AnosmiaNCT05152030
The Clinical Applicability of the 'TIB' Olfactory Test Device
An observational study of Anosmia and Hyposmia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 59 yearsHealthy volunteers can take part
- What is being tested?
- 'TIB' Olfactory Test and Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2020to 16 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Normosmic group were from community. Hyposmic and anosmic patients were from out patient clinic department of Otorhinolaryngology.
Who may be able to join
- 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.
Who cannot join
- History of sinonasal symptoms within a week before the test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Local Applicability of the 'TIB' Olfactory Test Device in the Era of COVID-19
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.
- Being tested
- 'TIB' Olfactory Test, Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC)
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'TIB' Olfactory TestDiagnostic 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| hyposmic patients | Not described Receives: Diagnostic Test: 'TIB' Olfactory Test; Diagnostic Test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC) | |
| anosmic patients | Not described Receives: Diagnostic Test: 'TIB' Olfactory Test; Diagnostic Test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC) | |
| normosmic group | Not described Receives: Diagnostic Test: 'TIB' Olfactory Test; Diagnostic Test: Traditional Chinese version of the University of Pennsylvania of Smell Identification Test (UPSIT-TC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
validity of TIB olfactory test
Criterion validity: Correlation between UPSIT-TC and TIB olfactory test
Measured: 30 minutes to 1 hour
Reliability of TIB olfactory test
Test-retest reliability
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Nov 2020
- Primary completion31 Aug 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnosmiaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rong-San Jiang, M.D., Ph.D., Study director, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152030
- Sponsor's protocol ID
- CE20329A#1
- Status last verified
- Nov 2021
- First submitted
- 26 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Local Applicability of the 'TIB' Olfactory Test Device in the Era of COVID-19
- ClinicalTrials.gov ID
- NCT05152030
- Acronym / sponsor ID
- CE20329A#1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 20 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Normosmic group were from community. Hyposmic and anosmic patients were from out patient clinic department of Otorhinolaryngology.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- History of sinonasal symptoms within a week before the test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'TIB' Olfactory TestA 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 | anosmic patients, hyposmic patients, normosmic group |
| 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. | Diagnostic test | anosmic patients, hyposmic patients, normosmic group |
Primary outcome
validity of TIB olfactory test
Time frame: 30 minutes to 1 hour
Criterion validity: Correlation between UPSIT-TC and TIB olfactory test
Reliability of TIB olfactory test
Time frame: 1 week
Test-retest reliability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong-San Jiang, M.D., Ph.D. study director
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anosmia and Hyposmia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity of TIB olfactory test (time frame: 30 minutes to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.