Aromatherapy Formulas for Sundowning and Sleep Quality in Patients With Dementia. (AROMA-SUN)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dementia; Sundowning
• Intervention / Treatment: Other: Aromatherapy Formula A; Other: Aromatherapy Formula B

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 Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taiwan
    • Kaohsiung, Taiwan, Taiwan, 802
      • Evergreen Senior Day Care Center
    • Tainan, Taiwan, Taiwan, 71754
      • Kang Yu Day Care Center, Tainan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental: Aromatherapy - Formula A then Formula B; 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.

Other: Aromatherapy Formula A; 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.; Other: Aromatherapy Formula B; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and the end of each 2-week aromatherapy phase (up to 6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and the end of each 2-week aromatherapy phase (up to 6 weeks)

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Principal Investigator: Jing-Jy Wang, PhD, RN, National Cheng Kung University, College of Medicine, Department of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): January 2, 2026
• Study Completion (Estimated): January 12, 2026

Study Registration Dates

• First Submitted: December 4, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Estimated): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Dementia; Sleep Quality; Aromatherapy; Sundowning; Essential Oils; Sundown Syndrome
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Dementia
• Other Study ID Numbers: NCKU HREC-F-111-613-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No