Olfactory Training Device for Loss of Smell

(SPLENDOR-OA Trial)

Overseen By Wassim Najjar, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Scent sensitivity, Congenital anosmia

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if ScentCare, a novel olfactory training device and accompanying companion web-based application, will lead to improved olfactory and well-being outcomes in elderly patients with Olfactory Dysfunction (OD). The main question it aims to answer is: - What effect does the olfactory training device (ScentCare) and accompanying companion web-based application have on olfaction? Researchers will compare ScentCare to solving Sudoku puzzles to see the effects of olfactory training using this novel device on olfaction. Previous studies have used Sudoku puzzles when studying the effect of smell training. Since smell training is thought to work by stimulating and engaging higher order cognition, Sudoku is a suitable activity for participants in the control group since it serves as a correlate with similar degree of stimulation. Participants will: * Use ScentCare (intervention) or solve Sudoku puzzles (control) twice daily for 3 months. * Visit the clinic twice, once upon enrollment and once three months later. * Complete a formal smell test using Sniffin' Sticks smell test at the beginning of the study and again at the end of the study (3 months) during the initial and follow up visit. * Complete questionnaires at the beginning of the study and again at the end of the study (3 months) during the initial and follow up visit.

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

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment ScentCare for loss of smell?

Research suggests that smell training, which is similar to the ScentCare treatment, can be helpful for people with various causes of smell loss. This indicates that ScentCare might also be effective in improving the sense of smell. ^{1 2 3 4 5}

Is the olfactory training device safe for humans?

The research does not provide specific safety data for the olfactory training device, but olfactory training is generally considered safe and is recommended for patients with smell loss. ^{2 5 6 7 8}

How is the ScentCare treatment for loss of smell different from other treatments?

ScentCare is unique because it involves an olfactory training device that can be used at home, allowing users to practice identifying different smells with adaptive challenges, unlike traditional treatments that often require clinical settings. ^{2 9 10 11 12}

Research Team

Nicholas Rowan, M.D.

Principal Investigator

Johns Hopkins University, Department of Otolaryngology - Head and Neck Surgery

Eligibility Criteria

This trial is for older adults experiencing a reduced sense of smell or Anomia. Participants must be willing to use the ScentCare device or solve Sudoku puzzles twice daily for three months and attend two clinic visits.

Inclusion Criteria

I have a reduced or no sense of smell.

I have never done smell training.

I am 60 years old or older.

Exclusion Criteria

Patients who are sensitive to any of the scents used in the study

Patients with a diagnosis of congenital anosmia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use ScentCare or solve Sudoku puzzles twice daily for 3 months

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in olfaction and quality of life after treatment

4 weeks

Treatment Details

Interventions

• ScentCare

Trial Overview The study tests if an olfactory training device called ScentCare can improve the sense of smell in elderly patients with Olfactory Dysfunction, compared to solving Sudoku puzzles as a control activity.

Participant Groups

Group I: Olfactory Training Experimental Treatment 1 Intervention

Participants will receive the ScentCare olfactory training device, which includes eight encapsulated scents: Eucalyptus, Cinnamon, Lemon, Coffee, Campfire, Cherry, Vanilla, and Lavender. To guide the participant in using the device, participants will have access to either a web-based application or a booklet, depending on the participant's preference. These resources will provide instructions on how to perform the smell training effectively. The training will be conducted twice daily over a period of three months.

Group II: Control Arm (Sudoku Puzzles) Experimental Treatment 1 Intervention

Participants will be asked to complete sudoku puzzles twice daily over a period of three months.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

Olfactory dysfunction is linked to serious health issues, including neurodegeneration, and requires comprehensive assessment methods, such as rigid nasal endoscopy and validated psychophysical tests, to ensure accurate diagnosis and treatment.

Smell training has been identified as a beneficial intervention for patients experiencing olfactory loss, suggesting that structured rehabilitation can improve outcomes across various causes of smell impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Position paper on olfactory dysfunction. Hummel, T., Whitcroft, KL., Andrews, P., et al.[2022]

The Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR) is a newly developed and validated quality-of-life measure specifically for patients experiencing parosmia, demonstrating strong reliability and validity in a study involving 134 patients and 20 healthy controls.

DisODOR effectively distinguishes between patients with parosmia and healthy individuals, with a significant mean score difference of 45.0, and is sensitive to changes in patients' conditions, making it a useful tool for evaluating treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Validation of the Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR). Ioerger, P., Kallogjeri, D., Roland, L., et al.[2023]

The Affordable Rapid Olfaction Measurement Array (AROMA) is a novel, essential oil-based smell test that shows strong reliability and correlation with the established University of Pennsylvania Smell Identification Test (UPSIT), making it a promising tool for assessing olfactory function.

AROMA not only correlates well with UPSIT but also with sinonasal outcomes and perceived loss of smell, suggesting it could be particularly useful for evaluating olfactory dysfunction in patients with sinonasal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affordable Rapid Olfaction Measurement Array: A Novel, Essential Oil-Based Test Strongly Correlated with UPSIT and Subjective Outcome Measures. Villwock, JA., Li, J., Moore, C., et al.[2022]

Olfactory training is the only therapy for olfactory loss with level 1a evidence supporting its efficacy, making it a valuable option for patients who currently have no other management alternatives.

This therapy is safe, easy to perform, and has the potential to help many patients, although more research is needed to determine the optimal duration and specific protocols for different patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evidence for olfactory training in treating patients with olfactory loss. Patel, ZM.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Health-related and specific olfaction-related quality of life in patients with chronic functional anosmia or severe hyposmia. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Position paper on olfactory dysfunction. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Development and Validation of the Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR). [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Affordable Rapid Olfaction Measurement Array: A Novel, Essential Oil-Based Test Strongly Correlated with UPSIT and Subjective Outcome Measures. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Position paper on olfactory dysfunction. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Flavor education and training in olfactory dysfunction: a pilot study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Causality Assessment of Olfactory and Gustatory Dysfunction Associated with Intranasal Fluticasone Propionate: Application of the Bradford Hill Criteria. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

The evidence for olfactory training in treating patients with olfactory loss. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Factors associated with relevant olfactory recovery after olfactory training: a retrospective study including 601 participants. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Olfactory training is helpful in postinfectious olfactory loss: a randomized, controlled, multicenter study. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation of olfaction after laryngectomy by means of a nasal airflow-inducing maneuver: the "polite yawning" technique. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

A Method for Computerized Olfactory Assessment and Training Outside of Laboratory or Clinical Settings. [2023]