P-EARLHI: Early Age-Related Hearing Loss Investigation Pilot Study
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hearing Intervention Group 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
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
|
Outcome Measures
Primary Outcome Measures
- Objective Physical Activity [2-week measurement taken between 4- and 6- months post study enrollment]
Activity level as measured by research-grade accelerometer
Secondary Outcome Measures
- Words in Noise Test [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Measures speech perception in noise performance
- International Outcome Inventory for Comprehensive Hearing Intervention [Measured at 6-months post study enrollment]
Self-reported hearing aid benefit measure
- Client Oriented Scale of Improvement [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported hearing aid benefit measure
- Hearing Handicap Inventory for Adults [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported hearing handicap
- Center for Epidemiological Studies Depression and Hopelessness Scale [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported depression
- Speech, Spatial and Qualities of Hearing Scale [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported hearing difficulties
- Social Network Index [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported social network information
- UCLA Loneliness Scale [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported loneliness
- The Positive and Negative Affect Schedule [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported positive and negative affect/mood
- The World Health Organization Well-Being Index [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported well being
- The Vanderbilt Fatigue Scale for Adults [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported fatigue
- Research & Development Short Form Survey (RAND36) [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported quality of life
- Single-item sedentary questionnaire [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported physical activity
- Modified four-square step test [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Measures physical function
- Expanded short physical performance battery [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Measures lower extremity function
- Baecke Physical Activity Questionnaire [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported physical activity
- PROMIS v2.0 Mobility Questionnaire [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported mobility
- User Experience Questionnaire+ [Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment]
Self-reported hearing device user experience
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Florida | Tampa | Florida | United States | 33620 |
Sponsors and Collaborators
- University of South Florida
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 005599