- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01867515
Spectral Dynamics and Speech Understanding by Hearing Impaired People
24. april 2018 opdateret af: VA Office of Research and Development
The purpose of this program of research is to understand the perception of the dynamic spectral properties of speech by hearing-impaired listeners, with the long-term goal of improving speech understanding by these individuals in adverse listening conditions.
The proposed research compares the performance of normally-hearing and hearing-impaired listeners on measures of speech understanding in the presence of different types of signal distortion and speech understanding of signals with enhanced spectral dynamics.
A computational model based on the amount of potential information available in speech will be used to quantify differences in speech intelligibility due to hearing status and stimulus characteristics.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a behavioral study of human auditory perception.
Each experiment in this study involves prospective data collection from three types of listeners.
The experimental listeners will be people with sensorineural hearing loss and the control listeners will either be subjects with normal hearing or normal-hearing listeners for whom hearing loss will be simulated through the use of a spectrally-shaped broadband noise.
The tasks of the subjects in this study involve either listening to synthesized sounds over earphones while seated comfortably in a sound-treated booth, and making responses indicating the subject's auditory perception of these sounds by touching specific areas on a touch-screen terminal; or, listening to recorded, acoustically modified syllables, words, or sentences over earphones and making responses indicating the subject's identification.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Oregon
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Portland, Oregon, Forenede Stater, 97239
- VA Portland Health Care System, Portland, OR
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz
- or, individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below
Exclusion Criteria:
- a conductive hearing impairment or other otological pathology
- hearing thresholds greater than 70 dB HL at any frequencies of 4000 Hz or below or pure-tone averages (averaged across 500, 1000, and 2000 Hz) of greater than 65 dB HL
- bilateral differences greater than 20 dB at any frequency below 4000 Hz
- an inability to complete the experimental tasks
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Younger normally-hearing listeners
Participants with auditory thresholds within the normal limits.
|
|
|
Aktiv komparator: Hearing-impaired listeners
individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below
|
|
|
Aktiv komparator: Older normally-hearing listeners
Participants with auditory thresholds within the normal limits.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent Correct Words Identified
Tidsramme: average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apart
|
The experimental approach compares speech identification performance among younger, normally-hearing listeners, older normally-hearing listeners and hearing-impaired listeners.
Tasks will be carried out in quiet and in the presence of continuous, speech-shaped background noise.
The investigators compared the understanding of unprocessed stimuli with 1) time-compressed stimuli, 2) time-compressed stimuli expanded in time via gaps and 3) uncompressed stimuli where portions of the signal were replaced with silence.
Experimental metrics were percentage of correct/incorrect speech identification in each listening condition.
|
average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apart
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Michelle R Molis, PhD, VA Portland Health Care System, Portland, OR
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2013
Primær færdiggørelse (Faktiske)
1. september 2016
Studieafslutning (Faktiske)
1. september 2016
Datoer for studieregistrering
Først indsendt
20. maj 2013
Først indsendt, der opfyldte QC-kriterier
29. maj 2013
Først opslået (Skøn)
4. juni 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. april 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. april 2018
Sidst verificeret
1. april 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C1020-R
- 5I01RX001020-03 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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