Methodology Issues in a Tailored Light Treatment for Persons With Dementia

Mount Sinai Health System

Status: Completed

Conditions: Depression; Sleep Disturbances

Treatments: Other: Inactive intervention; Other: Tailored Active intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01816152

7R01AG034157-11 (U.S. NIH Grant/Contract)

GCO 20-4007

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

Active Intervention

Active Comparator group

Description:

Light levels, primary and secondary measurements are obtained after a 4-week intervention period where active lighting is experienced by patients.

Treatment:

Other: Tailored Active intervention

Inactive intervention

Placebo Comparator group

Description:

Light levels, primary and secondary measurements are obtained after a 4-week intervention period where an inactive lighting is experienced by patients

Treatment:

Other: Inactive intervention