Visual-OLfactory Training in Participants With COVID-19 Resultant Loss of Smell

NCT04710394 | Completed

• 1 other identifier: 7011897206
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Olfactory dysfunction is a defining symptom of COVID-19 infection. As the number of total, confirmed COVID-19 cases approached 19 million in the United States, it is estimated that there will be 250,000 to 500,000 new cases of chronically diminished smell (hyposmia) and loss of smell (anosmia) this year. Olfactory dysfunction is proposed to worsen numerous common co-morbidities in patients and has been shown to lead to a decreased quality of life. There are very few effective treatments for hyposmia or anosmia, and there is no gold standard of treatment. One proposed treatment option is smell training, which has shown promising yet variable results in a multitude of studies. It garners its theoretical basis from the high degree of neuroplasticity within the olfactory system, both peripherally and centrally. However, due to a relative inadequacy of proper studies on olfactory training, it is unknown what the most efficacious method in which to undergo the training is. This study proposes two novel procedural modifications to smell training in an attempt to enhance its efficacy. The investigators propose using a bimodal visual-olfactory approach, rather than relying on olfaction alone, during smell training, as well as using patient-preferred scents in the training that are identified as important by the study participant, rather than pre-determined scents with inadequate scientific backing. The investigators hypothesize that by utilizing bimodal visual-olfactory training and patient-selected scents, the olfactory training will be more efficacious and more motivating for participants.

Conditions

Anosmia; Covid19; Ageusia; Hyposmia; Hypogeusia; SARS-CoV-2 Infection; COVID-19 Pandemic

Keywords

Anosmia; Loss of Smell; Loss of Taste; Hyposmia; Ageusia; Covid-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• University of Pennsylvania Smell Identification Test (UPSIT)

  The UPSIT includes 4 odor-impregnated booklets that contain 10 forced-choice multiple choice questions each for participants to scratch-and-sniff to identify various odors and is a commercially available test. Normosmia is defined as ≥34 for males and ≥35 for females, and a change of 4 points or more from baseline indicates a clinically meaningful result.

  Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)

Secondary Outcomes (3)

• Clinical Global Impression Severity (CGI-S) Scale

  Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)

• Clinical Global Impression Improvement (CGI-I) Scale

  Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)

• Olfactory Dysfunction Outcomes Rating (ODOR)

  Measurement will be taken at time zero (pre-intervention) and 12 weeks (post-intervention)

Study Arms (4)

Unimodal Olfactory Training with Conventional Odors

ACTIVE COMPARATOR

Participants will undergo smell training without a visual component, and train using 4 pre-determined scents: rose, lemon, eucalyptus, and clove.

Behavioral: Smell Training

Unimodal Olfactory Training with Patient-Preferred Odors

EXPERIMENTAL

Participants will undergo smell training without a visual component, and undergo an odor selection process in which they choose four scents to train with that they identify as important. A total of 24 scents will be included for patients to select from, including: Lemon, Orange, Grapefruit, Lime, Eucalyptus, Peppermint, Spearmint, Tea Tree, Rose, Lavender, Jasmine, Geranium, Frankincense, Cedarwood, Juniper, Sandalwood, Black Pepper, Oregano, Rosemary, Clove, Vanilla, Coffee, Cinnamon, Nutmeg.

Behavioral: Smell Training

Bimodal Visual, Olfactory Training with Conventional Odors

EXPERIMENTAL

Participants will undergo smell training while simultaneously focusing on a picture of the odor, and train using 4 pre-determined scents: rose, lemon, eucalyptus, and clove.

Behavioral: Smell Training

Bimodal Visual, Olfactory Training with Patient-Preferred Odors

EXPERIMENTAL

Participants will undergo smell training while simultaneously focusing on a picture of the odor, and undergo an odor selection process in which they choose four scents to train with that they identify as important. A total of 24 scents will be included for patients to select from, including: Lemon, Orange, Grapefruit, Lime, Eucalyptus, Peppermint, Spearmint, Tea Tree, Rose, Lavender, Jasmine, Geranium, Frankincense, Cedarwood, Juniper, Sandalwood, Black Pepper, Oregano, Rosemary, Clove, Vanilla, Coffee, Cinnamon, Nutmeg.

Behavioral: Smell Training

Interventions

Smell Training BEHAVIORAL

Participants will be provided with 4 labeled jars, each containing an odor pre-impregnated cotton pad. Participants will sniff each scent for 10 seconds, twice daily, once in the morning and once in evening. The participant will take 30 seconds of rest between each scent. All participants will undergo this smell training regimen for 12 weeks.

Also known as: Olfactory Training

Bimodal Visual, Olfactory Training with Conventional Odors; Bimodal Visual, Olfactory Training with Patient-Preferred Odors; Unimodal Olfactory Training with Conventional Odors; Unimodal Olfactory Training with Patient-Preferred Odors

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Subjective or clinically diagnosed olfactory dysfunction of 3 months duration or longer initially diagnosed within 2 weeks of a COVID-19 infection

You may not qualify if:

• Diagnosed olfactory dysfunction due to head trauma
• Chronic rhinosinusitis
• Congenital olfactory dysfunction
• Nasal polyps
• Neurodegenerative disorders (for example, Alzheimer or Parkinson Disease)
• Pre-Assessment UPSIT score ≥34 for males and ≥35 for females
• Pregnant
• Inability to read, write, and understand English
• Inability to perform home olfactory training (for example, due to limited access to internet)
• Residence outside of the the United States of America
• Previously conducting smell training

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine in Saint Louis

St Louis, Missouri, 63108, United States

Location

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Related Links

• Official study web application for administration of smell training intervention. All study participants will receive login credentials.

MeSH Terms

Conditions

Anosmia; COVID-19; Ageusia

Interventions

Olfactory Training

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Taste Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jay F. Piccirillo, M.D., FACS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-by-two factorial interventional study design will lend to achieving the study aims. Participants meeting eligibility criterion will be randomized to one of four arms: 1. Unimodal Olfactory Training with Conventional Odors 2. Unimodal Olfactory Training with Patient-Preferred Odors 3. Bimodal Visual, Olfactory Training with Conventional Odors 4. Bimodal Visual, Olfactory Training with Patient-Preferred Odors

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 14, 2021
• Study Start: January 11, 2021
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be made available within 12 months of the completion date of the research project, for 2 subsequent years.
• Access Criteria: Data access will be arranged through a data-sharing agreement, which will indicate the criteria for data access, documentation of IRB approval from requestor's institution, incorporation of appropriate privacy and confidentiality standards to ensure data security at the recipient site, and prohibit manipulation of data for the purposes of identifying subjects or redistribution to third parties. Data access will be managed by the Research Compliance and Recruitment Coordinator, and data maintenance will be managed by the Study Biostatistician.

Locations

US (1)