Scents of Progress: Leveraging a Novel Device for Olfactory Training in Older Adults

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06733636
Status
Recruiting
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Conditions

  • Anosmia
  • Hyposmia
  • Olfactory Dysfunction
  • Smell Loss

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sudoku Puzzles — OTHER
    Sudoku puzzles of consistent and regular difficulty
  • ScentCare (Olfactory Training Device) — OTHER
    ScentCare is a smell training device with eight encapsulated scents housed in separate compartments and is contained using a charcoal filter, which will be dispersed in the base of our device to prevent smell contamination in the user's environment. The outer casing contains an opening that can be manually rotated to line up with the casing on each scent. This is facilitated by a rod in the center of the device, which serves as the axis of rotation. By pressing the capsule, the desired scent is released through a hole in the casing, similar to the mechanism of a pen. The user presses the compartment back downwards into the casing when done. The ScentCare mobile application offers clear instructions for at-home smell training and testing, with features like scent randomization to prevent users from getting accustomed to a specific order. It provides detailed guidance on device use and allows users to schedule sessions and receive daily reminders, ensuring a structured training regimen.

Study Details

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.

Key Dates

Start date
Apr 15, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Olfactory Training
    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.
  • Other: Control Arm (Sudoku Puzzles)
    Participants will be asked to complete sudoku puzzles twice daily over a period of three months.

Primary Outcome Measure

Change in olfaction as assessed by Sniffin' Sticks olfactory testing kit [ Time Frame: Baseline and 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Outpatient Center, Department of Otolaryngology - Head and Neck SurgeryBaltimoreMaryland21287
Wassim Najjar, M.D.
[email protected]
443-997-6467
Nicholas Rowan, M.D. (PRINCIPAL_INVESTIGATOR)

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Johns Hopkins Outpatient Center, Department of Otolaryngology - Head and Neck Surgery· Baltimore, MD

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