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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05970211
Other study ID # 005599
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 19, 2023
Est. completion date August 15, 2024

Study information

Verified date July 2023
Source University of South Florida
Contact Michelle Arnold, PhD
Phone 8139741262
Email mlarnold@usf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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 information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 15, 2024
Est. primary completion date April 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of South Florida Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Physical Activity Activity level as measured by research-grade accelerometer 2-week measurement taken between 4- and 6- months post study enrollment
Secondary 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
Secondary International Outcome Inventory for Comprehensive Hearing Intervention Self-reported hearing aid benefit measure Measured at 6-months post study enrollment
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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