Treatment of Olfactory Dysfunction Using Vagus Nerve Stimulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-15

Study Completion Date

2026-10-15

Brief Summary

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Hyposmia, a reduced sense of smell, is commonly linked to viral infections like COVID-19. Currently, the sole recommended treatment is olfactory training, a method that is both time-intensive and limited in its effectiveness. Our team has previously evaluated a new type of olfactory training using nasal inserts that show increased adherence to training (compared to standard olfactory training using common household odors) but with similar treatment effect. The investigators recently demonstrated that brief transcutaneous vagus nerve stimulation (VNS) in the cymba conchae region affected participants olfactory abilities but only when a stimulation frequency relevant to olfactory bulb processing frequencies was used. The notion that VNS might modulate olfactory functions stems from findings in rats where VNS of the cervical nerve inhibited neurons within the periglomerular layers of the olfactory bulb. Although there is no known monosynaptic connection between the vagus nerve and the olfactory system in humans, VNS activates areas with mono-synaptic connections to the olfactory bulb, such as amygdala, hippocampus, and the hypothalamus. Given that VNS modulates the olfactory bulb in rats and our treatment protocol modulate olfactory functions in humans, the investigators hypothesize that VNS, when paired with olfactory training, will enhance olfactory functions in patients with hyposmia.

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Detailed Description

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Participants with hyposmia will be recruited and randomly assigned to one of two treatment groups. One group will engage in olfactory training using nasal inserts while the other will use olfactory training with nasal inserts along with VNS. Both interventions will take place at home, Monday through Friday, over a two-month period. To evaluate the outcomes, subjective and objective measures of olfactory function will be collected before, during, and after the treatment, along with assessments of quality of life and overall well-being. Treatment adherence will also be evaluated at the end of treatment.

Conditions

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Hyposmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Olfactory training with nasal inserts + VNS

Participants will complete olfactory training with scented nose plugs along with VNS

Group Type EXPERIMENTAL

Nasal Insert + VNS

Intervention Type OTHER

Participants will complete olfactory training with scented nose plugs along with VNS

Olfactory training with nasal inserts only

Participants will complete olfactory training with scented nose plugs

Group Type ACTIVE_COMPARATOR

Nasal Insert

Intervention Type OTHER

Participants will complete olfactory training with scented nose plugs

Interventions

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Nasal Insert + VNS

Participants will complete olfactory training with scented nose plugs along with VNS

Intervention Type OTHER

Nasal Insert

Participants will complete olfactory training with scented nose plugs

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Correct age (18-65)
* Physically and cognitively capable of participating in the study
* Having appropriate olfactory screening test scores (hyposmic)