ParosmiaParosmiaQNCT04868435
Triggers for Post-Viral Parosmia
An observational study of Parosmia and Smell Disorder, run by University of Reading at 1 site in United Kingdom.
Trial summary
Background: Many people lose their sense of smell after they have had a cold, flu or sinus infection. Recovery (if at all) generally starts with a "parosmia" phase which means every-day smells become distorted and over-poweringly objectionable, and this can lead to malnutrition and depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parosmia, Smell Disorder
- How many people
- 943 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Nov 2020to 3 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will be drawn from those currently suffering from parosmia only. Participants will initially be recruited from the AbScent membership which has a high proportion of UK and US members, but it will be rolled out internationally via ENT consultants.
Who may be able to join
- Individuals should be currently experiencing parosmia
Who cannot join
- Individuals below 18 years old will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triggers for Post-Viral Parosmia After COVID-19 and Non-COVID-19 Infections
Background: Many people lose their sense of smell after they have had a cold, flu or sinus infection. Recovery (if at all) generally starts with a "parosmia" phase which means every-day smells become distorted and over-poweringly objectionable, and this can lead to malnutrition and depression. We do not know much about how or why parosmia happens, but there are key foods common to those who suffer from parosmia which seem to trigger the distortion.
Parosmia and COVID-19 Loss of smell has recently been recognised as an official symptom of COVID-19, and we are starting to get reports of people who have recently had COVID-19 developing parosmia. The triggers seem to be similar to those of the common cold, flu or virus infections, but the journey between loss of smell and parosmia is different.
Read more
Hypotheses
- Triggers of distortion will be the same for all parosmics.
- There may be additional trigger foods in different cultures.
Questions
- What are the trigger foods and beverages for parosmia?
- Are there regional/cultural variations?
- Does Covid-19 parosmia differ from "standard" post-viral parosmia?
The overall aim of the project is to understand the mechanisms involved in parosmia. The approach is to identify foods and everyday aromas associated with parosmia and to determine whether they are the same across different continents/cultures/ethnic backgrounds, and whether Covid-19 parosmia is any different to non-Covid-19 parosmia. The questionnaire will ask about Covid-19 status, ethnic background, smell loss and parosmia, and the changes that occurred between smell loss and parosmia. The participants will then answer questions on up to 15 everyday smells, some of which our preliminary evidence shows are common triggers, and others which are not. The questionnaire will be globally distributed, for example through current collaborations in the UK, US, Germany, Iran, China, Japan and Brazil. It will be completed by participants who are currently experiencing parosmia.
All participants will be asked to record any foods that they find distorted and provide a list of aromas which returned undistorted.
Read the detailed description
The questionnaire will be sent out to those reporting early stages of parosmia as a result of post-viral infection, including post-COVID-19 infection. The questionnaire will record demographic data and ask about COVID-19 status, COVID-19 diagnosis and results of COVID-19 tests. It will ask about loss of smell, taste and chemesthesis (irritation from the heat of spices) and it will ask about the sequence of events leading to parosmia. Up to 15 everyday items will be rated for aroma description, intensity and valence. Participants will be asked to list other distorted foods, and also smells that returned undistorted. The questionnaire will be fully anonymous (unlinked anonymous) and voluntary. The questionnaire will be designed, distributed and data collected using the secure platform provided by Compusense.
- Conditions
- Parosmia, Smell Disorder
- Keywords
- Parosmia, COVID, Trigger foods
- Medical subject headings
- Olfaction Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
Outcomes from the questionnaire will be:
List of major trigger foods for anosmia.
Typical descriptions for smell distortions.
Severity of parosmia.
Patterns of anosmia/parosmia symptoms in post-viral infections including Covid-19.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start3 Nov 2020
- Primary completion31 Jul 2021
- Study completion3 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParosmiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 943 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- AbScent, University of London, University College London Hospitals
- Responsible party
- Principal investigator, Jane Parker, University of Reading
- Investigators
- Jane K Parker, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868435
- Sponsor's protocol ID
- UoR SREC 29/2020
- Acronym
- ParosmiaQ
- Status last verified
- May 2023
- First submitted
- 26 Apr 2021
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal identification data will be shared. The study is not under an obligation to share data, however it is possible that some of the individual (unlinked / non identifiable) data will be useful in a meta analysis and, hence sharing individual participant data (IPD) will be considered.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triggers for Post-Viral Parosmia After COVID-19 and Non-COVID-19 Infections
- ClinicalTrials.gov ID
- NCT04868435
- Acronym / sponsor ID
- ParosmiaQ / UoR SREC 29/2020
- Conditions
- Parosmia, Smell Disorder
- Keywords
- Parosmia, COVID, Trigger foods
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 943 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- AbScent, University of London, University College London Hospitals
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 3 Feb 2023 (actual)
- First posted
- 3 May 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.
Background: Many people lose their sense of smell after they have had a cold, flu or sinus infection. Recovery (if at all) generally starts with a "parosmia" phase which means every-day smells become distorted and over-poweringly objectionable, and this can lead to malnutrition and depression. We do not know much about how or why parosmia happens, but there are key foods common to those who suffer from parosmia which seem to trigger the distortion.
Parosmia and COVID-19 Loss of smell has recently been recognised as an official symptom of COVID-19, and we are starting to get reports of people who have recently had COVID-19 developing parosmia. The triggers seem to be similar to those of the common cold, flu or virus infections, but the journey between loss of smell and parosmia is different.
Hypotheses
- Triggers of distortion will be the same for all parosmics.
- There may be additional trigger foods in different cultures.
Questions
- What are the trigger foods and beverages for parosmia?
- Are there regional/cultural variations?
- Does Covid-19 parosmia differ from "standard" post-viral parosmia?
The overall aim of the project is to understand the mechanisms involved in parosmia. The approach is to identify foods and everyday aromas associated with parosmia and to determine whether they are the same across different continents/cultures/ethnic backgrounds, and whether Covid-19 parosmia is any different to non-Covid-19 parosmia. The questionnaire will ask about Covid-19 status, ethnic background, smell loss and parosmia, and the changes that occurred between smell loss and parosmia. The participants will then answer questions on up to 15 everyday smells, some of which our preliminary evidence shows are common triggers, and others which are not. The questionnaire will be globally distributed, for example through current collaborations in the UK, US, Germany, Iran, China, Japan and Brazil. It will be completed by participants who are currently experiencing parosmia.
All participants will be asked to record any foods that they find distorted and provide a list of aromas which returned undistorted.
Detailed description
The questionnaire will be sent out to those reporting early stages of parosmia as a result of post-viral infection, including post-COVID-19 infection. The questionnaire will record demographic data and ask about COVID-19 status, COVID-19 diagnosis and results of COVID-19 tests. It will ask about loss of smell, taste and chemesthesis (irritation from the heat of spices) and it will ask about the sequence of events leading to parosmia. Up to 15 everyday items will be rated for aroma description, intensity and valence. Participants will be asked to list other distorted foods, and also smells that returned undistorted. The questionnaire will be fully anonymous (unlinked anonymous) and voluntary. The questionnaire will be designed, distributed and data collected using the secure platform provided by Compusense.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be drawn from those currently suffering from parosmia only. Participants will initially be recruited from the AbScent membership which has a high proportion of UK and US members, but it will be rolled out internationally via ENT consultants.
Key inclusion criteria (1 listed)
- Individuals should be currently experiencing parosmia
Key exclusion criteria (1 listed)
- Individuals below 18 years old will be excluded from the study
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
Questionnaire
Time frame: 20 minutes
Outcomes from the questionnaire will be: List of major trigger foods for anosmia. Typical descriptions for smell distortions. Severity of parosmia. Patterns of anosmia/parosmia symptoms in post-viral infections including Covid-19.
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 May 2023.
- Support and advice for those with smell disordersLink provided by the sponsor.
- Individual participant dataSharing planned: No. No personal identification data will be shared. The study is not under an obligation to share data, however it is possible that some of the individual (unlinked / non identifiable) data will be useful in a meta analysis and, hence sharing individual participant data (IPD) will be considered.
Related trials for Parosmia
RecruitingObservational study
Longitudinal Deep Phenotyping of Central Mechanisms in Dysosmia: A Pilot Study Using Electrobulbogram (EBG), Functional MRI (fMRI), and Diffusion-Weighted Imaging (DWI)
Respiratory Tract Infection, Smell Disorder
Not yet recruitingObservational study
Neural Dissimilarity in Patients With Chronic Rhinosinusitis With Nasal Polyps Treated With Biologics
Olfactory Dysfunction, Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Recruiting
Olfactory Training as a Treatment for Olfactory Dysfunction Post COVID-19
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RecruitingPhase 2/3
Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT for Long COVID)
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Recruiting
Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia
Paraosmia
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.
Jane K Parker, PhD principal investigator
University of Reading
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 Parosmia and Smell Disorder, run by University of Reading at 1 site in United Kingdom.
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 May 2023. 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 United Kingdom. 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?
Questionnaire (time frame: 20 minutes). 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 May 2023.