SleepNCT05697757
Lighting for Older Adults With Dementia
A study testing Dynamic Lighting in people with Sleep and Mood, run by Arizona State University at 3 sites in United States.
Trial summary
This study aims to investigate the effect of a dynamic lighting intervention on sleep quality, circadian activity rhythms, and mood in older adults with dementia living in long-term care facilities. Read more about this study
- Who is it for?
- Ages 50 years and older
- What is being tested?
- Dynamic Lighting
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jan 2023to 30 Jun 2023
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged over 50.
- Diagnosed with mild to major dementia based on the physician and care facility manager's recommendation.
- Has no major organ failure, major diagnosis other than dementia, history of head injury, obstructing cataracts, macular degeneration, and blindness based on their Medical history.
- Not taking light therapy
- Female or male
- No current or planned use of light-altering devices (e.g., blue-blocking and/or tinted glasses and contact lenses)
- -
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sunshine Village
Phoenix, Arizona, 85032
ASU DeSmart Lab
Tempe, Arizona, 85281
Mirabella at ASU
Tempe, Arizona, 85281
About this study
Official title: Effects of Dynamic Lighting on Improving Sleep and Mood in Older Adults With Dementia.
This study aims to investigate the effect of a dynamic lighting intervention on sleep quality, circadian activity rhythms, and mood in older adults with dementia living in long-term care facilities. The dynamic lighting intervention is designed to create an ambient illumination that provides a high level of circadian stimulation in the morning and circadian-neutral lighting in the evenings through delivering varying light intensity and spectrum.
Read the detailed description
Light is the most important environmental element that is not only necessary to fulfill visual tasks but also is the main stimulus that regulates circadian rhythms. Daily exposure to proper lighting at the right time is reported as an effective non-pharmacological treatment to improve sleep disorders in various age groups including older adults. Several clinical studies have demonstrated the benefits of bright light therapy to improve sleep duration and sleep efficiency at night and reduce daytime sleepiness and behavioral disturbance (i.e., agitation, depression) in older adults. In most of these studies, lighting intervention includes a lightbox that exposes participants to an extra lighting source with specific characteristics (i.e., blue-enriched bright light) for only a few hours without considering the impacts of other lighting sources that individuals are exposed to throughout the day. A significant impediment to administrating bright light therapy for older adults with dementia is that these individuals typically require reminders to remain seated and awake in front of a lightbox long enough to benefit from the bright light exposure. An alternative way to deliver bright light is through providing circadian-effective ambient lighting. The circadian system responds best to high-intensity short-wavelength light (peak wavelength of 480 nm). However, the lighting design in long-term care facilities does not necessarily provide adequate intensity and spectrum to stimulate circadian rhythms in elder residences. Studies reported poor lighting conditions in nursing homes. According to these studies, daytime lighting in these institutions is not even sufficient to fulfill older adults' visual needs, while light at night is relatively often excessive. Thus, this study will be carried out to achieve the following aims:
Aim1: Investigate the effect of a dynamic lighting condition on circadian activity rhythms and selected sleep parameters in older adults with dementia.
Aim2: Evaluate the effect of a dynamic lighting condition on mood.
Findings from this study will provide initial guidance to the designers and administration of memory care facilities as to the lighting design recommendations of greatest benefits to the sleep, mood, and well-being of institutionalized older adults diagnosed with dementia.
The participants will be recruited from two memory care facilities from the greater Phoenix area, based on the recommendation of the managers at the memory care facilities.
Environment: In this study, the human-lighting interaction will occur in the common areas of the selected memory care facilities where older adults with dementia spend most of the daytime hours under the supervision of facility caregivers. Research personnel will install experimental luminaires in the memory care facility's common area. During this visit, research personnel will also give a number of actigraphs and light trackers (which will be used for data collection throughout the study) to caregivers and instruct them on how to use these devices on participants. Participants will also be instructed (by caregivers) on how to use each device.
Week 1 (Baseline): Patterns of sleep, moods, and light exposure will be monitored ad libitum for one week. The experimental luminaires will remain off during Week 1. Placing luminaires in the common area of the facility prior to the use of lighting interventions during Weeks 2 to 7 will minimize environmental variations between baseline and intervention measurements (e.g., new luminaires in the room) and decrease the bias resulting from the Hawthorne effect on collected data.
Weeks 2-7 (Intervention): The intervention period will start right after the baseline and continue for six constructive weeks. There are two lighting interventions, each of which is three weeks long. We will randomly assign one of the residences to start with (Dynamic > Placebo) lighting intervention while the other start with (Placebo > Dynamic) lighting intervention. Actigraphy will be conducted only on the last 7 days of each condition. Light spectrum and intensity will be tracked continuously throughout the waking hours (Blue Iris mobile sensor). Moreover, caregivers will complete CSDD and CMAI every seven days to assess the short and long-term effects of each condition on mood and agitation of older adult participants.
- Being tested
- Dynamic Lighting, Placebo Lighting
- Keywords
- Dynamic Lighting, Sleep, Mood, Dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic LightingOther
This will be an eighteen-hour lighting scheme that includes three modes: morning (6:00 - 12:00), afternoon (12:00 - 18:00), and evening (18:00 - 24:00). It mimics natural lighting by providing blue-enriched high-intensity lighting in the morning and neutral white medium-intensity lighting in the afternoon to maintain alertness without exerting substantial circadian effects. The biodynamic lighting will provide yellowish low-intensity lighting in the evening to minimize any circadian effect.
Placebo LightingOther
We will include an active placebo condition that will be a whole-day lighting scheme with constant color and brightness from morning to evening. The numbers of CCT and illuminance levels are selected based on the average room lighting
| Study group | Role | What they receive |
|---|---|---|
| Placebo Condition followed by Dynamic Condition | Experimental | Each lighting condition will last for three weeks (Weeks 2-4 or 5-7). The order of conditions will be randomized. Sleep data will be collected only on the last 7 days of each condition using actigraphy. Light spectrum and intensity will be tracked continuously throughout the waking hours (wearable light tracker). Moreover, caregivers will complete two questionnaires (CSDD and CMAI) every seven days to assess the short and long-term effects of each condition on mood and agitation of older adult participants. Receives: Other: Dynamic Lighting; Other: Placebo Lighting |
| Dynamic Condition followed by Placebo Condition | Experimental | Each lighting condition will last for three weeks (Weeks 2-4 or 5-7). The order of conditions will be randomized. Sleep data will be collected only on the last 7 days of each condition using actigraphy. Light spectrum and intensity will be tracked continuously throughout the waking hours (wearable light tracker). Moreover, caregivers will complete two questionnaires (CSDD and CMAI) every seven days to assess the short and long-term effects of each condition on mood and agitation of older adult participants. Receives: Other: Dynamic Lighting; Other: Placebo Lighting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nocturnal Sleep Duration (in minutes) as measured by actigraphy
Nocturnal Sleep Duration (in minutes) will be measured by Actigraphy. Longer sleep duration corresponds to improved sleep outcomes.
Measured: 24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.
Change in Percent Sleep Efficiency (total sleep time divided by time in bed) measured by actigraphy.
Percent Sleep Efficiency will be measured by actigraphy. Higher percentage corresponds to higher sleep quality.
Measured: 24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.
Minutes of wake after sleep onset measured by actigraphy.
Minutes of wake after sleep onset will be measured by actigraphy. Lower number indicates better sleep pattern and sleep outcomes.
Measured: 24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.
Changes in depression levels as measured by Cornell Scale of Depression in Dementia (CSDD).
Depression level is assessed using CSDD every 7 days throughout the 7-week protocol based on caregivers' observations of the participants' behavior during the week prior. Lower scores in CSDD indicates lower depression and better mood outcomes.
Measured: Every seven days throughout the 7-week protocol.
Changes in agitation levels measured by Cohen-Mansfield Agitation Inventory (CMAI).
Agitation level is assessed using CMAI every 7 days throughout the 7-week protocol based on caregivers' observations of the participants' behavior during the week prior. A lower score indicates lower levels of agitations and an improvement in mood.
Measured: Every seven days throughout the 7-week protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start13 Jan 2023
- Primary completion1 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Investigators will examine a series of participants (N=30), each of whom will participate in a seven-week experiment. The study will be conducted over seven successive one-week periods with two cohorts of participants experiencing the same series of lighting interventions in a counterbalanced manner.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona Alzheimer's Consortium, Arizona State University Knowledge Enterprise
- Responsible party
- Principal investigator, Nina Sharp, Arizona State University
- Investigators
- Nina Sharp, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697757
- Sponsor's protocol ID
- STUDY00016960
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: No individual participant data will be shared. Results will be published by the investigators in academic journals and conference proceedings. However, neither the name nor identity of the participants will be used in any publications. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in human-light interactions.
Publications
Alrahyani M, Youngstedt S, Fani M, Yague N, Yu F, Guest MA, Yeom D, Sharp N. Effects of applying biodynamic lighting on improving sleep, depression, and agitation in older adults with dementia: a pilot clinical trial. Geriatr Nurs. 2025 Jul-Aug;64:103435. doi: 10.1016/j.gerinurse.2025.103435. Epub 2025 Jul 4.
PubMed 40617163
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dynamic Lighting on Improving Sleep and Mood in Older Adults With Dementia.
- ClinicalTrials.gov ID
- NCT05697757
- Acronym / sponsor ID
- STUDY00016960
- Keywords
- Dynamic Lighting, Sleep, Mood, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Arizona Alzheimer's Consortium, Arizona State University Knowledge Enterprise
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Jan 2023 (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.
This study aims to investigate the effect of a dynamic lighting intervention on sleep quality, circadian activity rhythms, and mood in older adults with dementia living in long-term care facilities. The dynamic lighting intervention is designed to create an ambient illumination that provides a high level of circadian stimulation in the morning and circadian-neutral lighting in the evenings through delivering varying light intensity and spectrum.
Detailed description
Light is the most important environmental element that is not only necessary to fulfill visual tasks but also is the main stimulus that regulates circadian rhythms. Daily exposure to proper lighting at the right time is reported as an effective non-pharmacological treatment to improve sleep disorders in various age groups including older adults. Several clinical studies have demonstrated the benefits of bright light therapy to improve sleep duration and sleep efficiency at night and reduce daytime sleepiness and behavioral disturbance (i.e., agitation, depression) in older adults. In most of these studies, lighting intervention includes a lightbox that exposes participants to an extra lighting source with specific characteristics (i.e., blue-enriched bright light) for only a few hours without considering the impacts of other lighting sources that individuals are exposed to throughout the day. A significant impediment to administrating bright light therapy for older adults with dementia is that these individuals typically require reminders to remain seated and awake in front of a lightbox long enough to benefit from the bright light exposure. An alternative way to deliver bright light is through providing circadian-effective ambient lighting. The circadian system responds best to high-intensity short-wavelength light (peak wavelength of 480 nm). However, the lighting design in long-term care facilities does not necessarily provide adequate intensity and spectrum to stimulate circadian rhythms in elder residences. Studies reported poor lighting conditions in nursing homes. According to these studies, daytime lighting in these institutions is not even sufficient to fulfill older adults' visual needs, while light at night is relatively often excessive. Thus, this study will be carried out to achieve the following aims:
Aim1: Investigate the effect of a dynamic lighting condition on circadian activity rhythms and selected sleep parameters in older adults with dementia.
Aim2: Evaluate the effect of a dynamic lighting condition on mood.
Findings from this study will provide initial guidance to the designers and administration of memory care facilities as to the lighting design recommendations of greatest benefits to the sleep, mood, and well-being of institutionalized older adults diagnosed with dementia.
The participants will be recruited from two memory care facilities from the greater Phoenix area, based on the recommendation of the managers at the memory care facilities.
Environment: In this study, the human-lighting interaction will occur in the common areas of the selected memory care facilities where older adults with dementia spend most of the daytime hours under the supervision of facility caregivers. Research personnel will install experimental luminaires in the memory care facility's common area. During this visit, research personnel will also give a number of actigraphs and light trackers (which will be used for data collection throughout the study) to caregivers and instruct them on how to use these devices on participants. Participants will also be instructed (by caregivers) on how to use each device.
Week 1 (Baseline): Patterns of sleep, moods, and light exposure will be monitored ad libitum for one week. The experimental luminaires will remain off during Week 1. Placing luminaires in the common area of the facility prior to the use of lighting interventions during Weeks 2 to 7 will minimize environmental variations between baseline and intervention measurements (e.g., new luminaires in the room) and decrease the bias resulting from the Hawthorne effect on collected data.
Weeks 2-7 (Intervention): The intervention period will start right after the baseline and continue for six constructive weeks. There are two lighting interventions, each of which is three weeks long. We will randomly assign one of the residences to start with (Dynamic > Placebo) lighting intervention while the other start with (Placebo > Dynamic) lighting intervention. Actigraphy will be conducted only on the last 7 days of each condition. Light spectrum and intensity will be tracked continuously throughout the waking hours (Blue Iris mobile sensor). Moreover, caregivers will complete CSDD and CMAI every seven days to assess the short and long-term effects of each condition on mood and agitation of older adult participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Investigators will examine a series of participants (N=30), each of whom will participate in a seven-week experiment. The study will be conducted over seven successive one-week periods with two cohorts of participants experiencing the same series of lighting interventions in a counterbalanced manner.
| Arm | Type | Receives |
|---|---|---|
| Placebo Condition followed by Dynamic Condition | Experimental | Other: Dynamic Lighting, Other: Placebo LightingEach lighting condition will last for three weeks (Weeks 2-4 or 5-7). The order of conditions will be randomized. Sleep data will be collected only on the last 7 days of each condition using actigraphy. Light spectrum and intensity will be tracked continuously throughout the waking hours (wearable light tracker). Moreover, caregivers will complete two questionnaires (CSDD and CMAI) every seven days to assess the short and long-term effects of each condition on mood and agitation of older adult participants. |
| Dynamic Condition followed by Placebo Condition | Experimental | Other: Dynamic Lighting, Other: Placebo LightingEach lighting condition will last for three weeks (Weeks 2-4 or 5-7). The order of conditions will be randomized. Sleep data will be collected only on the last 7 days of each condition using actigraphy. Light spectrum and intensity will be tracked continuously throughout the waking hours (wearable light tracker). Moreover, caregivers will complete two questionnaires (CSDD and CMAI) every seven days to assess the short and long-term effects of each condition on mood and agitation of older adult participants. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged over 50.
- Diagnosed with mild to major dementia based on the physician and care facility manager's recommendation.
- Has no major organ failure, major diagnosis other than dementia, history of head injury, obstructing cataracts, macular degeneration, and blindness based on their Medical history.
- Not taking light therapy
- Female or male
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic LightingThis will be an eighteen-hour lighting scheme that includes three modes: morning (6:00 - 12:00), afternoon (12:00 - 18:00), and evening (18:00 - 24:00). It mimics natural lighting by providing blue-enriched high-intensity lighting in the morning and neutral white medium-intensity lighting in the afternoon to maintain alertness without exerting substantial circadian effects. The biodynamic lighting will provide yellowish low-intensity lighting in the evening to minimize any circadian effect. | Other | Dynamic Condition followed by Placebo Condition, Placebo Condition followed by Dynamic Condition |
| Placebo LightingWe will include an active placebo condition that will be a whole-day lighting scheme with constant color and brightness from morning to evening. The numbers of CCT and illuminance levels are selected based on the average room lighting | Other | Dynamic Condition followed by Placebo Condition, Placebo Condition followed by Dynamic Condition |
Primary outcome
Change in Nocturnal Sleep Duration (in minutes) as measured by actigraphy
Time frame: 24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.
Nocturnal Sleep Duration (in minutes) will be measured by Actigraphy. Longer sleep duration corresponds to improved sleep outcomes.
Change in Percent Sleep Efficiency (total sleep time divided by time in bed) measured by actigraphy.
Time frame: 24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.
Percent Sleep Efficiency will be measured by actigraphy. Higher percentage corresponds to higher sleep quality.
Minutes of wake after sleep onset measured by actigraphy.
Time frame: 24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.
Minutes of wake after sleep onset will be measured by actigraphy. Lower number indicates better sleep pattern and sleep outcomes.
Changes in depression levels as measured by Cornell Scale of Depression in Dementia (CSDD).
Time frame: Every seven days throughout the 7-week protocol.
Depression level is assessed using CSDD every 7 days throughout the 7-week protocol based on caregivers' observations of the participants' behavior during the week prior. Lower scores in CSDD indicates lower depression and better mood outcomes.
Changes in agitation levels measured by Cohen-Mansfield Agitation Inventory (CMAI).
Time frame: Every seven days throughout the 7-week protocol.
Agitation level is assessed using CMAI every 7 days throughout the 7-week protocol based on caregivers' observations of the participants' behavior during the week prior. A lower score indicates lower levels of agitations and an improvement in mood.
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 31 Jan 2024.
- Derived from this study: PubMed 40617163Alrahyani M, Youngstedt S, Fani M, Yague N, Yu F, Guest MA, Yeom D, Sharp N. Effects of applying biodynamic lighting on improving sleep, depression, and agitation in older adults with dementia: a pilot clinical trial. Geriatr Nurs. 2025 Jul-Aug;64:103435. doi: 10.1016/j.gerinurse.2025.103435. Epub 2025 Jul 4.
- Individual participant dataSharing planned: Yes. No individual participant data will be shared. Results will be published by the investigators in academic journals and conference proceedings. However, neither the name nor identity of the participants will be used in any publications. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in human-light interactions.
Related trials for Sleep
Not yet recruitingObservational study
Stress, Coping, and Sleep Health Study
Sleep
Enrolling by invitationObservational study
Trajectory Study: Predicting Cardiometabolic Health in Adolescents and Young Adults Based on Childhood Fitness, Sleep, and Diet
Cardiometabolic Health
Not yet recruitingObservational study
Heart and Brain Blood Flow in Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA)
Active, not recruiting
Maternal Sensory Interventions in Newborns
Neonatal Intensive Care Unit, Hospitalized Newborn
Recruiting
Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia
Psychological Distress, Insomnia
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.
Nina Sharp, PhD principal investigator
Arizona State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Lighting in people with Sleep and Mood, run by Arizona State University at 3 sites in United States.
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 7 inclusion and 0 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 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 in Nocturnal Sleep Duration (in minutes) as measured by actigraphy (time frame: 24 hours everyday during the last 7 days of each condition, namely 7 days of baseline, 7 days of dynamic, and 7 days of placebo.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05697757, which also lists 1 linked publication.
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 31 Jan 2024.