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

NCT06733636 | Recruiting

• 1 other identifier: IRB00467494
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Olfactory Dysfunction; Smell Loss; Anosmia; Hyposmia

Keywords

Olfactory Dysfunction; Olfactory Training; Smell Training; Smell Training Device; Smell Loss; Anosmia; Hyposmia

Outcome Measures

Primary Outcomes (1)

• Change in olfaction as assessed by Sniffin' Sticks olfactory testing kit

  Changes in olfaction between the two groups will be assessed using Sniffin' Sticks olfactory testing. The main outcome is a cumulative Threshold, Discrimination, and Identification (TDI) score, where a TDI score above 30.5 is considered normal, between 30.5 and 16 indicates hyposmia (reduced smell), and below 16 signifies anosmia (complete loss of smell).

  Baseline and 3 months

Secondary Outcomes (8)

• Change in peripheral olfaction as assessed by Sniffin' Sticks olfactory testing kit

  Baseline and 3 months

• Change in central olfaction as assessed by Sniffin' Sticks olfactory testing kit

  Baseline and 3 months

• Change in olfactory specific Quality of Life as Assessed by the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS)

  Baseline and 3 months

• Change in overall cognition as assessed by the Montreal Cognitive Assessment (MoCA) test

  Baseline and 3 months

• Change in overall anxiety as assessed by the General Anxiety Disorder Questionnaire-7 (GAD-7)

  Baseline and 3 months

Study Arms (2)

Olfactory Training

EXPERIMENTAL

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: ScentCare (Olfactory Training Device)

Control Arm (Sudoku Puzzles)

OTHER

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

Other: Sudoku Puzzles

Interventions

Sudoku Puzzles OTHER

Sudoku puzzles of consistent and regular difficulty

Control Arm (Sudoku Puzzles)

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.

Olfactory Training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

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

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Anosmia

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicholas Rowan, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wassim Najjar, M.D.

CONTACT

443-997-6467; wnajjar1@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: April 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)