The Clinical Applicability of the 'TIB' Olfactory Test Device

NCT05152030 | Completed

• 1 other identifier: CE20329A#1
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Anosmia; Hyposmia

Outcome Measures

Primary Outcomes (2)

• validity of TIB olfactory test

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

  30 minutes to 1 hour

• Reliability of TIB olfactory test

  Test-retest reliability

  1 week

Study Arms (3)

hyposmic patients

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

anosmic patients

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

normosmic group

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

Interventions

'TIB' Olfactory Test DIAGNOSTIC_TEST

A new smell identification test, 'TIB' Olfactory Test Device (Top International Biotech, Taipei) has been developed in Taiwan. It consists of 16 tests with an odorant embedded in fragrant microcapsules positioned on a strip. The examinee scratches the strip to release the odorant. The released odorant is sniffed and the examinee identifies the odorant by choosing a name from a set of 4 odor descriptors. This process is then repeated with the next odorant on the strip.

anosmic patients; hyposmic patients; normosmic group

Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC) DIAGNOSTIC_TEST

The University of Pennsylvania Smell Identification Test (UPSIT), which was developed at the University of Pennsylvania, is one of the most reliable and the most widely used olfactory test.The test consists of four 10-odorant booklets. Each odorant is embedded in 10 to 50 µm urea-formaldehyde polymer microencapsules fixed in a proprietary binder and positioned on a brown strip which is located at the bottom of each page of the test booklet.4 When the examinee takes the test, each of the 40 odorants is released by scratching the strip with a pencil tip. The released odorant is sniffed and the examinee identifies the odorant by choosing a name from a set of 4 odor descriptors.

anosmic patients; hyposmic patients; normosmic group

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Normosmic group were from community. Hyposmic and anosmic patients were from out patient clinic department of Otorhinolaryngology.

You may qualify if:

• 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.

You may not qualify if:

• History of sinonasal symptoms within a week before the test

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

Location

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rong-San Jiang, M.D., Ph.D.

  Taichung Veterans General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 9, 2021
• Study Start: November 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: September 16, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

TW (1)