ClinicalTrials.gg
CompletedNCT04868435ParosmiaQUpdated May 9, 2023

Triggers for Post-Viral Parosmia

An observational study in Parosmia and Smell Disorder, sponsored by University of Reading. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by University of Reading · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
943
Ages
18 Years and older
Sex
All
01

Study 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. 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

  1. Triggers of distortion will be the same for all parosmics.
  2. There may be additional trigger foods in different cultures.

Questions

  1. What are the trigger foods and beverages for parosmia?
  2. Are there regional/cultural variations?
  3. 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.

02

Conditions studied

  • Parosmia
  • Smell Disorder

Browse trials for

Keywords

  • Parosmia
  • COVID
  • Trigger foods
03

In context

Olfaction Disorders

70 studies on the registry are indexed under Olfaction Disorders; 18 are open to participants now.

This study's enrollment of 943 is above the median of 81 across 16 observational studies indexed under Olfaction Disorders.

Browse Olfaction Disorders studies →

Lead sponsor

University of Reading is the lead sponsor of 150 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals should be currently experiencing parosmia

Exclusion criteria

Exclusion Criteria:

  • Individuals below 18 years old will be excluded from the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
943 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 20 minutes

07

Study locations

1 site
  • University of Reading
    Reading, RG6 6AP, United Kingdom
08

References and documents

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2020 to primary completion in Jul 2021, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2021
First posted
May 3, 2021
StartActual
Nov 3, 2020
Primary completionActual
Jul 31, 2021
CompletionActual
Feb 3, 2023
Last update
May 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04868435
Collaborators
AbScent, University of London, University College London Hospitals
Responsible party
Jane Parker (Associate Professor, University of Reading) — Principal investigator
First posted
May 3, 2021
Start date
Nov 3, 2020
Primary completion
Jul 31, 2021
Completion
Feb 3, 2023
Last update
May 9, 2023

Study contacts

Jane K Parker, PhD
principal investigator · University of Reading

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion