High-Frequency Hearing LossNCT05145946
Tracking Biomarkers of Speech Intelligibility
A study testing Video Game Training Group 1 and Video Game Training Group 2 in people with High-Frequency Hearing Loss, run by Massachusetts Eye and Ear Infirmary.
Trial summary
Difficulties understanding speech in noisy environments repeatedly coincide with high-frequency hearing loss. This complaint is commonly exhibited in adults in middle/older age who have a history of noise exposure. Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- High-Frequency Hearing Loss
- What is being tested?
- Video Game Training Group 1 and Video Game Training Group 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High frequency hearing loss subjects - Thresholds of 15 dB HL or less for 0.25-2 kHz. Thresholds of 30-60 dB HL from 3-8 kHz.
- Normal hearing subjects - Thresholds of 15 dB HL or less from 0.5-8 kHz.
- Thresholds between left and right ears symmetric within 10 dB for all frequencies.
- Native English speakers.
Who cannot join
- Conductive hearing loss (as assessed by audiologist).
- Active otologic disease (as assessed by audiologist).
- Significant cognitive decline (Montreal Cognitive Assessment score > 25).
About this study
Official title: Neural Pathophysiology and Suprathreshold Processing in Older Adults With Elevated Thresholds
Difficulties understanding speech in noisy environments repeatedly coincide with high-frequency hearing loss. This complaint is commonly exhibited in adults in middle/older age who have a history of noise exposure. In this study, an immersive audiomotor training game will be utilized to drive improvements in speech intelligibility, controlled by an auditory memory training game. Physiological measures will be tracked that could inform clinical assessment of hearing in noise abilities.
Read the detailed description
Hearing loss is a chronic health disorder affecting approximately 15 percent of Americans. High-frequency hearing loss can be imperceptible when listening in quiet environments. However, in complex noisy environments, individuals can severely suffer from an inability to resolve speech. This is despite having normal audiometric thresholds in the low-frequency range within which speech signals are contained. There are several factors that could contribute to speech intelligibility difficulties that are imperceptible with typical hearing tests. These include impaired temporal encoding at the auditory nerve and the downstream sequelae of peripheral damage in the central auditory pathway. The goal of this study is to assess how a set of physiological measures of auditory/neural processing map onto suprathreshold hearing outcomes.
In a previous study, significant improvements in speech intelligibility have resulted from training on an immersive video game. The game uses a closed-loop audiomotor interface design that reinforces sensory-guided feedback. As a control, an auditory memory training game has been developed to replicate user expectations and procedural learning. In this study, an audiomotor game and control game will be used as mechanisms through which to track changes to physiological and perceptual biomarkers in a high frequency hearing loss cohort and a matched normal hearing cohort. Tests will be run pre-training, post- training, and at a follow-up point.
- Conditions
- High-Frequency Hearing Loss
- Being tested
- Video Game Training Group 1, Video Game Training Group 2
- Medical subject headings
- Hearing Loss, High-Frequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Game Training Group 1Behavioural
Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week.
Video Game Training Group 2Behavioural
Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week.
| Study group | Role | What they receive |
|---|---|---|
| Video Game Training Group 1 - High Frequency Hearing Loss | Experimental | Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have high frequency hearing loss. Receives: Behavioral: Video Game Training Group 1 |
| Video Game Training Group 1 - Normal Hearing | Active comparator | Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have normal hearing. Receives: Behavioral: Video Game Training Group 1 |
| Video Game Training Group 2 - High Frequency Hearing Loss | Sham comparator | Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have high frequency hearing loss. Receives: Behavioral: Video Game Training Group 2 |
| Video Game Training Group 2 - Normal Hearing | Sham comparator | Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have normal hearing. Receives: Behavioral: Video Game Training Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Speech Recognition in Noise Performance Accuracy
Keyword recognition accuracy for sentences in noise will be assessed with a clinical test, the QuickSiN. Signal to noise ratios vary from 25 to 0 dB in 5 dB steps.
Measured: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Secondary outcomes (3)
Change in the neural encoding fidelity for frequency modulated tones
EEG phase coherence to a 500 Hz tone modulated at variable depths at 2Hz.
Measured: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Change in the psychophysical frequency modulation detection threshold
Frequency modulation detection threshold of 500 Hz carrier modulated at 2Hz.
Measured: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Increase in pupil dilation while listening to sentences in noise
Growth in pupil dilation over the duration of the sentence will be measured while subjects perform the QuickSiN test at signal to noise ratios varying from 25 to 0 in 5 dB steps.
Measured: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Funding for this study ended prior to enrollment of any participants due to a change in funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Frequency Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Brandon Polley, Massachusetts Eye and Ear Infirmary
- Investigators
- Daniel B Polley, Ph.D., Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145946
- Sponsor's protocol ID
- pending_090721
- Status last verified
- Dec 2025
- First submitted
- 29 Sep 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Pathophysiology and Suprathreshold Processing in Older Adults With Elevated Thresholds
- ClinicalTrials.gov ID
- NCT05145946
- Acronym / sponsor ID
- pending_090721
- Conditions
- High-Frequency Hearing Loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding for this study ended prior to enrollment of any participants due to a change in funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Difficulties understanding speech in noisy environments repeatedly coincide with high-frequency hearing loss. This complaint is commonly exhibited in adults in middle/older age who have a history of noise exposure. In this study, an immersive audiomotor training game will be utilized to drive improvements in speech intelligibility, controlled by an auditory memory training game. Physiological measures will be tracked that could inform clinical assessment of hearing in noise abilities.
Detailed description
Hearing loss is a chronic health disorder affecting approximately 15 percent of Americans. High-frequency hearing loss can be imperceptible when listening in quiet environments. However, in complex noisy environments, individuals can severely suffer from an inability to resolve speech. This is despite having normal audiometric thresholds in the low-frequency range within which speech signals are contained. There are several factors that could contribute to speech intelligibility difficulties that are imperceptible with typical hearing tests. These include impaired temporal encoding at the auditory nerve and the downstream sequelae of peripheral damage in the central auditory pathway. The goal of this study is to assess how a set of physiological measures of auditory/neural processing map onto suprathreshold hearing outcomes.
In a previous study, significant improvements in speech intelligibility have resulted from training on an immersive video game. The game uses a closed-loop audiomotor interface design that reinforces sensory-guided feedback. As a control, an auditory memory training game has been developed to replicate user expectations and procedural learning. In this study, an audiomotor game and control game will be used as mechanisms through which to track changes to physiological and perceptual biomarkers in a high frequency hearing loss cohort and a matched normal hearing cohort. Tests will be run pre-training, post- training, and at a follow-up point.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Video Game Training Group 1 - High Frequency Hearing Loss | Experimental | Behavioral: Video Game Training Group 1Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have high frequency hearing loss. |
| Video Game Training Group 1 - Normal Hearing | Active comparator | Behavioral: Video Game Training Group 1Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have normal hearing. |
| Video Game Training Group 2 - High Frequency Hearing Loss | Sham comparator | Behavioral: Video Game Training Group 2Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have high frequency hearing loss. |
| Video Game Training Group 2 - Normal Hearing | Sham comparator | Behavioral: Video Game Training Group 2Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week. Participants will have normal hearing. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- High frequency hearing loss subjects - Thresholds of 15 dB HL or less for 0.25-2 kHz. Thresholds of 30-60 dB HL from 3-8 kHz.
- Normal hearing subjects - Thresholds of 15 dB HL or less from 0.5-8 kHz.
- Thresholds between left and right ears symmetric within 10 dB for all frequencies.
- Native English speakers.
Key exclusion criteria (3 listed)
- Conductive hearing loss (as assessed by audiologist).
- Active otologic disease (as assessed by audiologist).
- Significant cognitive decline (Montreal Cognitive Assessment score > 25).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video Game Training Group 1Closed-loop audiomotor game. Home-based training sessions for 3.5 hours per week over an 8-week. | Behavioural | Video Game Training Group 1 - High Frequency Hearing Loss, Video Game Training Group 1 - Normal Hearing |
| Video Game Training Group 2Auditory memory game. Home-based training sessions for 3.5 hours per week over an 8-week. | Behavioural | Video Game Training Group 2 - High Frequency Hearing Loss, Video Game Training Group 2 - Normal Hearing |
Primary outcome
Change in Speech Recognition in Noise Performance Accuracy
Time frame: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Keyword recognition accuracy for sentences in noise will be assessed with a clinical test, the QuickSiN. Signal to noise ratios vary from 25 to 0 dB in 5 dB steps.
3 secondary outcomes
Change in the neural encoding fidelity for frequency modulated tones
Time frame: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Change in the psychophysical frequency modulation detection threshold
Time frame: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Increase in pupil dilation while listening to sentences in noise
Time frame: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel B Polley, Ph.D. principal investigator
Massachusetts Eye and Ear Infirmary
Questions about this trial
What is this clinical trial studying?
A study testing Video Game Training Group 1 and Video Game Training Group 2 in people with High-Frequency Hearing Loss, run by Massachusetts Eye and Ear Infirmary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Speech Recognition in Noise Performance Accuracy (time frame: Pre-test / Post-test (8 weeks) / Follow-up (16 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.