing skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Training Effects on the Listening Skills of Children With Auditory Processing Disorder. Loo, JH., Rosen, S., Bamiou, DE.[2015]

The study involving 47 children (21 typically developing and 26 with suspected auditory processing disorder) found no significant differences in sound localization abilities between those with suspected APD and typically developing peers, suggesting that localization difficulties may not be a universal issue in APD.

Both groups showed a significant ability to benefit from spatial release from masking, indicating that children with suspected APD can still effectively separate speech from noise, although some individuals may struggle with localization in certain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Localization and Spatial Release From Masking in Children With Suspected Auditory Processing Disorder. Boothalingam, S., Purcell, DW., Allan, C., et al.[2020]

Recent research highlights the potential of glycine(B) site antagonists and NMDA channel blockers as neuroprotective agents for treating neurodegenerative diseases, with several candidates currently in development.

While NMDA receptor antagonists may be beneficial for chronic neurodegeneration, AMPA antagonists appear to be more effective for acute conditions like stroke or trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective potential of ionotropic glutamate receptor antagonists. Danysz, W., Parsons, CG.[2023]

The selective AMPA receptor antagonist NS1209 showed potential in preclinical studies for treating neuropathic pain and epilepsy, but the clinical trials were poorly designed and yielded inconclusive results, leading to its removal from the CNS development pipeline.

Despite initial promise, NS1209's development was hindered by slow progress and insufficient data, highlighting the challenges in CNS drug discovery and the need for better trial designs to improve the chances of success for similar compounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NS1209/SPD 502, A Novel Selective AMPA Antagonist for Stroke, Neuropathic Pain or Epilepsy? Drug Development Lessons Learned. Keppel Hesselink, JM.[2018]

In a study involving patients with moderate to catastrophic chronic subjective tinnitus, BGG492 (selurampanel) significantly reduced tinnitus loudness and annoyance after a single dose, indicating its potential efficacy as a treatment.

After 2 weeks of treatment, a greater proportion of patients showed improvement in tinnitus severity compared to placebo, although dizziness was a common side effect, particularly at the higher dose of 100mg TID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kucher, K., Johns, D., Wagner, F., et al.[2021]

Dizocilpine (DIZO), an NMDA receptor antagonist, significantly impaired maze performance in rats in a dose-dependent manner, particularly affecting cognitive measures like errors and alternation errors, with the highest dose causing severe motor ataxia.

In a delayed-matching-to-sample task, the 0.05 mg/kg dose of DIZO disrupted performance, especially in tasks requiring side changes, indicating that NMDA receptor activity is crucial for certain cognitive functions related to maze navigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NMDA receptor channel antagonism by dizocilpine (MK-801) impairs performance of rats in aversively motivated complex maze tasks. Spangler, EL., Bresnahan, EL., Garofalo, P., et al.[2019]

In a 4-week study involving 105 stable schizophrenia patients, CX516, an AMPA-receptor-positive modulator, did not show any significant improvement in cognitive function compared to placebo, regardless of the antipsychotic treatment (clozapine, olanzapine, or risperidone).

While CX516 was generally well tolerated, it was associated with side effects like fatigue, insomnia, and epigastric discomfort, and it did not outperform placebo in improving schizophrenia symptoms as measured by the PANSS total score.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A placebo-controlled add-on trial of the Ampakine, CX516, for cognitive deficits in schizophrenia. Goff, DC., Lamberti, JS., Leon, AC., et al.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effects of speech in noise and dichotic listening intervention programs on central auditory processing disorders. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Bone-anchored hearing aid surgery in older adults: implant loss and skin reactions. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Multiple benefits of personal FM system use by children with auditory processing disorder (APD). [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Auditory Training Effects on the Listening Skills of Children With Auditory Processing Disorder. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Auditory Localization and Spatial Release From Masking in Children With Suspected Auditory Processing Disorder. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Neuroprotective potential of ionotropic glutamate receptor antagonists. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

NS1209/SPD 502, A Novel Selective AMPA Antagonist for Stroke, Neuropathic Pain or Epilepsy? Drug Development Lessons Learned. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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]

9. United States pubmed.ncbi.nlm.nih.gov

NMDA receptor channel antagonism by dizocilpine (MK-801) impairs performance of rats in aversively motivated complex maze tasks. [2019]

10. England pubmed.ncbi.nlm.nih.gov

A placebo-controlled add-on trial of the Ampakine, CX516, for cognitive deficits in schizophrenia. [2018]