The Clinical Applicability of the 'TIB' Olfactory Test Device

Completed

• Conditions: Anosmia; Hyposmia
• Interventions: Diagnostic Test: 'TIB' Olfactory Test; Diagnostic Test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)

• 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

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-16
• Status Verified: 2021-11
• Study First Submitted: 2021-11-26
• Study First Submitted QC: 2021-11-26
• Last Update Submitted: 2021-11-26
• Study First Posted: 2021-12-09
• Last Update Posted: 2021-12-09

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

Arm && Interventions

Group	Intervention	Description
hyposmic patients	'TIB' Olfactory Test	-
normosmic group	Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)	-
hyposmic patients	Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)	-
anosmic patients	'TIB' Olfactory Test	-
normosmic group	'TIB' Olfactory Test	-
anosmic patients	Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)	-

Primary Outcome Measures

Name	Time	Method
validity of TIB olfactory test	30 minutes to 1 hour	Criterion validity: Correlation between UPSIT-TC and TIB olfactory test
Reliability of TIB olfactory test	1 week	Test-retest reliability

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan