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

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

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.

Study Overview

• Status: Completed
• Conditions: Behavioral Responses to Bright Light Therapy in Elders
• Intervention / Treatment: Other: exposure to bright light; Other: low luminosity red light

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Elizabethtown, Pennsylvania, United States, 17022
      • Masonic Villages

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
assessment of cognitive functioning using MicroCog	once prior to intervention, once near the end of intervention, once four weeks after intervention
Assessment of mood using the Geriatric Depression Scale	once prior to intervention, once near the end of intervention, once four weeks after intervention
assessment of quality of life using the SF-36	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	once prior to intervention, once near the end of intervention, once four weeks after intervention
assessment of mood using the Profile of Moods Survey	weekly throughout the duration of the study
assessment of sleep quality using the Epworth Sleepiness Scale	weekly throughout the duration of the study
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

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: January 4, 2010
• First Submitted That Met QC Criteria: January 4, 2010
• First Posted (ESTIMATE): January 5, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 11, 2010
• Last Update Submitted That Met QC Criteria: August 10, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: bright light therapy; entrainment; circadian rhythm,
• Other Study ID Numbers: 32704