Treatment of Postviral Olfactory Dysfunction

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06142565
• Collaborator: Region Skane (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 20

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyposmia	Device: Nose plug; Other: Regular olfactory training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Postviral Olfactory Dysfunction
• Actual Study Start Date: Oct 17, 2023
• Anticipated Primary Completion Date: Apr 17, 2024
• Anticipated Study Completion Date: Apr 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olfactory training with nose plugs Participants will complete olfactory training with scented nose plugs.	Device: Nose plug; Participants will complete olfactory training with scented nose plugs.
Active Comparator: Olfactory training with household odors Participants will complete olfactory training with odors found in their household.	Other: Regular olfactory training; Participants will complete olfactory training with regular odors found in their home.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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).

3. 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.

4. 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.

5. 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.

6. 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.

7. 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).

8. 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.

9. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet	Solna	Stockholm	Sweden	17177

Sponsors and Collaborators

• Karolinska Institutet
• Region Skane

Investigators

• Principal Investigator: Johan N Lundstrom, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johan Lundström, Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT06142565
• Other Study ID Numbers: 2023-03779-01; 2021-06527
• First Posted: Nov 21, 2023
• Last Update Posted: Nov 21, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anosmia

Study Results

No Results Posted as of Nov 21, 2023