A Randomized Controlled Trial of Smell Training and Trigeminal Nerve Stimulation in the Treatment of COVID-related Persistent Smell Loss

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Bernadette M. Cortese, Ph.D.
corteseb@musc.edu
843-792-6922
Time Frame
Start Date: 2023-10-02
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 180
Treatments
Active_comparator: Combination Trigeminal Nerve Stimulation (TNS) and active Smell Training (ST)
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
Active_comparator: Active Smell Training (ST)
5 minutes of daily ST conducted twice/day, 5 days/week for 12 weeks and a total of 120 training session
Placebo_comparator: Placebo Smell Training (PBO)
5 minutes of daily PBO conducted twice/day, 5 days/week for 12 weeks and a total of 120 training sessions
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov

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