Clinical trial NCT02448706: Variability In Hearing Aid Outcomes In Older Adults
Official title: Characterizing Variability in Hearing Aid Outcomes Among Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Presbycusis
Keywords: hearing aid
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2015-05-19
Enrollment: 49
Sex: ALL
Minimum age (years): 54
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Response to hearing aids is highly variable, with some individuals reporting much more benefit than others. Preliminary work by our laboratory and others suggests that patient factors-including cognition-may contribute to differences in how individuals respond to altered speech cues, such as those alterations introduced by hearing aid processing. The long-term goal of this work is to improve hearing aid outcomes by optimizing hearing aid processing for each individual.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Speech Intelligibility Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Effectiveness of Aural Rehabilitation (EAR)
timeFrame: 6 weeks
measure: Speech and Spatial Qualities of Hearing (SSQ) Questionnaire
timeFrame: 6 weeks
measure: Adherence
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado at Boulder
state: Colorado
Study officials:
affiliation: Northwestern University
name: Pamela E Souza, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado at Boulder
name: Kathryn H Arehart, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.