DementiaNCT03483896
Pilot Study to Examine Health Effects of Daylight Exposure on Dementia Patients
A study testing Daylight Intervention in people with Dementia and Depression, run by University of Southern California at 8 sites in United States.
Trial summary
This study is designed to test the hypothesis that an intervention increasing exposure to daylight indoors will reduce depression and other neuropsychiatric symptoms among people living with dementia in long term care facilities. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dementia, Depression, Behavior Disorders
- What is being tested?
- Daylight Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Jan 2017to 5 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents were recruited according to the trial inclusion criteria: 1) Alzheimer's disease and related dementias (ADRD) diagnosis, 2) no physical co-morbidities that precluded participation in the daily group intervention, and 3) a Mini-Mental State Exam (MMSE) score of 10 or higher
Who cannot join
- physical co-morbidities that precluded participation in the daily group intervention
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Alhambra Dementia Care
Alhambra, California, 91801
Sierra Vista Memory Care Community
Azusa, California, 91702
Calabasas Memory Care Community
Calabasas, California, 91302
Costa Mesa Dementia Care
Costa Mesa, California, 92627
Los Angeles Dementia Care (Beverly Place)
Los Angeles, California, 90048
Redondo Beach Dementia Care (Beach Cities)
Redondo Beach, California, 90277
San Juan Capistrano Memory Care Community
San Juan Capistrano, California, 92675
Tustin Hacienda Memory Care Community
Tustin, California, 92780
About this study
Official title: Pilot Study to Examine the Effects of Indoor Daylight Exposure on Depression and Other Neuropsychiatric Symptoms in People Living With Dementia in Long Term Care Facilities
This study is designed to test the hypothesis that an intervention increasing exposure to daylight indoors will reduce depression and other neuropsychiatric symptoms among people living with dementia in long term care facilities.
Read the detailed description
Exposure to sufficient daylight indoors is a novel and potentially effective nonpharmacological treatment option for reducing depression and other neuropsychiatric symptoms for people living with dementia in long term care facilities. However, there are currently no minimum requirements for daylight access in care facilities. In urban settings, it is common for residents to spend the majority of the day indoors, illuminated by electrical light sources that deliver light with significantly lower intensities and reduced spectrum compared with daylight.
A 12-week pilot study was conducted in 8 dementia care facilities involving (n = 83) participants addressing the hypothesis that an intervention increasing indoor exposure to daylight will reduce depression and other neuropsychiatric symptoms. At 4 facilities, staff was enlisted to increase daylight exposure by taking participants to a perimeter room with daylight exposure for socialization in the morning (8:00 - 10:00 AM) each day. At the other 4 facilities, a control group were taken to a similar sized area without daylight for socialization under typical electrical lighting conditions. Outcome measures for depression and other neuropsychiatric symptoms were taken at the beginning and end of the 12-week study.
- Conditions
- Dementia, Depression, Behavior Disorders
- Being tested
- Daylight Intervention
- Medical subject headings
- Dementia, Depression, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daylight InterventionOther
Staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | At the 4 facilities in the control arm, participants received the usual care. During the period from 8:00 - 10:00 AM each day, the control group was taken to a similar sized area indoors (without daylight) for socialization under typical electrical lighting conditions. |
| Daylight Intervention | Active comparator | At the 4 facilities in the active light intervention arm, staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study. Receives: Other: Daylight Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cornell Scale for Depression in Dementia (CSDD)
The Cornell Scale for Depression in Dementia (CSDD) was used to measure depression. The CSDD is designed for the assessment of depression in older people with dementia who can at least communicate basic needs. The CSDD scale ranges from 0 to 38, with higher scores indicating higher levels of depression. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 are associated with absence of significant depressive symptoms.
Measured: A CSDD score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.
Secondary outcomes (1)
Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH)
The Neuropsychiatric Inventory Nursing Home Version (NPI-NH) was used to measure neuropsychiatric symptomatology. The NPI-NH is a scale designed for assessment of people with dementia residing in extended care facilities. The NPI-NH includes ten behavioral areas (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior) and two types of neurovegetative changes (sleep and nighttime behavior disorders, appetite and eating disorders). Each of the 12 areas is scored on a subscale ranging from 0-12, where higher scores indicate greater neuropsychiatric symptomatology. A summary score is obtained from summing all 12 subscale scores. The summary score ranges from 0 - 144, where higher scores indicate greater neuropsychiatric symptomatology.
Measured: A NPI-NH score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start30 Jan 2017
- Primary completion10 May 2017
- Study completion5 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Konis, University of Southern California
- Investigators
- Kyle Konis, Ph.D, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483896
- Sponsor's protocol ID
- UP-16-00487
- Status last verified
- Dec 2018
- First submitted
- 21 Mar 2018
- Last updated
- 29 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Examine the Effects of Indoor Daylight Exposure on Depression and Other Neuropsychiatric Symptoms in People Living With Dementia in Long Term Care Facilities
- ClinicalTrials.gov ID
- NCT03483896
- Acronym / sponsor ID
- UP-16-00487
- Conditions
- Dementia, Depression, Behavior Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 5 Jun 2017 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Posted 29 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test the hypothesis that an intervention increasing exposure to daylight indoors will reduce depression and other neuropsychiatric symptoms among people living with dementia in long term care facilities.
Detailed description
Exposure to sufficient daylight indoors is a novel and potentially effective nonpharmacological treatment option for reducing depression and other neuropsychiatric symptoms for people living with dementia in long term care facilities. However, there are currently no minimum requirements for daylight access in care facilities. In urban settings, it is common for residents to spend the majority of the day indoors, illuminated by electrical light sources that deliver light with significantly lower intensities and reduced spectrum compared with daylight.
A 12-week pilot study was conducted in 8 dementia care facilities involving (n = 83) participants addressing the hypothesis that an intervention increasing indoor exposure to daylight will reduce depression and other neuropsychiatric symptoms. At 4 facilities, staff was enlisted to increase daylight exposure by taking participants to a perimeter room with daylight exposure for socialization in the morning (8:00 - 10:00 AM) each day. At the other 4 facilities, a control group were taken to a similar sized area without daylight for socialization under typical electrical lighting conditions. Outcome measures for depression and other neuropsychiatric symptoms were taken at the beginning and end of the 12-week study.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –At the 4 facilities in the control arm, participants received the usual care. During the period from 8:00 - 10:00 AM each day, the control group was taken to a similar sized area indoors (without daylight) for socialization under typical electrical lighting conditions. |
| Daylight Intervention | Active comparator | Other: Daylight InterventionAt the 4 facilities in the active light intervention arm, staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Residents were recruited according to the trial inclusion criteria: 1) Alzheimer's disease and related dementias (ADRD) diagnosis, 2) no physical co-morbidities that precluded participation in the daily group intervention, and 3) a Mini-Mental State Exam (MMSE) score of 10 or higher
Key exclusion criteria (1 listed)
- physical co-morbidities that precluded participation in the daily group intervention
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 |
|---|---|---|
| Daylight InterventionStaff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study. | Other | Daylight Intervention |
Primary outcome
Change in Cornell Scale for Depression in Dementia (CSDD)
Time frame: A CSDD score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.
The Cornell Scale for Depression in Dementia (CSDD) was used to measure depression. The CSDD is designed for the assessment of depression in older people with dementia who can at least communicate basic needs. The CSDD scale ranges from 0 to 38, with higher scores indicating higher levels of depression. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 are associated with absence of significant depressive symptoms.
1 secondary outcome
Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH)
Time frame: A NPI-NH score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kyle Konis, Ph.D principal investigator
University of Southern California
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daylight Intervention in people with Dementia and Depression, run by University of Southern California at 8 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 1 inclusion and 1 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 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Yes. Results are posted in the registry (first posted 29 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Cornell Scale for Depression in Dementia (CSDD) (time frame: A CSDD score was taken at the beginning of the 12-week study and once again at the end of the 12-week study.). 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 29 Mar 2019.