Variability In Hearing Aid Outcomes In Older Adults
Characterizing Variability in Hearing Aid Outcomes Among Older Adults
1 other identifier
interventional
49
1 country
1
Brief Summary
The goal of this project is to find out if the way a hearing aid processes a sound signal should be determined in part by an individual's cognitive characteristics. We anticipate that the outcome of this work will be a battery of assessments that will guide hearing aid processing for older patients with hearing loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
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
May 15, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedResults Posted
Study results publicly available
January 14, 2020
CompletedNovember 17, 2020
October 1, 2020
2 years
May 15, 2015
June 9, 2019
October 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Speech Intelligibility Score
Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words.
6 weeks
Secondary Outcomes (3)
Effectiveness of Aural Rehabilitation (EAR)
6 weeks
Speech and Spatial Qualities of Hearing (SSQ) Questionnaire
6 weeks
Adherence
6 weeks
Study Arms (2)
Hearing Aid Fitting Order A
ACTIVE COMPARATORHigh level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.
Hearing Aid Fitting Order B
ACTIVE COMPARATORLow level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL
- Non hearing aided wearer within the previous year
- Participants will be in good health (self-report)
- Normal or corrected to normal vision(≤20/50)
You may not qualify if:
- Conductive, or asymmetric hearing loss
- Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
- Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
- Significant history of otologic or neurologic disorders
- Non English speaking participants
- Score of 23 or below on Mini-Mental Status Exam (MMSE)
- Score of 22 or below on Montreal Cognitive Assessment (MoCA)
- Any clinically significant unstable or progressive medical condition
- Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.
- Participants will be divided into low and high working groups based upon the results of their Lunner working memory reading span test. Once either high or low working memory group is filled (approximately 25 participants) we will selectively enroll participants to fill the other category.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado at Boulder
Boulder, Colorado, 80309, United States
Related Publications (1)
Anderson M, Rallapalli V, Schoof T, Souza P, Arehart K. The use of self-report measures to examine changes in perception in response to fittings using different signal processing parameters. Int J Audiol. 2018 Nov;57(11):809-815. doi: 10.1080/14992027.2018.1490035. Epub 2018 Jul 27.
PMID: 30052097DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pamela Souza
- Organization
- Northwestern University
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela E Souza, PhD
Northwestern University
- PRINCIPAL INVESTIGATOR
Kathryn H Arehart, PhD
University of Colorado at Boulder
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor School of Communication
Study Record Dates
First Submitted
May 15, 2015
First Posted
May 19, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
November 17, 2020
Results First Posted
January 14, 2020
Record last verified: 2020-10