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Completed

NCT Number: NCT02502045

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

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.

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Key information

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Botsford Continuing Care

Farmington Hills, Michigan, 48336, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • received light treatment in last 3 months
  • 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.

Treatment and study plan

Morning Simulated Sunlight

Device

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

Non-therapeutic Red Light

Device

Non-therapeutic red light control at 5 lux will be used as the control condition

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 17, 2015
Registry last updated
Feb 20, 2017

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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