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| ID | Type | Description | Link |
|---|---|---|---|
| 1677 | Other Identifier | Stanford University IRB |
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| Name | Class |
|---|---|
| Palo Alto Veterans Institute for Research | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright Light | Experimental | received bright light |
|
| Control | Placebo Comparator | received regular light |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bright light | Device | Participants uses bright light |
| |
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time | The amount of actual sleep time in a sleep episode. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| WASO (Wake After Sleep Onset) | WASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good. | 2 weeks |
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Inclusion Criteria:Alzheimer's Disease Patients:
Caregivers:
Caregivers:
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| Name | Affiliation | Role |
|---|---|---|
| Jerome A Yesavage | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19943990 | Result | Spira AP, Friedman L, Beaudreau SA, Ancoli-Israel S, Hernandez B, Sheikh J, Yesavage J. Sleep and physical functioning in family caregivers of older adults with memory impairment. Int Psychogeriatr. 2010 Mar;22(2):306-11. doi: 10.1017/S1041610209991153. Epub 2009 Nov 30. | |
| 22406033 | Result | Friedman L, Spira AP, Hernandez B, Mather C, Sheikh J, Ancoli-Israel S, Yesavage JA, Zeitzer JM. Brief morning light treatment for sleep/wake disturbances in older memory-impaired individuals and their caregivers. Sleep Med. 2012 May;13(5):546-9. doi: 10.1016/j.sleep.2011.11.013. Epub 2012 Mar 10. |
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This was not required at the time.
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diagnosis changed for 2 care-recipients, so 2 dyads were not included in the final analysis.
Participants were recruited from the local community, from 2004-2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Bright Light - AD Patient | AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks |
| FG001 | Dim Light (Control) - AD Patients | AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks |
| FG002 | Bright Light - Caregiver | Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks |
| FG003 | Dim Light (Control) - Caregiver | Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Memory impaired older adults and their caregivers
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| ID | Title | Description |
|---|---|---|
| BG000 | Bright Light-AD Patients | AD patients received bright light |
| BG001 | Dim Light (Control) - AD Patients | AD patients received dim light in the Control condition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Sleep Time | The amount of actual sleep time in a sleep episode. | dyads consisting of 1 AD patient and 1 caregiver | Posted | Mean | Standard Deviation | units on a scale (minutes) | 2 weeks |
|
5 years
No serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bright Light-AD Patients | AD patients received bright light |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerome A. Yesavage, MD | Stanford University | 650-493-5000 | x64330 | yesavage@stanford.edu |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Device |
Participants uses dim light |
|
| Physician Decision |
|
| BG002 | Bright Light - Caregivers | Caregivers received bright light |
| BG003 | Dim Light (Control) - Caregivers | Caregivers received dim light in the Control condition |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Caregiver received Bright Light
| OG003 | Dim Light (Control) - Caregiver | Caregiver received regular (dim) Light |
|
|
| Secondary | WASO (Wake After Sleep Onset) | WASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good. | Posted | Mean | Standard Deviation | units on a scale (minutes) | 2 weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Dim Light (Control) - AD Patients | AD patients received dim light in the Control condition | 0 | 27 | 0 | 27 |
| EG002 | Bright Light - Caregivers | Caregivers received bright light | 0 | 32 | 0 | 32 |
| EG003 | Dim Light (Control) - Caregivers | Caregivers received dim light in the Control condition | 0 | 27 | 0 | 27 |
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| D001523 |
| Mental Disorders |