NCT04868435

Brief 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. 1.Triggers of distortion will be the same for all parosmics.
  2. 2.There may be additional trigger foods in different cultures.
  3. 3.What are the trigger foods and beverages for parosmia?
  4. 4.Are there regional/cultural variations?
  5. 5.Does Covid-19 parosmia differ from "standard" post-viral parosmia?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
943

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

April 26, 2021

Last Update Submit

May 8, 2023

Conditions

Keywords

ParosmiaCOVIDTrigger foods

Outcome Measures

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.

    20 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Individuals should be currently experiencing parosmia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, RG6 6AP, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Olfaction Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jane K Parker, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 3, 2021

Study Start

November 3, 2020

Primary Completion

July 31, 2021

Study Completion

February 3, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

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.

Locations