Methodology Issues in a Tailored Light Treatment for Persons With Dementia
Study Details
Study Description
Brief Summary
Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
In a within subjects, randomized placebo control study, a tailored light treatment will be used for short-term (4 weeks). Outcome measures include sleep measures (actigraphy), and questionnaires probing behavior and mood in those who have been diagnosed with Alzheimer's disease and related dementia. After a 4-week washout period, a placebo control inactive light will be used for another 4 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active Intervention Light levels, primary and secondary measurements are obtained after a 4-week intervention period where active lighting is experienced by patients. |
Other: Tailored Active intervention
Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.
|
| Placebo Comparator: Inactive intervention Light levels, primary and secondary measurements are obtained after a 4-week intervention period where an inactive lighting is experienced by patients |
Other: Inactive intervention
Subjects experience a baseline for 1 week and an inactive intervention for 4 weeks. The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.
|
Outcome Measures
Primary Outcome Measures
- Sleep Disturbance [Change from Baseline (week 0) and intervention (week 4)]
Caregivers and subjects are asked to complete the Pittsburgh Sleep Quality Index (PSQI), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The seven component scores are summed to provide a global score ranging from 0 to 21 and a score of 5 or above indicates sleep disturbance. A higher number indications a greater sleep disturbance
- Agitation [Change from Baseline (week 0) and intervention (week 4)]
Caregivers and subjects are asked to fill out the Cohen-Mansfield Agitation Score, which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. All scores are summed for one total score - a higher score indicates more agitation
- Depression [Change from Baseline (week 0) and intervention (week 4)]
Caregivers and subjects are asked to fill out subjective questionnaires assessing depression using the Cornell Scale for Depression in Dementia (CSDD) Questionnaires are assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The CSDD consists of 19 questions rated on a scale of 0 to 2 with all scores summed for a total score. A score greater than 12 indicates depression and a higher score indicates greater depression.
Secondary Outcome Measures
- Activity of Daily Living [Change from Baseline (week 0) and intervention (week 4)]
Caregivers and subjects are asked to fill out subjective Activity of Daily Living questionnaire (MDS-ADL), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. Scores range from 4 to 18 and a higher score indicates a higher dependence.
- Light/dark patterns [Change from Baseline (week 0) and intervention (week 4)]
Subjects are asked to wear a calibrated light meter to obtain light/dark and activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. These data are used to determine circadian disruption (correlation between light/dark and activity/rest) and light dose.
- Actigraphy [Change from Baseline (week 0) and intervention (week 4)]
Subjects are asked to wear an actigraph to obtain activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. Actigraphs are used to measure sleep efficiency.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
mild to moderate Alzheimer's disease and related dementia (ADRD) based on National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria,
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Clinical Dementia Rating (CDR) of 1 to 2,
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Mini-Mental State Examination (MMSE) between 8 and 24
Exclusion Criteria:
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major organ failure,
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major illness,
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history of head injury,
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hypertension or diabetes,
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use psychotropic (sleep aid) medicine, obstructing cataracts, macular degeneration, and blindness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
| 2 | Icahn School of Medicine at Mount Sinai | Troy | New York | United States | 12180 |
Sponsors and Collaborators
- Icahn School of Medicine at Mount Sinai
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Mariana G Figueiro, PhD, Icahn School of Medicine at Mount Sinai
Study Documents (Full-Text)
None provided.More Information
Publications
- Figueiro MG, Hamner R, Higgins P, Hornick T, Rea MS. Field measurements of light exposures and circadian disruption in two populations of older adults. J Alzheimers Dis. 2012;31(4):711-5.
- Hanford N, Figueiro M. Light therapy and Alzheimer's disease and related dementia: past, present, and future. J Alzheimers Dis. 2013;33(4):913-22. doi: 10.3233/JAD-2012-121645. Review.
- GCO 20-4007
- 7R01AG034157-11