Post-viral (infectious) olfactory loss/dysfunction (PVOL/PIOD) Ear, Nose and Throat
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. A partial or total loss of smell due to post-viral olfactory loss as confirmed on history, examination and with a smell test (TDI) score of <31/48 2. Within 3 years of the precipitating viral infection
Exclusion criteria
Exclusion criteria: 1. Participants with a history of: 1.1. Chronic rhinosinusitis with/without nasal polyposis 1.2. Severe nasal septal deviation 1.3. Major prior head injury 1.4. Congenital olfactory loss 1.5. Use of concurrent intranasal medications or possible medications know to affect olfaction 1.6. Chronic renal disease 1.7. Chronic hepatic disease 1.8. Allergy to peanuts, soy or vitamin A (drops contain peanut oil) 2. Significant medical, surgical or psychiatric disease that in the opinion of the PI would affect subject safety or influence the study outcomes 3. Current taking oral vitamin A supplements 4. Age less than 18 years 5. Pregnant women 6. Depending on the situation with regards to nasal endoscopy and COVID-19 at the time of study commencement we will exclude the following based on the endoscopy or the initial MRI scan: 6.1. Participants with any endoscopic findings of: 6.1.1. Chronic rhinosinusitis with/without nasal polyposis 6.1.2. Severe nasal septal deviation (preventing passage of 4mm endoscope) 6.1.3. Other inflammatory sinonasal disease 6.2. Participants with MRI changes indicating oedema in the sinuses and/or olfactory clefts 7. Participants must not have any metal implants, such as a pacemaker etc, as is standard for MRI scanning. 8. Any participants who move excessively during scanning 9. Any participant with a combined OBV of >85 mm³ as it is unlikely they will demonstrate a significant increase in overall volume based on previous studies of OBV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Olfactory bulb volume measured using MRI scan at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Right orbital sulcus volume measured using MRI scan at baseline and 3 months 2. Blood-oxygen-level-dependant (BOLD) signal in primary olfactory areas (amygdala, piriform, and insula) measured using fMRI scan at baseline and 3 months 3. Olfactory function measured using the psychophysical smell test (TDI) score at baseline and 3 months 4. Olfactory-related quality of life measured using the olfactory disorders questionnaire (ODQ) score at baseline and 3 months | — |
Countries
England, United Kingdom