Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 7:58 AM
Study NCT ID:
NCT05539560
Status:
RECRUITING
Last Update Posted:
2024-09-23
First Post:
2022-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction
Sponsor:
Ditte Gertz Mogensen
Organization:
Study Overview
Official Title:
The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction - A Randomized Placebo-controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMELLT2022
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: