Effect of Improved Indoor Lighting on Residents of Residential Care Homes with Dementia

Change from Baseline in sleep efficiency at Week 15

Sleep efficiency is the actual sleep time expressed as a percentage of time in bed as measured by actigraphy. Higher percentage indicates better sleep efficiency. Change = percentage point difference between Baseline and Week 15

Time frame: Baseline + Week 15

Change from Baseline in Fragmentation Index at Week 15

The Fragmentation Index is an indication of the degree of fragmentation of the sleep period, and can be used as an indication of sleep quality. This parameter is measured using actigraphy. Change = (Week 15 Fragmentation Index - Baseline Fragmentation Index)

Time frame: Baseline + Week 15

Change from Baseline in interdaily stability at Week 15

Interdaily stability quantifies the degree of regularity in the activity-rest pattern. Range of 0 to 1 where a value of 0 indicates a total lack of rhythm and a value of 1 indicates a perfectly stable rhythm. This parameter is measured using actigraphy. Change = (Week 15 Interdaily stability - Baseline Interdaily stability)

Time frame: Baseline + Week 15

Change from Baseline in Intradaily variability at Week 15

Intradaily variability quantifies the degree of fragmentation of activity-rest periods. The variable has a theoretical range of 0 to 2 with higher values indicating higher fragmentation. Typical values for healthy subjects will be below 1. This parameter is measured using actigraphy. Change = (Week 15 Intradaily variability - Baseline Intradaily variability)

Time frame: Baseline + Week 15

Change from Baseline in L5 average at Week 15

L5 average provides the average activity level for the sequence of the least five active hours.This value provides an indication of how restful (inactive) and regular the sleep periods are. This parameter is measured using actigraphy. Change = (Week 15 L5 average - Baseline L5 average)

Time frame: Baseline + Week 15

Change from Baseline in M10 average at Week 15

M10 average provides the average activity level for the sequence of the highest (most) ten active hours. This value provides an indication of how active and regular the wake periods are. This parameter is measured using actigraphy. Change = (Week 15 M10 average - Baseline M10 average)

Time frame: Baseline + Week 15

Change from Baseline in number of naps at Week 15

Average number of naps during the day. More naps during the day indicate poorer sleep patterns. This parameter is measured using actigraphy. Change = (Week 15 number of naps - Baseline number of naps)

Time frame: Baseline + Week 15

Change from Baseline in agitation on the Cohen-Mansfield Agitation Inventory at Week 15

The Cohen-Mansfield Agitation Inventory is used to assess agitation. It consists of 29 items regarding the manifestation of physically aggressive, physically non-aggressive and verbally agitated behaviors which are scored on a 7-point scale ranging from "Never" to "Several times per hour". The questionnaire is completed for each participant independently by 2 members of the nursing staff. Change = (Week 15 score - Baseline score)

Time frame: Baseline + Week 15

Change from Baseline in depression on the Cornell Scale for Depression in Dementia at Week 15

The Cornell Scale for Depression in Dementia is used to assess symptoms of depression in participants with dementia. It consists of different items where each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 as a rule are associated with absence of significant depressive symptoms. The questionnaire is completed for each participant independently by 2 members of the nursing staff. Change = (Week 15 score - Baseline score)

Time frame: Baseline + Week 15

Change from Baseline in pain on the Doloplus Scale-2 at Week 15

The Doloplus Scale-2 is used to assess pain and the impact of pain. The items are rated for severity on a scale of 0-3 (0=absent, 3=almost always present). The questionnaire is completed for each participant independently by 2 members of the nursing staff. Change = (Week 15 score - Baseline score)

Time frame: Baseline + Week 15

Change from Baseline in neuropsychiatric symptoms on the Neuropsychiatric Inventory at Week 15

The Neuropsychiatric Inventory (NPI) is used to assess a broad spectrum of neuropsychiatric symptoms, including hallucinations, delusions, and anxiety. The NPI examines 12 sub-domains of behavioral functioning: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, aberrant motor activity, night-time behavioral disturbances, and appetite and eating abnormalities The questionnaire is completed for each participant independently by 2 members of the nursing staff. Change = (Week 15 score - Baseline score)

Time frame: Baseline + Week 15