RECRUITING

Smell Training and Trigeminal Nerve Stimulation for COVID-related Smell Loss

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-02
Study Completion:2028-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05855369

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * treatment-seeking for COVID-related persistent SL (anosmia, hyposmia, phantosmia or parosmia)
  2. * SARS-coV-2 PCR-positive test prior to April 2021
  3. * normal sense of smell prior to COVID
  4. * naïve to both smell training (ST) and trigeminal nerve stimulation (TNS)
  5. * able to comprehend English and provide informed consent
  1. * history of head injury (e.g. sport, accident, combat blast)
  2. * sinonasal condition (e.g. upper respiratory infection, rhinosinusitis, polyps)
  3. * neurological disorder (e.g. epilepsy, neurodegenerative disorder, narcolepsy)
  4. * serious mental illness (e.g. schizophrenia, bipolar, or other psychotic disorder)
  5. * suicidal ideation within the last month
  6. * current (≤6 months) heavy cigarette smoker (heavy defined as ≥ 10 pack-years)
  7. * oral/nasal steroids or other intranasal medications within the last month
  8. * immunomodulatory medications
  9. * pregnant or trying to become pregnant

Contacts and Locations

Study Contact

Bernadette M. Cortese, Ph.D.
CONTACT
843-792-6922
corteseb@musc.edu
Bashar W. Badran, Ph.D.
CONTACT
843-792-6076
badran@musc.edu

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-02
Study Completion Date2028-05-31

Study Record Updates

Study Start Date2023-10-02
Study Completion Date2028-05-31

Terms related to this study

Keywords Provided by Researchers

  • COVID-19
  • Parosmia
  • Hyposmia
  • Anosmia
  • Phantosmia
  • Dysosmia
  • Olfactory Training
  • Neuromodulation
  • Non-invasive Brain Stimulation

Additional Relevant MeSH Terms

  • Smell Dysfunction
  • Olfactory Disorder
  • Long COVID