NCT00261768

Brief Summary

The purpose of this study is to see if noise reduction programs in digital hearing aids help patients hear better than hearing aids without these programs. We also want to know if we can predict how successful patients will be with hearing aids.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2004

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

June 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 23, 2010

Status Verified

March 1, 2010

Enrollment Period

2.5 years

First QC Date

December 1, 2005

Last Update Submit

March 19, 2010

Conditions

Sensorineural Hearing Loss

Keywords

Aginghearing aidshearing loss, sensorineuralspeech recognition

Outcome Measures

Primary Outcomes (1)

  • Words in Noise Test

    2 months

Study Arms (1)

1

EXPERIMENTAL

Noise reduction on

Behavioral: Digital noise reduction

Interventions

Digital noise reductionBEHAVIORAL
1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult onset sensorineural hearing loss
  • English as the first language
  • bilateral symmetrical sensorineural hearing loss
  • Patient is a candidate for directional microphone technology.
  • average audiometric thresholds for 500, 1000, 2000, 3000, and 4000 Hz no better than 25-dB HL in either ear.
  • no history of hearing aid use in the past 10 years
  • appropriate cognitive skills to participate in the study as determined by a passing score on the Mini Mental Scale.
  • Patient has a local telephone and address.

You may not qualify if:

  • evidence of outer ear, middle ear, or retrocochlear pathology
  • any threshold from 500 to 2000 Hz exceeds 70-dB HL
  • known neurological or psychiatric disorders as determined by chart review
  • known comorbid diseases that would prevent completion of the study as determined by chart review
  • visual impairment that would interfere with reading the questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Medical Center, Bay Pines

Bay Pines, Florida, 33708, United States

Location

James H. Quillen VA Medical Center

Mountain Home, Tennessee, 37684, 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

Study Officials

  • Richard Wilson, PhD

    James H. Quillen VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

December 1, 2005

First Posted

December 5, 2005

Study Start

June 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

March 23, 2010

Record last verified: 2010-03

Locations

US(2)