Clinical trial NCT01042587: Effect of Bright Light Treatment On Elders In a Long Term Care Environment
Official title: Effect of Bright Light Treatment On Elders In A Long Term Care Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Responses to Bright Light Therapy in Elders
Keywords: bright light therapy
circadian rhythm,
entrainment
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2010-01-05
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: assessment of cognitive functioning using MicroCog
timeFrame: once prior to intervention, once near the end of intervention, once four weeks after intervention
measure: Assessment of mood using the Geriatric Depression Scale
timeFrame: once prior to intervention, once near the end of intervention, once four weeks after intervention
measure: assessment of quality of life using the SF-36
timeFrame: once prior to intervention, once near the end of intervention, once four weeks after intervention
measure: assessment of sleep quality using the Pittsburgh Sleep Quality Index
timeFrame: once prior to intervention, once near the end of intervention, once four weeks after intervention
measure: assessment of mood using the Profile of Moods Survey
timeFrame: weekly throughout the duration of the study
measure: assessment of sleep quality using the Epworth Sleepiness Scale
timeFrame: weekly throughout the duration of the study
measure: day and nightime activity level (5 subjects per group only) using Actigraphy
timeFrame: two weeks prior to light exposure and the second two weeks during light exposure (continuous measurements)
Secondary outcomes:
measure: salivary melatonin levels
timeFrame: once prior and near the end of light exposure period
measure: salivary cortisol levels
timeFrame: once prior and near the end of light exposure period
Other outcomes:
Locations:
city: Elizabethtown
country: United States
facility: Masonic Villages
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Noel H Ballentine, MD
role: PRINCIPAL_INVESTIGATOR
References: