NCT05855369 Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT for Long COVID)
| NCT ID | NCT05855369 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Medical University of South Carolina |
| Condition | Smell Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 145 participants |
| Start Date | 2023-10-02 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 145 participants in total. It began in 2023-10-02 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05855369 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Smell Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05855369 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05855369 currently recruiting?
Yes, NCT05855369 is actively recruiting participants. Contact the research team at corteseb@musc.edu for enrollment information.
Where is the NCT05855369 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT05855369 clinical trial?
NCT05855369 is sponsored by Medical University of South Carolina. The trial plans to enroll 145 participants.