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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University Hospital
RECRUITING
Copenhagen
Contact Information
Primary
Ditte G Gertz Mogensen, PhD-student
ditte.gertz.mogensen@regionh.dk
+45 35457508
Backup
Vibeke Backer, Professor
nina.vibeke.backer@regionh.dk
+45 35456033
Time Frame
Start Date: 2022-06-29
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 65
Treatments
Experimental: Intervention group
Olfactory training twice a day with essential oils
Placebo_comparator: Control group
Olfactory training twice a day with fragrance-free oils
Related Therapeutic Areas
Sponsors
Leads: Ditte Gertz Mogensen

This content was sourced from clinicaltrials.gov