The Effect of Olfactory Training in Patients With COVID-19 Induced Olfactory Dysfunction - A Randomized Placebo-controlled Clinical Trial
Phase: NA
Conditions: COVID-19
Sponsor: Ditte Gertz Mogensen

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Association between olfactory training and quality 
of life in patients with impaired sense of taste and 
smell following COVID-19 
- a randomized controlled trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of contents  
Introduction ................................................................................................................................................. 3 
Background .................................................................................................................................................. 3 
The olfactory function ............................................................................................................................. 3 
Olfactory training .................................................................................................................................... 4 
Quality of life ............................................................................................................................................ 4 
Aim ............................................................................................................................................................ 5 
Hypothesis ................................................................................................................................................ 5 
Primary outcome ..................................................................................................................................... 5 
Secondary outcome .................................................................................................................................. 6 
Materials and methods ................................................................................................................................ 6 
Study design ............................................................................................................................................. 6 
Study population and recruitment ......................................................................................................... 6 
Procedures ................................................................................................................................................ 8 
Statistical analysis .................................................................................................................................... 9 
Risk and side effects .................................................................................................................................. 10 
Information from patient records and processing of personal data ..................................................... 10 
Economy ..................................................................................................................................................... 11 
Conflicts of interest .................................................................................................................................... 11 
Publication of results ................................................................................................................................. 11 
Ethical considerations ............................................................................................................................... 11 
References .................................................................................................................................................. 12 
 
 
 
 
 
 
 
 

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Introduction 
Loss of the sense of taste and smell occurs in 65-88% of patients infected with new corona virus and 
is considered the most common symptom of COVID-19 (1). In contrast to previous post-viral 
olfactory loss, in coronavirus it is often younger patients, with milder course of COVID-19, who 
experience the combined taste and smell loss (1,2). The duration of the impaired sense of taste and 
smell ranges from a few days to weeks after the cessation of infection (3). 20-28% of the patients 
have persistently impaired sense of taste and smell (4), which is also one of the most frequently 
reported late sequelae after infection with COVID-19 (3). 
Previous studies show that loss of the sense of smell is closely associated with a decline in quality of 
life (5,6). Smell training twice a day has been shown to be effective in other groups of patients with 
impaired sense of smell (7,8), whereas in patients with late sequelae of COVID-19, there is not yet 
evidence on the long-term effect of smell training and whether it can improve quality of life in this 
group of patients, and this should be investigated. 
 
Background  
Post-infectious olfactory loss is the second most common form of odour loss and occurs mainly after 
viral infections of the upper respiratory tract, such as influenza virus, rhinovirus, adenovirus and virus 
strains of the corona family (1). COVID-19, also a viral respiratory infection, was declared a 
pandemic by the WHO in March 2020 (3). COVID-19, which is caused by novel coronavirus (SARS-
CoV-2), can present as anything from mild illnesses with mild colds to severe lower respiratory tract 
infections (3,9). SARS-CoV-2, like previous corona variants, is transmitted by droplet and contact 
transmission (9). One of the earliest and most frequent symptoms of COVID-19 is the combined loss 
of the senses of smell and taste, which, unlike previous post-viral odour losses, has been shown to 
frequently affect younger patients, as well as women, with milder disease courses (1,9). 
 
The olfactory function 
Odour molecules reach the olfactory epithelium along two pathways, the orthonasal and retronasal. 
In orthonasal olfaction, odours in the external environment reach the epithelium through inhalation 
via the nostrils. This happens when we breathe or sniff with our mouth closed. Retronasal olfaction 
is the perception of odours emanating from the oral cavity during eating and drinking (10).  

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The retronasal passage is essential for the sense of taste, as the taste buds' discrimination between the 
different tastes must be combined with olfactory stimuli to obtain differentiable sensations of tastes 
and aromas (10). The sense of taste and smell are therefore perceptually closely linked, as they both 
contribute to the experience of taste (8,10), which is why patients with an impaired sense of smell 
will often complain of an impaired sense of taste. 
Olfactory dysfunction can be divided into quantitative and qualitative (1,8,11). The quantitative 
olfactory dysfunctions are categorized into hyposmia (reduced olfactory function) and anosmi 
(absence of all olfactory function). The qualitative olfactory dysfunctions are defined as disorders of 
odour identification, including parosmia (altered odour perception with odour present) and 
phantosmia (perception of smell without odour present) (1,8,11). The cause of the olfactory 
dysfunction caused by COVID-19 is thought to be comparable to previous post-viral olfactory 
dysfunction where the sensory loss is due to an effect on the mucosa and/or olfactory neurons (12). 
The olfactory dysfunction, as a late sequelae to COVID-19, can manifest both quantitatively and 
qualitatively as anosmia, hyposmia, parosmia and phantosmia (12). 
 
Olfactory training 
Olfactory training in patients with impaired sense of smell is often effective regardless of the etiology 
(8,11). However, the long-term effect is not yet known for the post-viral odour loss as a late follow-
up to COVID-19. Olfactory training is performed by smell the same four different odours for 20 
seconds in the morning and evening for three months, after which the patient is switched to a new set 
of odours (8,12). The scents should have a high concentration of fragrance molecules, so essential 
oils are recommended, for example, orange, lavender, peppermint and clove (13). It is thought that 
the effect of olfactory training is due to stimulation of the formation of new olfactory sensory neurons, 
but the effect may also be due to increased central registration of the olfactory stimuli themselves 
(8,11). Patients with loss of taste and smell will often experience an improvement in taste first, 
followed by a gradual improvement in smell (14). In the course after the postviral odour loss, 
parosmia is commonly known to occur and is considered a good prognostic factor (8,14). 
 
Quality of life 
International studies show that loss of the sense of smell is closely associated with deterioration in 
quality of life, as impaired sense of smell affects patients' eating experience, their sexual life and 
creates concerns about personal hygiene, which reduces participation in social life (5,6,11). 

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The loss of the sense of smell affects the patients' appetite, as the food is tasteless, and therefore 
reduces the pleasure of eating. The meal-related problems are not limited to the meal itself, but also 
to the tasting during preparation (5). Patients experience problems with tasting when the food burns, 
as well as smelling spoiled food, which can have an impact on their health (5,6). A common concern 
among patients with impaired sense of smell is the risk of not being able to smell smoke and gas, 
which can be a potential life-threatening hazard (5).  
Personal hygiene has also been reported as a problem in patients with impaired sense of smell, as 
patients are concerned about not being able to perceive their own body odours such as sweat and bad 
breath (5,6). Loss of the sense of smell may have implications for working life, as this sense is 
essential in some types of occupation. Some patients may therefore experience problems in their 
working lives and have to ask for special accommodations, where others have to change profession 
(5). 25-33% of patients with loss of the sense of smell even show depressive symptoms, and 
international studies show that parosmia and phantosmia in particular are risk factors for high 
depression scores (5,6). 
 
Aim 
The aim is to investigate whether guided systematic olfactory training with essential oils to improve 
impaired sense of taste and smell following COVID-19, can improve patients' quality of life. 
 
Hypothesis  
The impaired quality of life in patients with impaired sense of taste and 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. 
 
Primary outcome 
To demonstrate improvement in quality of life measured by the QoL questionnaire ‘Taste and Smell 
Tool for Evaluation’, in patients diagnosed with anosmia, hyposmia og parosmia following COVID-
19, randomised to three months of olfactory training with essential oils compared to control patients 
performing olfactory training with placebo oils. 

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Secondary outcome 
To demonstrate whether three months of olfactory training with essential oils can improve the sense 
of taste and smell, measured objectively by TDI, in patients diagnosed with anosmia, hyposmia or 
parosmia after infection with COVID-19, compared to patients performing olfactory training with 
placebo oils. 
To demonstrate whether three months of olfactory training with essential oils has an impact on 
depressive symptoms measured by the Major Depression Inventory (MDI), in patients with anosmia, 
hyposmia or parosmia after infection with COVID-19, compared to patients performing olfactory 
training with placebo oils. 
 
Materials and methods 
Study design 
Patients with impaired or complete loss of taste and smell following COVID-19, will be block 
randomised to the intervention or control group using SPSS. At randomisation, the type of odour loss 
related to COVID-19 (hyposmia/anosmia/parosmia) and gender is stratified. 
Patients in the intervention group receive four essential oils with scents of orange, lavender, clove, 
and peppermint. Patients in the control group also receive a fragrance kit, consisting of the same 
containers, but with fragrance-free oils added. Both the intervention and control 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 and a weekly 
status of their olfactory function (VAS).  
The nurse or medical student instructing the patients in the training and performing the TDI tests at 
the initial visit and at the follow-up visit after the intervention period is blinded. Patients receive a 
twice-weekly SMS reminder about olfactory training. 
 
Study population and recruitment  
The study population consists of patients referred to the Unit for Sense of Taste and Smell in the 
Department of Otorhinolaryngology Head & Neck and Audiology at Rigshospitalet. The referral 
criteria for the Unit are that the patients must have been assessed by a private practice 
otorhinolaryngologist who has performed an ENT examination (including endoscopy of the cavum 

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nasi and a prick test) and referral for MR regio olfactoria. Patients must have had complaints of taste 
and smell > 3 months and be diagnosed with hyposmia or anosmia based on Sniffin Sticks 12 (SIT12) 
or BSIT. 
Inclusion and exclusion criteria  
To be included in the intervention study, the patient must meet the following criteria: 
Inclusion criteria: 
- 
Impaired sense of taste and smell following COVID-19 > 3 months 
- 
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 
- 
Impaired sense of taste and smell >24 months 
- 
Does not read or speak Danish 
- 
Lack of compliance to perform daily olfactory training 
If patients meet the inclusion and exclusion criteria for participation in the intervention study at their 
initial visit in the Unit of Sense of Taste and Smell, they will receive information about the project 
from the investigator in her office, where the information can be given undisturbed. Patients are 
informed of all the advantages and disadvantages of participation in the study and based on this 
information, must give written informed consent prior to inclusion in the project. If patients wish to 
participate, they may be randomised at the initial visit to the intervention or control group and receive 
instruction in the performance of olfactory training. If patients wish to have further reflection time, 
they will be given the contact details of the study investigators and can then make enquiries if they 
are interested in participating in the study. These patients will be invited to a physical visit to the unit, 
where they will sign informed consent, be randomised, and receive instruction in the olfactory 
training. 
 

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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 (8,15). In practice, the TDI test is performed by a blinded nurse or medical 
student sitting with the patient in a room free of distracting factors and with the possibility of 
ventilation. The threshold test is performed first, followed by the discrimination test and finally the 
identification test (16,17). 
Threshold test: the patient must smell 16 times three scent pens with different scent intensities of n-
butanol. The test determines how strong the odour must be before the patient can detect it (16). Three 
scented pens are presented to the patient in randomised order; one scented pen contains n-butanol and 
two of the pens are odourless. The patient is asked to smell each of the three scent pens for four 
seconds with a five-second break between each pen. The next three pens are then presented to the 
patient for 30 seconds. During the threshold test, the patient is blindfolded and asked to identify which 
pen contains n-butanol. If the fragrance cannot be identified, the patient must make a guess. The score 
of the threshold test ranges between 1-16 (15). 
Discrimination test: the patient must smell 16 times three scent pens, in randomized order, where two 
of the pens contain the same scent and the third contains a different scent. The patient must smell 
each of the three pens for four seconds with a five-second break between each pen, after which 30 
seconds must elapse before the next three pens are presented to the patient. During this test, the patient 
is blindfolded and asked to identify which of the two scent pens smells different from the other two. 
If this pen cannot be identified, the patient is asked to make a guess (17). The score of the 
discrimination test ranges between 0-16  (15). 
Identification test: the patient must smell 16 scented pens with common odours. The patient has to 
identify the odours in the scent pens using four answer options for each odour (16). For the 
identification test, a Danish validated answer sheet is used, which is adapted to the linguistic and 
cultural factors of the Danish population (18). The patient is asked to smell each of the 16 scent pens 
for four seconds followed by a 30-second pause before the next scent pen is presented to the patient. 
If the odour cannot be identified from the four response options, the patient must make a guess (17). 
The score of the identification test ranges between 0-16 (15).  

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The results of the three subtests makes a total TDI score (11,15). 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. 
Taste test 
To assess patients’ sense of taste, taste sprays developed by XXX, are used. The sprays consist of the four 
basic tastes and a neutral resolution: 1) citric acid monohydrate resolution 5% (sour), 2) sucrose resolution 
10% (sweet), 3) natriumchlorid resolution 7,5% (salty), 4) Quinine hydrochloride 0,05% resolution (bitter), 
and 5) purified water (neutral). In practice, the taste test is performed by a nurse or medical student who sprays 
each of the five sprays on the patient’s tongue. The patient is then asked to indicate the perceived taste of 
either salty, sour, sweet, bitter og neutral.  After each spray, the patient should rinse their mouth with water. 
The patient scores one point for each correct recognition and can therefore have a maximum score of five 
points. 
Questionnaires  
Taste and Smell Tool for Evaluation: 
To investigate whether olfactory training can improve the quality of life in patients with anosmia, 
hyposmia or parosmia, the QoL questionnaire ‘Taste and Smell Tool for Evaluation’ is used. The 
questionnaire is Danish validated and aims to investigate the quality of life in this patient group.  
 
Major Depression Inventory (MDI): 
The Danish validated questionnaire, 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. 
 
Statistical analysis 
The statistical analysis of the data is performed using IBM SPSS Statistics. Results are presented as 
mean, SD, range and 95% CI. The parametric data are compared by paired and unpaired tests, and 
the non-parametric data by Wilcoxon Signed-Ranks Test and Mann-Whitney Test. Categorical 
variables are tested by chi-square test. A P-value <0.05 is considered significant. 
Power calculation 
As the primary outcome of the intervention study is to demonstrate an improvement in patients' 
quality of life measured by the QoL questionnaire ‘Taste and Smell Tool for Evaluation’, the power 

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calculation will be based on this questionnaire, which is currently being developed. As the 
questionnaire is not yet published, a provisional MCID of 1 point and SD=1 is set. α-value <0.05 and 
β-value of 80%. Therefore, 16 patients in the intervention group and 16 patients in the control group 
are needed to demonstrate a change in quality of life related to olfactory training. With an expected 
dropout rate of 20%, 19 patients will be needed in each group. The final result of the power calculation 
will depend on the questionnaire when published from the Flavour Clinic Holstebro (expected end of 
November 2022). It is expected that approximately 75 patients will be included in each group. 
 
Risk and side effects  
There are no serious side effects associated with participation in the trial. However, as previous 
research shows that the best effect of olfactory training is achieved if it is started within 12 months 
of the onset of symptoms, there is a risk that patients in the control group may have a worse prognosis 
than patients in the intervention group. As one of the referral criteria for the specialised assessment 
in the Unit of Sense of Taste and Smell is that patients should have had an impaired sense of smell 
for >3 months, there is a risk that patients in the control group may start olfactory training later than 
recommended. To reduce this risk, patients in the control group will receive a paid olfactory training 
kit on equal terms with the intervention group, soon after the end of the trial. As the intervention study 
is carried out in a public hospital in Denmark, the public patient reimbursement scheme will cover 
any injury suffered by the study participants during participation in the research project. 
 
Information from patient records and processing of personal data 
No personal data will be collected from patient records for this intervention study. The data included 
in the study consists of data from patient completed questionnaires and results from the clinical 
objective tests of the sense of taste and smell. Data are obtained and entered the REDCap database 
only after patient consent, as patients are recruited during their initial visit to the Unit of Sense of 
Taste and Smell. Consent allows the trial investigator and any controlling authority to retrieve 
information from the patient's electronic medical record. The study is carried out in full compliance 
with the Data Protection Regulation and the Danish Data Protection Act. The data collected will be 
treated confidentially and used exclusively for internal purposes and will therefore not be shared with 
external data processors. If consent is given during the study, electronic reminders for olfactory 
training and diary completion (SMS and e-mail) may be sent to participants. 

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Economy  
Patients do not receive payment or travel reimbursement for participating in the intervention study, 
as the visits to the Unit of Sense of Taste and Smell follow the normal control visits and thus do not 
require additional driving for patients. As this intervention study is a clinical trial that is part of the 
regular outpatient operation of the Department of Otorhinolaryngology Head & Neck and Audiology 
at Rigshospitalet, the evaluation of the patients, including the performance of the TDI test and taste 
test, is no extra cost. The nurse and/or medical student performing the clinical tests of patients' sense 
of taste and smell, as well as the investigator performing research as part of her employment as a 
clinical nurse specialist, are therefore paid by the Department. The purchase of the essential oils as 
well as placebo oils is covered by the department's Global Airways fund, which is administered by 
Professor, Vibeke Backer. 
 
Conflicts of interest  
There are no conflicts of interest to report related to this study. 
 
Publication of results  
The results of the study, both positive, negative, and inconclusive, will be published in relevant 
scientific journals and at scientific congresses, if possible. The results will also be published on 
ClinicalTrials.gov. 
 
Ethical considerations  
The study is conducted in accordance with the Helsinki Declaration (19).  The study is conducted in 
accordance with the Helsinki Declaration (19). Patients who meet the study's inclusion and exclusion 
criteria will receive information about the research project at their initial visit to the Unit of Sense of 
Taste and Smell. If, based on the participant information, patients wish to participate in the study, 
they will be asked to sign a written informed consent. The project has been notified to and approved 
by the Capital Region's research registry, Pactius (P-2021-803). The project has also been approved 
by the Scientific Ethics Committee of the Capital Region (H-21074055). 
 

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References 
1.  
Fjældstad AW, Ovesen T. Lugte- og smagstab ved COVID-19. 2020;1–7.  
2.  
Lechien JR, Chiesa-Estomba CM, De Siati DR, Horoi M, Le Bon SD, Rodriguez A, et al. 
Olfactory and gustatory dysfunctions as a clinical presentation of mild-to-moderate forms of 
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of life: A mutual relationship. Brain Sci. 2018;8(5).  
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Sorokowska A, Drechsler E, Karwowski M, Hummel T. Effects of olfactory training: A 
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paper on olfactory dysfunction. Rhinology. 2017;54:1–30.  
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Whitcroft KL, Hummel T. Olfactory Dysfunction in COVID-19: Diagnosis and 
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Assembly WG. WMA DECLARATION OF HELSINKI – ETHICAL PRINCIPLES FOR 
MEDICAL RESEARCH INVOLVING HUMAN SUBJECTS. 2013.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

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Informed consent for participation in a health science research project 
 
Research project title:  
Association between olfactory training and quality of life in patients with impaired sense of 
taste and smell following COVID-19 - a randomized controlled trial 
 
Trial participant declaration of consent: 
I have received written and oral information and I know enough about the purpose, the method, the 
advantages, and the disadvantages of the trial to give my consent to participate in the trial. 
 
I know that it is voluntary to participate and that I can withdraw my consent at any time without losing 
my present and future rights to receive treatment. 
 
I give my consent to participate in the research project and have received a copy of the declaration of 
consent, as well as a copy of the written information about the project. 
 
Name of the trial participant: ___________________________________________________ 
 
Date: _______________   
Signature: _________________________________ 
 
 
You will be informed if significant new information regarding your health is disclosed during the 
research project. If you request to not be informed about significant new information regarding your 
health that is being disclosed during the research project, please tick here: ____________ (x) 
 
Would you like to be informed about the results of the research project and any consequences it might 
have for you? 
Yes _____ (x) No _____ (x)  
 
Would you like to receive text messages from Department of Otorhinolaryngology, Head and Neck 
Surgery & Audiology with reminders to perform olfactory training and completion of the diary? 
 
Yes _____ (x) No _____ (x)  
 
 
Declaration from the person providing information: 
I declare that the trial participant has received oral and written information about the trial.  
I believe that sufficient information has been provided in order to make a decision regarding 
participation in this trial. 
Name of the person providing information: _______________________________________ 
 
Date: _______________   
Signature: _________________________________