Clinical trial NCT01816152: Methodology Issues in a Tailored Light Treatment for Persons With Dementia
Official title: Phase 1 Methodology Issues in a Tailored Light Treatment for Persons With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbances
Depression
Keywords: light treatment
circadian rhythms
sleep
agitation
depression
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-03-22
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia

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.

Eligibility criteria: Inclusion Criteria:

* mild to moderate Alzheimer's disease and related dementia (ADRD)

Exclusion Criteria:

* major organ failure,
* major illness,
* history of head injury,
* hypertension or diabetes,
* use psychotropic (sleep aid) medicine, obstructing cataracts, macular degeneration, and blindness

Primary outcomes:
measure: Sleep Disturbance
timeFrame: Change from Baseline (week 0) and intervention (week 4)
measure: Agitation
timeFrame: Change from Baseline (week 0) and intervention (week 4)
measure: Depression
timeFrame: Change from Baseline (week 0) and intervention (week 4)
Secondary outcomes:
measure: Activity of Daily Living
timeFrame: Change from Baseline (week 0) and intervention (week 4)
measure: Light/dark patterns
timeFrame: Change from Baseline (week 0) and intervention (week 4)
measure: Actigraphy
timeFrame: Change from Baseline (week 0) and intervention (week 4)
Other outcomes:
Locations:
city: Albany
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mariana G Figueiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.3233/JAD-2012-120484.
citation: 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.
citation: Figueiro MG, Plitnick BA, Lok A, Jones GE, Higgins P, Hornick TR, Rea MS. Tailored lighting intervention improves measures of sleep, depression, and agitation in persons with Alzheimer's disease and related dementia living in long-term care facilities. Clin Interv Aging. 2014 Sep 12;9:1527-37. doi: 10.2147/CIA.S68557. eCollection 2014.
citation: Figueiro MG, Plitnick B, Roohan C, Sahin L, Kalsher M, Rea MS. Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial. J Clin Sleep Med. 2019 Dec 15;15(12):1757-1767. doi: 10.5664/jcsm.8078. Epub 2019 Nov 8.