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Completed

NCT Number: NCT04806880

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.

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Key information

Conditions

Covid19 Anosmia COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nervous System Diseases Neurologic Manifestations Nidovirales Infections Olfaction Disorders Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Sensation Disorders Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ILC

Le Mans, 72000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

web-application

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Weprom

Other

Collaborators

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

Registry information

Official study title

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

Acronym: COVIDANOSMIA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2021
Registry last updated
Oct 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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