Clinical trial NCT00946530: Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Official title: Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Palo Alto Veterans Institute for Research
First posted: 2009-07-27
Enrollment: 118
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 1. 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.
2. 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.
3. Effectiveness: Bright light treatment will be more effective than dim light in improving quality of life.
4. An understanding of some of the genetic markers of memory and/or sleep problems.

Eligibility 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

Primary outcomes:
measure: Total Sleep Time
timeFrame: 2 weeks
Secondary outcomes:
measure: WASO (Wake After Sleep Onset)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: Stanford University
name: Jerome A Yesavage
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.