The Clinical Applicability of the 'TIB' Olfactory Test Device
Sponsor
Taichung Veterans General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05152030
Collaborator
(none)
180
1
10.5
17.2
Study Details
Study Description
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
180 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Validation of the Local Applicability of the 'TIB' Olfactory Test Device in the Era of COVID-19
Actual Study Start Date
:
Nov 1, 2020
Actual Primary Completion Date
:
Aug 31, 2021
Actual Study Completion Date
:
Sep 16, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| hyposmic patients
|
Diagnostic Test: 'TIB' Olfactory 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.
Diagnostic Test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)
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
|
Diagnostic Test: 'TIB' Olfactory 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.
Diagnostic Test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)
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.
|
| normosmic group
|
Diagnostic Test: 'TIB' Olfactory 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.
Diagnostic Test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)
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.
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taichung Veterans General Hospital | Taichung | Taiwan | 407219 |
Sponsors and Collaborators
- Taichung Veterans General Hospital
Investigators
- Study Director: Rong-San Jiang, M.D., Ph.D., Taichung Veterans General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT05152030
Other Study ID Numbers:
- CE20329A#1
First Posted:
Dec 9, 2021
Last Update Posted:
Dec 9, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: