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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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
University of South Florida
Tampa, Florida, United States
RECRUITINGObjective Physical Activity
Activity level as measured by research-grade accelerometer
Time frame: 2-week measurement taken between 4- and 6- months post study enrollment
Words in Noise Test
Measures speech perception in noise performance
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
Self-reported hearing aid benefit measure
Time frame: Measured at 6-months post study enrollment
Client Oriented Scale of Improvement
Self-reported hearing aid benefit measure
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
Self-reported hearing handicap
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
Self-reported depression
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
Self-reported hearing difficulties
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment
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Social Network Index
Self-reported social network information
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
Self-reported loneliness
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
Self-reported positive and negative affect/mood
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
Self-reported well being
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
Self-reported fatigue
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)
Self-reported quality of life
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
Self-reported physical activity
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
Measures physical function
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
Measures lower extremity function
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
Self-reported physical activity
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
Self-reported mobility
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+
Self-reported hearing device user experience
Time frame: Measured at time of study enrollment; between 6- and 8-weeks post study enrollment; and at 6-months post study enrollment