60 Participants NeededMy employer runs this trial

Smell Training for Loss of Smell

(SCENT-OL Trial)

BC
Overseen ByBernadette Cortese, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people who have lost their sense of smell by testing a new combination of treatments. Participants will use a special device that stimulates nerves on the forehead while they perform traditional smell training exercises. This combination, called Trigeminal Nerve Stimulation-enhanced Smell Training, is being studied to determine if it can improve not only smell but also mood, sleep, and overall quality of life. Individuals who have experienced smell loss and have not previously tried this nerve stimulation treatment may qualify to join. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

What prior data suggests that this trigeminal nerve stimulation-enhanced smell training is safe?

Research has shown that trigeminal nerve stimulation (TNS) is a safe and non-invasive technique. One study found that 30 minutes of TNS improved the sense of smell in healthy adults without major side effects. Another study confirmed that TNS is a simple and safe method to enhance the sense of smell. These studies reported no serious negative effects, suggesting that participants tolerate the treatment well. While these findings are promising, more research is needed to fully understand the safety and effectiveness of this treatment for different groups of people.12345

Why are researchers excited about this trial?

Researchers are excited about the Trigeminal Nerve Stimulation-enhanced Smell Training (TNS-enhanced ST) because it offers a new approach to treating loss of smell. Unlike traditional methods that mainly rely on olfactory training alone, this treatment incorporates trigeminal nerve stimulation, which might enhance the brain's ability to process smell. This technique involves an at-home, user-friendly setup where participants stimulate the trigeminal nerve via gel pads on their forehead, potentially making the treatment more effective and accessible. This novel mechanism of action could offer new hope for individuals struggling with smell loss.

What evidence suggests that Trigeminal Nerve Stimulation-enhanced Smell Training is effective for loss of smell?

This trial will evaluate the effectiveness of combining smell training with trigeminal nerve stimulation (TNS) to improve the sense of smell. Research has shown that 30 minutes of TNS can enhance the sense of smell without major side effects. Participants in this trial will undergo TNS-enhanced smell training for 8 weeks. Previous studies have indicated that participants who combined smell training with TNS reported overall improvements in mood, sleep, and quality of life. Specifically, one study found that adding TNS to smell training led to better results than smell training alone. Overall, the evidence suggests this combined method holds promise for individuals who have lost their sense of smell.12345

Are You a Good Fit for This Trial?

This trial is for people who have problems with their sense of smell, such as parosmia (distorted smells) or loss of smell. Participants should be able to do at-home treatments and attend a few in-person visits.

Inclusion Criteria

I have lost my sense of smell.
Able to comprehend English and provide informed consent
I am seeking treatment for my loss of smell.
See 2 more

Exclusion Criteria

Suicidal ideation within the last month
Medical records not available to confirm eligibility
Serious mental illness (e.g. schizophrenia, bipolar disorder)
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo TNS-enhanced smell training at home for 8 weeks, with 5 sessions per week. The first session is assisted by study staff.

8 weeks
3 visits (in-person)

Follow-up

Participants are monitored for improvements in olfactory function, mood, sleep, and quality of life after treatment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Trigeminal Nerve Stimulation-enhanced Smell Training

Trial Overview

The study tests whether combining non-invasive trigeminal nerve stimulation with standard smell training over 8 weeks can help improve the sense of smell. All participants receive both treatments and are monitored during three clinic visits.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Open Label Trigeminal Nerve Stimulation-enhanced Smell Training (TNS-enhanced ST)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

Citations

Smell Training and Trigeminal Nerve Stimulation for

This study aims to determine the efficacy of two at-hometreatments, smell training and non-invasive trigeminal nerve stimulation.

Smell Training + Trigeminal Nerve Stimulation for Loss of ...

One study found that 30 minutes of TNS improved smell in healthy adults without major side effects. stimulating the trigeminal nerve might effectively treat ...

Trigeminal Nerve Stimulation-enhanced Smell Training

8 weeks of TNS-enhanced ST will show significant improvement in mood, sleep and quality of life at 8 weeks compared to baseline.

Electrical stimulation of the trigeminal nerve improves ...

We investigated stimulation of the trigeminal nerve to enhance smell function. •. Findings reveal 30-min of stimulation boosts smell ability in healthy adults.

Study of Chemosensory Enhancement through ... - PMC

TNS-enhanced ST compared to ST will demonstrate significantly greater improvement in psychophysical olfactory function at 4 weeks. Hypothesis 2b.