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

Dementia Clinical Trial

Official title:

Invloed Van Verlichting (en Daglicht) op Bewoners Met Dementie in Woonzorgcentra

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06205654
• Other study ID #: S66305
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Elderly with dementia living in residential care homes often have limited access to adequate lighting (daylight). Light can however positively impact the individual on a number of factors, including sleep quality and mental health. The proposed non-invasive study seeks to evaluate the impact of an improved lighting environment in the living areas of residential care home residents with dementia on both the physical and mental well-being of these individuals. To assess sleep quality, an actigraphy device will be used from which a number of parameters corresponding to sleep quality can be obtained. Mental health/behaviour of the participants will be assessed by validated questionnaires. These questionnaires will be filled for each participant independently by 2 members of the nursing staff.

Two groups of residential care home residents will be observed during this study: an intervention group and a control group. In the intervention group, innovative lighting designs are already implemented in the living area. The control group will experience no significant modifications to their lighting conditions. Extra luminaires (floor lamp/table lamp) will be employed without significantly improving the light exposure during the day.

It is hypothesized that the introduction of enhanced lighting during the day in the living area of the intervention group will result in improved sleep quality and enhanced mental well-being.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Diagnosed with dementia

2. Residing in the selected living area

Exclusion Criteria:

1. Blind individuals

2. Not residing in the selected living area

3. Not diagnosed with dementia

Related Conditions & MeSH terms

• Dementia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Odisee University College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline + Week 15
Primary	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)	Baseline + Week 15
Primary	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)	Baseline + Week 15
Primary	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)	Baseline + Week 15
Primary	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)	Baseline + Week 15
Primary	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)	Baseline + Week 15
Primary	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)	Baseline + Week 15
Primary	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)	Baseline + Week 15
Primary	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)	Baseline + Week 15
Primary	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)	Baseline + Week 15
Primary	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)	Baseline + Week 15
Secondary	Age of participant	Age of participant at Baseline	Baseline measurement
Secondary	Gender of participant	Gender of participant at Baseline	Baseline measurement
Secondary	Length of stay in the nursing home of participant	Length of stay in the nursing home of participant at Baseline	Baseline measurement
Secondary	Marital status of participant	Marital status of participant at Baseline	Baseline measurement
Secondary	Frequency of visitors of participant	Frequency of visitors of participant at Baseline	Baseline measurement
Secondary	Mini-mental state examination of participant	The mini-mental state examination is a 30-point questionnaire that is used to measure cognitive impairment.	Baseline measurement
Secondary	Diagnosis of dementia of participant	Assessment of whether the participant has been determined to have dementia.	Baseline measurement
Secondary	Diagnosis of Parkinson's disease of participant	Assessment of whether the participant has been determined to have Parkinson's disease.	Baseline measurement
Secondary	Diagnosis of cancer of participant	Assessment of whether the participant has been determined to have cancer.	Baseline measurement
Secondary	Diagnosis of Chronic obstructive pulmonary disease of participant	Assessment of whether the participant has been determined to have Chronic obstructive pulmonary disease.	Baseline measurement
Secondary	Diagnosis of cardiovascular diseases of participant	Assessment of whether the participant has been determined to have cardiovascular diseases.	Baseline measurement
Secondary	Diagnosis of cerebral vascular accident of participant	Assessment of whether the participant has been determined to have cerebral vascular accident.	Baseline measurement
Secondary	Diagnosis of diabetes of participant	Assessment of whether the participant has been determined to have diabetes.	Baseline measurement
Secondary	Diagnosis of depression of participant	Assessment of whether the participant has been determined to have depression.	Baseline measurement