Clinical trial NCT06249685: Does Wearing Hearing Aids Impact the Affective State of Older Adults With Hearing Loss in Their Daily Lives?
Official title: Does Wearing Hearing Aids Impact the Affective State of Older Adults With Hearing Loss in Their Daily Lives?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Hearing Loss, Sensorineural
Emotions
Stress Physiology
Lead sponsor: University of Memphis
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: ABA Repeated Reversal design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-reported arousal
timeFrame: 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.
measure: Self-reported valence
timeFrame: 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 outcomes:
measure: Self-reported task-load
timeFrame: 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.
measure: Physiological arousal - heart rate
timeFrame: 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.
measure: Physiological arousal - respiration activity
timeFrame: 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.
measure: Physiological arousal - electrodermal responses
timeFrame: Day 7; day 28; and day 35 of the trial.
measure: Physiological valence - electromyography
timeFrame: Day 7; day 28; and day 35 of the trial.
measure: Emotion identification - Toronto Emotional Speech Set
timeFrame: Day 7; day 28; and day 35 of the trial.
measure: Word recognition - Toronto Emotional Speech Set
timeFrame: Day 7; day 28; and day 35 of the trial.
measure: Abbreviated Profile of Hearing Aid Benefit (APHAB)
timeFrame: Day 7; day 28; and day 35 of the trial.
measure: Hearing Handicap Inventory for Elderly-Screening version (HHIE-S)
timeFrame: Day 7; day 28; and day 35 of the trial.
measure: Emotional Communication in Hearing Questionnaire (EMO-CHeQ)
timeFrame: Day 7; day 28; and day 35 of the trial.
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Memphis
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Jani A Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: