Information and Education for Loss of Smell

Overseen By Pamela Dalton

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Monell Chemical Senses Center

Disqualifiers: Odor allergy or intolerance

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if information and education about smell dysfunction can enhance overall health and well-being for individuals who have lost their sense of smell. Participants will take smell tests and receive educational materials about smell issues, while a comparison group will not receive any intervention. The trial is designed for individuals who can read and understand English and have internet access, except when devices are provided at community events. Participants should not have allergies to any smell stimuli used in the tests. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational intervention is safe?

Research has shown that educational programs are generally safe and carry no physical risks. In this trial, the treatment involves providing information and education to help individuals understand and manage their smell issues. Participants receive knowledge and resources instead of physical or medical treatment.

As this trial is in an early stage, researchers are closely monitoring safety. However, similar studies have not reported negative effects from these educational programs. The use of non-invasive methods, such as educational materials, results in a very low risk of harm. Participants are more likely to gain better awareness and understanding rather than experience negative effects.

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to addressing loss of smell through patient-centered information and education. Unlike traditional treatments that may focus on medical interventions or medications, this approach emphasizes empowering patients with knowledge about smell dysfunction. Participants engage in smell tests and receive educational materials, which could enhance their understanding and management of their condition. This method has the potential to improve quality of life by equipping individuals with the tools to better navigate their sensory experience and adapt to their condition.

What evidence suggests that this educational intervention is effective for improving health and wellbeing in individuals with smell dysfunction?

Research has shown that patient-focused information and education can assist those with smell disorders. In this trial, participants in the "Smell Dysfunction Detection and Educational Intervention" arm will receive educational materials about their condition. Studies suggest these materials can improve health and well-being. They often include advice on community involvement and coping strategies. Although no treatment has proven highly effective, understanding their condition can lead to better outcomes for patients. Surveys indicate that informed and empowered patients may experience an improved quality of life. ^{1 2 3 4 5}

Who Is on the Research Team?

Valentina Parma

Principal Investigator

Monell Chemical Senses Center

Pamela Dalton

Principal Investigator

Monell Chemical Senses Center

Danielle Reed

Principal Investigator

Monell Chemical Senses Center

Are You a Good Fit for This Trial?

This trial is for individuals experiencing smell dysfunction, which may impact their mental and nutritional health, well-being, or safety. It aims to help those who might not be aware of their condition or its gradual onset due to aging or other factors.

Inclusion Criteria

Can read and understand English and have access to a reliable internet connection and a smart device or computer for the duration of the experimental sessions, unless they are part of community events in which smart devices are provided

Exclusion Criteria

Known intolerance or allergy to any of the odor stimuli used

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment and Intervention

Participants undergo initial assessment and smell testing intervention, including odor detection, intensity, identification, pleasantness, and discrimination tests.

1 week

1 visit (in-person or remote)

1-Month Follow-up

Participants are evaluated for psychological health and connection to care for smell dysfunction via surveys, text, or phone.

1 month

Remote follow-up

6-Month Follow-up

Participants are assessed for long-term psychological health improvements and healthcare provider contact.

6 months

Remote follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Patient-centered information and education

Trial Overview The study tests whether providing patients with information and education on coping strategies for smell dysfunction can improve their overall health outcomes and quality of life.

How Is the Trial Designed?

Group I: Smell dysfunction detection and educational intervention Experimental Treatment 1 Intervention

Participants will take smell tests and receive educational materials on smell dysfunction.

Group II: Normosmia Active Control 1 Intervention

No intervention

Who Is Running the Clinical Trial?

Monell Chemical Senses Center

Lead Sponsor

Trials

22

Recruited

2,200+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07222891

Impact of Smell Testing on Health Outcomes Participants with smell dysfunction will receive patient-centered information and education about i) community engagement with individuals ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11154145/

Integrating the patient's voice into the research agenda for ... Patient-centered research utilizing the USA Smell and Taste Patient Survey supports the benefit of incorporating the patient voice into research into treatments ...

3. monell.org monell.org/engaging-with-patients-for-better-treatments-and-outcomes-for-smell-and-taste-disorders/

Engaging With Patients for Better Treatments and ... A survey of 5,800 patients found that no treatments were highly effective, and age was a predictor of low effectiveness. Patients want to know ...

4. pcori.org pcori.org/research-results/2021/shared-agenda-clinical-research-smell-and-taste-sacr-st

Shared Agenda for Clinical Research on Smell and Taste ... Background: More than 3 million Americans will have sustained or long-term smell and/or taste loss from COVID-19.

5. health.osu.edu health.osu.edu/discovery-and-innovation/research-advances/loss-of-smell-treatment

Loss of smell treatment | Ohio State Health & Discovery Researchers at the Ohio State College of Medicine designed non-invasive prototypes that improve people's ability to smell.