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

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01042587
Collaborator
(none)
32
1
2
3
10.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: exposure to bright light
  • Other: low luminosity red light
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Bright Light Treatment On Elders In A Long Term Care Environment
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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.

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 Names:
  • modified commercially available Phillips Color Graze.
  • 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.

    Other: low luminosity red light
    Low level red light should not entrain circadian rhythm and will serve as a placebo control
    Other Names:
  • modified commercially available Phillips Color Graze
  • Outcome Measures

    Primary Outcome Measures

    1. assessment of cognitive functioning using MicroCog [once prior to intervention, once near the end of intervention, once four weeks after intervention]

    2. Assessment of mood using the Geriatric Depression Scale [once prior to intervention, once near the end of intervention, once four weeks after intervention]

    3. assessment of quality of life using the SF-36 [once prior to intervention, once near the end of intervention, once four weeks after intervention]

    4. assessment of sleep quality using the Pittsburgh Sleep Quality Index [once prior to intervention, once near the end of intervention, once four weeks after intervention]

    5. assessment of mood using the Profile of Moods Survey [weekly throughout the duration of the study]

    6. assessment of sleep quality using the Epworth Sleepiness Scale [weekly throughout the duration of the study]

    7. day and nightime activity level (5 subjects per group only) using Actigraphy [two weeks prior to light exposure and the second two weeks during light exposure (continuous measurements)]

    Secondary Outcome Measures

    1. salivary melatonin levels [once prior and near the end of light exposure period]

    2. salivary cortisol levels [once prior and near the end of light exposure period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Masonic Villages Elizabethtown Pennsylvania United States 17022

    Sponsors and Collaborators

    • Milton S. Hershey Medical Center

    Investigators

    • Principal Investigator: Noel H Ballentine, MD, Milton S. Hershey Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01042587
    Other Study ID Numbers:
    • 32704
    First Posted:
    Jan 5, 2010
    Last Update Posted:
    Aug 11, 2010
    Last Verified:
    Mar 1, 2010

    Study Results

    No Results Posted as of Aug 11, 2010