Hearing LossP-EARLHINCT05970211
Early Age-Related Hearing Loss Investigation Pilot Study
A study testing Phonak Audeo Lumity Receiver in Canal Hearing Aid in people with Hearing Loss, run by University of South Florida at 1 site in United States.
Trial summary
The purpose of this clinical trial pilot is to obtain feasibility and pilot data necessary to inform the hearing intervention being designed for a larger R01 clinical trial that seeks to determine whether best practice hearing aid intervention impacts hearing-related outcomes in adults with hearing loss aged 55 to 75… Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Phonak Audeo Lumity Receiver in Canal Hearing Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2023to 15 Aug 2024
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 55 to 75 years old with little or no experience with hearing aids
- English or Spanish speakers
Who cannot join
- Unable to complete written questionnaires on a tablet without assistance
- Refer for cognitive screening score based on criteria using the Mini Mental State Examination
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33620
Michelle Arnold, PhD, 813-974-1262, arctlab@usf.edu
Sarah Bochat, AuD, 8139741262, arctlab@usf.edu
About this study
The purpose of this clinical trial pilot is to obtain feasibility and pilot data necessary to inform the hearing intervention being designed for a larger R01 clinical trial that seeks to determine whether best practice hearing aid intervention impacts hearing-related outcomes in adults with hearing loss aged 55 to 75 years.
Secondary purposes include: To determine what effects best practice hearing aid intervention has on physical, social, and quality of life outcomes in adults with hearing loss aged 55 to 75 years.
Read the detailed description
This is an observational pre-post intervention feasibility study. In addition to the objective finding that adults with hearing loss experience higher rates of cognitive decline, they also tend to report lesser degrees of physical activity and increased cognitive fatigue, which is the feeling of tiredness or having a lack of energy. Unfortunately, the mechanism by which hearing loss relates to physical activity and fatigue, and the effect of hearing aids as an intervention to improve these factors, is unclear. Thus, the purpose of this study is twofold: First, we will establish the feasibility of administering a best practices hearing aid intervention to a sample of adults from the target age range of 55 - 75 years old to inform the larger clinical trial; Second, we will collect pilot data to explore the relationships between hearing loss, physical activity, socialization, fatigue and hearing-related outcomes before and after hearing aid intervention.
There are no experimental or investigational devices or agents used in this study. We are providing best-practices standard of care hearing intervention including hearing aids. We are additionally tracking activity using the ActiGraph wGT3X-BT, an FDA-approved Class II medical device that tracks continuous, high resolution physical activity and sleep/wake information.
Participation involves a minimum of 6 in-office study visits. Intervention sessions occur approximately 2 weeks apart, with a final long-term outcome session occurring approximately 6-months post the baseline intervention session.
Significant others of participants are invited to join the study and contribute data related to their own quality of life and their observations of the effects of the hearing intervention on the participant.
- Conditions
- Hearing Loss
- Being tested
- Phonak Audeo Lumity Receiver in Canal Hearing Aid
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phonak Audeo Lumity Receiver in Canal Hearing AidDevice
bilateral receiver in canal hearing aids provided as part of a best practices hearing loss intervention including devices, hearing centered counseling, and self management skills training for hearing loss
| Study group | Role | What they receive |
|---|---|---|
| Hearing Intervention Group | Experimental | Adults aged 55-75 with hearing loss who have little/no prior experience with hearing aids will be enrolled in the hearing intervention group. Receives: Device: Phonak Audeo Lumity Receiver in Canal Hearing Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Physical Activity
Activity level as measured by research-grade accelerometer
Measured: 2-week measurement taken between 4- and 6- months post study enrollment
Secondary outcomes (18)
Words in Noise Test
Measures speech perception in noise performance
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
International Outcome Inventory for Comprehensive Hearing Intervention
Self-reported hearing aid benefit measure
Measured: Measured at 6-months post study enrollment
Client Oriented Scale of Improvement
Self-reported hearing aid benefit measure
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Hearing Handicap Inventory for Adults
Self-reported hearing handicap
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Center for Epidemiological Studies Depression and Hopelessness Scale
Self-reported depression
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Speech, Spatial and Qualities of Hearing Scale
Self-reported hearing difficulties
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Social Network Index
Self-reported social network information
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
UCLA Loneliness Scale
Self-reported loneliness
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
The Positive and Negative Affect Schedule
Self-reported positive and negative affect/mood
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
The World Health Organization Well-Being Index
Self-reported well being
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
The Vanderbilt Fatigue Scale for Adults
Self-reported fatigue
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Research & Development Short Form Survey (RAND36)
Self-reported quality of life
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Single-item sedentary questionnaire
Self-reported physical activity
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Modified four-square step test
Measures physical function
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Expanded short physical performance battery
Measures lower extremity function
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Baecke Physical Activity Questionnaire
Self-reported physical activity
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
PROMIS v2.0 Mobility Questionnaire
Self-reported mobility
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
User Experience Questionnaire+
Self-reported hearing device user experience
Measured: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start19 Jun 2023
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
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.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Arnold, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970211
- Sponsor's protocol ID
- 005599
- Acronym
- P-EARLHI
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Age-Related Hearing Loss Investigation Pilot Study
- ClinicalTrials.gov ID
- NCT05970211
- Acronym / sponsor ID
- P-EARLHI / 005599
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 1 Aug 2023 (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 purpose of this clinical trial pilot is to obtain feasibility and pilot data necessary to inform the hearing intervention being designed for a larger R01 clinical trial that seeks to determine whether best practice hearing aid intervention impacts hearing-related outcomes in adults with hearing loss aged 55 to 75 years.
Secondary purposes include: To determine what effects best practice hearing aid intervention has on physical, social, and quality of life outcomes in adults with hearing loss aged 55 to 75 years.
Detailed description
This is an observational pre-post intervention feasibility study. In addition to the objective finding that adults with hearing loss experience higher rates of cognitive decline, they also tend to report lesser degrees of physical activity and increased cognitive fatigue, which is the feeling of tiredness or having a lack of energy. Unfortunately, the mechanism by which hearing loss relates to physical activity and fatigue, and the effect of hearing aids as an intervention to improve these factors, is unclear. Thus, the purpose of this study is twofold: First, we will establish the feasibility of administering a best practices hearing aid intervention to a sample of adults from the target age range of 55 - 75 years old to inform the larger clinical trial; Second, we will collect pilot data to explore the relationships between hearing loss, physical activity, socialization, fatigue and hearing-related outcomes before and after hearing aid intervention.
There are no experimental or investigational devices or agents used in this study. We are providing best-practices standard of care hearing intervention including hearing aids. We are additionally tracking activity using the ActiGraph wGT3X-BT, an FDA-approved Class II medical device that tracks continuous, high resolution physical activity and sleep/wake information.
Participation involves a minimum of 6 in-office study visits. Intervention sessions occur approximately 2 weeks apart, with a final long-term outcome session occurring approximately 6-months post the baseline intervention session.
Significant others of participants are invited to join the study and contribute data related to their own quality of life and their observations of the effects of the hearing intervention on the participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing Intervention Group | Experimental | Device: Phonak Audeo Lumity Receiver in Canal Hearing AidAdults aged 55-75 with hearing loss who have little/no prior experience with hearing aids will be enrolled in the hearing intervention group. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 55 to 75 years old with little or no experience with hearing aids
- English or Spanish speakers
Key exclusion criteria (2 listed)
- Unable to complete written questionnaires on a tablet without assistance
- Refer for cognitive screening score based on criteria using the Mini Mental State Examination
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 |
|---|---|---|
| Phonak Audeo Lumity Receiver in Canal Hearing Aidbilateral receiver in canal hearing aids provided as part of a best practices hearing loss intervention including devices, hearing centered counseling, and self management skills training for hearing loss | Device | Hearing Intervention Group |
Primary outcome
Objective Physical Activity
Time frame: 2-week measurement taken between 4- and 6- months post study enrollment
Activity level as measured by research-grade accelerometer
18 secondary outcomes
Words in Noise Test
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
International Outcome Inventory for Comprehensive Hearing Intervention
Time frame: Measured at 6-months post study enrollment
Client Oriented Scale of Improvement
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Hearing Handicap Inventory for Adults
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Center for Epidemiological Studies Depression and Hopelessness Scale
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Speech, Spatial and Qualities of Hearing Scale
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Social Network Index
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
UCLA Loneliness Scale
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
The Positive and Negative Affect Schedule
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
The World Health Organization Well-Being Index
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
The Vanderbilt Fatigue Scale for Adults
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Research & Development Short Form Survey (RAND36)
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Single-item sedentary questionnaire
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Modified four-square step test
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Expanded short physical performance battery
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Baecke Physical Activity Questionnaire
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
PROMIS v2.0 Mobility Questionnaire
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
User Experience Questionnaire+
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phonak Audeo Lumity Receiver in Canal Hearing Aid in people with Hearing Loss, run by University of South Florida 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Arnold, PhD (8139741262, mlarnold@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Physical Activity (time frame: 2-week measurement taken between 4- and 6- months post study enrollment). 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 1 Aug 2023.