- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03483896
Pilot Study to Examine Health Effects of Daylight Exposure on Dementia Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Alhambra, California, United States, 91801
- Alhambra Dementia Care
-
Azusa, California, United States, 91702
- Sierra Vista Memory Care Community
-
Calabasas, California, United States, 91302
- Calabasas Memory Care Community
-
Costa Mesa, California, United States, 92627
- Costa Mesa Dementia Care
-
Los Angeles, California, United States, 90048
- Los Angeles Dementia Care (Beverly Place)
-
Redondo Beach, California, United States, 90277
- Redondo Beach Dementia Care (Beach Cities)
-
San Juan Capistrano, California, United States, 92675
- San Juan Capistrano Memory Care Community
-
Tustin, California, United States, 92780
- Tustin Hacienda Memory Care Community
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- physical co-morbidities that precluded participation in the daily group intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
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.
|
|
Active Comparator: Daylight Intervention
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kyle Konis, Ph.D, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-16-00487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on Daylight Intervention
-
Boston University Charles River CampusRecruitingCardiovascular Diseases | Anxiety Disorders | Anxiety | Health BehaviorUnited States
-
Boston University Charles River CampusCompletedAnxiety | Pain, Chronic | Pain, MusculoskeletalUnited States
-
OSF Healthcare SystemRecruitingEpisodic MigraineUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoCompletedDepression | Adolescent - Emotional ProblemUnited States
-
Universidade Federal FluminenseCompleted
-
Taipei Veterans General Hospital, TaiwanNational Taipei University of Nursing and Health SciencesRecruitingEsophageal Neoplasms | Lung NeoplasmTaiwan
-
University Hospital RegensburgCompleted
-
Bispebjerg HospitalUnknownPhotodynamic Therapy | Basal Cell CarcinomasDenmark
-
Maastricht University Medical CenterPhilips Lighting EindhovenCompleted
-
University of AarhusTerminatedUnipolar DepressionDenmark