Wide Frequency Band Test of Hearing in Veterans

NCT02019888 | Completed Results

• 1 other identifier: C1268-R
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 2

Brief Summary

The accurate assessment of auditory status is critical for planning treatment for Veterans with hearing loss to include medical and audiological management. Current physiologic tests of auditory function in the standard clinical audiological test battery for Veterans have limited sensitivity in detecting some middle-ear disorders, and do not include a direct test of cochlear function. Recent studies have shown promise for new wide-bandwidth (WB) tests of absorbance for improved sensitivity in the assessment of middle-ear function including acoustic reflex testing. The addition of WB tests of cochlear function included in the WB test battery provides an opportunity to improve audiological diagnosis of a range of hearing disorders in Veterans. The automation provided by the WB test battery could provide additional benefits in reducing the duration of the evaluation, leaving more time for evaluation of test findings and counseling. Results from this study may lead to the improvement of audiological care for Veterans with hearing loss.

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural; Otosclerosis; Tympanic Membrane Perforation; Otitis Media With Effusion; Cholesteatoma

Keywords

Ear, Middle; Ear, Inner; Audiometry; Acoustic impedance tests

Outcome Measures

Primary Outcomes (1)

• Experimental Middle Ear Test: Ambient Wideband Absorbance

  Ambient Wideband Absorbance is the experimental middle ear test. Results were compared to the Secondary Outcome Measure of Clinical Peak Static Acoustic Admittance. Wideband absorbance was averaged across frequencies from 250 to 8000 Hz on a ratio scale from 0 to 1. In general, higher absorbance is indicative of a better outcome (i.e., better middle ear function).

  Assessed at the time of enrollment during one 2.5- to 3-hour visit.

Secondary Outcomes (3)

• Middle Ear Muscle Reflex Test

  Assessed at the time of enrollment during one 2.5- to 3-hour visit.

• Wideband Otoacoustic Emission Test

  Assessed at the time of enrollment during one 2.5- to 3-hour visit.

• Clinical Middle Ear Test: Peak Static Acoustic Admittance

  Assessed at the time of enrollment during one 2.5- to 3-hour visit.

Study Arms (3)

Normal hearing adults

Adults between 20 and 79 years old with hearing at all audiometric frequencies between 250 and 8000 Hz at less than or equal to 25 dB HL

Adults with sensory neural hearing loss

Adults between 20 and 79 years old with sensory neural hearing at one or more audiometric frequencies between 250 and 8000 Hz.

Adults with middle ear disorders

Adults between 20 and 89 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans will be recruited for this study who have had a hearing evaluation from the VA Audiology Service at the Portland VA Medical Center and the H. Quillen VA Medical Center. We may also recruit from approved subject registries at each study site, and from those who respond to approved fliers posted at the each site.

You may qualify if:

• Adults with normal hearing
• Veteran status
• Age between 20 and 79 years
• All puretone thresholds at 25 dB HL or lower
• Adults with sensory neural hearing loss
• Veteran status
• Age between 20 and 79 years
• Average hearing thresholds between 26 and 55 dB HL
• Adults with middle ear disorders
• Veteran status
• Adult between 20 and 89 years
• Diagnosis of middle ear disorder

You may not qualify if:

• Draining ear
• Sensory neural hearing loss greater than 55 dB HL
• Cerumen impaction of ear canal

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Father Flanagan's Boys' Home: collaborator

Study Sites (2)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN

Mountain Home, Tennessee, 37684, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural; Otosclerosis; Tympanic Membrane Perforation; Otitis Media with Effusion; Cholesteatoma

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Otitis Media; Otitis; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: M. Patrick Feeney
• Organization: NCRAR

Patrick.Feeney@va.gov

503-273-5306

Study Officials

• M. Patrick Feeney, PhD

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: December 24, 2013
• Study Start: December 1, 2014
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)