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

This study has been completed.
Sponsor:
Information provided by:
Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01042587
First received: January 4, 2010
Last updated: August 10, 2010
Last verified: March 2010
  Purpose

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 Intervention
Behavioral Responses to Bright Light Therapy in Elders
Other: exposure to bright light
Other: low luminosity red light

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Bright Light Treatment On Elders In A Long Term Care Environment

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • assessment of cognitive functioning using MicroCog [ Time Frame: once prior to intervention, once near the end of intervention, once four weeks after intervention ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • assessment of mood using the Profile of Moods Survey [ Time Frame: weekly throughout the duration of the study ] [ Designated as safety issue: No ]
  • assessment of sleep quality using the Epworth Sleepiness Scale [ Time Frame: weekly throughout the duration of the study ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • salivary melatonin levels [ Time Frame: once prior and near the end of light exposure period ] [ Designated as safety issue: No ]
  • salivary cortisol levels [ Time Frame: once prior and near the end of light exposure period ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: modified commercially available Phillips Color Graze

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01042587

Locations
United States, Pennsylvania
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
  More Information

No publications provided

Responsible Party: Noel H Ballentine, MD, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01042587     History of Changes
Other Study ID Numbers: 32704
Study First Received: January 4, 2010
Last Updated: August 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
bright light therapy
circadian rhythm,
entrainment

ClinicalTrials.gov processed this record on September 22, 2014