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Association Between Smell Training and Quality of Life in Patients With Impaired Sense of Smell Following COVID-19 (SMELLT2022)

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Olfactory training with essential oils
Olfactory training with fragrance-free oils
Sponsored by
Ditte Gertz Mogensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Olfactory training, Quality of life, Olfactory dysfunction, Covid-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Olfactory dysfunction caused by COVID-1
  • Hyposmia (15-30) or anosmia (<15) assessed by TDI test with Sniffin Sticks performed in the Unit for Sense of Taste and Smell or medical assessment of 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

Sites / Locations

  • Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

Olfactory training twice a day with essential oils

Olfactory training twice a day with fragrance-free oils

Outcomes

Primary Outcome Measures

Change in Quality of Life
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).

Secondary Outcome Measures

Change in Extended Sniffin' Sticks Test score
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.
Change in Major Depression Inventory score (MDI)
Change in MDI score measured by Major Depression Inventory. The theoretical sum score ranges from 0 (no depression) to 50 (maximum depression).

Full Information

First Posted
September 2, 2022
Last Updated
September 13, 2022
Sponsor
Ditte Gertz Mogensen
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1. Study Identification

Unique Protocol Identification Number
NCT05539560
Brief Title
Association Between Smell Training and Quality of Life in Patients With Impaired Sense of Smell Following COVID-19
Acronym
SMELLT2022
Official Title
Association Between Olfactory Training and Quality of Life in Patients With Impaired Sense of Taste and Smell Following COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ditte Gertz Mogensen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim: The aim is to investigate whether guided systematic olfactory training with essential oils to improve impaired sense of smell following COVID-19, can improve patients' quality of life. Hypothesis: The impaired quality of life in patients with impaired sense of smell following COVID-19, can be significantly improved in patients performing olfactory training with essential oils, compared to patients performing olfactory training with placebo oils. Study design: The study is a 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 (15-30) or anosmia (<15) assessed by Sniffin' Sticks Olfactory Test for Threshold, Discrimination and Identification (TDI) performed in the Unit for Sense of Taste and Smell or medical assessment of parosmia based on medical history > 18 years of age Exclusion criteria: Cause of hyposmia, anosmia or parosmia other than COVID-19 Impaired sense of taste and smell >24 months 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. Taste test: To assess patients' sense of taste, taste sprays with the basic tastes are used. Questionnaires: 'Taste and Smell Tool for Evaluation' is used to investigate quality of life related to impaired sense of taste and smell. 'Major Depression Inventory' (MDI) is used in the project to assess whether the patient is depressed and to make a possible assessment of the severity of depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Olfactory training, Quality of life, Olfactory dysfunction, Covid-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Olfactory training twice a day with essential oils
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Olfactory training twice a day with fragrance-free oils
Intervention Type
Other
Intervention Name(s)
Olfactory training with essential oils
Other Intervention Name(s)
Urtegaarden ApS Essential Oils
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Olfactory training with fragrance-free oils
Other Intervention Name(s)
Urtegaarden ApS Essential Oils (Fragrance-free custom made)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Quality of Life
Description
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).
Time Frame
3 months follow-up
Secondary Outcome Measure Information:
Title
Change in Extended Sniffin' Sticks Test score
Description
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
Title
Change in Major Depression Inventory score (MDI)
Description
Change in MDI score measured by Major Depression Inventory. The theoretical sum score ranges from 0 (no depression) to 50 (maximum depression).
Time Frame
3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Olfactory dysfunction caused by COVID-1 Hyposmia (15-30) or anosmia (<15) assessed by TDI test with Sniffin Sticks performed in the Unit for Sense of Taste and Smell or medical assessment of 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ditte G Gertz Mogensen, PhD-student
Phone
+45 35457508
Email
ditte.gertz.mogensen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Vibeke Backer, Professor
Phone
+45 35456033
Email
nina.vibeke.backer@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vibeke G Backer, Professor
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ditte Gertz Mogensen, PhD-student
Phone
+45 35457508
Email
ditte.gertz.mogensen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Vibeke Backer, Professor
Phone
+45 3545 6033
Email
nina.vibeke.backer@regionh.dk

12. IPD Sharing Statement

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Association Between Smell Training and Quality of Life in Patients With Impaired Sense of Smell Following COVID-19

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