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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 time: 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 time: 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 time: 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 time: 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

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 more

Other outcome measures

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 more

Trial 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,456 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,670 Total Patients Enrolled

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90 Patients Enrolled for Anomia

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

330 Previous Clinical Trials

178,291 Total Patients Enrolled

4 Trials studying Anomia

331 Patients Enrolled for Anomia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research investigation open to individuals aged 85 and above?

"Under 65 years old adults satisfying the age of consent are welcome to apply for this study."

Answered by AI

Are there still openings for participants in this clinical trial?

"That is correct. According to information hosted on clinicaltrials.gov, this medical investigation was first published on October 2nd 2023 and is currently seeking participants. Altogether, 180 patients from one research centre need to be recruited for the study's completion."

Answered by AI

What is the current participation rate in this experiment?

"Affirmative. In accordance with the information provided on clinicaltrials.gov, this medical trial is currently seeking participants and was first publicized on October 2nd 2023 before undergoing an update ten days later. The study requires 180 volunteers at a single location to complete the trial."

Answered by AI

What is the chief goal of this clinical trial?

"This clinical trial will be monitored over a period of 4 and 12 weeks with the aim of assessing any changes in olfactory loss from baseline. Secondary objectives include evaluating shifts in sleep quality (measured via Pittsburgh Sleep Quality Index), symptoms of depression (calculated through Patient Health Questionnaire-9) and sustained attention (Sustained Attention to Response Task)."

Answered by AI

Am I eligible to join this research experiment?

"This clinical trial seeks 180 individuals, between the ages of majority and retirement age, who are seeking treatment for post-COVID olfactory impairments such as anosmia. Other eligibility requirements include a pre-April 2021 positive SARS-coV-2 PCR result, normal sense of smell before contracting COVID, lack of prior experience with either smell training or trigeminal nerve stimulation (TNS), English comprehension skills to understand the informed consent process."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Bernadette Cortese 2023. "Smell Training and Trigeminal Nerve Stimulation for COVID-related Smell Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05855369.

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