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The Clinical Applicability of the 'TIB' Olfactory Test Device

T

Taichung Veterans General Hospital

Status

Completed

Conditions

Anosmia
Hyposmia

Treatments

Diagnostic Test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)
Diagnostic Test: 'TIB' Olfactory Test

Study type

Observational

Funder types

Other

Identifiers

NCT05152030
CE20329A#1

Details and patient eligibility

About

The aim of this study was to evaluate the validity and test-retest reliability of the 'TIB' Olfactory Test Device, a new olfactory test tool developed by Top International Biotech, Taipei, and to determine its normative values. The olfactory function of 180 subjects was evaluated using both the traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC) and TIB. The subjects consisted of 60 healthy volunteers (normosmic group), 60 hyposmic patients, and 60 anosmic patients. The healthy volunteers were retested with the UPSIT-TC and TIB at an inter-test interval of at least 7 days. The cut-off scores of TIB among the different groups were determined by receiver operating characteristic curve.

Enrollment

180 patients

Sex

All

Ages

20 to 59 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Normosmic group were self-reported absence of deficits in olfaction. Hyposmic patients were loss of olfactory function with a phenyl ethyl alcohol (PEA) odor detection threshold below -1. Anosmic patients were loss of olfactory function with a PEA threshold equal to -1.

Exclusion criteria

  • History of sinonasal symptoms within a week before the test

Trial design

180 participants in 3 patient groups

hyposmic patients
Treatment:
Diagnostic Test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)
Diagnostic Test: 'TIB' Olfactory Test
anosmic patients
Treatment:
Diagnostic Test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)
Diagnostic Test: 'TIB' Olfactory Test
normosmic group
Treatment:
Diagnostic Test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)
Diagnostic Test: 'TIB' Olfactory Test

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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