Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05539560

The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction

Led by Ditte Gertz Mogensen · Updated on 2024-09-23

65

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Aim: The aim is to investigate the effect of olfactory training with essential oils versus olfactory training with placebo-oils in patients with COVID-19 induced olfactory dysfunction Study design: The study is a placebo-controlled randomized clinical trial with an intervention group and a control group. The intervention group receive four essential oils with scents of orange, lavender, clove, and peppermint. Patients in the control group receive a fragrance kit, consisting of the same containers, but with fragrance-free oils added. Both groups are instructed to smell each of the four oils for 30 seconds in the morning and evening, over a three-month intervention period. Patients are given a diary in which to record their olfactory training. The nurse or medical student instructing the patients in the training and performing the smell and taste tests is blinded. Study population: Patients referred to the Unit for Sense of Taste and Smell in the Department of Otorhinolaryngology Head \& Neck and Audiology at Rigshospitalet. Inclusion criteria: * Impaired sense of taste and smell following COVID-19 \> 3 months * Hyposmia (16.25-30.5) or anosmia (\<16) assessed by Sniffin' Sticks Olfactory Test for Threshold, Discrimination and Identification (TDI) performed in the Unit for Sense of Taste and Smell with or without parosmia based on medical history * \> 18 years of age Exclusion criteria: * Cause of hyposmia, anosmia or parosmia other than COVID-19 * Does not read or speak Danish * Lack of compliance to perform daily olfactory training Procedures: \- TDI-test: To assess patients' sense of smell, the TDI-test with Sniffin' Sticks is used, which is a validated tool with normative data. Questionnaires: \- 'Taste and Smell Tool for Evaluation' is used to investigate quality of life related to impaired sense of taste and smell.

CONDITIONS

Official Title

The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Olfactory dysfunction caused by COVID-19
  • Hyposmia (16.25-30.5) or anosmia (<16) with or without parosmia assessed by TDI test with Sniffin Sticks performed in the Unit for Sense of Taste and Smell
  • Age greater than 18 years
Not Eligible

You will not qualify if you...

  • Cause of hyposmia, anosmia or parosmia other than COVID-19
  • Does not read or speak Danish
  • Lack of compliance to perform daily olfactory training

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University Hospital

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

D

Ditte G Gertz Mogensen, PhD-student

CONTACT

V

Vibeke Backer, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction | DecenTrialz