At-Home Olfactory Training

NCT ID: NCT03611673

Last Updated: 2023-07-20

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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-02

Study Completion Date

2021-04-19

Brief Summary

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The purpose of this study is to determine the impact of a twice daily at-home olfactory training program with a twenty scent, essential oil-based smell test in patients with olfactory dysfunction.

Detailed Description

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This study randomizes participants to receive either a four scent or fourteen scent olfactory retraining protocol. Baseline olfaction will be tested with a currently commercially available smell test as well as an essential oil based smell test. The protocol involves twice daily retraining where the participant inhales the scent and makes a mental note of what they should be smelling. The training period is six months total with a visit at 3 months to re-assess smell function as well as at six months.

Conditions

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Olfactory Disorder

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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Group A: 15 Scents

Participants will be asked to inhale 15 different scents two times a day.

Group Type EXPERIMENTAL

Smell Test

Intervention Type OTHER

Oils are used for each of the different scents. Each scent will be put on an aromatherapy inhaling stick.

Group B: 4 Scents

Participants will be asked to inhale 4 different scents two times a day.

Group Type ACTIVE_COMPARATOR

Smell Test

Intervention Type OTHER

Oils are used for each of the different scents. Each scent will be put on an aromatherapy inhaling stick.

Interventions

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Smell Test

Oils are used for each of the different scents. Each scent will be put on an aromatherapy inhaling stick.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have clinical olfactory dysfunction

Exclusion Criteria

* Pregnant women
* Unable to perform routine follow-up
* Current participation in another clinical trial during this trial
* Patients with dementia, Alzheimer's disease, Parkinson's disease, or other neurocognitive disorders
* Diagnosis of other systemic conditions known to impact the sinonasal cavity such as Wegener's granulomatosis, Churg Strauss, and immunodeficiency
* Patients who are allergic to any of the smells or components of our olfactory testing
* Chronic rhinosinusitis, malignant tumors and/or oncologic therapies (radiation/chemotherapy)
* History of surgery on the nose or paranasal sinuses
* Patients using medications that may impact olfactory function (i.e. corticosteroids)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Villwock, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00141820

Identifier Type: -

Identifier Source: org_study_id

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