Does Wearing Hearing Aids Impact the Affective State of Older Adults With Hearing Loss in Their Daily Lives?

Not Applicable

Completed

• Conditions: Stress Physiology; Hearing Loss; Hearing Loss, Sensorineural; Emotions
• Interventions: Device: Bilateral hearing devices

• Registration Number: NCT06249685
• Lead Sponsor: University of Memphis

Brief 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.

Detailed 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 Timeline

• Study Start: 2020-07-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-31
• Study First Submitted QC: 2024-01-31
• Last Update Submitted: 2024-01-31
• Study First Posted: 2024-02-08
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Read More

Exclusion Criteria

• History of otologic surgery or chronic middle or outer ear pathology
• Evidence of retrocochlear involvement
• Known psychiatric or neurologic disorder.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aided	Bilateral hearing devices	Fitted with bilateral hearing devices.

Primary Outcome Measures

Name	Time	Method
Self-reported valence	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.	Valence rating measured with the Self-assessment manikin (SAM)
Self-reported arousal	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.	Arousal rating measured with the Self-assessment manikin (SAM)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Memphis; 🇺🇸 Memphis, Tennessee, United States