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

October 1, 2018 updated by: Jerome A Yesavage,, Stanford University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bright Light
received bright light
Device: Bright light
Participants uses bright light
PLACEBO_COMPARATOR: Control
received regular light
Device: Control
Participants uses dim light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Sleep Time
Time Frame: 2 weeks
The amount of actual sleep time in a sleep episode.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WASO (Wake After Sleep Onset)
Time Frame: 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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Palo Alto Veterans Institute for Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 24, 2009

First Posted (ESTIMATE)

July 27, 2009

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-06302009-2840
  • 1677 (Stanford University IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This was not required at the time.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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