An interventional study of Olfactory Training in Anosmia and SARS CoV 2 Infection, sponsored by University College, London. Completed at 4 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-18.
Sponsored by University College, London · Not applicable, Interventional, and Treatment
Our study aims to determine the prevalence of anosmia in patients SARS-Cov-2/Covid-19 infection (both by symptom reporting and smell testing), the efficacy of early olfactory training for the treatment of anosmia caused by infection and the long-term impact of smell dysfunction with a one-year follow-up.
Around 10-15% of patients with acquired anosmia have Post Viral Olfactory Loss (PVOL). Coronaviruses are a known cause for anosmia. At the onset of the COVID-19 pandemic, reports from China, South Korea, US and Europe suggest that a significant proportion of COVID-19 patients describe a loss of smell and taste as the only symptoms or as part of mild flu-like symptoms. It is now well-established that these symptoms are important components of the COVID-19 sequelae with persistent dysfunction described in a subset of individuals.
For this study, individuals, mainly comprising mainly healthcare workers in the UK, with persistent and sudden loss of sense of smell (at least 4 weeks) were recruited to ascertain the prevalence of COVID-19 associated smell dysfunction. A positive COVID-19 test was not a requirement for participation if not readily available nor accessible, however, information regarding COVID-19 antigen and antibody testing was collected post-hoc from those for who data are readily available. All participants (n=227) underwent initial psychophysical smell testing using the Brief Smell Identification Test (BSIT), gustatory testing using Taste Strips and completed the Smell Qx questionnaire. This questionnaire collected relevant demographic information, medical history, details of COVID-19 symptoms experienced, as well as information on olfactory and gustatory function, including those related to quality-of-life.
Participants, who scored 8 or below on the BSIT (indicative of semi-quantitative smell loss) were further invited to participate in the early olfactory training randomized controlled trial. Participants were randomized to undergo either 12 weeks of olfactory training or receive safety information. At the end of the 12-weeks, participants completed a follow-up BSIT and survey.
All participants enrolled at baseline within the eligible timeframe, for whom a valid email address was available, were further invited to participate in 1 year follow-up assessments. This included all participants irrespective of baseline BSIT result and RCT participation. The follow-up included a final electronic survey and BSIT. In addition to questions related to their sense of smell, which were identical to those in the baseline and 12-week follow-up surveys, participants were also asked about any symptoms of long-Covid.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 63 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-
12 weeks of observation, safety information provided
12-weeks of daily olfactory training
Other: Olfactory Training
Sniffin' Sticks (Duft-Quartett, Burghart Messtechnik, GmbH, Germany)
Brief Smell Identification Test (BSIT)
The absolute difference between the intervention and control arms in BSIT score smell improvement, measured as a change from baseline at 12-weeks.
Time frame: 12-weeks
Quality of Life Score
Within subject changes to scoring of questionnaire quality of life items at 12-weeks compared to baseline
Time frame: 12-weeks
Compliance (anecdotal)
Participant compliance to olfactory training through anecdotal reporting
Time frame: 12-weeks
Safety (anecdotal)
Safety of the use of Sniffin' Sticks through anecdotal reporting
Time frame: 12-weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University College, London