Treatment of Postviral Olfactory Dysfunction

NCT ID: NCT06142565

Last Updated: 2025-09-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-17

Study Completion Date

2025-07-01

Brief Summary

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A decreased sense of smell (hyposmia) is often caused by viral infections, such as COVID-19. Today, the only recommended treatment for hyposmia is olfactory training, a time consuming method with limitations in terms of both compliance and effect. The aim of this study is therefore to evaluate, as well as optimize, a new treatment method for olfactory loss.

Hyposmic participants will be recruited and randomized into two different treatment conditions. One group will do regular olfactory training and the other will do passive olfactory training with scented nose plugs. The training will be conducted in the home of the individual monday through friday for two consecutive months. Subjective and objectvie measures of olfactory problems will be assessed before and after treatment, as well as subjective measures related to quality of live and genereal wellbeing.

Detailed Description

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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 nose plugs

Participants will complete olfactory training with scented nose plugs.

Group Type EXPERIMENTAL

Nose plug

Intervention Type DEVICE

Participants will complete olfactory training with scented nose plugs.

Olfactory training with household odors

Participants will complete olfactory training with odors found in their household.

Group Type ACTIVE_COMPARATOR

Regular olfactory training

Intervention Type OTHER

Participants will complete olfactory training with regular odors found in their home.

Interventions

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Nose plug

Participants will complete olfactory training with scented nose plugs.

Intervention Type DEVICE

Regular olfactory training

Participants will complete olfactory training with regular odors found in their home.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Anosmics
* Individuals with other diagnoses that could affect the study results
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Johan Lundström

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johan N Lundstrom

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet

Solna, Stockholm County, Sweden

Site Status

Countries

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Sweden

References

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Winter AL, Henecke S, Thunell E, Swartz M, Martinsen J, Sahlstrand Johnson P, Lundstrom JN. Olfactory training using nasal inserts is more effective due to increased adherence. Rhinology. 2025 Aug 1;63(4):477-485. doi: 10.4193/Rhin24.369.

Reference Type BACKGROUND
PMID: 40278843 (View on PubMed)

Other Identifiers

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2021-06527

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023-03779-01

Identifier Type: -

Identifier Source: org_study_id

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