- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05260307
Poprawa percepcji przestrzennej i rozumienia mowy w mieszankach Multitalker
The purpose of this study is to investigate several approaches for improving spatial perception and speech intelligibility in multitalker listening situations for hearing-aid users. The hypotheses are that spatial perception and speech intelligibility will be improved by (1) increased high-frequency audibility, (2) speech envelope enhancement, and/or (3) appropriate sound image externalization.
Przegląd badań
Szczegółowy opis
The purpose of this study is to investigate several approaches for improving spatial perception and speech intelligibility in multitalker listening situations for hearing-aid users. Aim 1 will investigate how well different amplification strategies provide access to the spectrotemporally sparse speech information that is available in multitalker mixtures. The hypothesis is that subtle differences in high-frequency audibility across different strategies may have much greater effects on the intelligibility of sparse speech than intact speech. This Aim will involve 40 subjects with hearing loss across 2 experiments. Aim 2 is an exploratory aim that will investigate the potential of a speech enhancement algorithm to improve spatial hearing in multitalker mixtures. The hypothesis is that speech enhancement, in addition to its established monaural benefits, will enhance the salience of interaural time differences and thus provide binaural benefits in multitalker mixtures. This Aim will involve 30 subjects with normal hearing and 60 subjects with hearing loss across 3 experiments. Aim 3 will investigate how different hearing-aid styles affect sound externalization. The hypothesis is that hearing aids can disrupt sound externalization, which in turn impacts speech intelligibility in multitalker mixtures. This Aim will involve 30 subjects with normal hearing and 60 subjects with hearing loss across 3 experiments.
This is a prospective design involving adult human subjects. While the investigators will recruit subjects with normal and impaired hearing, all subjects will be assigned to the same set of experimental conditions. Therefore, for the purposes of intervention (or prospective assignment), the subjects can be treated as a single group completing the same intervention (or set of interventions). The behavioral experiments involve listening to speech sounds (either unaided, with hearing aids, or with simulated hearing aids), and providing responses related to spatial perception or speech intelligibility. The order of experimental conditions will be randomized for each subject in order to control for order effects. All of the experimental tasks and outcome measures have been previously established, have good reliability and validity, and will be appropriate for informing future studies.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Virginia A Best, PhD
- Numer telefonu: (617) 353-2622
- E-mail: ginbest@bu.edu
Kopia zapasowa kontaktu do badania
- Nazwa: Christine Mason
- Numer telefonu: cmason@bu.edu
- E-mail: cmason@bu.edu
Lokalizacje studiów
-
-
Massachusetts
-
Boston, Massachusetts, Stany Zjednoczone, 02215
- Rekrutacyjny
- Boston University
-
Kontakt:
- Virginia Best
- Numer telefonu: 617-353-2622
- E-mail: ginbest@bu.edu
-
Główny śledczy:
- Virginia A Best, PhD
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria: Normal-Hearing Subjects
- 18 to 35 years of age
- Audiometric thresholds that do not exceed 20 dB HL at any frequency from 250 to 8000 Hz
- Able to provide informed consent and understand experimental instructions
- Normal or corrected-to-normal vision
Inclusion Criteria: Hearing-Impaired Subjects
- 18 to 80 years of age
- Documented sensorineural hearing loss
- Able to provide informed consent and understand experimental instructions
- Normal or corrected-to-normal vision
Exclusion Criteria (some experiments)
- Non-native speakers of English
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Inny: Experimental condition
Participants will be presented with sound stimuli under a number of experimental conditions that simulate different hearing-aid conditions. |
The intervention will be a hearing aid or a modification to the sound stimulus that simulates a hearing aid configuration, style, or processing strategy. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Speech intelligibility at baseline
Ramy czasowe: Baseline
|
Speech intelligibility scores will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in percent correct (0-100%). |
Baseline
|
|
Speech intelligibility post-intervention
Ramy czasowe: Up to 4 hours
|
Speech intelligibility scores will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in percent correct (0-100%). |
Up to 4 hours
|
|
Speech reception threshold at baseline
Ramy czasowe: Baseline
|
Speech reception thresholds will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in decibels (the level of the target speech relative to the masker speech needed to identify 50% of the words in a sentence). |
Baseline
|
|
Speech reception threshold post-intervention
Ramy czasowe: Up to 4 hours
|
Speech reception thresholds will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in decibels (the level of the target speech relative to the masker speech needed to identify 50% of the words in a sentence). |
Up to 4 hours
|
|
Interaural time difference discrimination at baseline
Ramy czasowe: Baseline
|
Thresholds for the discrimination of interaural time differences in speech will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in microseconds. |
Baseline
|
|
Interaural time difference discrimination post-intervention
Ramy czasowe: Up to 4 hours
|
Thresholds for the discrimination of interaural time differences in speech will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in microseconds. |
Up to 4 hours
|
|
Externalization rating at baseline
Ramy czasowe: Baseline
|
Externalization judgments for speech will be measured in a baseline condition (e.g. unaided) and in a number of different hearing-aid conditions (post-intervention). Scale is in percent (0-100%). |
Baseline
|
|
Externalization rating post-intervention
Ramy czasowe: Up to 4 hours
|
Externalization judgments for speech will be measured in a baseline condition (e.g. unaided) and in a number of different hearing-aid conditions (post-intervention). Scale is in percent (0-100%). |
Up to 4 hours
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Virginia A Best, PhD, Boston University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 4218E
- R01DC015760 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Individual participant data that underlie results in a publication will be made publicly available.
Ramy czasowe udostępniania IPD
The data will be made available at the time of the relevant publication.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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