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临床试验/NCT07386808
NCT07386808进行中(未招募)不适用

An Analysis of the Improvement of Sleep Disorders in Patients With Alzheimer's Disease After Sunlight Exposure Therapy.

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月13日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Pittsburgh Sleep Quality Index, PSQI

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Routine nursing care

Other

no additional sunlight therapy

干预措施: sunlight therapy (Behavioral)

结局指标

主要结局

Pittsburgh Sleep Quality Index, PSQI

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

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.

Pittsburgh Sleep Quality Index, PSQI

时间窗: on enrollment days, 7, and 14 after enrollment

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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