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The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction (SMELLT2022)

D

Ditte Gertz Mogensen

Status

Enrolling

Conditions

COVID-19

Treatments

Other: Olfactory training with essential oils
Other: Olfactory training with fragrance-free oils

Study type

Interventional

Funder types

Other

Identifiers

NCT05539560
2022-ENT-1-olfactory

Details and patient eligibility

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.

Enrollment

65 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

65 participants in 2 patient groups, including a placebo group

Intervention group
Experimental group
Description:
Olfactory training twice a day with essential oils
Treatment:
Other: Olfactory training with essential oils
Control group
Placebo Comparator group
Description:
Olfactory training twice a day with fragrance-free oils
Treatment:
Other: Olfactory training with fragrance-free oils

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Vibeke Backer, Professor; Ditte G Gertz Mogensen, PhD-student

Data sourced from clinicaltrials.gov

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