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

NCT05539560 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-09-23

No results posted yet for this study

Summary

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

Interventions

OTHER

Olfactory training with essential oils

Olfactory training twice daily with essential oils from Urtegaarden Aps with scents of orange, lavender, clove and peppermint. The olfactory training is performed every morning and evening, by smelling each of the oils for 30 seconds.

OTHER

Olfactory training with fragrance-free oils

Olfactory training twice daily with fragrance-free oils from Urtegaarden Aps in the same four containers as the intervention group. The olfactory training is performed every morning and evening, by smelling each of the oils for 30 seconds.

Sponsors & Collaborators

  • Ditte Gertz Mogensen

    lead OTHER

Principal Investigators

  • Vibeke G Backer, Professor · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-29
Primary Completion
2024-04-30
Completion
2025-09-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05539560 on ClinicalTrials.gov