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OpenTrials
Completed

NCT Number: NCT00946530

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

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

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

55 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

About this study

  • 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.
  • 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.
  • Effectiveness: Bright light treatment will be more effective than dim light in improving quality of life.
  • An understanding of some of the genetic markers of memory and/or sleep problems.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bright light

Device

Participants uses bright light

Control

Device

Participants uses dim light

Primary outcomes

  1. Total Sleep Time

    Time frame: 2 weeks

    The amount of actual sleep time in a sleep episode.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Palo Alto Veterans Institute for Research

Registry information

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jul 27, 2009
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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