Early Age-Related Hearing Loss Investigation Pilot Study

NCT05970211 | Unknown FDA Device

• 1 other identifier: 005599
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Objective Physical Activity

  Activity level as measured by research-grade accelerometer

  2-week measurement taken between 4- and 6- months post study enrollment

Secondary Outcomes (18)

• 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

• International Outcome Inventory for Comprehensive Hearing Intervention

  Measured at 6-months post study enrollment

• 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

• 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

• 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

Study Arms (1)

Hearing Intervention Group

EXPERIMENTAL

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

Interventions

Phonak Audeo Lumity Receiver in Canal Hearing Aid DEVICE

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

Hearing Intervention Group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 55 to 75 years old with little or no experience with hearing aids
• English or Spanish speakers

You may not qualify if:

• Unable to complete written questionnaires on a tablet without assistance
• Refer for cognitive screening score based on criteria using the Mini Mental State Examination

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michelle Arnold, PhD

CONTACT

8139741262; mlarnold@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: August 1, 2023
• Study Start: June 19, 2023
• Primary Completion: April 15, 2024
• Study Completion: August 15, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

US (1)