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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new smell training device, ScentCare, can improve the sense of smell and overall well-being in elderly individuals with a diminished sense of smell. Participants will either use ScentCare or solve Sudoku puzzles twice daily for three months. They will visit the clinic twice to complete a smell test and some questionnaires. Ideal participants are those aged 60 or older, who speak English, have a reduced sense of smell, and have not previously tried smell training. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance the quality of life for many.

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 prior data suggests that this olfactory training device is safe for elderly patients with olfactory dysfunction?

Research has shown that olfactory training, such as that used with the ScentCare device, is generally safe. Previous studies found that this type of training can improve the sense of smell in individuals, regardless of smell loss, without significant side effects. Although detailed safety data specifically for ScentCare is lacking, olfactory training methods are typically well-tolerated. Participants in these studies did not report any major negative effects. This suggests that using ScentCare is likely safe for participants in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ScentCare olfactory training device because it offers a novel approach to treating loss of smell by using a carefully curated selection of scents. Unlike traditional methods that might involve medications or passive scent exposure, this device actively engages users in twice-daily training with scents like Eucalyptus and Coffee, which could enhance the brain's ability to recognize and distinguish smells. With the added flexibility of using a web-based app or a booklet for guidance, it makes the training accessible and adaptable to individual preferences, potentially leading to more effective outcomes.

What evidence suggests that the ScentCare device is effective for olfactory dysfunction?

Studies have shown that smell training can help people who have lost their sense of smell. One study found that individuals with smell issues who used a smell training device like ScentCare performed better on smell tests than those who did not. In this trial, participants in the olfactory training arm will use the ScentCare device, which employs various scents such as eucalyptus and vanilla, to potentially re-activate the brain's smell pathways. Research suggests that this type of training can stimulate the brain and may aid in recovering some sense of smell. Although more studies are needed, early results appear promising for those with smell problems. ^{1 2 3 5 6}

Who Is on the Research Team?

Nicholas Rowan, M.D.

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06733636?term=eucalyptus%20globulus%20lead&rank=2&checkSpell=

Study Details | Scents of Progress: Leveraging a Novel ...

After three months of either smell training with ScentCare or completing Sudoku puzzles, participants will be re-evaluated using the Sniffin' Sticks test and ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9891899/

Does Olfactory Training Improve Brain Function and Cognition ...

Effectiveness of Olfactory Training on Different Severities of Posttraumatic Smell Loss. Adults w/ Olfactory Loss after TBI: N = 42 (Mage ...

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trialx.com

trialx.com/clinical-trials/listings/317227/scents-of-progress-leveraging-a-novel-device-for-olfactory-training-in-older-adults/

Leveraging a Novel Device for Olfactory Training in Older ...

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 ...

4.

withpower.com

withpower.com/trial/phase-olfactory-dysfunction-2025-ea40d

Olfactory Training Device for Loss of Smell

DisODOR effectively distinguishes between patients with parosmia and healthy individuals, with a significant mean score difference of 45.0, and is sensitive to ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0149763422003426

Olfactory training – Thirteen years of research reviewed

Only four studies report the rate of clinically relevant improvement in patients with idiopathic olfactory loss. The clinically significant change ranges from 6 ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07221123

Boosting Olfactory and Sensory Training Study (BOOST)

The goal of this study is to examine two types of olfactory interventions (olfactory training vs overnight odor diffuser) in adults with HIV ...