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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06249685
Other study ID # PRO-FY2020-252
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date June 1, 2022

Study information

Verified date January 2024
Source University of Memphis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: - Bilateral, uncomplicated, adult-onset mild-to-moderate hearing loss. - No previous experience with hearing aids - Fluent English speakers - Have adequate literacy and cognitive competence to complete informed consent and required questionnaires with minimal assistance. - Able to transport themselves to the data collection site and participate in the study without assistance from researchers. Exclusion Criteria: - History of otologic surgery or chronic middle or outer ear pathology - Evidence of retrocochlear involvement - Known psychiatric or neurologic disorder.

Study Design


Intervention

Device:
Bilateral hearing devices
Three week trial while wearing bilateral hearing devices.

Locations

Country Name City State
United States University of Memphis Memphis Tennessee

Sponsors (1)

Lead Sponsor Collaborator
University of Memphis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported arousal Arousal rating measured with the Self-assessment manikin (SAM) Measured several times per day for 6 days in each arm of the study (ecological momentary assessment); and at a lab appointment on day 7; day 28; and day 35 of the trial.
Primary Self-reported valence Valence rating measured with the Self-assessment manikin (SAM) Measured several times per day for 6 days in each arm of the study (ecological momentary assessment) and at a lab appointment on day 7; day 28; and day 35 of the trial.
Secondary Self-reported task-load Task-load rating measured with the NASA-TLX Measured several times per day for 6 days in each arm of the study (ecological momentary assessment) and at a lab appointment on day 7; day 28; and day 35 of the trial.
Secondary Physiological arousal - heart rate Heartbeats per minute easured several times per day for 6 days in each arm of the study (ecological momentary assessment) and at a lab appointment on day 7; day 28; and day 35 of the trial.
Secondary Physiological arousal - respiration activity Breaths per minute easured several times per day for 6 days in each arm of the study (ecological momentary assessment) and at a lab appointment on day 7; day 28; and day 35 of the trial.
Secondary Physiological arousal - electrodermal responses Skin conductance in response to emotionally evocative sounds (International Affective Digital Sounds) at soft, average, loud levels Day 7; day 28; and day 35 of the trial.
Secondary Physiological valence - electromyography Facial sEMG in response to emotionally evocative sounds (International Affective Digital Sounds) at soft, average, loud levels Day 7; day 28; and day 35 of the trial.
Secondary Emotion identification - Toronto Emotional Speech Set Percent correct identification of emotion contained in auditory stimuli at soft, average, loud levels Day 7; day 28; and day 35 of the trial.
Secondary Word recognition - Toronto Emotional Speech Set Percent correctly identified single word auditory stimuli at soft, average, loud levels Day 7; day 28; and day 35 of the trial.
Secondary Abbreviated Profile of Hearing Aid Benefit (APHAB) Validated questionnaire that assesses frequency of problems with speech communication and aversiveness of sounds in daily listening Day 7; day 28; and day 35 of the trial.
Secondary Hearing Handicap Inventory for Elderly-Screening version (HHIE-S) Validated questionnaire that measures the effects of hearing impairment on emotional and social adjustment Day 7; day 28; and day 35 of the trial.
Secondary Emotional Communication in Hearing Questionnaire (EMO-CHeQ) Validated questionnaire that assesses benefits of hearing aids in addressing emotional communication. Day 7; day 28; and day 35 of the trial.
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