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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Hearing Loss, Sensorineural; Emotions; Stress Physiology
• Intervention / Treatment: Device: Bilateral hearing devices

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38152
      • University of Memphis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline-Unaided; No hearing aids.
Experimental: Aided; Fitted with bilateral hearing devices.	Device: Bilateral hearing devices; Three week trial while wearing bilateral hearing devices.; Other Names: RIC; Hearing aid; Hearing aids; Receiver-in-the-canal
No Intervention: Follow-up-Unaided; No hearing aids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Memphis
• Investigators: Principal Investigator: Jani A Johnson, PhD, University of Memphis

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 31, 2024
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: PRO-FY2020-252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes