NCT07386808

Brief Summary

This observational study aimed to understand the effect of intervention A on sleep disorders in individuals with Alzheimer's disease receiving sunlight therapy. The primary question of the study was: Does sunlight therapy improve sleep disorders in Alzheimer's disease? Participants will complete a questionnaire, undergo sunlight therapy. They were informed that sun exposure therapy could effectively improve sleep, and behavioral interventions were discussed to develop a health education plan. Patients received monthly telephone support and encouragement from the time of admission until the next follow-up visit. Three months after admission (until the next follow-up visit), patients completed questionnaires including the Pittsburgh Sleep Quality Index (PSQI), the Neuropsychiatric Inventory (NPI), and the Quality of Life-Alzheimer's Disease (QOL-AD) questionnaire.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started May 2026

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 Progress35%
May 2026Dec 2026

First Submitted

Initial submission to the registry

January 15, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 13, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 17, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

January 15, 2026

Last Update Submit

July 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pittsburgh Sleep Quality Index, PSQI

    The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality. It has seven dimensions: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, medication use, and daytime activity impairment. A higher PSQI score indicates poorer sleep quality. The total score ranges from 0 to 21, with a minimum score of 0, indicating very good sleep quality over the past month. Lower scores indicate better sleep quality, while a total score of 5 or below is generally considered to indicate fair sleep quality.

    on enrollment days, three months after admission (until the next follow-up visit).

Study Arms (1)

Routine nursing care

OTHER

no additional sunlight therapy

Behavioral: sunlight therapy

Interventions

Participants will complete a questionnaire, undergo sunlight therapy. They were informed that sun exposure therapy could effectively improve sleep, and behavioral interventions were discussed to develop a health education plan. Patients received monthly telephone support and encouragement from the time of admission until the next follow-up visit. Three months after admission (until the next follow-up visit), patients completed questionnaires including the Pittsburgh Sleep Quality Index (PSQI), the Neuropsychiatric Inventory (NPI), and the Quality of Life-Alzheimer's Disease (QOL-AD) questionnaire.

Routine nursing care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with Alzheimer's disease
  • CDR: 0.5 - 1 point
  • Conscious and able to cooperate with behavioral interventions and telephone interviews
  • Complaints of sleep disturbances, including: daytime sleepiness, difficulty falling asleep, fragmented sleep, nighttime awakening, nocturnal wandering, and sunset syndrome.
  • A cohabiting family member is required as the primary caregiver, who understands and cooperates with this intervention and has signed a consent form.
  • If the patient is already taking sleeping pills, the maintenance dose will not be adjusted.

You may not qualify if:

  • Individuals with other brain injury conditions, such as cerebral palsy, brain tumors, traumatic brain injury, or stroke.
  • Individuals with visual impairments (assessed by comparing numbers with fingers at a distance of 30 cm upon admission).
  • Institutional residents.
  • Individuals living alone.
  • Individuals unable to cooperate with behavioral interventions and telephone interviews.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Alzheimer DiseaseSleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersChronobiology DisordersDyssomniasSleep Wake DisordersOccupational Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

February 4, 2026

Study Start

May 13, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 17, 2026

Record last verified: 2026-05

Locations