Alzheimer's Disease (AD)NCT07386808
Improvement of Sleep Disorders in Patients With Alzheimer's Disease After Sunlight Exposure Therapy.
A study testing sunlight therapy in people with Alzheimer's Disease (AD) and Sleep Disorders, Circadian Rhythm, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease (AD), Sleep Disorders, Circadian Rhythm
- What is being tested?
- sunlight therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 May 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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. 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.
- Being tested
- sunlight therapy
- Medical subject headings
- Alzheimer Disease, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunlight therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine nursing care | Other | no additional sunlight therapy Receives: Behavioral: sunlight therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: on enrollment days, three months after admission (until the next follow-up visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start13 May 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386808
- Sponsor's protocol ID
- 202511021RIND
- Status last verified
- May 2026
- First submitted
- 15 Jan 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of the Improvement of Sleep Disorders in Patients With Alzheimer's Disease After Sunlight Exposure Therapy.
- ClinicalTrials.gov ID
- NCT07386808
- Acronym / sponsor ID
- 202511021RIND
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine nursing care | Other | Behavioral: sunlight therapyno additional sunlight therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sunlight therapyParticipants 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. | Behavioural | Routine nursing care |
Primary outcome
Pittsburgh Sleep Quality Index, PSQI
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sunlight therapy in people with Alzheimer's Disease (AD) and Sleep Disorders, Circadian Rhythm, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index, PSQI (time frame: on enrollment days, three months after admission (until the next follow-up visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.