Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pilot Study to Examine Health Effects of Daylight Exposure on Dementia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483896
Recruitment Status : Completed
First Posted : March 30, 2018
Results First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Kyle Konis, University of Southern California

Brief 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.

Condition or disease Intervention/treatment Phase
Dementia Depression Behavior Disorders Other: Daylight Intervention Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : January 30, 2017
Actual Primary Completion Date : May 10, 2017
Actual Study Completion Date : June 5, 2017

Resource links provided by the National Library of Medicine


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.
Other: Daylight Intervention
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483896


Locations
Layout table for location information
United States, California
Alhambra Dementia Care
Alhambra, California, United States, 91801
Sierra Vista Memory Care Community
Azusa, California, United States, 91702
Calabasas Memory Care Community
Calabasas, California, United States, 91302
Costa Mesa Dementia Care
Costa Mesa, California, United States, 92627
Los Angeles Dementia Care (Beverly Place)
Los Angeles, California, United States, 90048
Redondo Beach Dementia Care (Beach Cities)
Redondo Beach, California, United States, 90277
San Juan Capistrano Memory Care Community
San Juan Capistrano, California, United States, 92675
Tustin Hacienda Memory Care Community
Tustin, California, United States, 92780
Sponsors and Collaborators
University of Southern California
Investigators
Layout table for investigator information
Principal Investigator: Kyle Konis, Ph.D University of Southern California
  Study Documents (Full-Text)

Documents provided by Kyle Konis, University of Southern California:

Layout table for additonal information
Responsible Party: Kyle Konis, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03483896     History of Changes
Other Study ID Numbers: UP-16-00487
First Posted: March 30, 2018    Key Record Dates
Results First Posted: March 29, 2019
Last Update Posted: March 29, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders