Treatment of Postviral Olfactory Dysfunction

Hyposmia Clinical Trial

Official title:

Treatment of Postviral Olfactory Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142565
• Other study ID #: 2023-03779-01
• Secondary ID: 2021-06527
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: April 17, 2024

Study information

• Verified date: November 2023
• Source: Karolinska Institutet
• Contact: Johan N Lundström
• Phone: +46700913149
• Email: johan.lundstrom[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 17, 2024
• Est. primary completion date: April 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anosmia
• Hyposmia

Intervention

Device:
• Nose plug
Participants will complete olfactory training with scented nose plugs.

Other:
• Regular olfactory training
Participants will complete olfactory training with regular odors found in their home.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Solna	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective olfactory function	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.	2 months
Primary	Subjective symptoms and social/emotional consequences	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).	2 months
Primary	Subjective health	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.	2 months
Primary	Subjective olfactory function	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.	2 months
Primary	Subjective degree of suffering from olfactory impairment	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.	2 months
Primary	Subjective parosmia	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.	2 months
Primary	Subjective depressive symptoms	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).	2 months
Primary	Subjective general wellbeing	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.	2 months
Primary	Compliance	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.	2 months