- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07386808
Improvement of Sleep Disorders in Patients With Alzheimer's Disease After Sunlight Exposure Therapy.
An Analysis of the Improvement of Sleep Disorders in Patients With Alzheimer's Disease After Sunlight Exposure Therapy.
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, and have their sleep patterns recorded for 14 days.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taiwan
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Taipei, Taiwan, Taiwan, 100
- National Taiwan University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Routine nursing care
no additional sunlight therapy
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They were informed that sun exposure therapy could effectively improve sleep, and behavioral interventions were discussed to develop a health education plan.
Telephone follow-ups were conducted on days 3, 7, 10, and 14 after enrollment to understand the sun exposure practices of the experimental group, including the duration of sun exposure, whether the light source was indoor light or sunlight, and positive encouragement was provided.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburgh Sleep Quality Index, PSQI
Time Frame: 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.
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on enrollment days, 7, and 14 after enrollment
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202511021RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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