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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00946530
Other study ID # SU-06302009-2840
Secondary ID 1677
Status Completed
Phase N/A
First received
Last updated
Start date September 2004
Est. completion date December 2010

Study information

Verified date October 2018
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Bright light
Participants uses bright light
Control
Participants uses dim light

Locations

Country Name City State
United States VA Palo Alto Health Care System Palo Alto California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University Palo Alto Veterans Institute for Research

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. E — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Total Sleep Time The amount of actual sleep time in a sleep episode. 2 weeks
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. 2 weeks
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