Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06340919 |
| Other study ID # |
1406014978-241 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 21, 2024 |
| Est. completion date |
May 31, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Purdue University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
