Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT for Long COVID) (NCT05855369) | Clinical Trial Compass
RecruitingPhase 2/3
Study of Chemosensory Enhancement Through Neuromodulation Training (SCENT for Long COVID)
United States145 participantsStarted 2023-10-02
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Psychophysical Olfactory Function from Baseline to 4 and 12 Weeks
Timeframe: 2 times: 4 weeks, 12 weeks
2
Change in Perceived Intensity of Odorants from Baseline to 4 and 12 Weeks
Timeframe: 2 times: 4 weeks, 12 weeks
3
Change in Perceived Hedonics of Odorants from Baseline to 4 and 12 Weeks
Timeframe: 2 times: 4 weeks, 12 weeks
4
Change in Olfactory-related Quality of Life from Baseline to 4 and 12 Weeks
Timeframe: 2 times: 4 weeks, 12 weeks
5
Change in Impact of Olfactory Loss from Baseline to 4 and 12 Weeks