Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
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| ClinicalTrials.gov Identifier: NCT00946530 |
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Recruitment Status :
Completed
First Posted : July 27, 2009
Results First Posted : March 29, 2017
Last Update Posted : October 3, 2018
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Sponsor:
Stanford University
Collaborator:
Palo Alto Veterans Institute for Research
Information provided by (Responsible Party):
Jerome A Yesavage,, Stanford University
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Brief Summary:
The aim of this study is to demonstrate the efficacy of timed exposure to bright light for the treatment of disturbed nighttime sleep and daytime wake in community-dwelling dementia patients and their caregivers, and to determine if there are genetic relationships between memory problems and sleep problems
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sleep Initiation and Maintenance Disorders | Device: Bright light Device: Control | Not Applicable |
- Efficacy: Up to 4 weeks of morning bright light exposure will be more efficacious than morning dim light in consolidating nighttime sleep as assessed by actigraphy.
- Predictors of response: We expect the primary predictor of treatment response will be initial MMSE score. Secondary predictors include baseline sleep/wake and circadian parameters and age.
- Effectiveness: Bright light treatment will be more effective than dim light in improving quality of life.
- An understanding of some of the genetic markers of memory and/or sleep problems.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 118 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease |
| Study Start Date : | September 2004 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
| Arm | Intervention/treatment |
|---|---|
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Experimental: Bright Light
received bright light
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Device: Bright light
Participants uses bright light |
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Placebo Comparator: Control
received regular light
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Device: Control
Participants uses dim light |
Primary Outcome Measures :
- Total Sleep Time [ Time Frame: 2 weeks ]The amount of actual sleep time in a sleep episode.
Secondary Outcome Measures :
- WASO (Wake After Sleep Onset) [ Time Frame: 2 weeks ]WASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good.
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| Ages Eligible for Study: | 55 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:Alzheimer's Disease Patients:
- Stanford Alzheimer's Disease Core Center member or potential member, with diagnostic criteria met for probable AD, living with caregiver willing to participate in the protocol
- Non-institutionalized
Caregivers:
- Living in home of AD patient and willing to participate in protocol Exclusion Criteria:Alzheimer's Disease Patients:
- History of manic or bipolar disorder
- Prior bright light treatment
- Irregular or non-24 hour sleep/wake cycle
- Positive result on multi-staged RLS/PLMD
- Medical/Ophthalmologic Exclusions
- RDI >20 on overnight EdenTrace® recording
Caregivers:
- History of manic or bipolar disorder
- Medical/Ophthalmologic Exclusions
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946530
Locations
| United States, California | |
| VA Palo Alto Health Care System | |
| Palo Alto, California, United States, 94304 | |
Sponsors and Collaborators
Stanford University
Palo Alto Veterans Institute for Research
Investigators
| Principal Investigator: | Jerome A Yesavage | Stanford University |
Publications of Results:
| Responsible Party: | Jerome A Yesavage,, Professor of Psychiatry, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00946530 |
| Other Study ID Numbers: |
SU-06302009-2840 1677 ( Other Identifier: Stanford University IRB ) |
| First Posted: | July 27, 2009 Key Record Dates |
| Results First Posted: | March 29, 2017 |
| Last Update Posted: | October 3, 2018 |
| Last Verified: | October 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | This was not required at the time. |
Additional relevant MeSH terms:
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Alzheimer Disease Sleep Initiation and Maintenance Disorders Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders |