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临床试验/NCT06340919
NCT06340919Unknown不适用

Hearing Aid Algorithms for Sudden Sounds

Purdue University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Speech recognition

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •Retrocochlear hearing loss

研究组 & 干预措施

Control

No Intervention

Each participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to OFF.

Low Sudden Sound Reduction

Experimental

Each participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to Low.

干预措施: Sudden Sound Reduction Setting (Device)

High Sudden Sound Reduction

Experimental

Each participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to High.

干预措施: Sudden Sound Reduction Setting (Device)

Maxiumum Sudden Sound Reduction

Experimental

Each participant will listen to recordings of sentences processed by a hearing aid with settings for treating sudden sounds set to Maximum.

干预措施: Sudden Sound Reduction Setting (Device)

结局指标

主要结局

Speech recognition

时间窗: Through study completion, on average 2 hours

Number of keywords repeated from a sentence just heard

Recall

时间窗: Through study completion, on average 2 hours

Number of keywords repeated from a sentence heard previously

Preference

时间窗: Through study completion, on average 2 hours

Paired comparison, preference ratings

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AlexanderLab

Associate Professor

Purdue University

研究点 (1)

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