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

NCT04806880 | Completed

• 1 other identifier: WP-2020-06
• Study Type: observational
• Target: 1,155
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Keywords

Web-application; Anosmia; COVID-19; coaching

Outcome Measures

Primary Outcomes (1)

• Evaluation of the rate of patients presenting an improvement in their anosmia

  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 Outcomes (3)

• Evaluation of the time until recovery of at least 1point in 10 (Visual Analog Scale) from anosmia,

  16 weeks

• Assessment of the duration of anosmia

  16 weeks

• Evaluation of the recovery of at least one point in 10 (Visual Analog Scale) depending on the oils

  16 weeks

Study Arms (1)

users

Users of web-application

Device: Web-application

Interventions

Web-application DEVICE

support for olfactory coaching consisting of the inhalation of fragrant essential oils.

users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weprom: lead
• Kelindi: collaborator
• Centre National de la Recherche Scientifique, France: collaborator
• Hospital of Tours: collaborator

Study Sites (1)

ILC

Le Mans, 72000, France

Location

MeSH Terms

Conditions

COVID-19; Anosmia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabrice DENIS, MD

  Weprom

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: January 25, 2021
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 11, 2021

Record last verified: 2021-03

Locations

FR (1)