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

NCT07288736 | Active Not Recruiting

• 1 other identifier: NCKU HREC-F-111-613-2
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dementia; Sundowning

Keywords

Aromatherapy; Essential Oils; Sundowning; Sundown Syndrome; Sleep Quality; Dementia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in sleep quality (Chinese Pittsburgh Sleep Quality Index, CPSQI)

  Baseline and the end of each 2-week aromatherapy phase (up to 6 weeks)

Study Arms (1)

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.

Other: Aromatherapy Formula A; Other: Aromatherapy Formula B

Interventions

Aromatherapy Formula A OTHER

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.

Experimental: Aromatherapy - Formula A then Formula B

Aromatherapy Formula B OTHER

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.

Experimental: Aromatherapy - Formula A then Formula B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (2)

Evergreen Senior Day Care Center

Kaohsiung, Taiwan, 802, Taiwan

Location

Kang Yu Day Care Center, Tainan

Tainan, Taiwan, 71754, Taiwan

Location

MeSH Terms

Conditions

Dementia; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Jing-Jy Wang, PhD, RN

  National Cheng Kung University, College of Medicine, Department of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: September 15, 2025
• Primary Completion: January 2, 2026
• Study Completion: January 12, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)