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

NCT ID: NCT06249685

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-06-01

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.

Conditions

Hearing Loss; Hearing Loss, Sensorineural; Emotions; Stress Physiology

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Baseline-Unaided

No hearing aids.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Aided

Fitted with bilateral hearing devices.

Group Type: EXPERIMENTAL

Bilateral hearing devices

Intervention Type: DEVICE

Three week trial while wearing bilateral hearing devices.

Follow-up-Unaided

No hearing aids.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bilateral hearing devices

Three week trial while wearing bilateral hearing devices.

Intervention Type: DEVICE

Other Intervention Names

Hearing aid; Hearing aids; Receiver-in-the-canal; RIC

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Memphis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jani A Johnson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Memphis

Locations

University of Memphis

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

PRO-FY2020-252

Identifier Type: -

Identifier Source: org_study_id