Smell DisorderNCT04532632
Taste and Smell Impairment in Critically Ill COVID-19 Patients
An observational study of Smell Disorder and Taste Disorders, run by Pinar Ay Sayin at 1 site in Turkey (Türkiye).
Trial summary
Evaluating the smell and taste perceptions of patients hospitalized in the intensive care unit with suspicion of Coronavirus disease-19 diagnosis with a survey study Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Smell Disorder, Taste Disorders, Coronavirus Infection
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 9 Oct 2020
- How long will I take part?
- 10 Days
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between the ages of 18-80, who were treated in the intensive care unit with the diagnosis of Coronavirus disease-19 and were discharged
Who may be able to join
- Adults between the ages of 18-80
- Agree to participate in the study
- Patients treated in the intensive care unit with the diagnosis of Coronavirus disease-19
Who cannot join
- Pre-existing smell and taste impairment
- The patients have no enough cooperation to answer the questionnaire
- Having additional diseases such as dementia and Alzheimer
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Etfal Research and Training Hospital
Istanbul, 34371
About this study
Evaluating the smell and taste perceptions of patients hospitalized in the intensive care unit with suspicion of Coronavirus disease-19 diagnosis with a survey study
Read the detailed description
Patients who were treated in the intensive care unit of Şişli Hamidiye Etfal Training and Research Hospital with the diagnosis of Coronavirus disease-19 will be determined by scanning the hospital registry system. It was planned that patients discharged from the intensive care unit would be called by phone and their complaints about smell and taste disorders were evaluated with a questionnaire.
- Conditions
- Smell Disorder, Taste Disorders, Coronavirus Infection
- Keywords
- Coronavirus disease-19, anosmia, hyposmia, dysgeusia
- Medical subject headings
- Olfaction Disorders, Taste Disorders, Coronavirus Infections, COVID-19, Anosmia, Dysgeusia
What is being measured
The primary outcome is the main question the study is designed to answer.
taste and smell impairment
incidence of taste and smell impairment in critically ill subjects
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Sep 2020
- Primary completion1 Oct 2020
- Study completion9 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smell DisorderStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Pinar Ay Sayin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pinar Ay Sayin, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532632
- Sponsor's protocol ID
- 3334-02
- Status last verified
- Nov 2020
- First submitted
- 28 Aug 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hopkins C, Surda P, Whitehead E, Kumar BN. Early recovery following new onset anosmia during the COVID-19 pandemic - an observational cohort study. J Otolaryngol Head Neck Surg. 2020 May 4;49(1):26. doi: 10.1186/s40463-020-00423-8.
PubMed 32366299Sayin I, Yasar KK, Yazici ZM. Taste and Smell Impairment in COVID-19: An AAO-HNS Anosmia Reporting Tool-Based Comparative Study. Otolaryngol Head Neck Surg. 2020 Sep;163(3):473-479. doi: 10.1177/0194599820931820. Epub 2020 Jun 9.
PubMed 32513096
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taste and Smell Impairment in Critically Ill COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04532632
- Acronym / sponsor ID
- 3334-02
- Conditions
- Smell Disorder, Taste Disorders, Coronavirus Infection
- Keywords
- Coronavirus disease-19, anosmia, hyposmia, dysgeusia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pinar Ay SayinUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 31 Aug 2020 (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.
Evaluating the smell and taste perceptions of patients hospitalized in the intensive care unit with suspicion of Coronavirus disease-19 diagnosis with a survey study
Detailed description
Patients who were treated in the intensive care unit of Şişli Hamidiye Etfal Training and Research Hospital with the diagnosis of Coronavirus disease-19 will be determined by scanning the hospital registry system. It was planned that patients discharged from the intensive care unit would be called by phone and their complaints about smell and taste disorders were evaluated with a questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18-80, who were treated in the intensive care unit with the diagnosis of Coronavirus disease-19 and were discharged
Key inclusion criteria (3 listed)
- Adults between the ages of 18-80
- Agree to participate in the study
- Patients treated in the intensive care unit with the diagnosis of Coronavirus disease-19
Key exclusion criteria (3 listed)
- Pre-existing smell and taste impairment
- The patients have no enough cooperation to answer the questionnaire
- Having additional diseases such as dementia and Alzheimer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
taste and smell impairment
Time frame: up to 3 months
incidence of taste and smell impairment in critically ill subjects
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 10 Nov 2020.
- Background: PubMed 32366299Hopkins C, Surda P, Whitehead E, Kumar BN. Early recovery following new onset anosmia during the COVID-19 pandemic - an observational cohort study. J Otolaryngol Head Neck Surg. 2020 May 4;49(1):26. doi: 10.1186/s40463-020-00423-8.
- Background: PubMed 32513096Sayin I, Yasar KK, Yazici ZM. Taste and Smell Impairment in COVID-19: An AAO-HNS Anosmia Reporting Tool-Based Comparative Study. Otolaryngol Head Neck Surg. 2020 Sep;163(3):473-479. doi: 10.1177/0194599820931820. Epub 2020 Jun 9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Smell Disorder and Taste Disorders, run by Pinar Ay Sayin at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 10 Nov 2020. 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 Turkey (Türkiye). 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?
taste and smell impairment (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04532632, which also lists 2 linked publications.
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 10 Nov 2020.