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

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.

• Change in peripheral olfaction as assessed by Sniffin' Sticks olfactory testing kit [Срок оценки: Baseline and 3 months]
• Change in central olfaction as assessed by Sniffin' Sticks olfactory testing kit [Срок оценки: Baseline and 3 months]
• Change in olfactory specific Quality of Life as Assessed by the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) [Срок оценки: Baseline and 3 months]
• Change in overall cognition as assessed by the Montreal Cognitive Assessment (MoCA) test [Срок оценки: Baseline and 3 months]
• Change in overall anxiety as assessed by the General Anxiety Disorder Questionnaire-7 (GAD-7) [Срок оценки: Baseline and 3 months]
• Change in overall depression as assessed by the Patient Health Questionnaire-8 (PHQ-8) [Срок оценки: Baseline and 3 months]
• Compliance as assessed by the number of patients who consistently used the olfactory training device or solved the Sudoku puzzles [Срок оценки: 3 months post intervention]
• Device usability as assessed by the System Usability Scale (SUS) [Срок оценки: 3 months post intervention]