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The Clinical Applicability of the 'TIB' Olfactory Test Device

Completed
Conditions
Anosmia
Hyposmia
Registration Number
NCT05152030
Lead Sponsor
Taichung Veterans General Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
180
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
validity of TIB olfactory test30 minutes to 1 hour

Criterion validity: Correlation between UPSIT-TC and TIB olfactory test

Reliability of TIB olfactory test1 week

Test-retest reliability

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Taichung Veterans General Hospital

🇨🇳

Taichung, Taiwan

Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan

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