Behavioral Responses to Bright Light Therapy in EldersBrightLightsNCT01042587
Effect of Bright Light Treatment On Elders In a Long Term Care Environment
A study testing exposure to bright light and low luminosity red light in people with Behavioral Responses to Bright Light Therapy in Elders, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavioral Responses to Bright Light Therapy in Elders
- What is being tested?
- exposure to bright light and low luminosity red light
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- residents in Masonic Villages, Elizabethtown, PA long term care
- ability to give informed consent and complete the neuropsychological tests
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- improve sleep quality
- improve cognitive scores
- improve depression scores
- improve quality of life scores.
Read the 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.
- Being tested
- exposure to bright light, low luminosity red light
- Keywords
- bright light therapy, circadian rhythm,, entrainment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure to bright lightOther
Also called modified commercially available Phillips Color Graze.
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.
low luminosity red lightOther
Also called modified commercially available Phillips Color Graze
Low level red light should not entrain circadian rhythm and will serve as a placebo control
| Study group | Role | What they receive |
|---|---|---|
| bright light | Active comparator | 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. Receives: Other: exposure to bright light |
| red light | Sham comparator | 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. Receives: Other: low luminosity red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of cognitive functioning using MicroCog
Measured: once prior to intervention, once near the end of intervention, once four weeks after intervention
Assessment of mood using the Geriatric Depression Scale
Measured: once prior to intervention, once near the end of intervention, once four weeks after intervention
assessment of quality of life using the SF-36
Measured: 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
Measured: once prior to intervention, once near the end of intervention, once four weeks after intervention
assessment of mood using the Profile of Moods Survey
Measured: weekly throughout the duration of the study
assessment of sleep quality using the Epworth Sleepiness Scale
Measured: weekly throughout the duration of the study
day and nightime activity level (5 subjects per group only) using Actigraphy
Measured: two weeks prior to light exposure and the second two weeks during light exposure (continuous measurements)
Secondary outcomes (2)
salivary melatonin levels
Measured: once prior and near the end of light exposure period
salivary cortisol levels
Measured: once prior and near the end of light exposure period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral Responses to Bright Light Therapy in EldersStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Noel H Ballentine, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042587
- Sponsor's protocol ID
- 32704
- Acronym
- BrightLights
- Status last verified
- Mar 2010
- First submitted
- 4 Jan 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bright Light Treatment On Elders In A Long Term Care Environment
- ClinicalTrials.gov ID
- NCT01042587
- Acronym / sponsor ID
- BrightLights / 32704
- Keywords
- bright light therapy, circadian rhythm,, entrainment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- improve sleep quality
- improve cognitive scores
- improve depression scores
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bright light | Active comparator | Other: exposure to bright lightBright 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. |
| red light | Sham comparator | Other: low luminosity red lightLow 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- residents in Masonic Villages, Elizabethtown, PA long term care
- ability to give informed consent and complete the neuropsychological tests
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exposure to bright lightAlso: modified commercially available Phillips Color Graze.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 | bright light |
| low luminosity red lightAlso: modified commercially available Phillips Color GrazeLow level red light should not entrain circadian rhythm and will serve as a placebo control | Other | red light |
Primary outcome
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)
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noel H Ballentine, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exposure to bright light and low luminosity red light in people with Behavioral Responses to Bright Light Therapy in Elders, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of cognitive functioning using MicroCog (time frame: once prior to intervention, once near the end of intervention, once four weeks after intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2010.