Clinical trial NCT06733636: Scents of Progress: Leveraging a Novel Device for Olfactory Training in Older Adults
Official title: SPLENDOR-OA; Scents of Progress: Leveraging a Novel Device for Olfactory Training in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Olfactory Dysfunction
Smell Loss
Anosmia
Hyposmia
Keywords: Olfactory Dysfunction
Olfactory Training
Smell Training
Smell Training Device
Smell Loss
Anosmia
Hyposmia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in olfaction as assessed by Sniffin' Sticks olfactory testing kit
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in peripheral olfaction as assessed by Sniffin' Sticks olfactory testing kit
timeFrame: Baseline and 3 months
measure: Change in central olfaction as assessed by Sniffin' Sticks olfactory testing kit
timeFrame: Baseline and 3 months
measure: Change in olfactory specific Quality of Life as Assessed by the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS)
timeFrame: Baseline and 3 months
measure: Change in overall cognition as assessed by the Montreal Cognitive Assessment (MoCA) test
timeFrame: Baseline and 3 months
measure: Change in overall anxiety as assessed by the General Anxiety Disorder Questionnaire-7 (GAD-7)
timeFrame: Baseline and 3 months
measure: Change in overall depression as assessed by the Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Baseline and 3 months
measure: Compliance as assessed by the number of patients who consistently used the olfactory training device or solved the Sudoku puzzles
timeFrame: 3 months post intervention
measure: Device usability as assessed by the System Usability Scale (SUS)
timeFrame: 3 months post intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center, Department of Otolaryngology - Head and Neck Surgery
state: Maryland
Study officials:
affiliation: Johns Hopkins University, Department of Otolaryngology - Head and Neck Surgery
name: Nicholas Rowan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: