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

NCT ID: NCT06733636

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2026-05-30

Brief Summary

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.

Detailed Description

This research is being done to better understand the efficacy of an investigational device and its companion phone application (together called "ScentCare") in treating olfactory dysfunction.

Although the sense of smell is commonly overlooked, it is a unique and special human sensory function that has implications for quality of life, such as the enjoyment of food and nutrition or the ability to perceive dangers, such as smoke or noxious fumes. Although smell training is a well-established rehabilitation treatment for people with olfactory dysfunction (OD) or loss of smell, no standardized smell training method is currently available. Thus, the investigators invented a device and companion phone app that standardizes and compiles smell training. The investigators are seeking data on how to improve the device and its efficacy in general.

This study will have participants complete formal smell testing prior to using the ScentCare or Sudoku daily for three months and after the completion of the intervention. Participants will also answer a survey (questionnaires asked will include olfactory specific qualify of life assessment, cognitive assessment, depression assessment, anxiety assessment, device use and compliance) upon enrollment and after completion of the intervention (3 months follow up).

Once enrolled, participants will be randomized to either the "experimental" or "control" group. Participants in the experimental group will be given an olfactory training device and instructions for the smartphone-based olfactory training application. This olfactory training device consists of a hand-held rotating wheel with 8 individual scent chambers allowing personalized exposure to odorants (smells) according to the training app's instructions. If the participant does not have a smartphone, the participant will be given a training booklet with corresponding cues and instructions. Twice daily, 5-minute training sessions will be completed for 3 months. Participants in the control group will not undergo olfactory training but will be asked to complete sudoku puzzles for the same duration as the training for the experimental group.

After three months of either smell training with ScentCare or completing Sudoku puzzles, participants will be re-evaluated using the Sniffin' Sticks test and the same surveys to assess the impact of the intervention. Results will be compared between the two groups. Additionally, participants in the ScentCare group will provide feedback on the device's feasibility, ease of use, and overall effectiveness to inform its potential for broader application.

Conditions

Olfactory Dysfunction; Smell Loss; Anosmia; Hyposmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ScentCare (Olfactory Training Device)

Intervention Type: 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.

Control Arm (Sudoku Puzzles)

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

Group Type: OTHER

Sudoku Puzzles

Intervention Type: OTHER

Sudoku puzzles of consistent and regular difficulty

Interventions

Sudoku Puzzles

Sudoku puzzles of consistent and regular difficulty

Intervention Type: OTHER

ScentCare (Olfactory Training Device)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults 60 years of age or older.
• English-speaking patients.
• Patients with a diminished or lost sense of smell.
• Patients who have not done smell training before

Exclusion Criteria

• Patients who are sensitive to any of the scents used in the study.
• Patients with a diagnosis of congenital anosmia.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Rowan, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Wassim Najjar, M.D.

Role: CONTACT

wnajjar1@jh.edu

443-997-6467

Facility Contacts

Wassim Najjar, M.D.

Role: primary

wnajjar1@jh.edu

443-997-6467

Other Identifiers

IRB00467494

Identifier Type: -

Identifier Source: org_study_id