Scents of Progress: Leveraging a Novel Device for Olfactory Training in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sudoku Puzzles, ScentCare (Olfactory Training Device).
- Who it may be relevant to
- Registry conditions: Olfactory Dysfunction, Smell Loss, Anosmia, Hyposmia. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SPLENDOR-OA; Scents of Progress: Leveraging a Novel Device for Olfactory Training in Older Adults
Overview
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.
Interventions
- Other Sudoku Puzzles
Sudoku puzzles of consistent and regular difficulty - 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
Primary outcome measures
- Change in olfaction as assessed by Sniffin' Sticks olfactory testing kit [Time frame: Baseline and 3 months]
Secondary outcome measures (8)
- Change in peripheral olfaction as assessed by Sniffin' Sticks olfactory testing kit [Time frame: Baseline and 3 months]
- Change in central olfaction as assessed by Sniffin' Sticks olfactory testing kit [Time frame: Baseline and 3 months]
- Change in olfactory specific Quality of Life as Assessed by the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) [Time frame: Baseline and 3 months]
- Change in overall cognition as assessed by the Montreal Cognitive Assessment (MoCA) test [Time frame: Baseline and 3 months]
- Change in overall anxiety as assessed by the General Anxiety Disorder Questionnaire-7 (GAD-7) [Time frame: Baseline and 3 months]
- Change in overall depression as assessed by the Patient Health Questionnaire-8 (PHQ-8) [Time frame: Baseline and 3 months]
- Compliance as assessed by the number of patients who consistently used the olfactory training device or solved the Sudoku puzzles [Time frame: 3 months post intervention]
- Device usability as assessed by the System Usability Scale (SUS) [Time frame: 3 months post intervention]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Johns Hopkins Outpatient Center, Department of Otolaryngology - Head and Neck Surgery — Baltimore
Identifiers
NCT: NCT06733636 · IRB00467494