DementiaNCT05168098
Impact of the Olfactory Stimulation on the People With Mild Dementia Via the Horticultural Therapy
A study testing board game comparison and olfactory stimulation intervention in people with Dementia, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
The aim of this study is to examine the effect of the olfactory stimulation intervention on the people with mild to moderate dementia. We recruit 28 participants who has been diagnosed with mild to moderate dementia from 2 day care centers in Taipei. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Dementia
- What is being tested?
- board game comparison and olfactory stimulation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2019to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages >50 years with a diagnosis of mild or moderate dementia
- being admitted to the day care center and living in the community
- being willing to do blood test with a family member's consent.
Who cannot join
- experience in chronic rhinitis or sinusitis, which causes loss of smell; inability to perform the cognitive exam or olfactory test (e.g., having a severe hearing impairment)
- inability to attend group activities due to severe emotional or aggressive behaviors
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine the effect of the olfactory stimulation intervention on the people with mild to moderate dementia. We recruit 28 participants who has been diagnosed with mild to moderate dementia from 2 day care centers in Taipei. They are randomly assigned to three groups, including the olfactory intervention group, game comparison group, and control group. Beside the control group, the participant with two other groups were required to attend twelve weeks intervention (twice a week, thirty minutes for one section). Every participants completed the olfactory test, both paper-pencil and computer-based examination for cognition, blood test and psychological measurement before and after the intervention. The results showed that the participant in olfactory intervention group significant improved score in the LOTCA-G examination, and the Aβ1-42 concentration of the blood test significant increase in the control group; furthermore, the olfactory intervention group is lowest concentration among three groups in the Tau concentration of the blood test via ANCOVA analysis.
- Conditions
- Dementia
- Being tested
- board game comparison, olfactory stimulation intervention
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
board game comparisonOther
The group used 24 board games popular among the elderly population in Taiwan, including Noah's Ark, Splash Attack, Pengoloo, Speedy, and Zingo. Because some games were too complicated for the participants to play, some game rules were modified into more simple and directive thinking.
olfactory stimulation interventionOther
The group used 15 flavors of essential oil (i.e., lavender, rosemary, sweet orange, lemongrass, mint, and hinoki) and essence (i.e., lemon, coffee, peach, magnolia, chocolate, jasmine, strawberry, pomelo, and passion fruit), purposefully selecting two to three flavors for each session. Because some flavors are familiar to the participants and some are not, the familiar flavors were initially used to trigger memory. The unfamiliar flavors (i.e., lavender, rosemary, sweet orange, and lemon) were used in later sessions because those were recognized as having potential effects on cognitive function
| Study group | Role | What they receive |
|---|---|---|
| olfactory intervention group | Experimental | Not described Receives: Other: olfactory stimulation intervention |
| game comparison group | Active comparator | Not described Receives: Other: board game comparison |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ImmunoMaggnetic-Reduction (IMR) blood tests
A registered nurse drew 5 cc of blood from each participant twice, including pretest and posttest by the following procedure:
Step 1: Plasma preparation 10-ml K3 EDTA tubes were used for collecting blood, immediately followed by gently inverting each blood tube 10 times. Blood tubes were centrifuged at room temperature at 2500g for 15 minutes with an aid of a swing-out (backet) rotor. Every 1-ml plasma (supernatant) was transferred to a fresh 1.5-ml eppendorf using a disposable 1-ml micropipette tip. All the plasma samples were frozen at -80 °C before measurements.
Step 2: Assays of plasma biomarkers IMR kits were used in assaying amyloid B 1-42 and tau protein (Tau). For assaying AB1-42, 60-ul reagent was mixed with 60-ul plasma. For assaying Tau, 80-ul reagent was mixed with 40-ul plasma. Duplicated measurements were conducted for each biomarker per plasma sample. The average value of the duplicated measured concentrations is reported.
Measured: 60 min
Secondary outcomes (4)
Mini-mental State Examination
All the participants were received the interview of MMSE twice, including pretest and posttest. A trained research assistant performed the test face to face. The MMSE is a widely used tool for clinical evaluation, with five major domains (orientation, registration, attention and calculation, recall, language). The examination is composed of 11 questions; the score ranges from 0 to 30, with a higher score indicating better cognitive function.
Measured: 60 min.
Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
All the participants were received the interview of LOTCA-G twice, including pretest and posttest. A trained research assistant performed the test face to face. The LOTCA-G, a modified version of the LOTCA for adults aged >70 years or for clients with a slower response to cognitive tasks, contains 23 subsets in 7 cognitive areas (orientation, visual perception, spatial perception, praxis, visuomotor organization, thinking operations, memory). Each question is scored from 1 (severe deficit) to 4 (average performance), with scores ranging from 23 to 100, with higher scores indicating better cognitive performance (Erez \& Katz, 2004). LOTCA-G, a well-established test of discriminant validity for individuals with dementia, can be used to monitor changes in cognitive function during an intervention.
Measured: 60 min.
The Top International Biotech Smell Identification Test (TIBSIT)
All the participants were received the interview of TIBSIT twice, including pretest and posttest. TIBSIT, which consists of 16 tests (1 odor for 2 repeated tests) and a questionnaire, has 8 odors relevant for the Taiwanese population. Each participant completed the test with the assistance of a trained research assistant, if necessary. Within a test, the participant scratches the paper off the fragrant microcapsules using a pencil, smells the fragrance, and then answers two questions. The first question is a single choice from among four answers to identify the closest name of the odor, and the second is a three-item choice of not detectable (smell nothing, 0 points); detectable, but not sure (can smell something but unsure, 1 point); and detectable (can smell and know exactly what it is, 2 points). A total of 48 points are available for 16 tests.
Measured: 60 min.
Geriatric Depression Scale (GDS-15)
All the participants were received the interview of GDS-15 twice, including pretest and posttest. A trained research assistant performed the test face to face. GDS-15, a 15-item, short, easy-to-conduct questionnaire, to assess participants' emotional changes during the intervention. The answers are reported on a yes-no scale; the total scores range from 0 to 15, with higher scores indicating more severe depression.
Measured: 60 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Oct 2019
- Primary completion31 Aug 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168098
- Sponsor's protocol ID
- MOST 108-2410-H-003-128-
- Other IDs
- 201901HM030
- Status last verified
- Dec 2021
- First submitted
- 8 Dec 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin LJ, Li KY. Comparing the effects of olfactory-based sensory stimulation and board game training on cognition, emotion, and blood biomarkers among individuals with dementia: A pilot randomized controlled trial. Front Psychol. 2022 Sep 20;13:1003325. doi: 10.3389/fpsyg.2022.1003325. eCollection 2022.
PubMed 36204759
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Olfactory Stimulation on the People With Mild Dementia Via the Horticultural Therapy
- ClinicalTrials.gov ID
- NCT05168098
- Acronym / sponsor ID
- MOST 108-2410-H-003-128-
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 23 Dec 2021 (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 aim of this study is to examine the effect of the olfactory stimulation intervention on the people with mild to moderate dementia. We recruit 28 participants who has been diagnosed with mild to moderate dementia from 2 day care centers in Taipei. They are randomly assigned to three groups, including the olfactory intervention group, game comparison group, and control group. Beside the control group, the participant with two other groups were required to attend twelve weeks intervention (twice a week, thirty minutes for one section). Every participants completed the olfactory test, both paper-pencil and computer-based examination for cognition, blood test and psychological measurement before and after the intervention. The results showed that the participant in olfactory intervention group significant improved score in the LOTCA-G examination, and the Aβ1-42 concentration of the blood test significant increase in the control group; furthermore, the olfactory intervention group is lowest concentration among three groups in the Tau concentration of the blood test via ANCOVA analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| olfactory intervention group | Experimental | Other: olfactory stimulation intervention |
| game comparison group | Active comparator | Other: board game comparison |
| control group | No intervention | – |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ages >50 years with a diagnosis of mild or moderate dementia
- being admitted to the day care center and living in the community
- being willing to do blood test with a family member's consent.
Key exclusion criteria (2 listed)
- experience in chronic rhinitis or sinusitis, which causes loss of smell; inability to perform the cognitive exam or olfactory test (e.g., having a severe hearing impairment)
- inability to attend group activities due to severe emotional or aggressive behaviors
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 |
|---|---|---|
| board game comparisonThe group used 24 board games popular among the elderly population in Taiwan, including Noah's Ark, Splash Attack, Pengoloo, Speedy, and Zingo. Because some games were too complicated for the participants to play, some game rules were modified into more simple and directive thinking. | Other | game comparison group |
| olfactory stimulation interventionThe group used 15 flavors of essential oil (i.e., lavender, rosemary, sweet orange, lemongrass, mint, and hinoki) and essence (i.e., lemon, coffee, peach, magnolia, chocolate, jasmine, strawberry, pomelo, and passion fruit), purposefully selecting two to three flavors for each session. Because some flavors are familiar to the participants and some are not, the familiar flavors were initially used to trigger memory. The unfamiliar flavors (i.e., lavender, rosemary, sweet orange, and lemon) were used in later sessions because those were recognized as having potential effects on cognitive function | Other | olfactory intervention group |
Primary outcome
ImmunoMaggnetic-Reduction (IMR) blood tests
Time frame: 60 min
A registered nurse drew 5 cc of blood from each participant twice, including pretest and posttest by the following procedure: Step 1: Plasma preparation 10-ml K3 EDTA tubes were used for collecting blood, immediately followed by gently inverting each blood tube 10 times. Blood tubes were centrifuged at room temperature at 2500g for 15 minutes with an aid of a swing-out (backet) rotor. Every 1-ml plasma (supernatant) was transferred to a fresh 1.5-ml eppendorf using a disposable 1-ml micropipette tip. All the plasma samples were frozen at -80 °C before measurements. Step 2: Assays of plasma biomarkers IMR kits were used in assaying amyloid B 1-42 and tau protein (Tau). For assaying AB1-42, 60-ul reagent was mixed with 60-ul plasma. For assaying Tau, 80-ul reagent was mixed with 40-ul plasma. Duplicated measurements were conducted for each biomarker per plasma sample. The average value of the duplicated measured concentrations is reported.
4 secondary outcomes
Mini-mental State Examination
Time frame: 60 min.
Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
Time frame: 60 min.
The Top International Biotech Smell Identification Test (TIBSIT)
Time frame: 60 min.
Geriatric Depression Scale (GDS-15)
Time frame: 60 min.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Derived from this study: PubMed 36204759Lin LJ, Li KY. Comparing the effects of olfactory-based sensory stimulation and board game training on cognition, emotion, and blood biomarkers among individuals with dementia: A pilot randomized controlled trial. Front Psychol. 2022 Sep 20;13:1003325. doi: 10.3389/fpsyg.2022.1003325. eCollection 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing board game comparison and olfactory stimulation intervention in people with Dementia, run by National Taiwan Normal University at 1 site in Taiwan.
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 3 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: finished, as of the sponsor's last update on 23 Dec 2021. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ImmunoMaggnetic-Reduction (IMR) blood tests (time frame: 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05168098, which also lists 1 linked publication.
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 23 Dec 2021.