60 Participants Needed

Olfactory Training Device for Loss of Smell

(SPLENDOR-OA Trial)

WN
Overseen ByWassim Najjar, M.D.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12356

Who Is on the Research Team?

NR

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?
2Treatment groups
Experimental Treatment
Group I: Olfactory TrainingExperimental Treatment1 Intervention
Group II: Control Arm (Sudoku Puzzles)Experimental Treatment1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

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 ...
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 ...
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 ...
Olfactory Training Device for Loss of SmellDisODOR effectively distinguishes between patients with parosmia and healthy individuals, with a significant mean score difference of 45.0, and is sensitive to ...
Olfactory training – Thirteen years of research reviewedOnly four studies report the rate of clinically relevant improvement in patients with idiopathic olfactory loss. The clinically significant change ranges from 6 ...
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 ...
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