The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction
NCT ID: NCT05539560
Last Updated: 2024-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
65 participants
INTERVENTIONAL
2022-06-29
2025-09-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention group
Olfactory training twice a day with essential oils
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.
Control group
Olfactory training twice a day with fragrance-free oils
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Does not read or speak Danish
* Lack of compliance to perform daily olfactory training
18 Years
ALL
No
Sponsors
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Ditte Gertz Mogensen
OTHER
Responsible Party
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Ditte Gertz Mogensen
PhD-student
Principal Investigators
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Vibeke G Backer, Professor
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Locations
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Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University Hospital
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Mogensen DG, Aanaes K, Andersen IB, Jarden M, Backer V. Effect of Olfactory Training in COVID-19 Related Olfactory Dysfunction-A Placebo-Controlled Trial. Laryngoscope. 2025 May 15. doi: 10.1002/lary.32275. Online ahead of print.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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2022-ENT-1-olfactory
Identifier Type: -
Identifier Source: org_study_id
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