Trial Outcomes & Findings for Methodology Issues in a Tailored Light Treatment for Persons With Dementia (NCT NCT01816152)
NCT ID: NCT01816152
Last Updated: 2026-07-27
Results Overview
Caregivers (on behalf of subjects who cannot complete) and subjects are asked to complete the Pittsburgh Sleep Quality Index (PSQI), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The seven component scores are summed to provide a global score ranging from 0 to 21 and a score of 5 or above indicates sleep disturbance. A higher number indications a greater sleep disturbance
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
Change from Baseline (week 0) and intervention (week 4)
Results posted on
2026-07-27
Participant Flow
Participants experienced each of the conditions
Participant milestones
| Measure |
High Active, Then Inactive, Then Mid Level
Tailored Active intervention: Subjects experience a baseline for 1 week Participants experience an intervention at least 2 hours daily for 4 weeks at each intervention.
High Active intervention: at least 500 lux at the eye of the participant. Mid level intervention: at least 300 lux at the eye of the participant. Inactive intervention: at most 50 lux at the eye of the participant.
|
High Active, Then Mid Level, Then Inactive Intervention
Participants experience an intervention at least 2 hours daily for 4 weeks at each intervention.
High Active intervention: at least 500 lux at the eye of the participant. Mid level intervention: at least 300 lux at the eye of the participant. Inactive intervention: at most 50 lux at the eye of the participant.
|
Mid Level, Then Inactive Then High Active
Tailored Active intervention: Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 500 lux at the eye of the patient during at least 2 hours daily.
|
Mid Level, Then High Active, Then Inactive
Participants experience an intervention at least 2 hours daily for 4 weeks at each intervention.
High Active intervention: at least 500 lux at the eye of the participant. Mid level intervention: at least 300 lux at the eye of the participant. Inactive intervention: at most 50 lux at the eye of the participant.
|
Inactive, Then High Active, Then Mid Level
Participants experience an intervention at least 2 hours daily for 4 weeks at each intervention.
High Active intervention: at least 500 lux at the eye of the participant. Mid level intervention: at least 300 lux at the eye of the participant. Inactive intervention: at most 50 lux at the eye of the participant.
|
Inactive, Then Mid Level, Then High Active
Participants experience an intervention at least 2 hours daily for 4 weeks at each intervention.
High Active intervention: at least 500 lux at the eye of the participant. Mid level intervention: at least 300 lux at the eye of the participant. Inactive intervention: at most 50 lux at the eye of the participant.
|
|---|---|---|---|---|---|---|
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Second Period
NOT COMPLETED
|
2
|
2
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0
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0
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1
|
1
|
|
First Period (4 Weeks)
STARTED
|
7
|
7
|
7
|
7
|
8
|
8
|
|
First Period (4 Weeks)
COMPLETED
|
6
|
7
|
7
|
6
|
7
|
7
|
|
First Period (4 Weeks)
NOT COMPLETED
|
1
|
0
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0
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1
|
1
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1
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|
Washout 1 (1 Week)
STARTED
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6
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7
|
7
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6
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7
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7
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Washout 1 (1 Week)
COMPLETED
|
6
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7
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7
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6
|
7
|
7
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|
Washout 1 (1 Week)
NOT COMPLETED
|
0
|
0
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0
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0
|
0
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0
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|
Second Period
STARTED
|
6
|
7
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7
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6
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7
|
7
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|
Second Period
COMPLETED
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4
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5
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7
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6
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6
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6
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|
Washout 2 (1 Week)
STARTED
|
4
|
5
|
7
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6
|
6
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6
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|
Washout 2 (1 Week)
COMPLETED
|
4
|
5
|
7
|
6
|
6
|
6
|
|
Washout 2 (1 Week)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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|
Third Period
STARTED
|
4
|
5
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7
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6
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6
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6
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Third Period
COMPLETED
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4
|
4
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7
|
5
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5
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6
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Third Period
NOT COMPLETED
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0
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1
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0
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1
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1
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0
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Reasons for withdrawal
| Measure |
High Active, Then Inactive, Then Mid Level
Tailored Active intervention: Subjects experience a baseline for 1 week Participants experience an intervention at least 2 hours daily for 4 weeks at each intervention.
High Active intervention: at least 500 lux at the eye of the participant. Mid level intervention: at least 300 lux at the eye of the participant. Inactive intervention: at most 50 lux at the eye of the participant.
|
High Active, Then Mid Level, Then Inactive Intervention
Participants experience an intervention at least 2 hours daily for 4 weeks at each intervention.
High Active intervention: at least 500 lux at the eye of the participant. Mid level intervention: at least 300 lux at the eye of the participant. Inactive intervention: at most 50 lux at the eye of the participant.
|
Mid Level, Then Inactive Then High Active
Tailored Active intervention: Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 500 lux at the eye of the patient during at least 2 hours daily.
|
Mid Level, Then High Active, Then Inactive
Participants experience an intervention at least 2 hours daily for 4 weeks at each intervention.
High Active intervention: at least 500 lux at the eye of the participant. Mid level intervention: at least 300 lux at the eye of the participant. Inactive intervention: at most 50 lux at the eye of the participant.
|
Inactive, Then High Active, Then Mid Level
Participants experience an intervention at least 2 hours daily for 4 weeks at each intervention.
High Active intervention: at least 500 lux at the eye of the participant. Mid level intervention: at least 300 lux at the eye of the participant. Inactive intervention: at most 50 lux at the eye of the participant.
|
Inactive, Then Mid Level, Then High Active
Participants experience an intervention at least 2 hours daily for 4 weeks at each intervention.
High Active intervention: at least 500 lux at the eye of the participant. Mid level intervention: at least 300 lux at the eye of the participant. Inactive intervention: at most 50 lux at the eye of the participant.
|
|---|---|---|---|---|---|---|
|
First Period (4 Weeks)
Lost to Follow-up
|
1
|
0
|
0
|
1
|
1
|
1
|
|
Second Period
Lost to Follow-up
|
1
|
1
|
0
|
0
|
1
|
1
|
|
Second Period
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Third Period
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Third Period
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
0
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Baseline Characteristics
Methodology Issues in a Tailored Light Treatment for Persons With Dementia
Baseline characteristics by cohort
| Measure |
Participants With Dementia
n=44 Participants
All participants experience a baseline for first week and an active intervention for 4 weeks total for any of the 3 conditions in any order until they have experienced all 3 conditions.
The high active intervention is a bluish white light source delivering at least 500 lux at the eye of the patient during at least 2 hours daily.
The Mid level active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.
The Inactive intervention is a bluish white light source delivering at least 50 lux at the eye of the patient during at least 2 hours daily.
|
|---|---|
|
Age, Continuous
|
80.4 years
STANDARD_DEVIATION 10.4 • n=9 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline (week 0) and intervention (week 4)Population: Participants experienced all conditions
Caregivers (on behalf of subjects who cannot complete) and subjects are asked to complete the Pittsburgh Sleep Quality Index (PSQI), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The seven component scores are summed to provide a global score ranging from 0 to 21 and a score of 5 or above indicates sleep disturbance. A higher number indications a greater sleep disturbance
Outcome measures
| Measure |
High Active Intervention - 500 Lux
n=31 Participants
Tailored Active intervention: Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 500 lux at the eye of the patient during at least 2 hours daily.
|
Mid Level Active Intervention - 300 Lux
n=31 Participants
Tailored Active intervention: Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.
|
Inactive Intervention - 50 Lux
n=31 Participants
Inactive intervention: Subjects experience a baseline for 1 week and an inactive intervention for 4 weeks. The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.
|
|---|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Baseline
|
7.8 score on a scale
Standard Deviation 3.6
|
8.9 score on a scale
Standard Deviation 3.5
|
8.5 score on a scale
Standard Deviation 4.6
|
|
Pittsburgh Sleep Quality Index (PSQI)
Week 4
|
5.6 score on a scale
Standard Deviation 3.5
|
7.1 score on a scale
Standard Deviation 3.7
|
6.5 score on a scale
Standard Deviation 4.0
|
PRIMARY outcome
Timeframe: Change from Baseline (week 0) and intervention (week 4)Population: Participants experienced all conditions
Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out the Cohen-Mansfield Agitation Score, which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. 29 item instrument, each item scored 1-7. Total range score from 29-203 - a higher score indicates more agitation
Outcome measures
| Measure |
High Active Intervention - 500 Lux
n=31 Participants
Tailored Active intervention: Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 500 lux at the eye of the patient during at least 2 hours daily.
|
Mid Level Active Intervention - 300 Lux
n=31 Participants
Tailored Active intervention: Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.
|
Inactive Intervention - 50 Lux
n=31 Participants
Inactive intervention: Subjects experience a baseline for 1 week and an inactive intervention for 4 weeks. The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.
|
|---|---|---|---|
|
Cohen-Mansfield Agitation Inventory (CMAI)
Baseline
|
36.6 score on a scale
Standard Deviation 18.6
|
34.9 score on a scale
Standard Deviation 8.2
|
38.4 score on a scale
Standard Deviation 13.2
|
|
Cohen-Mansfield Agitation Inventory (CMAI)
Week 4
|
35.2 score on a scale
Standard Deviation 14.6
|
33.3 score on a scale
Standard Deviation 6.3
|
35.2 score on a scale
Standard Deviation 12
|
PRIMARY outcome
Timeframe: Change from Baseline (week 0) and intervention (week 4)Population: Participants experienced all conditions
Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out subjective questionnaires assessing depression using the Cornell Scale for Depression in Dementia (CSDD) Questionnaires are assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The CSDD consists of 19 questions rated on a scale of 0 to 2 with all scores summed for a total score range 0-38. A score greater than 12 indicates depression and a higher score indicates greater depression.
Outcome measures
| Measure |
High Active Intervention - 500 Lux
n=31 Participants
Tailored Active intervention: Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 500 lux at the eye of the patient during at least 2 hours daily.
|
Mid Level Active Intervention - 300 Lux
n=31 Participants
Tailored Active intervention: Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.
|
Inactive Intervention - 50 Lux
n=31 Participants
Inactive intervention: Subjects experience a baseline for 1 week and an inactive intervention for 4 weeks. The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.
|
|---|---|---|---|
|
Cornell Scale for Depression in Dementia (CSDD) Questionnaire
Baseline
|
7.5 score on a scale
Standard Deviation 5.5
|
8.8 score on a scale
Standard Deviation 5.7
|
9.8 score on a scale
Standard Deviation 7.8
|
|
Cornell Scale for Depression in Dementia (CSDD) Questionnaire
Week 4
|
6.4 score on a scale
Standard Deviation 5.1
|
7 score on a scale
Standard Deviation 5.4
|
6.8 score on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Change from Baseline (week 0) and intervention (week 4)Population: Instrument not administered due to protocol amendment. Data not collected therefore calculations cannot be done.
Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out subjective Activity of Daily Living questionnaire (MDS-ADL), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. Scores range from 4 to 18 and a higher score indicates a higher dependence.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Change from Baseline (week 0) and intervention (week 4)Population: Participants experienced all conditions
Subjects are asked to wear a calibrated light meter to obtain light/dark and activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. These data are used to determine circadian disruption (correlation between light/dark and activity/rest) and light dose. Circadian stimulus (CS) is the amount of light needed to activate the circadian system. The range is 0 to 0.6 the higher the number the greater the CS dose
Outcome measures
| Measure |
High Active Intervention - 500 Lux
n=31 Participants
Tailored Active intervention: Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 500 lux at the eye of the patient during at least 2 hours daily.
|
Mid Level Active Intervention - 300 Lux
n=31 Participants
Tailored Active intervention: Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.
|
Inactive Intervention - 50 Lux
n=31 Participants
Inactive intervention: Subjects experience a baseline for 1 week and an inactive intervention for 4 weeks. The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.
|
|---|---|---|---|
|
Circadian Stimulus Dose
Baseline
|
0.16 score on a scale
Standard Deviation 0.13
|
0.19 score on a scale
Standard Deviation 0.13
|
0.21 score on a scale
Standard Deviation 0.15
|
|
Circadian Stimulus Dose
Week 4
|
0.24 score on a scale
Standard Deviation 0.11
|
0.20 score on a scale
Standard Deviation 0.12
|
0.2 score on a scale
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Change from Baseline (week 0) and intervention (week 4)Population: Participants experienced all conditions
Subjects are asked to wear an actigraph to obtain activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. Actigraphs are used to measure sleep efficiency. Full scale score from 0-100, higher score indicates better efficiency.
Outcome measures
| Measure |
High Active Intervention - 500 Lux
n=31 Participants
Tailored Active intervention: Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 500 lux at the eye of the patient during at least 2 hours daily.
|
Mid Level Active Intervention - 300 Lux
n=31 Participants
Tailored Active intervention: Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.
|
Inactive Intervention - 50 Lux
n=31 Participants
Inactive intervention: Subjects experience a baseline for 1 week and an inactive intervention for 4 weeks. The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.
|
|---|---|---|---|
|
Sleep Efficiency Score
Baseline
|
76 score on a scale
Standard Deviation 12
|
80 score on a scale
Standard Deviation 9
|
81 score on a scale
Standard Deviation 10
|
|
Sleep Efficiency Score
Week 4
|
77 score on a scale
Standard Deviation 12
|
77 score on a scale
Standard Deviation 14
|
79 score on a scale
Standard Deviation 10
|
Adverse Events
High Active Intervention - 300 Lux
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mid Level Active Intervention - 300lux
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inactive Intervention - 50 Lux
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mariana Figueiro, PhD
Icahn School of Medicine at Mount Sinai
Phone: (518) 366-9306
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place