DementiaNCT06205654
Effect of Improved Indoor Lighting on Residents of Residential Care Homes with Dementia
An observational study of Dementia, run by KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- How many people
- 98 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Sep 2024to 10 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Two residential care homes are participating in this study. In one residential care home, improved lighting was implemented in two living rooms. The intervention group consists of participants living in one of these living rooms. The control group consists of participants living in the other residential care home (where improved lighting was not implemented).
Who may be able to join
- Diagnosed with dementia
- Residing in the selected living area
Who cannot join
- Blind individuals
- Not residing in the selected living area
- Not diagnosed with dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Invloed Van Verlichting (en Daglicht) Op Bewoners Met Dementie in Woonzorgcentra
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.
- Conditions
- Dementia
- Keywords
- Lighting, Integrative lighting, Dementia, Nursing home, Residential care home
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | innovative lighting designs are implemented in the living area. | |
| Control | no significant modifications to their lighting conditions are implemented in the living area |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline + Week 15
Secondary outcomes (14)
Age of participant
Age of participant at Baseline
Measured: Baseline measurement
Gender of participant
Gender of participant at Baseline
Measured: Baseline measurement
Length of stay in the nursing home of participant
Length of stay in the nursing home of participant at Baseline
Measured: Baseline measurement
Marital status of participant
Marital status of participant at Baseline
Measured: Baseline measurement
Frequency of visitors of participant
Frequency of visitors of participant at Baseline
Measured: Baseline measurement
Mini-mental state examination of participant
The mini-mental state examination is a 30-point questionnaire that is used to measure cognitive impairment.
Measured: Baseline measurement
Diagnosis of dementia of participant
Assessment of whether the participant has been determined to have dementia.
Measured: Baseline measurement
Diagnosis of Parkinson's disease of participant
Assessment of whether the participant has been determined to have Parkinson's disease.
Measured: Baseline measurement
Diagnosis of cancer of participant
Assessment of whether the participant has been determined to have cancer.
Measured: Baseline measurement
Diagnosis of Chronic obstructive pulmonary disease of participant
Assessment of whether the participant has been determined to have Chronic obstructive pulmonary disease.
Measured: Baseline measurement
Diagnosis of cardiovascular diseases of participant
Assessment of whether the participant has been determined to have cardiovascular diseases.
Measured: Baseline measurement
Diagnosis of cerebral vascular accident of participant
Assessment of whether the participant has been determined to have cerebral vascular accident.
Measured: Baseline measurement
Diagnosis of diabetes of participant
Assessment of whether the participant has been determined to have diabetes.
Measured: Baseline measurement
Diagnosis of depression of participant
Assessment of whether the participant has been determined to have depression.
Measured: Baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start9 Sep 2024
- Primary completion3 Feb 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Odisee University College
- Responsible party
- Principal investigator, Wouter Ryckaert, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205654
- Sponsor's protocol ID
- S66305
- Status last verified
- Feb 2025
- First submitted
- 4 Jan 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invloed Van Verlichting (en Daglicht) Op Bewoners Met Dementie in Woonzorgcentra
- ClinicalTrials.gov ID
- NCT06205654
- Acronym / sponsor ID
- S66305
- Conditions
- Dementia
- Keywords
- Lighting, Integrative lighting, Dementia, Nursing home, Residential care home
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Odisee University College
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | –innovative lighting designs are implemented in the living area. |
| Control | – | –no significant modifications to their lighting conditions are implemented in the living area |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Two residential care homes are participating in this study. In one residential care home, improved lighting was implemented in two living rooms. The intervention group consists of participants living in one of these living rooms. The control group consists of participants living in the other residential care home (where improved lighting was not implemented).
Key inclusion criteria (2 listed)
- Diagnosed with dementia
- Residing in the selected living area
Key exclusion criteria (3 listed)
- Blind individuals
- Not residing in the selected living area
- Not diagnosed with dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in sleep efficiency at Week 15
Time frame: Baseline + 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
Change from Baseline in Fragmentation Index at Week 15
Time frame: Baseline + 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)
Change from Baseline in interdaily stability at Week 15
Time frame: Baseline + 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)
Change from Baseline in Intradaily variability at Week 15
Time frame: Baseline + 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)
Change from Baseline in L5 average at Week 15
Time frame: Baseline + 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)
Change from Baseline in M10 average at Week 15
Time frame: Baseline + 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)
Change from Baseline in number of naps at Week 15
Time frame: Baseline + 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)
Change from Baseline in agitation on the Cohen-Mansfield Agitation Inventory at Week 15
Time frame: Baseline + 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)
Change from Baseline in depression on the Cornell Scale for Depression in Dementia at Week 15
Time frame: Baseline + 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)
Change from Baseline in pain on the Doloplus Scale-2 at Week 15
Time frame: Baseline + 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)
Change from Baseline in neuropsychiatric symptoms on the Neuropsychiatric Inventory at Week 15
Time frame: Baseline + 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)
14 secondary outcomes
Age of participant
Time frame: Baseline measurement
Gender of participant
Time frame: Baseline measurement
Length of stay in the nursing home of participant
Time frame: Baseline measurement
Marital status of participant
Time frame: Baseline measurement
Frequency of visitors of participant
Time frame: Baseline measurement
Mini-mental state examination of participant
Time frame: Baseline measurement
Diagnosis of dementia of participant
Time frame: Baseline measurement
Diagnosis of Parkinson's disease of participant
Time frame: Baseline measurement
Diagnosis of cancer of participant
Time frame: Baseline measurement
Diagnosis of Chronic obstructive pulmonary disease of participant
Time frame: Baseline measurement
Diagnosis of cardiovascular diseases of participant
Time frame: Baseline measurement
Diagnosis of cerebral vascular accident of participant
Time frame: Baseline measurement
Diagnosis of diabetes of participant
Time frame: Baseline measurement
Diagnosis of depression of participant
Time frame: Baseline measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in sleep efficiency at Week 15 (time frame: Baseline + Week 15). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.