Effect of Therapeutic Light on Sleep, Circadian Rhythm, and Global Function in Women With Alzheimer's

February 17, 2017 updated by: Yale University

A Study to Examine the Effect of Therapeutic Light on Sleep, Circadian Rhythm, and Global Function in Women With Alzheimer's Disease

Determine effect and duration of effect of timed therapeutic light compared to control light on parameters of circadian rhythmicity, physiologic plasticity, sleep, and global function in women with Alzheimer's Disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The impact of disturbed sleep on cognition and functional domains is vitally important to study in order to increase our understanding of Alzheimer's disease (AD) phenomenology. Research has shown that the severity of sleep disturbance and dementia advance in parallel and possibly in a manner amenable to therapeutic intervention. In AD, sleep disruption is characterized by changes in sleep architecture. It is our contention that neuropathology specific to AD alters the circadian system at the suprachiasmatic nucleus (SCN). Environmental light is the most powerful regulator of this circadian system,4,5 and is known to have a significant regulatory effect on pineal melatonin synthesis and secretion via the SCN and multisynaptic pathways downstream from the SCN. This study will explore further the efficacy of a particular type of therapeutic light intervention in regulating the circadian system in AD, using data analytic methods capable of detecting changes at multiple time scales. Our central hypothesis is that properly-timed light exposure in individuals with AD will synchronize disorganized circadian and sleep-wake rhythms and improve functional plasticity [approximate entropy (ApEn), fractal dimension (FD)], thereby resulting in increased sleep efficiency (SE), reductions in sleep fragmentation (SF), reduced excessive daytime sleepiness (EDS) and dementia-related behaviors, and improvements in cognition and other daytime behaviors. Women are nearly twice as likely as men to develop AD due to longer life expectance and emerging evidence. In light of this increased risk and also to enhance other aspects of biological uniformity in our study, this project will investigate women with AD.

Study Type

Interventional

Enrollment (Actual)

18

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
    • Michigan
      • Farmington Hills, Michigan, United States, 48336
        • Botsford Continuing Care

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

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. baseline sleep efficiency index < .85
  2. Mini-Mental State Exam-2 Standard Version (MMSE-2:SV) score of 0-20
  3. be medically stable

Exclusion Criteria:

  1. received light treatment in last 3 months
  2. are totally blind in both eyes, have photosensitivity or photophobia, Parkinsons disease, known untreated sleep apnea or other sleep disorders, seizure disorder, bipolar, schizophrenia, are actively receiving chemotherapy or radiation therapy for cancer.

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Morning Simulated Sunlight
Timed morning simulated sunlight (Philips Wake Up Light, Model HF3520) peaking at 300 lux delivered over a 40 minute ramp between 5-9 a.m. for 14 consecutive days. A flexible window of has been allowed to accommodate participants and care routines.
Device: Morning Simulated Sunlight
Timed morning simulated sunlight (Philips Wake Up Light, Model HF3520) peaking at 300 lux delivered over a 40 minute ramp between 5-9 a.m. for 14 consecutive days
PLACEBO_COMPARATOR: Non-Therapeutic Red Light
Non-therapeutic red light control at 5 lux will be used as the control condition
Device: Non-therapeutic Red Light
Non-therapeutic red light control at 5 lux will be used as the control condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sleep characteristics
Time Frame: 2 weeks
Change in sleep characteristics and rest-activity rhythm after 2 weeks of light therapy as measured by actigraphy
2 weeks

Collaborators and Investigators

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

Sponsor

Yale University

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

May 1, 2012

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (ESTIMATE)

July 17, 2015

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2017

Last Update Submitted That Met QC Criteria

February 17, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1310012895

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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