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A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification

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ClinicalTrials.gov Identifier: NCT03728907
Recruitment Status : Withdrawn (We did not receive the equipment from our subcontractor in a time frame that would allow us to complete the study.)
First Posted : November 2, 2018
Last Update Posted : June 8, 2021
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Carol L Mackersie, San Diego State University

Tracking Information
First Submitted Date  ICMJE October 31, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date June 8, 2021
Estimated Study Start Date  ICMJE August 1, 2021
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
Real-ear aided output [ Time Frame: two weeks ]
aided output (in dB SPL) measured across frequencies in the ears of the participants
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • Device Oriented Scale of Improvement (DOSO) [ Time Frame: two weeks ]
    Questionnaire (25 items) to assess benefit from hearing aids on a 7 pt scale; a larger number is associated with better outcome
  • Computerized Assisted Speech Perception Assessment (CASPA) [ Time Frame: two weeks ]
    Speech recognition test; phoneme recognition score as percentage correct
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification
Official Title  ICMJE A Comparison of User-adjusted and Audiologist-adjusted Hearing Amplification
Brief Summary Fifty adults with mild to moderately severe sensorineural hearing loss will be fit with hearing amplification using two adjustment techniques. For the "audiologist fitting" technique, a licensed audiologist will adjust the hearing device using the standard of care procedures which include adjustment and verification of output to match prescribed targets (NAL-NL2) and subsequent fine tuning to optimize adjustments based on participant feedback. The second technique is "user-adjustment" of the device consisting of adjustment to overall level, high-frequency boost, and low-frequency cut by the participant while listening to speech. A cross-over design will be used in which half the participants are initially fit using the audiologist technique and the other half are initially fit using the user self-adjustment technique. Following a seven-day field trial, participants will return to the lab and the aids will be reset use the other technique. Participants will be blinded to the condition. During each seven-day field trial, users will have access to a volume control, Following the end of the two trials, participants will return to the lab for outcome assessment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Repeated-measures crossover design
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Outcomes assessors and participants will not be aware of which hearing setting (audiologist adjusted vs. self-adjusted) they are wearing
Primary Purpose: Treatment
Condition  ICMJE Hearing Loss
Intervention  ICMJE Device: Hearing aid fitting technique- audiologist or user-adjusted
See information under 'arm' description
Study Arms  ICMJE
  • Active Comparator: Audiologist-adjusted first
    This arm will complete the field trial with the audiologist-adjusted fitting first, followed by the user-adjustment fitting.
    Intervention: Device: Hearing aid fitting technique- audiologist or user-adjusted
  • Experimental: User-adjusted first
    This arm will complete the trial with the user-adjusted fitting first followed by the audiologist-adjusted fitting.
    Intervention: Device: Hearing aid fitting technique- audiologist or user-adjusted
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 3, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
50
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • bilateral hearing loss with a minimum of 40 dB HL thresholds at 2000 Hz
  • English speaking

Exclusion Criteria:

  • Score less than 21 on the MoCa (Montreal Cognitive Assessment)
  • Evidence of conductive or retrocochlear pathology
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728907
Other Study ID Numbers  ICMJE 2183099
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Carol L Mackersie, San Diego State University
Study Sponsor  ICMJE San Diego State University
Collaborators  ICMJE University of California, San Diego
Investigators  ICMJE Not Provided
PRS Account San Diego State University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP