Variability In Hearing Aid Outcomes In Older Adults

Not Applicable

Completed

• Conditions: Presbycusis; Hearing Loss
• Interventions: Device: Hearing Aid Fitting A; Device: Hearing Aid Fitting B

• Registration Number: NCT02448706
• Lead Sponsor: Northwestern University

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.

Study Timeline

• Study First Submitted: 2015-05-15
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-19
• Study Start: 2015-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Results First Submitted: 2019-06-09
• Results First Submitted QC: 2020-01-10
• Results First Posted: 2020-01-14
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hearing Aid Fitting Order B	Hearing Aid Fitting B	Low level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.
Hearing Aid Fitting Order A	Hearing Aid Fitting A	High level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.
Hearing Aid Fitting Order A	Hearing Aid Fitting B	High level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.
Hearing Aid Fitting Order B	Hearing Aid Fitting A	Low level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Speech Intelligibility Score	6 weeks	Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words.

Secondary Outcome Measures

Name	Time	Method
Speech and Spatial Qualities of Hearing (SSQ) Questionnaire	6 weeks	Listener rates her/his perceived ability. Each question describes a different situation, such as listening to one talker in quiet. Test is scored from 0 to 10, with 10 = best score.
Effectiveness of Aural Rehabilitation (EAR)	6 weeks	The listener rates the extent to which hearing has improved with the hearing aid (0=least improved, 100=most improved).
Adherence	6 weeks	Average number of hours per day the hearing aid was worn.

Trial Locations

Locations (1)

University of Colorado at Boulder; 🇺🇸 Boulder, Colorado, United States