Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946530
• Other study ID #: SU-06302009-2840
• Secondary ID: 1677
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Sleep Initiation and Maintenance Disorders

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