The Automated Mobile Interactive Audiometer - Feasibility and Reliability in a Clinical Setting

April 6, 2018 updated by: Matt Bromwich
This observational study aims to validate the use of a tablet based audiometer to provide an accurate, efficient, and cost-effective means for diagnosis of hearing conditions in controlled and uncontrolled environments in adult and elderly populations.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In the 2011 report on Disability, the World Health Organization rated hearing loss as the most prevalent disability in the world. More than 30% of adults have disabling hearing loss complicating the management of their comorbid diseases. Isolation, mental illness and lack of family support are just some of the negative impacts of this invisible disability. In the next 25 years the number of hearing impaired individuals over the age of 65 in Canada will double, while at the same time there is a projected 50% shortfall in audiological service providers. The resultant service deficit is compounded by the lack of equipment and familiarity with hearing healthcare at the primary care level, causing increased inefficiency, unnecessary referrals, and unmet needs.

In Canada, there is a critical need to improve the number of health professionals with the requisite skills to meet the needs of the aging population. This project is aimed at developing a novel approach to address the increasing need for hearing healthcare in the adults while managing the strain on the healthcare system.

Healthcare workers (such as general practitioners, registered nurses and allied heath workers) can play an important role in supporting and motivating adults to seek help and aid in the referral process. However, few healthcare workers receive formal training in the identification, diagnosis, treatment options, referral process, and special needs of older adults with hearing loss. This lack of training, resources and equipment is a significant gap in the care provided to the elderly and impacts all other aspects of elder care.

Undiagnosed/untreated hearing loss can lead to physiological changes associated with auditory deprivation, as well as psychosocial changes of social isolation and depression. It can result in emotional, physical, cognitive, and behavioral consequences including impaired activities of daily living, decline in independence and reduced quality of life. In spite of the prevalence and impact of hearing loss and the benefits of rehabilitation in reducing the psychological, social, and emotional consequences of hearing loss, referral by physicians for assessment and rehabilitation is low and the majority of adults who could benefit from the use of hearing aids do not use this technology. Early identification can help to reduce these deleterious effects, and lead to easier adjustment to hearing aid use.

In spite of the numerous recent technological advances in field of hearing amplification devices, current technologies may not be effective for older adults who have central auditory processing and cognitive processing difficulties. Additionally, untreated hearing loss lowers performance on aurally administered diagnostic tests used to quantify the severity of dementia and can significantly confound the clinical picture in this population. Furthermore, the use of amplification is associated with reduction in problem behavior in persons with a primary diagnosis of Alzheimer's disease and a reduction in hearing handicap for persons with Alzheimer's disease and their significant others.

This study aims to validate the use of a tablet based audiometer to provide an accurate, efficient, and cost-effective means for diagnosis of hearing conditions in controlled and uncontrolled environments in adult and elderly populations.

Observations between the soundbooth and iPad audiograms will include the following frequencies 250, 500, 1000, 2000, 4000, 6000 and 8000 Hz. Each iPad audiogram consists of an interactive game that takes approximately 10-20 minutes to complete. The conventional audiogram will take place before the iPad audiogram. We expect our study to add a maximum of 20-30 minutes to each enrolled patient's visit. The iPad audiogram observations will not be used by the patient's physician for diagnostic and treatment purposes.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Debora L Hogan, M.Sc.N.
  • Phone Number: 72978 613-737-8899
  • Email: dhogan@ohri.ca

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Recruiting
        • The Ottawa Hospital Civic and General Campuses

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults (> or equal to18 years) attending the ENT/Audiology clinic at The Ottawa Hospital (CIVIC Campus) will be eligible to participate.

Description

Inclusion Criteria:

  • For Group I and II all adults over the age of 18 years who attend an Audiology clinic for conventional Audiometry at the Civic campus will be eligible for this study.
  • For Group III adults over the age of 18 years who attend ENT clinic but aren't undergoing conventional audiometric testing will be eligible.

Exclusion Criteria:

  • Patients who self report being unable to play the iPad game.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Automated Mobile Interactive Audiometer, Test Retest
Each participant will act as his/her own control. The iPad audiogram will be compared to the audiogram in sound booth or to a second iPad audiogram.
Device: Automated Mobile Interactive Audiometer
iPad game
Automated Mobile Interactive Audiometer, Validation.
iPad testing will be compared to conventional audiometry in the sound booth.
Device: Automated Mobile Interactive Audiometer
iPad game
Automated Mobile Interactive Audiometer, Speech Recognition
Testing with NU-6 word lists will be conducted by the iPad and by an audiologist in the sound booth.
Device: Automated Mobile Interactive Audiometer
iPad game
Automated Mobile Interactive Audiometer, Cochlear Implant
Participants with cochlear implants will be tested using iPad against conventional audiometry (warble tone) in the sound booth.
Device: Automated Mobile Interactive Audiometer
iPad game

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validate the use of an iPad audiometer for hearing testing in adults aged 18 and older in Ottawa, Canada.
Time Frame: 8 months
iPad audiogram will be compared to conventional audiogram (sound booth) and test/retest reliability of the iPad will be measured in Group 3.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matt Bromwich

Collaborators

Children's Hospital of Eastern Ontario
Clearwater Clinical

Investigators

  • Principal Investigator: David Schramm, MD, The Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150561-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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