RECRUITING

Innovations in Hearing Accessibility and Technology (IHAT) Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The research will explore outcomes of different service delivery models of over-the-counter (OTC) hearing aids by comparing them to prescription hearing aids fitted by specialists in individuals with mild to moderate hearing loss. The investigators will examine how each type affects users' experiences, behavior, thinking skills, and brain activity related to hearing. Additionally, the study will focus on what types of people prefer each hearing aid option, what helps or hinders these choices, and compare the costs of four different service options. This approach will help transition from research findings into real-world practice, providing useful information for healthcare providers and policymakers about OTC hearing aid options.

Official Title

Effectiveness Trial to Examine the Emerging Service Delivery Models for Over-the-Counter (OTC) Hearing Aids

Quick Facts

Study Start:2024-11-13
Study Completion:2029-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06689865

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult onset, bilateral, mild-to-moderate sensorineural hearing loss documented by audiological evaluation
  2. * Aged 40 years or older
  3. * No previous HA experience greater than 3 months
  4. * Able to read and understand patient education materials
  5. * Willing to be randomized to one of the four groups, and
  6. * Owns a smartphone
  1. * Hearing loss that is too severe for OTC HAs
  2. * Middle ear disorders or conductive pathology present
  3. * Asymmetrical hearing loss
  4. * Diagnosed neurological condition such as dementia or Parkinson's disease or a score lower than 25 on the MOCA
  5. * Non-English speaking as it may impact the ability to complete our test battery

Contacts and Locations

Study Contact

Research Service Professional
CONTACT
303-724-8465
ihat@cuanschutz.edu
Preeti Pandey, PhD
CONTACT
preeti.pandey@cuanschutz.edu

Principal Investigator

Vinaya Manchaiah, AuD, MBA, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Anu Sharma, PhD
PRINCIPAL_INVESTIGATOR
University of Colorado, Boulder

Study Locations (Sites)

University of Colorado School of Medicine
Aurora, Colorado, 80045
United States
University of Colorado Boulder
Boulder, Colorado, 80305
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Vinaya Manchaiah, AuD, MBA, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver
  • Anu Sharma, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Boulder

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-13
Study Completion Date2029-03-31

Study Record Updates

Study Start Date2024-11-13
Study Completion Date2029-03-31

Terms related to this study

Keywords Provided by Researchers

  • hearing loss
  • hearing aids
  • OTC hearing aids
  • service delivery models
  • effectiveness trial
  • Over-the-counter hearing aids

Additional Relevant MeSH Terms

  • Hearing Loss
  • Hearing Aids
  • OTC Hearing Aids