Early Age-Related Hearing Loss Investigation Pilot Study (P-EARLHI)

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.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Phonak Audeo Lumity Receiver in Canal Hearing Aid

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Arnold, PhD; Phone Number: 8139741262; Email: mlarnold@usf.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33620
      • Recruiting
      • University of South Florida
      • Contact: Michelle Arnold, PhD; Phone Number: 813-974-1262; Email: arctlab@usf.edu
      • Contact: Sarah Bochat, AuD; Phone Number: 8139741262; Email: arctlab@usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Physical Activity	Activity level as measured by research-grade accelerometer	2-week measurement taken between 4- and 6- months post study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
International Outcome Inventory for Comprehensive Hearing Intervention	Self-reported hearing aid benefit measure	Measured at 6-months post study enrollment
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of South Florida

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss, Sensorineural; Hearing Loss; Deafness; Presbycusis
• Other Study ID Numbers: 005599

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes