DementiaAROMA-SUNNCT07288736
Aromatherapy Formulas for Sundowning and Sleep Quality in Patients With Dementia.
A study testing Aromatherapy Formula A and Aromatherapy Formula B in people with Dementia and Sundowning, run by National Cheng-Kung University Hospital at 2 sites in Taiwan.
Trial summary
Dementia is common in aging societies and is often accompanied by sundowning syndrome and sleep problems. These symptoms can be very distressing for patients and place a heavy burden on family members and professional caregivers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia, Sundowning
- What is being tested?
- Aromatherapy Formula A and Aromatherapy Formula B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesTaiwan
- Study dates
- 15 Sep 2025to 12 Jan 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of dementia by a specialist according to DSM-5 (any type) OR SPMSQ score < 8.
- Manifesting sundown syndrome with a score ≥ 26 on the CMAI-C.
- Able to speak Mandarin or Taiwanese.
Who cannot join
- Clinical diagnosis of a psychiatric disorder (e.g., schizophrenia, bipolar disorder).
- Acute stage of illness within the past 2 weeks.
- Olfactory disorder or loss of smell (anosmia).
- Allergy to essential oil fragrances.
- Currently receiving aromatherapy.
- Respiratory disease (e.g., asthma, COPD).
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Evergreen Senior Day Care Center
Kaohsiung, Taiwan, 802
Kang Yu Day Care Center, Tainan
Tainan, Taiwan, 71754
About this study
Official title: The Distinctive Effects of Aroma-Formulas on Sundown Syndrome, Mood and Sleep Quality of Patients With Dementia
Dementia is common in aging societies and is often accompanied by sundowning syndrome and sleep problems. These symptoms can be very distressing for patients and place a heavy burden on family members and professional caregivers. Aromatherapy using essential oils, especially lavender, has shown promise in reducing behavioral symptoms in people with dementia, but evidence on compound essential oil formulas and their effects on both sundowning and sleep quality remains limited.
This study will compare two different compound essential oil formulas for people with dementia living in long-term care facilities in southern Taiwan. Each participant will receive both formulas at different times in a repeated crossover design. In Phase 1, participants will receive a stimulating formula in the morning (rosemary and lemon) and a relaxing formula in the afternoon (lavender and sweet orange). In Phase 2, they will receive a calming blend that includes sweet orange, spike lavender, true lavender, vetiver, bergamot, and Roman chamomile. Aromatherapy will be administered by diffusion twice a day, five days per week, for two weeks in each phase.
The main outcomes are changes in agitation and sleep quality, measured using the Chinese versions of the Cohen-Mansfield Agitation Inventory and the Pittsburgh Sleep Quality Index. The findings are expected to provide preliminary evidence on whether compound essential oil formulas can be a simple, non-drug approach to help manage sundowning syndrome and improve sleep in people with dementia.
Read the detailed description
Dementia is increasingly prevalent in rapidly aging societies and is frequently accompanied by neuropsychiatric symptoms, including sundowning syndrome and disturbed sleep-wake cycles. Sundowning behaviors-such as agitation, wandering, and confusion that worsen in the late afternoon or evening-are particularly challenging to manage and are associated with poorer sleep quality, increased use of psychotropic medications, and heightened caregiver burden. Non-pharmacological interventions that are safe, simple, and feasible in long-term care settings are urgently needed.
Aromatherapy has emerged as a potentially useful complementary therapy for behavioral and psychological symptoms of dementia. Prior studies have suggested that lavender and other essential oils may reduce agitation and promote relaxation; however, most existing evidence focuses on single oils, small samples, or non-standardized protocols. Data on compound essential oil formulations, especially those targeting both sundowning syndrome and sleep quality, remain limited.
This study is designed to evaluate the comparative effectiveness of two compound essential oil formulas on agitation related to sundowning and on overall sleep quality in patients with dementia. A repeated crossover design will be used. Participants will be recruited from long-term care facilities in southern Taiwan and must have a medical diagnosis of dementia and observable sundowning or sleep disturbance.
The intervention includes two 2-week aromatherapy phases, separated by an appropriate washout period. Aromatherapy is delivered by diffusion in the dementia care unit twice daily (09:00 and 14:00), five days per week.
Phase 1 (Formula A):
Morning: Formula A1, a 2:1 blend of organic rosemary (Rosmarinus officinalis) and organic lemon (Citrus limon) essential oils, intended to promote alertness and daytime activity.
Afternoon: Formula A2, a 2:1 blend of organic lavender (Lavandula angustifolia) and organic sweet orange (Citrus sinensis) essential oils, intended to reduce agitation and support evening relaxation.
Phase 2 (Formula B):
Participants receive a calming compound blend (Formula B) that includes organic sweet orange, spike lavender, true lavender, vetiver, bergamot, and Roman chamomile. This formulation is designed to provide broader anxiolytic, sedative, and stabilizing effects across the day.
All essential oils are high-quality organic products, and diffusion is carried out under standardized conditions by trained staff. Usual medical and nursing care continues throughout the study.
Outcome measures focus on behavioral agitation and sleep quality. Agitation associated with sundowning is assessed using the Chinese version of the Cohen-Mansfield Agitation Inventory (CCMAI), and sleep quality is evaluated using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI). Demographic and clinical characteristics are collected to describe the sample and to explore potential covariates.
Because each participant serves as his or her own control across the two aromatherapy sequences, data will be analyzed using a linear mixed model (LMM) to examine within-subject changes over time, while accounting for period and sequence effects. The primary comparisons will focus on differences in CCMAI and CPSQI scores between Formula A and Formula B phases.
The expected outcome is to generate preliminary clinical evidence that compound essential oil formulations can be integrated as a simple, low-risk, non-pharmacological strategy to manage sundowning symptoms and improve sleep in people with dementia. If effective, these aromatherapy protocols could be adapted for long-term care facilities, community programs, and home-based caregiving, thereby helping to reduce caregiver burden and improve quality of life for both patients and families.
- Conditions
- Dementia, Sundowning
- Being tested
- Aromatherapy Formula A, Aromatherapy Formula B
- Keywords
- Aromatherapy, Essential Oils, Sundowning, Sundown Syndrome, Sleep Quality, Dementia
- Medical subject headings
- Dementia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy Formula AOther
Participants receive Aromatherapy Formula A for 2 weeks. In the morning, Formula A1 (a 2:1 blend of organic rosemary and organic lemon essential oils) is diffused in the dementia care unit; in the afternoon, Formula A2 (a 2:1 blend of organic lavender and organic sweet orange essential oils) is diffused. Aromatherapy is administered by diffusion twice daily (around 09:00 and 14:00), 5 days per week, during the 2-week intervention period.
Aromatherapy Formula BOther
Participants receive Aromatherapy Formula B for 2 weeks. Formula B is a calming compound essential oil blend containing organic sweet orange (Citrus sinensis), spike lavender (Lavandula latifolia), true lavender (Lavandula angustifolia), vetiver (Vetiveria zizanoides), bergamot (Citrus bergamia), and Roman chamomile (Chamaemelum nobile). The blend is diffused in the dementia care unit twice daily (around 09:00 and 14:00), 5 days per week, during the 2-week intervention period. In the crossover sequence, this phase follows a 2-week washout period after Formula A.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Aromatherapy - Formula A then Formula B | Experimental | Participants will receive a two-phase aromatherapy intervention. In Phase 1, they will receive Aromatherapy Formula A for 2 weeks, followed by a 2-week washout period. In Phase 2, they will receive Aromatherapy Formula B for another 2 weeks. Aromatherapy will be administered by diffusion twice daily (09:00 and 14:00), 5 days per week, in the dementia care unit. Receives: Other: Aromatherapy Formula A; Other: Aromatherapy Formula B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in agitation/sundowning behaviors (Chinese Cohen-Mansfield Agitation Inventory, CCMAI)
Agitation and sundowning behaviors will be assessed using the Chinese version of the Cohen-Mansfield Agitation Inventory (CCMAI). The inventory includes 29 items rated on a 7-point frequency scale (1 = never, 7 = several times an hour). A total score is calculated by summing all items, with higher scores indicating more severe agitation/sundowning. Change in CCMAI total score will be compared within participants across aromatherapy intervention phases.
Measured: Baseline and the end of each 2-week aromatherapy phase (up to 6 weeks)
Secondary outcomes (1)
Change in sleep quality (Chinese Pittsburgh Sleep Quality Index, CPSQI)
Sleep quality will be assessed using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI). The CPSQI consists of 19 self- or proxy-rated items that generate seven component scores and a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. For this study, the primary sleep outcome will be the global CPSQI score. Change in CPSQI global score will be compared within participants across the two aromatherapy phases.
Measured: Baseline and the end of each 2-week aromatherapy phase (up to 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start15 Sep 2025
- Primary completion2 Jan 2026 (estimated)
- Study completion12 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, two-period crossover trial without randomization. All participants first receive Aromatherapy Formula A in Phase 1 for 2 weeks (5 days per week, twice daily diffusion at 9:00 a.m. and 2:00 p.m.), followed by a 2-week washout period. In Phase 2, the same participants receive Aromatherapy Formula B for 2 weeks with the same schedule. Each participant serves as his or her own control to evaluate changes in sundown syndrome and sleep quality.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing-Jy Wang, PhD, RN, Principal investigator, National Cheng Kung University, College of Medicine, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288736
- Sponsor's protocol ID
- NCKU HREC-F-111-613-2
- Acronym
- AROMA-SUN
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared at this time. The dataset involves a small group of vulnerable older adults with dementia living in long-term care facilities, and the current IRB approval and informed consent do not include secondary data sharing. Only de-identified aggregate results will be reported in publications and presentations. IPD sharing may be considered in the future with additional ethics approval and appropriate data-sharing agreements to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Distinctive Effects of Aroma-Formulas on Sundown Syndrome, Mood and Sleep Quality of Patients With Dementia
- ClinicalTrials.gov ID
- NCT07288736
- Acronym / sponsor ID
- AROMA-SUN / NCKU HREC-F-111-613-2
- Conditions
- Dementia, Sundowning
- Keywords
- Aromatherapy, Essential Oils, Sundowning, Sundown Syndrome, Sleep Quality, Dementia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 2 Jan 2026 (estimated)
- Study completion
- 12 Jan 2026 (estimated)
- First posted
- 17 Dec 2025 (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.
Dementia is common in aging societies and is often accompanied by sundowning syndrome and sleep problems. These symptoms can be very distressing for patients and place a heavy burden on family members and professional caregivers. Aromatherapy using essential oils, especially lavender, has shown promise in reducing behavioral symptoms in people with dementia, but evidence on compound essential oil formulas and their effects on both sundowning and sleep quality remains limited.
This study will compare two different compound essential oil formulas for people with dementia living in long-term care facilities in southern Taiwan. Each participant will receive both formulas at different times in a repeated crossover design. In Phase 1, participants will receive a stimulating formula in the morning (rosemary and lemon) and a relaxing formula in the afternoon (lavender and sweet orange). In Phase 2, they will receive a calming blend that includes sweet orange, spike lavender, true lavender, vetiver, bergamot, and Roman chamomile. Aromatherapy will be administered by diffusion twice a day, five days per week, for two weeks in each phase.
The main outcomes are changes in agitation and sleep quality, measured using the Chinese versions of the Cohen-Mansfield Agitation Inventory and the Pittsburgh Sleep Quality Index. The findings are expected to provide preliminary evidence on whether compound essential oil formulas can be a simple, non-drug approach to help manage sundowning syndrome and improve sleep in people with dementia.
Detailed description
Dementia is increasingly prevalent in rapidly aging societies and is frequently accompanied by neuropsychiatric symptoms, including sundowning syndrome and disturbed sleep-wake cycles. Sundowning behaviors-such as agitation, wandering, and confusion that worsen in the late afternoon or evening-are particularly challenging to manage and are associated with poorer sleep quality, increased use of psychotropic medications, and heightened caregiver burden. Non-pharmacological interventions that are safe, simple, and feasible in long-term care settings are urgently needed.
Aromatherapy has emerged as a potentially useful complementary therapy for behavioral and psychological symptoms of dementia. Prior studies have suggested that lavender and other essential oils may reduce agitation and promote relaxation; however, most existing evidence focuses on single oils, small samples, or non-standardized protocols. Data on compound essential oil formulations, especially those targeting both sundowning syndrome and sleep quality, remain limited.
This study is designed to evaluate the comparative effectiveness of two compound essential oil formulas on agitation related to sundowning and on overall sleep quality in patients with dementia. A repeated crossover design will be used. Participants will be recruited from long-term care facilities in southern Taiwan and must have a medical diagnosis of dementia and observable sundowning or sleep disturbance.
The intervention includes two 2-week aromatherapy phases, separated by an appropriate washout period. Aromatherapy is delivered by diffusion in the dementia care unit twice daily (09:00 and 14:00), five days per week.
Phase 1 (Formula A):
Morning: Formula A1, a 2:1 blend of organic rosemary (Rosmarinus officinalis) and organic lemon (Citrus limon) essential oils, intended to promote alertness and daytime activity.
Afternoon: Formula A2, a 2:1 blend of organic lavender (Lavandula angustifolia) and organic sweet orange (Citrus sinensis) essential oils, intended to reduce agitation and support evening relaxation.
Phase 2 (Formula B):
Participants receive a calming compound blend (Formula B) that includes organic sweet orange, spike lavender, true lavender, vetiver, bergamot, and Roman chamomile. This formulation is designed to provide broader anxiolytic, sedative, and stabilizing effects across the day.
All essential oils are high-quality organic products, and diffusion is carried out under standardized conditions by trained staff. Usual medical and nursing care continues throughout the study.
Outcome measures focus on behavioral agitation and sleep quality. Agitation associated with sundowning is assessed using the Chinese version of the Cohen-Mansfield Agitation Inventory (CCMAI), and sleep quality is evaluated using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI). Demographic and clinical characteristics are collected to describe the sample and to explore potential covariates.
Because each participant serves as his or her own control across the two aromatherapy sequences, data will be analyzed using a linear mixed model (LMM) to examine within-subject changes over time, while accounting for period and sequence effects. The primary comparisons will focus on differences in CCMAI and CPSQI scores between Formula A and Formula B phases.
The expected outcome is to generate preliminary clinical evidence that compound essential oil formulations can be integrated as a simple, low-risk, non-pharmacological strategy to manage sundowning symptoms and improve sleep in people with dementia. If effective, these aromatherapy protocols could be adapted for long-term care facilities, community programs, and home-based caregiving, thereby helping to reduce caregiver burden and improve quality of life for both patients and families.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, two-period crossover trial without randomization. All participants first receive Aromatherapy Formula A in Phase 1 for 2 weeks (5 days per week, twice daily diffusion at 9:00 a.m. and 2:00 p.m.), followed by a 2-week washout period. In Phase 2, the same participants receive Aromatherapy Formula B for 2 weeks with the same schedule. Each participant serves as his or her own control to evaluate changes in sundown syndrome and sleep quality.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Aromatherapy - Formula A then Formula B | Experimental | Other: Aromatherapy Formula A, Other: Aromatherapy Formula BParticipants will receive a two-phase aromatherapy intervention. In Phase 1, they will receive Aromatherapy Formula A for 2 weeks, followed by a 2-week washout period. In Phase 2, they will receive Aromatherapy Formula B for another 2 weeks. Aromatherapy will be administered by diffusion twice daily (09:00 and 14:00), 5 days per week, in the dementia care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of dementia by a specialist according to DSM-5 (any type) OR SPMSQ score < 8.
- Manifesting sundown syndrome with a score ≥ 26 on the CMAI-C.
- Able to speak Mandarin or Taiwanese.
Key exclusion criteria (6 listed)
- Clinical diagnosis of a psychiatric disorder (e.g., schizophrenia, bipolar disorder).
- Acute stage of illness within the past 2 weeks.
- Olfactory disorder or loss of smell (anosmia).
- Allergy to essential oil fragrances.
- Currently receiving aromatherapy.
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 |
|---|---|---|
| Aromatherapy Formula AParticipants receive Aromatherapy Formula A for 2 weeks. In the morning, Formula A1 (a 2:1 blend of organic rosemary and organic lemon essential oils) is diffused in the dementia care unit; in the afternoon, Formula A2 (a 2:1 blend of organic lavender and organic sweet orange essential oils) is diffused. Aromatherapy is administered by diffusion twice daily (around 09:00 and 14:00), 5 days per week, during the 2-week intervention period. | Other | Experimental: Aromatherapy - Formula A then Formula B |
| Aromatherapy Formula BParticipants receive Aromatherapy Formula B for 2 weeks. Formula B is a calming compound essential oil blend containing organic sweet orange (Citrus sinensis), spike lavender (Lavandula latifolia), true lavender (Lavandula angustifolia), vetiver (Vetiveria zizanoides), bergamot (Citrus bergamia), and Roman chamomile (Chamaemelum nobile). The blend is diffused in the dementia care unit twice daily (around 09:00 and 14:00), 5 days per week, during the 2-week intervention period. In the crossover sequence, this phase follows a 2-week washout period after Formula A. | Other | Experimental: Aromatherapy - Formula A then Formula B |
Primary outcome
Change in agitation/sundowning behaviors (Chinese Cohen-Mansfield Agitation Inventory, CCMAI)
Time frame: Baseline and the end of each 2-week aromatherapy phase (up to 6 weeks)
Agitation and sundowning behaviors will be assessed using the Chinese version of the Cohen-Mansfield Agitation Inventory (CCMAI). The inventory includes 29 items rated on a 7-point frequency scale (1 = never, 7 = several times an hour). A total score is calculated by summing all items, with higher scores indicating more severe agitation/sundowning. Change in CCMAI total score will be compared within participants across aromatherapy intervention phases.
1 secondary outcome
Change in sleep quality (Chinese Pittsburgh Sleep Quality Index, CPSQI)
Time frame: Baseline and the end of each 2-week aromatherapy phase (up to 6 weeks)
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 8 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared at this time. The dataset involves a small group of vulnerable older adults with dementia living in long-term care facilities, and the current IRB approval and informed consent do not include secondary data sharing. Only de-identified aggregate results will be reported in publications and presentations. IPD sharing may be considered in the future with additional ethics approval and appropriate data-sharing agreements to protect participant privacy.
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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.
Jing-Jy Wang, PhD, RN principal investigator
National Cheng Kung University, College of Medicine, Department of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy Formula A and Aromatherapy Formula B in people with Dementia and Sundowning, run by National Cheng-Kung University Hospital at 2 sites 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 6 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: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
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?
Change in agitation/sundowning behaviors (Chinese Cohen-Mansfield Agitation Inventory, CCMAI) (time frame: Baseline and the end of each 2-week aromatherapy phase (up to 6 weeks)). 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 8 Jan 2026.