Comprehensive Wide Bandwidth Test Battery of Auditory Function in Veterans (CWTBAFV)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
Boys Town National Research Hospital
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02019888
First received: December 18, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Comprehensive Wide Bandwidth Test Battery of Auditory Function in Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Middle ear test [ Time Frame: Assessed at time of enrollment ] [ Designated as safety issue: No ]
    The standard clinical middle ear test, 226 Hz tympanometry, and the experimental wideband middle ear tests of absorbance and admittance.


Secondary Outcome Measures:
  • Middle ear muscle reflex test [ Time Frame: Assessed at time of enrollment ] [ Designated as safety issue: No ]
    The standard clinical middle ear muscle reflex test assessed with 226 Hz admittance changes, and the experimental wideband middle ear muscle reflex test assessed with wideband admittance and absorbance changes.

  • Wideband otoacoustic emission test [ Time Frame: Assessed at time of enrollment ] [ Designated as safety issue: No ]
    An otoacoustic emission test assessed using a transient wideband stimulus from 1000 to 8000 Hz.


Estimated Enrollment: 640
Study Start Date: August 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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 dBHL
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 79 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Draining ear
  • Sensory neural hearing loss greater than 55 dB HL
  • Cerumen impaction of ear canal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019888

Contacts
Contact: M. P Feeney, PhD (503) 273-5306 Patrick.Feeney@va.gov

Locations
United States, Oregon
Portland VA Medical Center, Portland, OR Not yet recruiting
Portland, Oregon, United States, 97239
Contact: M. P Feeney, PhD    (503) 273-5306    Patrick.Feeney@va.gov   
Principal Investigator: M. Patrick Feeney, PhD         
United States, Tennessee
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN Not yet recruiting
Mountain Home, Tennessee, United States, 37684
Contact: Kim S Schairer, PhD    423-926-1171 ext 7138    Kim.Schairer@va.gov   
Sponsors and Collaborators
Boys Town National Research Hospital
Investigators
Principal Investigator: M. Patrick Feeney, PhD Portland VA Medical Center, Portland, OR
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02019888     History of Changes
Other Study ID Numbers: C1268-R, C1268-R
Study First Received: December 18, 2013
Last Updated: May 21, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Ear, Middle
Ear, Inner
Audiometry
Acoustic impedance tests

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Conductive
Hearing Loss, Sensorineural
Hearing Loss, Mixed Conductive-Sensorineural
Cholesteatoma
Otitis
Otitis Media
Otitis Media with Effusion
Otosclerosis
Tympanic Membrane Perforation
Keratosis
Skin Diseases
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Wounds and Injuries

ClinicalTrials.gov processed this record on July 26, 2014