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

Not Applicable

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Device: Control; Device: Bright light

• Registration Number: NCT00946530
• Lead Sponsor: Stanford University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2013-12-05
• Results First Submitted QC: 2017-02-09
• Results First Posted: 2017-03-29
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	received regular light
Bright Light	Bright light	received bright light

Primary Outcome Measures

Name	Time	Method
Total Sleep Time	2 weeks	The amount of actual sleep time in a sleep episode.

Secondary Outcome Measures

Name	Time	Method
WASO (Wake After Sleep Onset)	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.

Trial Locations

Locations (1)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States