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Hearing LossNCT06340919

Hearing Aid Algorithms for Sudden Sounds

A study testing Sudden Sound Reduction Setting in people with Hearing Loss, run by Purdue University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study explores the impact of hearing aid settings for managing sudden sounds on speech comprehension and recall in individuals with hearing loss. Participants will undergo a comprehensive audiological evaluation, case history, and cognitive assessments. Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Hearing Loss
What is being tested?
Sudden Sound Reduction Setting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
21 Feb 2024to 31 May 2025
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 18 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Air conduction thresholds 25-70 dB HL from 2000 - 6000 Hz
  • Native English speakers

Who cannot join

  • Retrocochlear hearing loss

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Purdue University

    West Lafayette, Indiana, 47907

Other trials in United States

About this study

This study explores the impact of hearing aid settings for managing sudden sounds on speech comprehension and recall in individuals with hearing loss. Participants will undergo a comprehensive audiological evaluation, case history, and cognitive assessments. Subsequently, they will participate in listening experiments designed to measure sentence recognition, storage, and retrieval under various sudden sound reduction conditions recorded through a hearing aid. The experiment will be complemented by subjective preference ratings to identify participant comfort and listening clarity associated with different sudden sound reduction settings.

Read the detailed description

Participants will first undergo a comprehensive audiologic test battery and questionnaires. The audiologic test battery will consist of (a) pure tone audiometry: basic and extended high frequency, (b) tympanometry, (c) wideband acoustic immittance, (d) acoustic reflexes, and (e) otoacoustic emissions. They will also complete online questionnaires at home: (a) loudness and annoyance, (b) noise exposure, (c) general survey concerning hearing in difficult situations, medical and otologic history, noise exposure, tinnitus, balance, sensory sensitivity (lights, sound, touch, smell, taste), and amplification. In addition, they will complete online tests of temporal gap detection.

Participants who meet the study inclusion criteria (hearing aid candidacy based on air conduction thresholds between 2000 and 6000 Hz) will return to the lab for two additional sessions. During the first session, before starting the main experiment, they will complete the Working Memory Questionnaire (Vallat-Azouvi et al., 2012), which evaluates short-term storage, attention, and executive control. The first main experiment evaluates sentence recognition, storage, and retrieval. Participants will hear two sentences in a row: one by a male or female talker and the other by a person of the opposite gender. Participants are asked to remember the first sentence while listening to the second sentence. They will be asked to repeat the last sentence aloud (a measure of sentence recognition). Then, they will be asked to type the first sentence (a measure of sentence storage and retrieval). Most, but not all, sentences will have sudden soft sounds and one sudden loud sound. Participants will hear each pair of sentences only once; they will not be allowed to replay the audio.

Sentence pairs were recorded through hearing aids in an anthropomorphic manikin with one of four treatments for sudden sounds: (1) off, (2) low, (3) high, and (4) maximum. Participants will listen to 36 sentence pairs for each of the four treatments. All will contain sudden soft sounds (e.g., keyboard typing, footsteps, chewing, etc.) throughout the two sentences; half will contain a sudden loud sound (e.g., gunshot, door slamming, iPhone notification, etc.) at the onset of a keyword in the first sentence and the other half in the second sentence. Control stimuli do not contain sudden sounds. Conditions assigned to each sentence list (18 pairs) will be randomly assigned to each sentence participant. In addition, all stimuli were recorded using one of eight standardized audiometric configurations. Participants will listen to the recordings made with the audiogram that best matches the hearing loss in one of their ears. Participants can scale the overall output up or down 15 dB to accommodate differences in loudness preferences. Finally, all recordings were filtered before playback to remove the resonance associated with the external ear properties of the anthropomorphic manikin using the test earphones.

Participants will return to the lab for a second session in which they will rate their preferences for the different sudden sound reduction settings. Before beginning the experiment, they will complete the Visual Letter Monitoring (VLM) test (Gatehouse et al., 2003). The VLM test assesses attention, reaction time, continuous performance, and working memory capabilities. Participants will observe letters displayed one at a time in large font on a computer screen. Letters will switch between vowels and consonants in an unbroken sequence with intervals of 2 ("slow") or 1 second ("fast"). Participants will press the space bar on the computer keyboard or a button on the touchscreen whenever three sequential letters (Consonant-Vowel-Consonant) form a word.

For the subjective preference portion of the experiment, participants listen to sentences recorded with two different sudden sound reduction settings (6 combinations comprised of off, low, high, or maximum). Each sentence will be played twice, in succession, but with different pairs of settings from trial to trial. Following each trial, they will select which setting they prefer overall. Additionally, they will choose the setting they favor more for the speech (identified as the clearest, most natural, and least distorted) and the setting they favor for the noise (deemed the most comfortable, least annoying, and softest). To indicate their preference, participants will press the "1" button if the first setting was more to their liking or the "2" button if they found the second setting superior. Participants are permitted to revise their choice and switch their selection. They can re-listen to the sentence pairing as many times as needed. Participants will listen to 72 sentences for each combination of settings to provide sufficient power to conduct single-subject statistical analyses.

Conditions
Hearing Loss
Being tested
Sudden Sound Reduction Setting
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sudden Sound Reduction SettingDevice

    Each participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to Low, High, or Maximum. Recordings with the different settings will be randomized from trial to trial.

Study groups in NCT06340919
Study groupRoleWhat they receive
ControlNo interventionEach participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to OFF.
Low Sudden Sound ReductionExperimentalEach participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to Low.
Receives: Device: Sudden Sound Reduction Setting
High Sudden Sound ReductionExperimentalEach participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to High.
Receives: Device: Sudden Sound Reduction Setting
Maxiumum Sudden Sound ReductionExperimentalEach participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to Maximum.
Receives: Device: Sudden Sound Reduction Setting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speech recognition

    Number of keywords repeated from a sentence just heard

    Measured: Through study completion, on average 2 hours

  2. Recall

    Number of keywords repeated from a sentence heard previously

    Measured: Through study completion, on average 2 hours

  3. Preference

    Paired comparison, preference ratings

    Measured: Through study completion, on average 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start21 Feb 2024
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06340919
Sponsor's protocol ID
1406014978-241
Status last verified
Mar 2024
First submitted
24 Mar 2024
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Data stored as a CSV file will be shared. Individual participants' responses to each trial (audio recording) will be provided.

Questions about this trial

What is this clinical trial studying?

A study testing Sudden Sound Reduction Setting in people with Hearing Loss, run by Purdue University at 1 site in United States.

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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Results are not available in the source record.

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?

Speech recognition (time frame: Through study completion, on average 2 hours). The study lists 3 primary outcomes in all. 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 2 Apr 2024.

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