Early Age-Related Hearing Loss Investigation Pilot Study

Hearing Loss Clinical Trial

— P-EARLHI  

Official title:

Early Age-Related Hearing Loss Investigation Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970211
• Other study ID #: 005599
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Presbycusis

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