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Olfactory dysfunction (OD) like hyposmia or anosmia has been realized as a common symptom or even cardinal sign of the disease and can be persisting after recovering.
There are two different hypotheses on the pathogenesis of OD in past COVID-19: The central hypothesis, which speculates on neurotrophic abilities on olfactory receptors in the neuroepithelium, and the peripheral hypothesis, which speculates on damage of the sensory olfactory epithelium.
Potential treatment strategies aim for the unique neural plasticity of the olfactory system and its potential for recovery.
Clinical studies and case reports have shown a promising effect of olfactory training (OT) by frequent sniffing and/or exposure to odors 2-4 times a day for several weeks.
The main objective of the study is to assess the effects of olfactory training in patients with COVID-19 related OD on:
The sense of smell is an important function for social relationships and is therefore a challenging clinical problem with few proven therapeutic options.
With this new approach, we want to investigate a possible simple treatment for an impedimental symptom of COVID-19, but also learn more about the pathomechanism of post-infectious OD.
To our knowledge, this will be the first study comparing patients with COVID-19 associated OD with and without OT in clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olfactory training group | Experimental | 12 weeks of olfactory traiing with Sniffin' sticks "Duftquartett". |
|
| no olfactory training with natural history of the disease | No Intervention | natural history of the disease |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sniffin' sticks Duftquartett | Device | 4-odor training set over 12 weeks with Sniffin' sticks "Duftquartett" |
|
| Measure | Description | Time Frame |
|---|---|---|
| primary endpoint | changes between groups from baseline to week 12/termination visit regarding correct odor identification and discrimination | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale | from 0 to 10, higher score means better subjective olfaction | 12 weeks |
| Short-Form-36 Health Survey Questionnaire (SF-36) | Quality of Life Each domain is scored from 0 to 100, higher scores mean better health status |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beatrice Heim, MD PhD | Medical University Innsbruck | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40436445 | Derived | De Cleene N, Jagusch F, Schmutzhard J, Gottfried T, Peball M, Djamshidian A, Ellmerer P, Goebel G, Helbok R, Kindl P, Loffler-Ragg J, Weiss G, Seppi K, Heim B; SMELL study-group. Protocol for olfactory training in persisting COVID-19-associated loss of smell (SMELL): a monocentric randomised controlled trial conducted in Innsbruck. BMJ Open. 2025 May 27;15(5):e094027. doi: 10.1136/bmjopen-2024-094027. |
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Data supporting the results will be archived in an appropriate public repository
after publication of the primary data
data will be deposited in appropriate public repositories
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000086582 | Anosmia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 12 weeks |
| Mood inventory | Will be applied in German | 12 weeks |
| Hospital Anxiety and Depression Scale | Anxiety and Depression Each item is scored on a 4-point scale from 0 to 3; lower scores mean less anxiety/depression | 12 weeks |
| Patient Progress and treatment response over time | Using Patient Global Impression of Improvement | 12 weeks |
| Clinical treatment response over time | Using Clinical Global Impression of Improvement | 12 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |