NCT07431164

Brief Summary

This study evaluates an augmented reality (AR)-based aromatherapy education program designed for older adults with early-stage dementia in Taiwan. Participants are randomly assigned to either the intervention group, which receives AR-supported aromatherapy education sessions, or a comparison group receiving standard activities. The primary objective is to assess changes in neuropsychiatric symptoms and psychological well-being. Secondary outcomes include cognitive function and quality of life. The study aims to explore the feasibility and potential clinical benefits of integrating digital technology with non-pharmacological dementia care approaches.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 9, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 18, 2026

Last Update Submit

March 5, 2026

Conditions

Keywords

Augmented Realitydigital healthdementiaaromatherapyhealth education

Outcome Measures

Primary Outcomes (1)

  • Change in Neuropsychiatric Symptoms Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)

    Neuropsychiatric symptoms are assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q), an informant-based instrument evaluating behavioral and psychological symptoms over the past month. Each symptom is rated for severity on a 3-point scale (1 = mild, 2 = moderate, 3 = severe). Total scores range from 0 to 36, with higher scores indicating more severe neuropsychiatric symptoms (worse outcome). Changes in total scores from baseline will be analyzed.

    Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)

Secondary Outcomes (4)

  • Pain (Abbey Pain Scale)

    Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)

  • Insomnia (Athens Insomnia Scale)

    Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)

  • Well-Being (WHO-5)

    Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)

  • Life Satisfaction (SWLS)

    Baseline, Week 4 (Post-Intervention), and Week 16 (Follow-up)

Study Arms (2)

AR-Based Aromatherapy Education Group

EXPERIMENTAL

Participants receive a structured augmented reality (AR)-based aromatherapy education program designed to reduce neuropsychiatric symptoms and enhance psychological well-being in older adults with early-stage dementia. The intervention includes guided AR modules integrating sensory stimulation, aromatherapy education, and interactive cognitive engagement over the study period.

Behavioral: Augmented Reality-Based Aromatherapy Education Program

Standard Care Control Group

NO INTERVENTION

Participants receive routine care without AR-based aromatherapy intervention during the study period.

Interventions

The augmented reality-based aromatherapy education module was developed using the Neuropsychiatric Symptom Checklist-Q (NPI-Q) framework to match specific neuropsychiatric symptoms with corresponding aromatherapy interventions. This intervention program was designed and refined by a multidisciplinary team of experts. The course comprises 12 units, completed over four consecutive weeks through 2-3 units per week. To ensure a systematic approach, each session integrates three units, allowing for comprehensive coverage of symptom clusters within a structured timeframe. Each symptom corresponds to a specific aromatherapy activity and its associated learning objectives.

AR-Based Aromatherapy Education Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age ≥ 65 years
  • AD-8 score ≥ 2, indicating suspected cognitive impairment
  • Ability to communicate and complete study questionnaires
  • No significant visual, hearing, or olfactory impairments
  • Willingness to participate in AR-based intervention sessions

You may not qualify if:

  • Diagnosed psychiatric disorder
  • Complex chronic physical diseases
  • Moderate to severe dementia
  • Neuropsychiatric Inventory Questionnaire (NPI-Q) symptom score \> 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, Taipei City, 10610, Taiwan

Location

MeSH Terms

Conditions

DementiaCognitive DysfunctionHealth Education

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition DisordersAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Jong-Long Guo, PhD

    National Taiwan Normal University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned in a 1:1 ratio to either the AR-based aromatherapy education intervention group or a comparison group receiving standard activities. Both groups are followed concurrently over the same study period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2026

First Posted

February 24, 2026

Study Start

May 23, 2025

Primary Completion

October 30, 2025

Study Completion

March 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) that underlie the results reported in this trial will be made available upon reasonable request after publication. Access requires a formal request to the corresponding author and approval. Data will be shared in accordance with institutional review board approval and applicable data protection regulations. Researchers requesting access must provide a methodologically sound proposal and sign a data use agreement. Only de-identified data will be shared; no direct identifiers will be released.

Locations