NCT01867515

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 26, 2018

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

3.1 years

First QC Date

May 20, 2013

Results QC Date

September 1, 2017

Last Update Submit

April 24, 2018

Conditions

Keywords

HearingHearing Loss, sensorineuralSpeech Perception

Outcome Measures

Primary Outcomes (1)

  • Percent Correct Words Identified

    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

Study Arms (3)

Younger normally-hearing listeners

ACTIVE COMPARATOR

Participants with auditory thresholds within the normal limits. * age between 18 and 35 * individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz Acoustic distortion of speech

Other: Acoustic distortion of speech

Hearing-impaired listeners

ACTIVE COMPARATOR

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 * age 18 to 65 Acoustic distortion of speech

Other: Acoustic distortion of speech

Older normally-hearing listeners

ACTIVE COMPARATOR

Participants with auditory thresholds within the normal limits. * age between 36 and 65 * individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz Acoustic distortion of speech

Other: Acoustic distortion of speech

Interventions

Hearing-impaired listenersOlder normally-hearing listenersYounger normally-hearing listeners

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Michelle R. Molis, PhD
Organization
VA Portland HCS, RR&D National Center for Auditory Rehabilitative Research

Study Officials

  • Michelle R Molis, PhD

    VA Portland Health Care System, Portland, OR

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2013

First Posted

June 4, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 26, 2018

Results First Posted

April 26, 2018

Record last verified: 2018-04

Locations