Aromatherapy Formulas for Sundowning and Sleep Quality in Patients With Dementia.

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Change in agitation/sundowning behaviors (Chinese Cohen-Mansfield Agitation Inventory, CCMAI) — 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.

Trial sites (2)

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