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

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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Dementia
Depression
Behavior Disorders
Intervention Other: Daylight Intervention
Enrollment 83
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Daylight Intervention
Hide Arm/Group Description 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.

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.

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.

Period Title: Overall Study
Started 33 50
Completed 31 46
Not Completed 2 4
Arm/Group Title Control Daylight Intervention Total
Hide Arm/Group Description 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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 31 46 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 46 participants 77 participants
84.7  (7.3) 85.6  (6.9) 85.3  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 46 participants 77 participants
Female
25
  80.6%
31
  67.4%
56
  72.7%
Male
6
  19.4%
15
  32.6%
21
  27.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 31 participants 46 participants 77 participants
White race
29
  93.5%
42
  91.3%
71
  92.2%
Non-white race
2
   6.5%
4
   8.7%
6
   7.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 46 participants 77 participants
31 46 77
Cornell Scale for Depression in Dementia (CSDD)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on CSDD scale
Number Analyzed 28 participants 38 participants 66 participants
4.4  (4.5) 5.0  (5.4) 4.4  (4.5)
[1]
Measure Description: 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.
[2]
Measure Analysis Population Description: Included patients with CSDD obtained within 4 months of start of study, leading to 28 analyzed for the control group (of 31) and 38 analyzed for the Daylight Intervention group (of 46). Baseline means and SDs reported here do not account for clustering within facility.
Neuropsychiatric Inventory Nursing Home Version (NPI-NH)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on NPH-NH scale
Number Analyzed 31 participants 46 participants 77 participants
16.3  (14.5) 16.0  (19.1) 16.1  (17.3)
[1]
Measure Description:

The NPI-NH includes ten behavioral areas and two types of neurovegetative changes. 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.

Baseline means and SDs reported here do not account for clustering within facility.

1.Primary Outcome
Title Change in Cornell Scale for Depression in Dementia (CSDD)
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
Included patients with CSDD obtained within 4 months of start of study, leading to 28 analyzed for the control group (of 31) and 38 analyzed for the Daylight Intervention group (of 46). Baseline means and SDs reported here do not account for clustering within facility.
Arm/Group Title Control Daylight Intervention
Hide Arm/Group Description:
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.

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.

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.

Overall Number of Participants Analyzed 28 36
Mean (Standard Error)
Unit of Measure: units on CSDD scale
1.5  (1.0) -2.0  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Daylight Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH)
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Daylight Intervention
Hide Arm/Group Description:
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.

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.

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.

Overall Number of Participants Analyzed 31 46
Mean (Standard Error)
Unit of Measure: Units on NPH-NH scale
3.1  (3.2) -2.8  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Daylight Intervention
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.0
Estimation Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Daylight Intervention
Hide Arm/Group Description 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.

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.

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.

All-Cause Mortality
Control Daylight Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   2/33 (6.06%)   1/50 (2.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Control Daylight Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Daylight Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/50 (0.00%) 
Scheduling problems with baseline measures led to CSDD scores from health records being used for some participants with scoring dates that predated the start of the study by up to 4 months.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Kyle Konis, Ph.D
Organization: University of Southern California
Phone: (213) 740-2723
EMail: kkonis@usc.edu
Layout table for additonal information
Responsible Party: Kyle Konis, University of Southern California
ClinicalTrials.gov Identifier: NCT03483896     History of Changes
Other Study ID Numbers: UP-16-00487
First Submitted: March 21, 2018
First Posted: March 30, 2018
Results First Submitted: May 15, 2018
Results First Posted: March 29, 2019
Last Update Posted: March 29, 2019