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Smell Training + Trigeminal Nerve Stimulation for Loss of Smell from COVID-19
Phase 2 & 3
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Naïve to both smell training (ST) and trigeminal nerve stimulation (TNS)
Treatment-seeking for COVID-related persistent SL (anosmia, hyposmia, phantosmia or parosmia)
Must not have
Immunomodulatory medications
History of head injury (e.g. sport, accident, combat blast)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 time: 6 months
Summary
This trial studies treatments to improve smell loss caused by long COVID, with daily at-home care and 3 in-person visits. It may help participants and society.
Who is the study for?
This trial is for individuals seeking treatment for persistent smell loss due to COVID-19, confirmed by a positive test before April 2021. Participants must have had a normal sense of smell before COVID and be new to both smell training and trigeminal nerve stimulation. They should not have any history of significant head injuries, sinonasal conditions, neurological disorders, serious mental illness, recent heavy smoking, or use of certain medications.
What is being tested?
The study tests the effectiveness of at-home treatments: active smell training versus placebo and non-invasive trigeminal nerve stimulation over 12 weeks with follow-up after six months. It involves daily home sessions, three in-person visits to MUSC Department of Psychiatry and Behavioral Sciences, and completing electronic questionnaires.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from the trigeminal nerve stimulation device or irritation related to the olfactory training process. As this is a non-drug intervention trial focusing on sensory retraining and nerve stimulation, severe side effects are unlikely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never undergone smell training or trigeminal nerve stimulation.
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I am seeking treatment for long-lasting smell issues due to COVID.
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I had a normal sense of smell before getting COVID.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking drugs that affect my immune system.
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I have had a head injury from sports, an accident, or combat.
Select...
I have a neurological condition like epilepsy or narcolepsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 time: 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 time: 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Impact of Olfactory Loss from Baseline to 4 and 12 Weeks
Change in Olfactory-related Quality of Life from Baseline to 4 and 12 Weeks
Change in Perceived Hedonics of Odorants from Baseline to 4 and 12 Weeks
+2 moreSecondary study objectives
Change in Cognitive Function from Baseline to 4 and 12 Weeks
Change in Excessive Daytime Sleepiness from Baseline to 4 and 12 Weeks
Change in Long COVID Symptoms from Baseline to 4 and 12 Weeks
+5 moreOther study objectives
Durability of Treatment on Long COVID Symptoms at the 6-month Follow Up
Durability of Treatment on Mood at the 6-month Follow Up
Durability of Treatment on Sleepiness and Sleep Quality at the 6-month Follow Up
+2 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Combination Trigeminal Nerve Stimulation (TNS) and active Smell Training (ST)Active Control2 Interventions
30 minutes of once/day TNS and twice/day ST conducted 5 days/week for 12 weeks and a total of 60 stimulation and 120 smell training sessions
Group II: Active Smell Training (ST)Active Control1 Intervention
5 minutes of daily ST conducted twice/day, 5 days/week for 12 weeks and a total of 120 training session
Group III: Placebo Smell Training (PBO)Placebo Group1 Intervention
5 minutes of daily PBO conducted twice/day, 5 days/week for 12 weeks and a total of 120 training sessions
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
979 Previous Clinical Trials
7,400,814 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,843 Previous Clinical Trials
8,173,053 Total Patients Enrolled
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
361 Previous Clinical Trials
181,878 Total Patients Enrolled