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

NCT06249685 | Completed FDA Device

• 1 other identifier: PRO-FY2020-252
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• 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.

• 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.

• 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.

• Physiological arousal - electrodermal responses

  Day 7; day 28; and day 35 of the trial.

• Physiological valence - electromyography

  Day 7; day 28; and day 35 of the trial.

Study Arms (3)

Baseline-Unaided

NO INTERVENTION

No hearing aids.

Aided

EXPERIMENTAL

Fitted with bilateral hearing devices.

Device: Bilateral hearing devices

Follow-up-Unaided

NO INTERVENTION

No hearing aids.

Interventions

Bilateral hearing devices DEVICE

Three week trial while wearing bilateral hearing devices.

Also known as: Hearing aid, Hearing aids, Receiver-in-the-canal, RIC

Aided

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Memphis: lead

Study Sites (1)

University of Memphis

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• Jani A Johnson, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ABA Repeated Reversal design

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: July 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)