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

Completed

• Conditions: Covid19
• Interventions: Device: Web-application

• Registration Number: NCT04806880
• Lead Sponsor: Weprom

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-25
• Status Verified: 2021-03
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-19
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Last Update Submitted: 2021-10-08
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1155

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
users	Web-application	Users of web-application

Primary Outcome Measures

Name	Time	Method
Evaluation of the rate of patients presenting an improvement in their anosmia	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

Secondary Outcome Measures

Name	Time	Method
Evaluation of the recovery of at least one point in 10 (Visual Analog Scale) depending on the oils	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
Evaluation of the time until recovery of at least 1point in 10 (Visual Analog Scale) from anosmia,	16 weeks	Time between the date of first use of the application and the date of recovery of at least one point of anosmia
Assessment of the duration of anosmia	16 weeks	Time between the date of diagnosis or onset of anosmia and the date of final recovery

Trial Locations

Locations (1)

ILC; 🇫🇷 Le Mans, France