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
Vibeke Backer, Professor
CONTACT
NCT Number: NCT05539560
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Copenhagen, 2100, Denmark
Location status: Recruiting
Ditte Gertz Mogensen, PhD-student
CONTACT
Vibeke Backer, Professor
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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)
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.
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).
Contact information is provided by the study sponsor or research team.
Ditte G Gertz Mogensen, PhD-student
CONTACT
Vibeke Backer, Professor
CONTACT
Ditte Gertz Mogensen
Other
The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction - A Randomized Placebo-controlled Clinical Trial
Acronym: SMELLT2022
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.
Published trials that share one or more normalized conditions with this study.
NCT05384561
Anosmia, COVID-19
Trois-Rivières, Quebec, Canada
View Trial DetailsNCT07149428
Anosmia, Behavior
Bethesda, Maryland, United States
View Trial DetailsNCT05184192
Anosmia, COVID-19
St Louis, Missouri, United States
View Trial DetailsNCT04526054
Anosmia, COVID-19
Garches, France
View Trial Details