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
Phase: NA
Conditions: Dementia, Depression, Behavior Disorders
Sponsor: University of Southern California

TITLE PAGE 
 
PROTOCOL NUMBER: UP-16-00487 
 
TITLE: Examining Health Effects of Daylight Exposure on Dementia Patients in Los Angeles 
Assisted Living Facilities 
 
PRINCIPAL INVESTIGATOR(S): Kyle Konis, Ph.D 
Assistant Professor of Architecture 
USC School of Architecture, WAH 204 
University of Southern California 
Los Angeles, CA 90089-0291 
kkonis@usc.edu 
 
 
 
 
 
CO-INVESTIGATOR(S): 
 
Wendy J. Mack, Ph.D 
Professor of Biostatistics and Gerontology 
Dept. of Preventive Medicine, Keck School of Medicine 
University of Southern California 
2001 Soto St., SSB 202Y, Los Angeles, CA 90033 
wmack@usc.edu 
 
Edward L. Schneider, M.D. 
Dean Emeritus and Professor of Gerontology 
Leonard Davis School of Gerontology 
and 
Professor of Biological Sciences 
Dornsife College of Letters, Arts and Sciences  
and  
Professor of Medicine 
Keck School of Medicine 
University of Southern California 
Los Angeles, CA 90089-0191 
eschneid@usc.edu 
 
SPONSOR: University of Southern California  
 
 
 
 

PARTICIPANTS/LOCATONS: 
 
Alhambra Dementia Care 
1118 N. Stoneman Ave. Alhambra, CA 
91801 
Calabasas Memory Care 
Community 
25100 Calabasas Rd Calabasas, CA 
91302 
Costa Mesa Dementia Care 
350 W. Bay St. Costa Mesa, CA 92627 
Los Angeles Dementia Care 
(Beverly Place) 
330 N Hayworth Ave Los Angeles, CA 
90048 
Redondo Beach Dementia Care 
(Beach Cities) 
514 N Prospect Ave Redondo Beach, CA 
90277 
San Juan Capistrano Memory 
Care Community 
30311 Camino Capistrano, San Juan 
Capistrano, CA 92675 
Sierra Vista Memory Care 
Community 
125 W Sierra Madre Ave Azusa, CA 
91702 
Tustin Hacienda Memory Care 
Community 
240 E. Third St. Tustin, CA 92780 
 
 
AMENDMENTS/REVISIONS: The original protocol was amended to change the scale used to 
assess depression from the Geriatric Depression Scale (GDS) to the Cornell Scale for Depression 
in Dementia (CSDD). (Approved 10/10/2016). 
 
 
 

1.0 BACKGROUND INFORMATION 
The Alzheimer's Association (2004) estimates that clinically significant depression occurs in 
about 20 to 40 percent of people with Alzheimer disease. The percentage increases to 70 to 80 
percent for Alzheimer residents in assisted care facilities. Treatment of depression in Alzheimer 
disease can improve sense of well-being, quality of life, and individual function, even in the 
presence of ongoing decline in memory and thinking. In institutionalized settings, lack of 
sufficient exposure to bright light is considered one of the primary contributors to disruption of 
the circadian system, with cascading effects of sleep disruption, agitated behavior, depression, 
and cognitive decline (Day et al., 2000). Exposure to bright light (2500 - 10,000 lux) typically 
administered in the morning, has been shown through a large body of research to be an effective 
non-pharmaceutical treatment option for depression (Golden, et al., 2005). Light therapy has also 
been shown to be an effective treatment for sleep disturbances (Dowling, et al., 2005) and for 
ameliorating behavioral problems (Cohen-Mansfield, 2001) for people with Alzheimer disease. 
However, reliable and well-designed studies examining the efficacy of light therapy in treating 
depression among people with Alzheimer disease are extremely limited (Forbes et al., 2009). 
Moreover, the conventional approach to administering the bright light stimulus, through boxes 
containing arrays of fluorescent light fixtures, is problematic for people with Alzheimer disease 
due to reported side effects of headache, eye strain, nausea, and agitation (Labbate 1994; 
Terman, 1999). We hypothesize that exposure to sufficient daylight indoors can serve as an 
effective non-drug treatment option for people with Alzheimer disease and depression, with the 
potential to lead to fewer adverse effects than noted with light box treatments. Aside from the 
intervention, the residents and staff participating in this study will not experience any changes to 
their normal routine and duties. Staff supervised socialization can, but does not necessarily 
include interaction with other residents in the facility or engagement in "free time" activities such 
as watching TV. We are aware that any changes outside of the intervention, either with staff 
specified roles or residents could potentially interfere with the results of the study. 
 
2.0 OBJECTIVES AND PURPOSE 
This study is designed to test the hypothesis that an intervention increasing exposure to daylight 
will reduce depression and negative behaviors and increase cognitive function among Alzheimer 
patients in Los Angeles dementia care facilities. 
 
3.0 STUDY DESIGN 
The research will be conducted as a 12-week field study in eight Silverado dementia care 
facilities in Los Angeles and Orange County. Silverado is an assisted living service provider that 
delivers care for those with Alzheimer, dementia and other memory-impairing diseases. Data 
collection will occur twice during the study: baseline measures at the beginning of the study and 
outcome measures at the end of the study.  
 
4.0 TREATMENT OF SUBJECTS 
 
4.1 Intervention Group 
At two facilities, the active light intervention will enlist staff to increase daylight exposure to 
Alzheimer residents by taking them to daylit perimeter room in the morning (8:00 - 10:00 AM) 
where vertical daylight illuminance at eye level exceeds 2500 lux and where direct sun exposure 

can be avoided. The intervention will consist of two hours of daylight exposure administered 
beginning at 8:00 AM in the morning each day (7 days / week) over the 12-week 
study. 
 
4.2 Control Group 
Patients at the other two facilities will receive usual care. During the period from 8:00 AM to 
10:00 AM each day, the control group of Alzheimer residents will be taken to a similar sized 
area indoors without daylight exposure for socialization under typical interior fluorescent 
lighting conditions. 
 
4.3 Outcome Measures 
The following outcome measures will be taken: 
1. Patient outcomes will be completed at baseline and 12-weeks. For each of our major 
outcomes, we will use instruments that are well-validated for use in testing effects of 
short- to long-term interventions in AD: 
a. Depression: Cornell Scale for Depression in Dementia (CSDD) 
b. Neuropsychiatric Inventory Nursing Home Version (NPI-NH) 
2. Trial conduct/methods outcomes: 
a. Facility and staff support and participation: facilitators and obstacles. 
b. Fidelity of light and control intervention: facilitators and obstacles. 
c. Data collection fidelity: patient outcomes and light measures. 
d. Estimates of subject recruitment, consent, and attrition rates: facilitators and 
obstacles. 
e. Estimates (and confidence intervals) for study/trial planning: intervention effect 
size, variance of outcome measures, within-facility correlation in outcome 
measures, within-patient correlation in outcome measures (repeated measures). 
 
4.4 Lighting Measures 
Physical lighting measurements will be recorded continuously at 1-minute intervals throughout 
the study using research grade photometric sensors and data logging equipment to establish 24- 
hour patterns of light / dark exposure. Additionally, in-situ measurements will be taken using a 
spectrometer to assess the spectral power distribution of light exposure at seated eye level.  
 
5.0 SELECTION AND EXCLUSION OF SUBJECTS 
5.1 Inclusion criteria for enrollment 
The trial inclusion criteria is an AD diagnosis and no physical co-morbidities that preclude 
participation in the daily group intervention. Based on current facility records, we estimate the 
intervention and control groups will include approximately 160 Alzheimer disease participants 
total (20 patients per facility). Demographic information obtained during the study preparation 
phase (mean age, gender, type of dementia by diagnosis, depression level, length of time in 
facility, date of onset of dementia, ethnicity) will be obtained to show that the facilities are 
comparable. 
 
5.2 Exclusion criteria for enrollment 
Outcome measurements will be confined to those who meet the trial inclusion criteria (AD 
diagnosis, no physical co-morbidities that preclude participation in the daily group intervention). 

 
6.0 STATISTICS 
All analyses will include factors for facility and intervention (nested within facility). Baseline 
analyses will include descriptors of the study sample (age, gender, ethnicity, onset of 
Alzheimer's disease) as well as initial levels of the outcome measures (depression, cognition, 
behavior) and will utilize analysis of variance for continuous data and chi-square methods for 
categorical data to compare the intervention groups. If the intervention groups are found to differ 
on baseline levels of the outcome variables or other variables related to outcome, these variables 
will be included as adjusting covariates in the comparisons of 12-week outcomes. 12-week 
outcomes will be compared between intervention groups with analysis of variance (2-level factor 
for intervention, 8-level factor for facility, with intervention nested within facility). For planning 
of larger trials, the following estimates will be made (along with 95% confidence intervals) for 
each patient outcome: intervention effect size (mean group difference in outcome), variance in 
outcome (across patients, across facilities), within-facility correlation in outcomes (correlations 
in outcomes amongst patients within a facility), within-patient correlation in outcomes (repeated 
measures, baseline and 12-weeks). 
 
6.1 Sample Size 
As a pilot study, the planned sample size is not based on statistical power to detect 
specified effect sizes on intervention outcomes. Rather, the planned sample of 80 subjects per 
intervention group was selected in terms of pilot study feasibility. The planned sample is 
considered more than sufficiently adequate to address pilot trial questions related to feasibility 
(of study recruitment and conduct, delivery of intervention, data collection) and estimates of 
trial-related parameters, along with 95% confidence intervals (mean intervention effect size, 
variance in outcome measures in the study population, within-facility correlation in outcome 
measures, within-patient correlation in outcome measures). As pilot studies are well known to 
over-estimate intervention effect sizes and under-estimate measures of variance, it is crucial that 
confidence intervals (precision of the estimates) are also calculated and available for planning of 
larger studies. 
 
7.0 ASSESSMENT OF SAFETY 
The proposed study does not include any drug or device treatment and presents minimal (if any) 
risk to participants.  
 
8.0 DISCONTINUATION OF THE STUDY 
Participants do not have to remain in the intervention spaces if they do not want to while 
participating in the study. The informed consent form indicates to the Legally Authorized 
Representative (LAR) that he/she may withdraw his/her consent at any time and discontinue the 
participation of his/her family member without penalty. 
 
9.0 ETHICS 
All study staff are trained and credentialed to perform the duties assigned to them. In our 
proposed study, we are obtaining informed consent and HIPAA authorization from the legal 
representative of the participants in the study. All study staff have fulfilled the training mandated 
by their respective departments or institutions. Participant privacy and data confidentiality will 
be addressed via the following methods: 

 Research procedures will be conducted in person in a private setting. 
 Data will be captured and reviewed in a private setting. 
 Only authorized research study personnel will be present during research related 
activities. 
 The collection of information about participants is limited to the amount necessary 
to achieve aims of the research. 
 Participants will not be approached in a setting or location that may constitute an 
invasion of privacy or could potentially stigmatize them. 
 
10. DATA HANDLING AND RECORD KEEPING 
All data will be coded and the key codes kept separately and securely. Research data will be 
protected against inappropriate use or disclosure via the following methods: 
 Locked office 
 Restricted access to authorized study personnel 
 Secure computer/laptop 
 Individual ID plus password protection 
 Security software (firewall, antivirus, anti-intrusion) is installed and regularly 
 updated in all servers, workstations, laptops, and other devices used in the study 
 Restrictions on copying study related materials 
 
11.0 REFERENCES 
Dowling GA, Hubbard EM, Mastick J, Luxenberg JS, Burr RL, and Van Someren EJW, (2005). 
Effect of morning bright light treatment for rest-activity disruption in institutionalized patients 
with severe Alzheimer's disease. Int Psychogeriatr. 2005 June; 17(2): 221-236. 
 
Day K., Carreon D., Stump D. (2000). The Therapeutic Design of Environments for People With 
Dementia A Review of the Empirical Research. The Gerontologist (2000) 40 (4): 397-416. 
Golden RN, Gaynes BN, Ekstrom RD, Hamer RM, Jacobsen FM, Suppes T, Wisner KL, 
Nemeroff CB. (2005).  
 
The Efficacy of Light Therapy in the Treatment of Mood Disorders: A Review and 
Meta-Analysis of the Evidence. Am J Psychiatry 2005; 162:656-662. 
 
Cohen-Mansfield, J. (2001). Nonpharmacologic Interventions for Inappropriate Behaviors in 
Dementia, A Review, Summary, and Critique Am J Geriatr Psychiatry 9:4, Fall 2001. 
 
Forbes D, Morgan DG, Bangma J, Peacock S, Adamson J. (2009). Light Therapy for Managing 
Sleep, Behaviour, and Mood Disturbances in Dementia (Review). Copyright 2009 The Cochrane 
Collaboration. Published by John Wiley & Sons, Ltd. 
 
Labbate LA, Lafer B, Thibault A, Sachs GS. (1994). Side effects induced by bright light 
treatment for seasonal affective disorder. J Clin Psychiatry 1994; 55:189-191. 
 
 Terman M, Terman JS (1999). Bright light therapy: side effects and benefits across the symptom 
spectrum. J Clin Psychiatry 1999; 60:799, 808.