Early Age-Related Hearing Loss Investigation Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Age-Related Hearing Loss Investigation Pilot Study

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Phonak Audeo Lumity Receiver in Canal Hearing Aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 55 to 75 years old with little or no experience with hearing aids English or Spanish speakers Exclusion Criteria: Unable to complete written questionnaires on a tablet without assistance Refer for cognitive screening score based on criteria using the Mini Mental State Examination

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hearing Intervention Group<br>Adults aged 55-75 with hearing loss who have little/no prior experience with hearing aids will be enrolled in the hearing intervention group. | Device: Phonak Audeo Lumity Receiver in Canal Hearing Aid<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Physical Activity | Activity level as measured by research-grade accelerometer | 2-week measurement taken between 4- and 6- months post study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Words in Noise Test | Measures speech perception in noise performance | 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 at 6-months post study enrollment | 
| Client Oriented Scale of Improvement | Self-reported hearing aid benefit measure | 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment |