Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
145 (estimated)
Sponsor
Medical University of South Carolina · Other
Who this trial is looking for
This trial is looking for people with ongoing smell loss after COVID-19. Participants will do daily treatment at home and attend three study visits at a research center over 12 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have ongoing smell loss related to COVID-19
I tested positive for COVID-19 at least a month ago
I had a normal sense of smell before COVID-19
I have never tried smell training or nerve stimulation
I can understand English and give my consent
You may not be able to join if
I have had a head injury
I have a sinus condition
I have a neurological disorder
I have a serious mental illness
I have had suicidal thoughts in the last month
I currently smoke heavily
I have taken oral or nasal steroids in the last month
I am pregnant or trying to become pregnant
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Persistent smell loss that can include diminished or distorted smell function is a common symptom of long COVID syndrome. There are limited treatment options for long COVID-related smell loss. This study aims to determine the efficacy of two at-home treatments, smell training and non-invasive trigeminal nerve stimulation. This study requires participants to conduct daily at-home treatment sessions…
Persistent smell loss that can include diminished or distorted smell function is a common symptom of long COVID syndrome. There are limited treatment options for long COVID-related smell loss. This study aims to determine the efficacy of two at-home treatments, smell training and non-invasive trigeminal nerve stimulation. This study requires participants to conduct daily at-home treatment sessions, attend three in-person study visits at the MUSC Department of Psychiatry and Behavioral Sciences, and complete electronic questionnaires over the 12-week trial, and again at the six-month timepoint. Participants in this trial may benefit directly with an improvement in sense of smell. However, participation may also help society more generally, as this study will provide new information about long COVID-related smell loss and its treatment.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* treatment-seeking for COVID-related persistent SL (anosmia, hyposmia, phantosmia or parosmia)
* at least 1-month from SARS-coV-2 PCR-positive and/or rapid home-positive tests
* normal sense of smell prior to COVID
* naïve to both smell training (ST) and trigeminal nerve stimul…
Inclusion Criteria:
* treatment-seeking for COVID-related persistent SL (anosmia, hyposmia, phantosmia or parosmia)
* at least 1-month from SARS-coV-2 PCR-positive and/or rapid home-positive tests
* normal sense of smell prior to COVID
* naïve to both smell training (ST) and trigeminal nerve stimulation (TNS)
* able to comprehend English and provide informed consent
Exclusion Criteria:
* history of head injury (e.g. sport, accident, combat blast)
* sinonasal condition (e.g. upper respiratory infection, rhinosinusitis, polyps)
* neurological disorder (e.g. epilepsy, neurodegenerative disorder, narcolepsy)
* serious mental illness (e.g. schizophrenia, bipolar, or other psychotic disorder)
* suicidal ideation within the last month
* current (≤6 months) heavy cigarette smoker (heavy defined as ≥ 10 pack-years)
* oral/nasal steroids or other intranasal medications within the last month
* immunomodulatory medications
* pregnant or trying to become pregnant
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