Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia

Study Overview
=================
Brief Summary
-----------------
To test the effect of a tailored lighting intervention controlled by the Readings At Desk (RAD) controller on sleep and mood in Alzheimer's disease participants.

Detailed Description
-----------------
Each participant will be enrolled for 22 weeks. Participants will be randomly assigned to receive either the active or control lighting condition. Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition. Assessments will be performed before and at the end of each lighting intervention.

Official Title
-----------------
Using a Wireless Controller to Deliver a Lighting Intervention to Persons With Dementia

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Device: Active lighting intervention
* Device: Control lighting intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of Alzheimer's disease with a Mini Mental Score Examination (MMSE) between 0 and 19 a score >5 on the PSQI. Exclusion criteria: - use of sleep medication

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants will randomly be assigned to initially receive the active or control lighting intervention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active lighting intervention then Control lighting condition<br>Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition. | Device: Active lighting intervention<br>* Lighting intervention designed to impact the circadian system<br>Device: Control lighting intervention<br>* Lighting intervention designed to have no impact on the circadian system<br>|
| Active Comparator: Control lighting condition then Active light intervention<br>Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition. | Device: Active lighting intervention<br>* Lighting intervention designed to impact the circadian system<br>Device: Control lighting intervention<br>* Lighting intervention designed to have no impact on the circadian system<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep disturbance using the Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index (PSQI) is composed of 19 items that generate 7 component scores. The sum of the 7 component scores yields a single global score with a range of 0 to 21. A global score >5 is considered to indicate sleep disturbances. A lower global score indicates improvement in sleep disturbance. | up to 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression screening utilizing the Cornell Scale for Depression in Dementia (CSDD) | The CSDD is a a 19-item tool designed to rate symptoms of depression in patients with dementia. This tool evaluates the presence and extent of mood-related signs. Scores range from 0 to 38 with a higher score indicating higher depressive symptoms. | up to 22 weeks | 
| Sleep efficiency measured by actigraphy | Sleep efficiency is calculated from the wrist worn actigraph by the software program as the percentage of the time in bed spent sleeping. The ratio of total sleep time (TST) to total time in bed (TIB) multiplied by 100 to yield a percentage. | up to 22 weeks |