Study Evaluating the Olfactory Recovery of Anosmia Post COVID-19 by Olfactory Rehabilitation Assisted by Web-application (COVIDANOSMIA)

October 8, 2021 updated by: Weprom

Prospective Study Evaluating the Olfactory Recovery of Anosmia Post COVID-19 by Olfactory Rehabilitation Assisted by Web-application

Anosmia is a symptom present in 40 to 80% of patients and usually only lasts 1 to 2 weeks. However, in nearly one in five patients, it can last beyond or even several months with consequences in terms of undernutrition and depression. However, olfactory rehabilitation is a technique validated in post-infectious anosmia since 2014 and recommended by international learned societies to accelerate recovery with nearly 63% improvement in anosmia In the context of the health crisis linked to the coronavirus, approximately 1 million French people will have persistent anosmia following an infection with COVID-19. A web-application to support the olfactory coaching of anosmic patients and help with follow-up seems relevant to promote recovery and the proper conduct of this coaching.

covidanosmie.fr is a web application dedicated to olfactory rehabilitation, accessible free of charge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Mans, France, 72000
        • ILC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All users of the application who have not objected to the use of their data

Description

Inclusion Criteria:

  • Post-COVID anosmia lasting more than 1 month
  • Consent to the use of data via the application

Exclusion Criteria:

  • Other causes of anosmia than COVID
  • Contraindication to olfactory coaching (allergy to one of the aromatic oils)
  • Minor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
users
Users of web-application
Device: Web-application
support for olfactory coaching consisting of the inhalation of fragrant essential oils.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the rate of patients presenting an improvement in their anosmia
Time Frame: 16 weeks
Number of patients with an improvement in anosmia (increase of at least 1 point on the visual analogue scale 0-10) on the number of users
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the time until recovery of at least 1point in 10 (Visual Analog Scale) from anosmia,
Time Frame: 16 weeks
Time between the date of first use of the application and the date of recovery of at least one point of anosmia
16 weeks
Assessment of the duration of anosmia
Time Frame: 16 weeks
Time between the date of diagnosis or onset of anosmia and the date of final recovery
16 weeks
Evaluation of the recovery of at least one point in 10 (Visual Analog Scale) depending on the oils
Time Frame: 16 weeks
Evolution of the VAS according to the different oils, proportion of patients with an increase of at least 1 point in anosmia on a visual analog scale (from 0 no smell to 10 normal smell) of each oil
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weprom

Collaborators

Centre National de la Recherche Scientifique, France
Kelindi
Hospital of Tours

Investigators

  • Study Director: Fabrice DENIS, MD, Weprom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 25, 2021

Primary Completion (ACTUAL)

August 1, 2021

Study Completion (ACTUAL)

August 1, 2021

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (ACTUAL)

March 19, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WP-2020-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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