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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06249685
• Other study ID #: PRO-FY2020-252
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Deafness
• Emotions
• Hearing Loss
• Hearing Loss, Sensorineural
• Stress Physiology

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.