Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Older Cancer Patients Within a Comprehensive Geriatric Assessment - BIS

Older Cancer Patients Clinical Trial

— UHEAR-BIS  

Official title:

Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Older Cancer Patients Within a Comprehensive Geriatric Assessment - BIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662998
• Other study ID #: AZGS2015133
• Status: Completed
• Phase: N/A
• First received: January 19, 2016
• Last updated: February 14, 2018
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: February 2018
• Source: General Hospital Groeninge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to validate uHear™, an iOS-based tool, as a screening tool to detect significant hearing impairment as part of a comprehensive geriatric assessment in patients aged 70 years and older. The pass or fail screening cut-off is defined as having two or more consecutive hearing grades starting from the moderate-severe threshold zone ranging from 0.5 - 2.0 kHz.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Patients should have reached the age of 70 or more at enrolment

• Histologically confirmed diagnosis of solid cancer or hematologic malignancy. All stages of cancer are eligible

• Patients should be fluent in Dutch or French

• Patients must receive their primary oncology care in the participating hospital

• Patients should be cognitively capable of performing the audiology assessment

• Patients should be scheduled to receive a CGA

• Patients should have signed informed consent

Exclusion Criteria:

• Patients who do not match the above inclusion criteria

• Patients presenting with clinically diagnosed Meniere's disease, retrocochlear hearing loss, autoimmune inner ear disease, fluctuating hearing loss or a history of sudden sensory neural hearing loss

• Patients who already have a hearing aid or a previously diagnosed hearing loss

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Older Cancer Patients

Locations

Country	Name	City	State
Belgium	General Hospital Groeninge, Cancer Center	Kortrijk

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Groeninge

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Lycke M, Debruyne PR, Lefebvre T, Martens E, Ketelaars L, Pottel H, Van Eygen K, Derijcke S, Werbrouck P, Vergauwe P, Stellamans K, Clarysse P, Dhooge I, Schofield P, Boterberg T. The use of uHear™ to screen for hearing loss in older patients with cancer — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of uHear™ with its new scoring method as a screening tool to detect hearing loss in older cancer patients		baseline