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

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

Sponsors

Lead Sponsor: Stanford University

Collaborator: Palo Alto Veterans Institute for Research

Source 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.

Overall Status Completed
Start Date September 2004
Completion Date December 2010
Primary Completion Date December 2010
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Total Sleep Time 2 weeks
Secondary Outcome
Measure Time Frame
WASO (Wake After Sleep Onset) 2 weeks
Enrollment 118
Condition
Intervention

Intervention Type: Device

Intervention Name: Bright light

Description: Participants uses bright light

Arm Group Label: Bright Light

Intervention Type: Device

Intervention Name: Control

Description: Participants uses dim light

Arm Group Label: Control

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

Gender: All

Minimum Age: 55 Years

Maximum Age: 100 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Jerome A Yesavage Principal Investigator Stanford University
Location
Facility: VA Palo Alto Health Care System
Location Countries

United States

Verification Date

October 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Stanford University

Investigator Full Name: Jerome A Yesavage,

Investigator Title: Professor of Psychiatry

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Bright Light

Type: Experimental

Description: received bright light

Label: Control

Type: Placebo Comparator

Description: received regular light

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Source: ClinicalTrials.gov