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OpenTrials
Completed

NCT Number: NCT02662998

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

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.

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Key information

Conditions

Older Cancer Patients

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital Groeninge, Cancer Center

Kortrijk, 8500, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Validation of uHear™ with its new scoring method as a screening tool to detect hearing loss in older cancer patients

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

General Hospital Groeninge

Other

Registry information

Acronym: UHEAR-BIS

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2016
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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