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NCT06817499

Treatment of Olfactory Dysfunction Using Vagus Nerve Stimulation

Active, enrolled NA Last updated 27 August 2025
What this trial tests

NA trial testing Nasal Insert + VNS in Hyposmia in 40 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
15 March 2025
Primary endpoint
15 May 2026
15 October 2026

Quick facts

Lead sponsorKarolinska Institutet
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment40
Start date15 March 2025
Primary completion15 May 2026
Estimated completion15 October 2026
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Karolinska Institutet

Who can join

Adults 18 to 65, any sex, with Hyposmia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Hyposmia

Currently open trials in the same condition.

Other Karolinska Institutet trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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