Clinical trial NCT02761798: The Automated Mobile Interactive Audiometer - Feasibility and Reliability in a Clinical Setting
Official title: The Automated Mobile Interactive Audiometer - Feasibility and Reliability in a Clinical Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Clearwater Clinical
name: Children's Hospital of Eastern Ontario
First posted: 2016-05-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Validate the use of an iPad audiometer for hearing testing in adults aged 18 and older in Ottawa, Canada.
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Civic and General Campuses
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: David Schramm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bastianelli M, Mark AE, McAfee A, Schramm D, Lefrancois R, Bromwich M. Adult validation of a self-administered tablet audiometer. J Otolaryngol Head Neck Surg. 2019 Nov 7;48(1):59. doi: 10.1186/s40463-019-0385-0.