The Distinctive Effects of Aroma-Formulas on Sundown Syndrome, Mood and Sleep Quality of Patients With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in agitation/sundowning behaviors (Chinese Cohen-Mansfield Agitation Inventory, CCMAI)
研究概览
简要总结
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.
详细描述
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):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This is an open-label study; no masking procedures will be used. Participants, care providers, and investigators are aware of the aroma formula administered in each treatment period.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of dementia by a specialist according to DSM-5 (any type) OR SPMSQ score <
- •Manifesting sundown syndrome with a score ≥ 26 on the CMAI-C.
- •Able to speak Mandarin or Taiwanese.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Aromatherapy Formula A (Other)
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.
干预措施: Aromatherapy Formula B (Other)
结局指标
主要结局
Change in agitation/sundowning behaviors (Chinese Cohen-Mansfield Agitation Inventory, CCMAI)
时间窗: 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.
次要结局
- Change in sleep quality (Chinese Pittsburgh Sleep Quality Index, CPSQI)(Baseline and the end of each 2-week aromatherapy phase (up to 6 weeks))