Early Age-Related Hearing Loss Investigation Pilot Study
- Conditions
- Hearing Loss
- Interventions
- Device: Phonak Audeo Lumity Receiver in Canal Hearing Aid
- Registration Number
- NCT05970211
- Lead Sponsor
- University of South Florida
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Adults aged 55 to 75 years old with little or no experience with hearing aids
- English or Spanish speakers
- Unable to complete written questionnaires on a tablet without assistance
- Refer for cognitive screening score based on criteria using the Mini Mental State Examination
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hearing Intervention Group Phonak Audeo Lumity Receiver in Canal Hearing Aid Adults aged 55-75 with hearing loss who have little/no prior experience with hearing aids will be enrolled in the hearing intervention group.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
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
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
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
International Outcome Inventory for Comprehensive Hearing Intervention Measured 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
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
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
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
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
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
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
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
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 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
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
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
Trial Locations
- Locations (1)
University of South Florida
🇺🇸Tampa, Florida, United States