Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT for Long COVID)
A Randomized Controlled Trial of Smell Training and Trigeminal Nerve Stimulation in the Treatment of COVID-related Persistent Smell Loss
Medical University of South Carolina
145 participants
Oct 2, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria9
- 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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Interventions
Non-invasive, pain-free, low-level electrical stimulation to the forehead to modulate the trigeminal nerve and enhance smell function through activation of the highly connected olfactory-intranasal trigeminal brain circuits.
Sniffing various higher intensity odorant chemicals while performing odor-related cognitive tasks. 16 odorant chemicals will be used for training including: 2 phenyl ethanol, eugenol, lemon, eucalyptus, cinnamon, peppermint, coffee, mandarin, lavender, vanilla, lilac, ginger, chocolate, thyme, banana, and bacon.
Sniffing the same lower intensity odorant chemicals (i.e. N-butanol and 2-phenyl ethanol) over the course of the trial and performing no odor-related cognitive tasks.
Locations(1)
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NCT05855369