Olfactory DysfunctionSPLENDOR-OANCT06733636
Scents of Progress: Leveraging a Novel Device for Olfactory Training in Older Adults
A study testing Sudoku Puzzles and ScentCare (Olfactory Training Device) in people with Olfactory Dysfunction and Smell Loss, run by Johns Hopkins University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Olfactory Dysfunction, Smell Loss, Anosmia
- What is being tested?
- Sudoku Puzzles and ScentCare (Olfactory Training Device)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are sensitive to any of the scents used in the study.
- Patients with a diagnosis of congenital anosmia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Outpatient Center, Department of Otolaryngology - Head and Neck Surgery
Baltimore, Maryland, 21287
Wassim Najjar, M.D., 443-997-6467, wnajjar1@jh.edu
Nicholas Rowan, M.D.
About this study
Official title: SPLENDOR-OA; Scents of Progress: Leveraging a Novel Device for Olfactory Training in Older Adults
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?
Read more
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.
Read the 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
- Being tested
- Sudoku Puzzles, ScentCare (Olfactory Training Device)
- Keywords
- Olfactory Dysfunction, Olfactory Training, Smell Training, Smell Training Device, Smell Loss, Anosmia, Hyposmia
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sudoku PuzzlesOther
Sudoku puzzles of consistent and regular difficulty
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sudoku Puzzles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 3 months
Secondary outcomes (8)
Change in peripheral olfaction as assessed by Sniffin' Sticks olfactory testing kit
Changes in peripheral olfaction between the two groups will be assessed using Sniffin' Sticks. Sniffin's Sticks tests olfactory function in three domains: threshold, discrimination, and identification. Threshold testing allows for peripheral olfaction testing. The most dilute concentration of odorant that the participant is able to reliably detect is determined. Score ranges between 1 and 16, with higher score indicating better peripheral olfaction.
Measured: Baseline and 3 months
Change in central olfaction as assessed by Sniffin' Sticks olfactory testing kit
Changes in central olfaction between the two groups will be assessed using Sniffin' Sticks. Sniffin's Sticks tests olfactory function in three domains: threshold, discrimination, and identification. The discrimination and identification tests allow for central olfaction testing. In discrimination testing, the participant is evaluated on their ability to discern the unique scent among three scented sticks. In identification testing, the patient names the smell using a multiple choice form which offers four options for every scented stick, only one of which is correct.
Both tests have scores ranging between 0 and 16, with higher scores indicating better central olfaction.
Measured: Baseline and 3 months
Change in olfactory specific Quality of Life as Assessed by the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS)
Changes in overall olfactory wellbeing between the two groups will be assessed using Quality of life (QoL) assessment (Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS). This instrument consists of 17 negative statements graded from 0 to 3 for a maximum score range of 0-51 (higher scores reflect worse QOL). The QOD-NS has 4 distinct factor domains, broadly categorized as those that relate to eating, anxiety, social interactions, and annoyance.
Measured: Baseline and 3 months
Change in overall cognition as assessed by the Montreal Cognitive Assessment (MoCA) test
Changes in overall cognition will be assessed between the two groups using Montreal Cognitive Assessment (MoCA) test which is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. This test involves memorizing a short list of words, naming objects shown in pictures, copying shapes and performing other tasks. The test is scored out of a maximum of 30 points, and the results are interpreted as follows:
26 or higher: Normal cognitive health; 18-25: Mild cognitive impairment (MCI); 10-17: Moderate cognitive impairment; Less than 10: Severe cognitive impairment
Measured: Baseline and 3 months
Change in overall anxiety as assessed by the General Anxiety Disorder Questionnaire-7 (GAD-7)
Changes in overall anxiety will done using the Generalized Anxiety Disorder Questionnaire-7 (GAD-7). The GAD-7 consists of 7 items (scored 0-21) to assess anxiety symptoms over the previous 2 weeks. Higher scores indicate higher frequency of symptoms. Scores greater than or equal to 10 are indicative of generalized anxiety disorder.
Measured: Baseline and 3 months
Change in overall depression as assessed by the Patient Health Questionnaire-8 (PHQ-8)
Changes in overall depression will be assessed using the Patient Health Questionaire-8 (PHQ-8). This consists of a 2-item screen (scored 0-6) from PHQ-2, with a score above 2 prompting PHQ-8. The PHQ-8 consists of 8 items (scored 0-24) to assess depressive symptoms over the previous 2 weeks. Higher scores indicate higher frequency of symptoms, and a score greater than or equal to 10 is indicative of major depression.
Measured: Baseline and 3 months
Compliance as assessed by the number of patients who consistently used the olfactory training device or solved the Sudoku puzzles
Patient compliance will be tracked for both groups over the three-month period. Sudoku users will log the number of puzzles completed daily and the time spent on each, while ScentCare users will rely on the companion app to monitor the frequency of their smell training sessions. Compliance data from both methods will be compared after the trial.
Measured: 3 months post intervention
Device usability as assessed by the System Usability Scale (SUS)
Device usability will be evaluated using the System Usability Scale (SUS), a validated 10-item questionnaire. Participants will rate each statement on a scale from 1 (strongly disagree) to 5 (strongly agree). Score range 10-50. Usability scores will be calculated based on SUS guidelines to assess ScentCare's usability and identify areas for improvement.
Measured: 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start15 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Olfactory DysfunctionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Rowan, M.D., Principal investigator, Johns Hopkins University, Department of Otolaryngology - Head and Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733636
- Sponsor's protocol ID
- IRB00467494
- Acronym
- SPLENDOR-OA
- Status last verified
- Apr 2026
- First submitted
- 10 Dec 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPLENDOR-OA; Scents of Progress: Leveraging a Novel Device for Olfactory Training in Older Adults
- ClinicalTrials.gov ID
- NCT06733636
- Acronym / sponsor ID
- SPLENDOR-OA / IRB00467494
- Conditions
- Olfactory Dysfunction, Smell Loss, Anosmia, Hyposmia
- Keywords
- Olfactory Dysfunction, Olfactory Training, Smell Training, Smell Training Device, Smell Loss, Anosmia, Hyposmia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olfactory Training | Experimental | Other: ScentCare (Olfactory Training Device)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. |
| Control Arm (Sudoku Puzzles) | Other | Other: Sudoku PuzzlesParticipants will be asked to complete sudoku puzzles twice daily over a period of three months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are sensitive to any of the scents used in the study.
- Patients with a diagnosis of congenital anosmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sudoku PuzzlesSudoku puzzles of consistent and regular difficulty | Other | Control Arm (Sudoku Puzzles) |
| 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. | Other | Olfactory Training |
Primary outcome
Change in olfaction as assessed by Sniffin' Sticks olfactory testing kit
Time frame: Baseline and 3 months
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).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Rowan, M.D. principal investigator
Johns Hopkins University, Department of Otolaryngology - Head and Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sudoku Puzzles and ScentCare (Olfactory Training Device) in people with Olfactory Dysfunction and Smell Loss, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wassim Najjar, M.D. (443-997-6467, wnajjar1@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in olfaction as assessed by Sniffin' Sticks olfactory testing kit (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.