Effect of Bright Light Treatment On Elders In a Long Term Care Environment

Overview

The investigators hypothesize that significant exposure to artificial morning bright light (approximately 200 lux of primarily blue light at eye level for thirty minutes daily) as compared to sham bright red light (placebo) will: 1. improve sleep quality 2. improve cognitive scores 3. improve depression scores 4. improve quality of life scores.

Full Title of Study: “Effect of Bright Light Treatment On Elders In A Long Term Care Environment”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: June 2010

Detailed Description

Bright light therapy has been shown to improve depression and insomnia in multiple studies. These are common conditions among elders, particularly those residing in long term care environments. Bright light therapy has been inadequately studied in the geriatric population. We will show that a groups of twenty elders can simultaneous be exposed to bright light and that it will result in improvements in multiple realms of behavior and quality of life. Elders will be tested with a number of neuropsychological test batteries prior to exposure to bright light and again at the end of a four week exposure. Some subjects will have daytime and night time activity levels monitored with actigraphy. Cortisol and melatonin levels will be obtained prior to and at the end of the exposure period.

Interventions

  • Other: exposure to bright light
    • Elders will be engaged in an activity period which will focus their attention in the direction of bright light, thus ensuring viewing the light source for a daily exposure of thirty minutes.
  • Other: low luminosity red light
    • Low level red light should not entrain circadian rhythm and will serve as a placebo control

Arms, Groups and Cohorts

  • Active Comparator: bright light
    • Bright light has been shown to entrain circadian rhythm so our treatment arm will use thirty minutes of early morning exposure to bright blue light for a four week period.
  • Sham Comparator: red light
    • Low level red light is a weak entrainment stimulus of circadian rhythm. Elders in the control group will be exposed to low level red light as a placebo for thirty minutes daily for four weeks.

Clinical Trial Outcome Measures

Primary Measures

  • assessment of cognitive functioning using MicroCog
    • Time Frame: once prior to intervention, once near the end of intervention, once four weeks after intervention
  • Assessment of mood using the Geriatric Depression Scale
    • Time Frame: once prior to intervention, once near the end of intervention, once four weeks after intervention
  • assessment of quality of life using the SF-36
    • Time Frame: once prior to intervention, once near the end of intervention, once four weeks after intervention
  • assessment of sleep quality using the Pittsburgh Sleep Quality Index
    • Time Frame: once prior to intervention, once near the end of intervention, once four weeks after intervention
  • assessment of mood using the Profile of Moods Survey
    • Time Frame: weekly throughout the duration of the study
  • assessment of sleep quality using the Epworth Sleepiness Scale
    • Time Frame: weekly throughout the duration of the study
  • day and nightime activity level (5 subjects per group only) using Actigraphy
    • Time Frame: two weeks prior to light exposure and the second two weeks during light exposure (continuous measurements)

Secondary Measures

  • salivary melatonin levels
    • Time Frame: once prior and near the end of light exposure period
  • salivary cortisol levels
    • Time Frame: once prior and near the end of light exposure period

Participating in This Clinical Trial

Inclusion Criteria

  • residents in Masonic Villages, Elizabethtown, PA long term care – ability to give informed consent and complete the neuropsychological tests Exclusion Criteria:

  • blindness – severe illness expected to preclude the ability to complete treatment – moderate to severe dementia that precludes the ability to complete testing – light sensitivity making treatment to light therapy uncomfortable

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Milton S. Hershey Medical Center
  • Provider of Information About this Clinical Study
    • Noel H Ballentine, MD, Penn State Milton S. Hershey Medical Center
  • Overall Official(s)
    • Noel H Ballentine, MD, Principal Investigator, Milton S. Hershey Medical Center

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