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NCT Number: NCT05539560

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Ditte Gertz Mogensen, PhD-student

CONTACT

[email protected]

+45 35457508

Vibeke Backer, Professor

CONTACT

[email protected]

+45 3545 6033

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • > 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

Treatment and study plan

Olfactory training with essential oils

Other

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 names: Urtegaarden ApS Essential Oils

Olfactory training with fragrance-free oils

Other

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.

Other names: Urtegaarden ApS Essential Oils (Fragrance-free custom made)

Primary outcomes

  1. Change in Extended Sniffin' Sticks Test score

    Time frame: 3 months follow-up

    Change in TDI score measured by Burghart Extended Sniffin' Sticks Test (TDI test). The TDI test, consists of a threshold test, a discrimination test, and an identification test. The results of the three subtests makes a total TDI score, where the minimum score is 1 and the maximum score is 48. A score >30 indicates normal olfactory function, a score between 15-30 indicates hyposmia and a score <15 indicates anosmia in the form of severely impaired or complete loss of olfaction.

Secondary outcomes

  1. Change in Quality of Life

    Time frame: 3 months follow-up

    Change in Quality of Life measured by the questionnaire Taste and Smell Tool for Evaluation. The minimum score is 21 and the maximum score is 105. A higher score means worse outcome (quality of life).

Study contacts

Contact information is provided by the study sponsor or research team.

Ditte G Gertz Mogensen, PhD-student

CONTACT

[email protected]

+45 35457508

Vibeke Backer, Professor

CONTACT

[email protected]

+45 35456033

Sponsors and collaborators

Lead sponsor

Ditte Gertz Mogensen

Other

Registry information

Official study title

The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction - A Randomized Placebo-controlled Clinical Trial

Acronym: SMELLT2022

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Sep 14, 2022
Registry last updated
Sep 23, 2024

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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