Hearing LossNCT06249685
Does Wearing Hearing Aids Impact the Affective State of Older Adults With Hearing Loss in Their Daily Lives?
A study testing Bilateral hearing devices in people with Hearing Loss and Hearing Loss, Sensorineural, run by University of Memphis at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Hearing Loss, Hearing Loss, Sensorineural, Emotions
- What is being tested?
- Bilateral hearing devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of otologic surgery or chronic middle or outer ear pathology
- Evidence of retrocochlear involvement
- Known psychiatric or neurologic disorder.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Bilateral hearing devices
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral hearing devicesDevice
Also called Hearing aid, Hearing aids, Receiver-in-the-canal, RIC
Three week trial while wearing bilateral hearing devices.
| Study group | Role | What they receive |
|---|---|---|
| Baseline-Unaided | No intervention | No hearing aids. |
| Aided | Experimental | Fitted with bilateral hearing devices. Receives: Device: Bilateral hearing devices |
| Follow-up-Unaided | No intervention | No hearing aids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported arousal
Arousal rating measured with the Self-assessment manikin (SAM)
Measured: 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: 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
Task-load rating measured with the NASA-TLX
Measured: 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
Heartbeats per minute
Measured: 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
Breaths per minute
Measured: 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
Skin conductance in response to emotionally evocative sounds (International Affective Digital Sounds) at soft, average, loud levels
Measured: Day 7; day 28; and day 35 of the trial.
Physiological valence - electromyography
Facial sEMG in response to emotionally evocative sounds (International Affective Digital Sounds) at soft, average, loud levels
Measured: Day 7; day 28; and day 35 of the trial.
Emotion identification - Toronto Emotional Speech Set
Percent correct identification of emotion contained in auditory stimuli at soft, average, loud levels
Measured: Day 7; day 28; and day 35 of the trial.
Word recognition - Toronto Emotional Speech Set
Percent correctly identified single word auditory stimuli at soft, average, loud levels
Measured: Day 7; day 28; and day 35 of the trial.
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Validated questionnaire that assesses frequency of problems with speech communication and aversiveness of sounds in daily listening
Measured: Day 7; day 28; and day 35 of the trial.
Hearing Handicap Inventory for Elderly-Screening version (HHIE-S)
Validated questionnaire that measures the effects of hearing impairment on emotional and social adjustment
Measured: Day 7; day 28; and day 35 of the trial.
Emotional Communication in Hearing Questionnaire (EMO-CHeQ)
Validated questionnaire that assesses benefits of hearing aids in addressing emotional communication.
Measured: Day 7; day 28; and day 35 of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Jul 2020
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- ABA Repeated Reversal design
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Memphis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jani A Johnson, PhD, Principal investigator, University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249685
- Sponsor's protocol ID
- PRO-FY2020-252
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Wearing Hearing Aids Impact the Affective State of Older Adults With Hearing Loss in Their Daily Lives?
- ClinicalTrials.gov ID
- NCT06249685
- Acronym / sponsor ID
- PRO-FY2020-252
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural, Emotions, Stress Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of MemphisUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- ABA Repeated Reversal design
| Arm | Type | Receives |
|---|---|---|
| Baseline-Unaided | No intervention | –No hearing aids. |
| Aided | Experimental | Device: Bilateral hearing devicesFitted with bilateral hearing devices. |
| Follow-up-Unaided | No intervention | –No hearing aids. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- History of otologic surgery or chronic middle or outer ear pathology
- Evidence of retrocochlear involvement
- Known psychiatric or neurologic disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral hearing devicesAlso: Hearing aid, Hearing aids, Receiver-in-the-canal, RICThree week trial while wearing bilateral hearing devices. | Device | Aided |
Primary outcome
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)
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)
10 secondary outcomes
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.
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.
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.
Physiological arousal - electrodermal responses
Time frame: Day 7; day 28; and day 35 of the trial.
Physiological valence - electromyography
Time frame: Day 7; day 28; and day 35 of the trial.
Emotion identification - Toronto Emotional Speech Set
Time frame: Day 7; day 28; and day 35 of the trial.
Word recognition - Toronto Emotional Speech Set
Time frame: Day 7; day 28; and day 35 of the trial.
Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time frame: Day 7; day 28; and day 35 of the trial.
Hearing Handicap Inventory for Elderly-Screening version (HHIE-S)
Time frame: Day 7; day 28; and day 35 of the trial.
Emotional Communication in Hearing Questionnaire (EMO-CHeQ)
Time frame: Day 7; day 28; and day 35 of the trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jani A Johnson, PhD principal investigator
University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral hearing devices in people with Hearing Loss and Hearing Loss, Sensorineural, run by University of Memphis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.