Treatment of Postviral Olfactory Dysfunction

Not Applicable

Active, not recruiting

• Conditions: Hyposmia
• Interventions: Device: Nose plug; Other: Regular olfactory training

• Registration Number: NCT06142565
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-10-17
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-21
• Status Verified: 2024-06
• Primary Completion: 2024-06-21
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olfactory training with nose plugs	Nose plug	Participants will complete olfactory training with scented nose plugs.
Olfactory training with household odors	Regular olfactory training	Participants will complete olfactory training with odors found in their household.

Primary Outcome Measures

Name	Time	Method
Subjective health	2 months	Does the use of scented nose plugs increase the effect of olfactory training on subjective health compared to regular olfactory training? For this outcome, we will use the Self-Rated Health 5 measure and SF-36.
Objective olfactory function	2 months	Does the use of scented nose plugs increase the effect of olfactory training on objective olfactory function compared to regular olfactory training? For this outcome, we will use the standardized Sniffin' Sticks test to assess olfactory function.
Subjective degree of suffering from olfactory impairment	2 months	Does the use of scented nose plugs increase the effect of olfactory training on subjective degree of suffering from olfactory impairment compared to regular olfactory training? For this outcome, we will use the Questionnaire of Olfactory Disorders - Negative Statements.
Subjective parosmia	2 months	Does the use of scented nose plugs increase the effect of olfactory training on subjective parosmia compared to regular olfactory training? For this outcome, we will use the Landis parosmia questionnaire.
Subjective depressive symptoms	2 months	Does the use of scented nose plugs increase the effect of olfactory training on depressive symptoms compared to regular olfactory training? For this outcome, we will use the Beck Depression Inventory (BDI).
Subjective general wellbeing	2 months	Does the use of scented nose plugs increase the effect of olfactory training on depressive symptoms compared to regular olfactory training? For this outcome, we will use the General Well Being Schedule.
Subjective symptoms and social/emotional consequences	2 months	Does the use of scented nose plugs increase the effect of olfactory training on subjective symptoms and social/emotional consequences compared to regular olfactory training? For this outcome, we will use the Sino-Nasal Outcome Test (SNOT).
Subjective olfactory function	2 months	Does the use of scented nose plugs increase the effect of olfactory training on subjective olfactory function compared to regular olfactory training? For this outcome, we will use the Self-Reported Mini Olfactory Questionnaire.
Compliance	2 months	Does the use of scented nose plugs increase the compliance of olfactory training compared to regular olfactory training? For this outcome, we will use questions asking the participants about their experience during the olfactory training, specifically targeting their compliance, such as how often they actually completed the olfactory training and how often they forgot to.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Solna, Stockholm, Sweden