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Clinical Trial Summary

The proposed field trial will clarify the real-world effectiveness of HAs in remediating deficits in emotion processing for older adults with mild-to-moderate hearing loss. This study will employ a repeated reversal design to establish baseline affective state without HAs, when wearing amplification, and after HAs are removed. This study will triangulate self-report, behavioral, and physiological measures to capture nuances of emotional processing in the laboratory and in daily listening. Naturalistic stimuli will be used as it occurs in daily life to elicit emotional experiences, and ecological momentary assessment and commercially-available wearable sensors will be used to track changes in emotional state in daily listening. Anchoring real-world emotional experiences with controlled laboratory experiences will validate wearable sensors. Additionally, laboratory emotional stimuli will be related to real-world emotional experiences to establish the utility of laboratory stimuli in future studies. It is likely that benefits in emotional processing will have differential effects based on individual characteristics (such as degree of hearing loss, age, gender, cognitive ability, and personality), so participants will be analyzed according to larger groupings based on individual differences.


Clinical Trial Description

Thirty-five participants will complete preliminary measures, including assessments of routine audiometrics, demographics, personality, and working memory. For each arm of the trial (baseline-unaided; aided; follow-up unaided) participants will be issued sensors to use while pursuing normal daily life activities. These sensors can provide information such as heart rate (HR) and respiration activity, which have been associated with the arousal dimension of emotion. Participants also will download a mobile app that will automatically prompt them throughout their day to indicate their perceived arousal and valence and listening-related workload. For each arm of the trial interindividual and intraindividual emotion perception, speech understanding, and perceived workload will be also be assessed using laboratory-based self-report, behavioral, and physiological measures. Subjective measures of hearing aid benefit, emotional consequences of hearing loss, and the effect of hearing loss on emotional communication will be assessed through validated questionnaires at the conclusion of each arm of the trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06249685
Study type Interventional
Source University of Memphis
Contact
Status Completed
Phase N/A
Start date July 1, 2020
Completion date June 1, 2022

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