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Completed

NCT Number: NCT06249685

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.

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Key information

Conditions

Hearing Loss Ear Diseases Emotions Hearing Disorders Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Stress Physiology

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Memphis

Memphis, Tennessee, 38152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bilateral hearing devices

Device

Three week trial while wearing bilateral hearing devices.

Other names: Hearing aid, Hearing aids, Receiver-in-the-canal, RIC

Primary outcomes

  1. Self-reported arousal

    Time frame: 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.

    Arousal rating measured with the Self-assessment manikin (SAM)

  2. Self-reported valence

    Time frame: 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.

    Valence rating measured with the Self-assessment manikin (SAM)

Secondary outcomes

  1. Self-reported task-load

    Time frame: 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.

    Task-load rating measured with the NASA-TLX

  2. Physiological arousal - heart rate

    Time frame: 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.

    Heartbeats per minute

  3. Physiological arousal - respiration activity

    Time frame: 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.

    Breaths per minute

  4. Physiological arousal - electrodermal responses

    Time frame: Day 7; day 28; and day 35 of the trial.

    Skin conductance in response to emotionally evocative sounds (International Affective Digital Sounds) at soft, average, loud levels

  5. Physiological valence - electromyography

    Time frame: Day 7; day 28; and day 35 of the trial.

    Facial sEMG in response to emotionally evocative sounds (International Affective Digital Sounds) at soft, average, loud levels

  6. Emotion identification - Toronto Emotional Speech Set

    Time frame: Day 7; day 28; and day 35 of the trial.

    Percent correct identification of emotion contained in auditory stimuli at soft, average, loud levels

  7. Word recognition - Toronto Emotional Speech Set

    Time frame: Day 7; day 28; and day 35 of the trial.

    Percent correctly identified single word auditory stimuli at soft, average, loud levels

  8. Abbreviated Profile of Hearing Aid Benefit (APHAB)

    Time frame: Day 7; day 28; and day 35 of the trial.

    Validated questionnaire that assesses frequency of problems with speech communication and aversiveness of sounds in daily listening

  9. Hearing Handicap Inventory for Elderly-Screening version (HHIE-S)

    Time frame: Day 7; day 28; and day 35 of the trial.

    Validated questionnaire that measures the effects of hearing impairment on emotional and social adjustment

  10. Emotional Communication in Hearing Questionnaire (EMO-CHeQ)

    Time frame: Day 7; day 28; and day 35 of the trial.

    Validated questionnaire that assesses benefits of hearing aids in addressing emotional communication.

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2024
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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