NCT00371449

Brief Summary

The primary complaint of individuals with hearing loss is difficulty understanding speech in the presence of background noise. Although hearing aids help individuals understand speech in background noise better, there is a high rate of hearing aid rejection in part due to continued difficulty understanding speech in complex listening situations. The results of this study may demonstrate that speech-in-noise test results can be a predictor of hearing aid success. The results of this study also may lead to further studies that can evaluate interventions to improve hearing aid success for individuals who are identified as unsuccessful hearing aid users.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2006

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

April 2, 2015

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

September 1, 2006

Results QC Date

February 18, 2015

Last Update Submit

April 8, 2015

Conditions

Hearing LossPresbycusis

Keywords

hearing losshearing aids

Outcome Measures

Primary Outcomes (1)

  • Words-in-noise Test

    The WIN consists of two lists of 35 Northwestern University Auditory Test No. 6 words (NU-6; Tillman and Carhart, 1966) presented in a 6-talker babble at 7 SNRs ranging from 24- to 0-dB in 4-dB decrements. Thus for each list, five unique words spoken by a female talker are presented at each SNR with the level of the babble fixed (Department of Veterans Affairs, 2006). The SNR at which the 50% point occurs is calculated with the Spearman-Kärber equation (Finney, 1952). Normal performance on the WIN is between 0 and 6-dB S/N.

    aided (after wearing hearing aids for at least 3 months)

Secondary Outcomes (5)

  • Acceptable Noise Level Test

    aided (after wearing hearing aids for at least 3 months)

  • International Outcomes Inventory for Hearing Aids (IOI-HA)

    aided (after wearing hearing aids for at least 3 months)

  • Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)

    aided (after wearing hearing aids for at least 3 months)

  • Satisfaction With Amplification in Daily Life (SADL)

    aided (after wearing hearing aids for at least 3 months)

  • Speech Spatial and Qualities of Hearing Scale (SSQ)

    aided (after wearing hearing aids for at least 3 months)

Study Arms (1)

hearing aid users

hearing aid users

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults with sensorineural hearing loss

You may qualify if:

  • adult onset of hearing loss,
  • symmetrical, sensorineural hearing loss,
  • no more than 60 dB HL hearing loss measured via an average of air conduction thresholds at .5, 1, and 2 kHz in each ear, and
  • use of binaural hearing aids of the same make and model for each ear
  • at least 3 months of hearing aid use.

You may not qualify if:

  • enrollment in group audiologic rehabilitation classes,
  • currently using an FM system,
  • inability to read and write American English, and
  • signs of middle ear or retrocochlear pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James H. Quillen VA Medical Center

Mountain Home, Tennessee, 37684, United States

Location

MeSH Terms

Conditions

Hearing LossPresbycusis

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHearing Loss, Sensorineural

Results Point of Contact

Title
Sherri L. Smith
Organization
Mountain Home VA Medical Center
sherri.smith@va.gov
423.926.1171

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2006

First Posted

September 4, 2006

Study Start

November 1, 2006

Primary Completion

October 1, 2008

Study Completion

June 1, 2009

Last Updated

April 29, 2015

Results First Posted

April 2, 2015

Record last verified: 2015-04

Locations

US(1)