The "Light for the Brain" Study

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02677987
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 47
• Location: 1
• Arms: 2
• Duration (Months): 59
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Cognitive impairment (such as memory problems) due to cancer and its treatment can interfere with quality of life and can linger long after treatment has ended, yet research examining cognitive rehabilitation approaches has produced limited clinical benefit. The proposed study will provide information about systematic light exposure for the treatment of cognitive impairment in hematopoietic stem cell transplant (HSCT) survivors and will investigate how it works. This study would facilitate the development of this potential treatment, giving health care providers and cancer survivors a much-needed tool to help with cancer-related cognitive impairment.

Condition or Disease	Intervention/Treatment	Phase
Hematopoietic Stem Cell Transplantation; Cognitive Impairments; Sleep; Depression; Fatigue; Quality of Life	Device: Intervention systematic light exposure; Device: Comparison systematic light exposure	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Treating Cognitive Impairments in Cancer Patients Via Systematic Light Exposure
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention light 30 minutes of intervention systematic light exposure daily for 4 weeks.	Device: Intervention systematic light exposure; Bright light using Litebook device.
Active Comparator: Comparison light 30 minutes of comparison systematic light exposure daily for 4 weeks.	Device: Comparison systematic light exposure; Dim light using modified Litebook device.

Outcome Measures

Primary Outcome Measures

1. Cognitive Functioning (Neuropsychological Tests) [Baseline to end-of-intervention to 8 weeks after the intervention]

   Global composite z-score from baseline to 8 weeks after the intervention based on the HVLT-R; BVMT-R; Psychomotor vigilance task; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Block Design; D-KEFS Color-Word Inhibition, Verbal Fluency; Conners Continuous Performance Test III. Raw scores at baseline of tests within single domains were averaged and then standardized to z-scores. The mean of the z-scores was calculated, and then this composite z-score was standardized to z-scores. Follow up intervention z-scores were calculated based on differences between raw scores at baseline and raw scores at follow-up time points and divided by the standard deviation of the baseline domain z-score) within each domain, and then averaged to create follow up global composite scores. A z-score below 0 indicated poorer performance than at baseline and a z-score above 0 indicated better performance than at baseline.

Secondary Outcome Measures

1. Circadian Activity Rhythms (Actigraphy) [Baseline to end of intervention to 8 weeks later]

   F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness.

2. Sleep Quality (Pittsburgh Sleep Quality Index) [Baseline, mid intervention, end of intervention, 8 weeks later]

   The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality

3. Fatigue (FACIT-fatigue) [Baseline, mid-intervention, end of the intervention, 8 weeks later]

   This is a 13-item measure of fatigue.

4. Depressed Mood (CESD) [Baseline, Mid-intervention, End of intervention, 8 weeks later]

   The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report instrument that measures symptoms of depressed mood over the past week.

5. Neurobehavioral Functioning (Frontal Systems Behavioral Scale) [Baseline, mid-intervention, end-of-intervention, 8 weeks later]

   Total raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology.

6. Quality of Life (FACT-BMT) [Baseline, End of intervention, 8 weeks post-intervention]

   This 50-item scale is a commonly used and well-validated measure of the functional status of cancer patients who have undergone BMT (SCT).

7. Interleukin-6 [Baseline and end-of-intervention]

   Serum cytokine IL-6 in pg/mL

8. Pro-inflammatory Cytokine - TNF Alpha [Baseline and end-of-intervention]

   Serum cytokine TNF-α in pg/mL

9. C-Reactive Protein [Baseline and end-of-intervention]

   C-reactive protein in mg/L

10. Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory) [Baseline, mid-intervention, end of intervention, 8 weeks after intervention]

    The 33-item Patient Assessment of Own Functioning Inventory (PAOFI) is a reliable and valid measure of perceptions of cognitive functioning (Bell et al., 2013; Chelune et al., 1986). Using a Likert scale from 1 (Almost Always) to 6 (Almost Never), ratings of 1-3 were scored "1" indicating impairment, and ratings from 4 to 6 were scored "0" indicating no impairment. Total impairment was calculated by summing the number of impaired items.

Other Outcome Measures

1. Treatment Satisfaction (FACT-TS) [During the 4th week of the intervention]

   Range between 0 and 5, with 5 meaning higher treatment satisfaction

2. Credibility/Expectancy (Credibility/Expectancy Questionnaire) [Baseline]

   Treatment credibility and outcome expectancy were assessed at baseline with the mean of the first 3 items of the Credibility/Expectancy Questionnaire. Items are scored on a Likert scale from 1 to 9, and the term "symptoms" was replaced with "thinking, memory and concentration problems." Higher scores represent greater credibility and outcome expectancy.

3. Usage of Light Box (Integrated Meter Measurement and Litebook Log) [Throughout intervention period (4 weeks)]

   Length of time light box has been used.

4. Chronotype (Morningness-eveningness Questionnaire) [Baseline]

   Measure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Have a history of HSCT,

2. 1 to 5 years post-HSCT,

3. Relapse-free since most recent HSCT,

4. Age 21 or older,

5. English language proficient

6. Able to provide informed consent

7. Endorse subjective cognitive impairment.

Exclusion Criteria:

1. Diagnosed or suspected neurological, psychiatric (including bipolar disorder or mania), or medical condition that might impair cognitive functioning (other than those caused by the cancer or its treatment),

2. Visual, hearing, or physical impairment sufficient to interfere with cognitive testing or participation,

3. Have a history of whole brain irradiation or surgery,

4. Active diagnosis of autoimmune and/or inflammatory disorder or disorders that may influence immune processes,

5. Chronic use of oral steroid medication,

6. History of systematic light exposure treatment,

7. Diagnosed sleep apnea or narcolepsy,

8. Use of photosensitizing medications,

9. Plan to travel across meridians during the study,

10. Work night, early morning, or swing shifts,

11. Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Feinberg School of Medicine	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Lisa M Wu, PhD, Northwestern University

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jul 16, 2020

More Information

Publications

None provided.

• Responsible Party: Lisa M. Wu, Assistant Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT02677987
• Other Study ID Numbers: STU00201700; 7K07CA184145-02
• First Posted: Feb 9, 2016
• Last Update Posted: Apr 18, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

Participant Flow

Arm/Group Title	Intervention Light	Comparison Light
Arm/Group Description	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.
Period Title: Overall Study
STARTED	23	24
COMPLETED	19	24
NOT COMPLETED	4	0

Baseline Characteristics

Arm/Group Title	Intervention Light	Comparison Light	Total
Arm/Group Description	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.	Total of all reporting groups
Overall Participants	23	24	47
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.0 (11.2)	55.5 (13.0)	56.8 (12.1)
Sex: Female, Male (Count of Participants)
Female	17 73.9%	13 54.2%	30 63.8%
Male	6 26.1%	11 45.8%	17 36.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 8.7%	1 4.2%	3 6.4%
Not Hispanic or Latino	21 91.3%	23 95.8%	44 93.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 4.3%	2 8.3%	3 6.4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 4.3%	2 8.3%	3 6.4%
White	19 82.6%	19 79.2%	38 80.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	2 8.7%	1 4.2%	3 6.4%
Region of Enrollment (participants) [Number]
United States	23 100%	24 100%	47 100%
Wechsler Test of Adult Reading (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	105.6 (9.5)	110.3 (11.1)	108.0 (8.3)

Outcome Measures

1. Primary Outcome

Title	Cognitive Functioning (Neuropsychological Tests)
Description	Global composite z-score from baseline to 8 weeks after the intervention based on the HVLT-R; BVMT-R; Psychomotor vigilance task; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Block Design; D-KEFS Color-Word Inhibition, Verbal Fluency; Conners Continuous Performance Test III. Raw scores at baseline of tests within single domains were averaged and then standardized to z-scores. The mean of the z-scores was calculated, and then this composite z-score was standardized to z-scores. Follow up intervention z-scores were calculated based on differences between raw scores at baseline and raw scores at follow-up time points and divided by the standard deviation of the baseline domain z-score) within each domain, and then averaged to create follow up global composite scores. A z-score below 0 indicated poorer performance than at baseline and a z-score above 0 indicated better performance than at baseline.
Time Frame	Baseline to end-of-intervention to 8 weeks after the intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Light	Comparison Light
Arm/Group Description	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.
Measure Participants	21	18
End of intervention	0.24 (0.14)	0.16 (0.14)
8 weeks after intervention	0.43 (0.14)	0.50 (0.14)

2. Secondary Outcome

Title	Circadian Activity Rhythms (Actigraphy)
Description	F statistic from actigraphy was assessed as a measure of circadian activity rhythm robustness.
Time Frame	Baseline to end of intervention to 8 weeks later

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Light	Comparison Light
Arm/Group Description	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.
Measure Participants	19	18
Baseline	1696.19 (290.49)	1551.72 (293.04)
End of intervention	1999.72 (295.87)	1373.88 (293.04)
8 weeks after intervention	1858.04 (293.04)	1466.82 (295.87)

3. Secondary Outcome

Title	Sleep Quality (Pittsburgh Sleep Quality Index)
Description	The Pittsburgh Sleep Quality Index consists of 19 self-rated items used to calculate sleep quality
Time Frame	Baseline, mid intervention, end of intervention, 8 weeks later

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comparison Light	Intervention Light
Arm/Group Description	30 minutes of comparison systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.
Measure Participants	24	20
Baseline	7.3157 (0.7672)	8.5000 (0.6910)
Mid-treatment	6.7500 (0.8544)	7.7500 (0.7137)
End of treatment	6.5296 (0.7567)	7.5500 (0.6343)
8 weeks later	6.1922 (0.7345)	8.3745 (0.8023)

4. Secondary Outcome

Title	Fatigue (FACIT-fatigue)
Description	This is a 13-item measure of fatigue.
Time Frame	Baseline, mid-intervention, end of the intervention, 8 weeks later

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comparison Light	Intervention Light
Arm/Group Description	30 minutes of comparison systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.
Measure Participants	24	20
Baseline	29.9804 (1.7374)	30.0000 (1.5458)
Mid-intervention	29.5833 (2.1666)	33.6356 (1.3701)
End of intervention	30.8219 (1.9725)	33.7513 (1.4237)
8 weeks post-intervention	30.5041 (2.1484)	32.3366 (1.8079)

5. Secondary Outcome

Title	Depressed Mood (CESD)
Description	The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report instrument that measures symptoms of depressed mood over the past week.
Time Frame	Baseline, Mid-intervention, End of intervention, 8 weeks later

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comparison Light	Intervention Light
Arm/Group Description	30 minutes of comparison systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.
Measure Participants	24	23
Baseline	18.6293 (1.3655)	20.4500 (1.4378)
Mid-intervention	20.4583 (1.5343)	18.1000 (1.0366)
End of intervention	19.1489 (1.2097)	17.0500 (1.1821)
8 weeks post intervention	20.1206 (1.6286)	19.0299 (1.1423)

6. Secondary Outcome

Title	Neurobehavioral Functioning (Frontal Systems Behavioral Scale)
Description	Total raw score for entire scale (minimum = 46, maximum = 230) with a higher score indicating greater neurobehavioral symptomatology.
Time Frame	Baseline, mid-intervention, end-of-intervention, 8 weeks later

Outcome Measure Data

Analysis Population Description

Participants did not always complete this measure, which accounts for why there are sometimes fewer participants than the overall number of participants analyzed at different time points. Linear mixed models allows for missing time points.

Arm/Group Title	Comparison Light	Intervention Light
Arm/Group Description	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.
Measure Participants	24	22
Baseline	91.39 (17.71)	89.36 (19.57)
Mid-intervention	92.96 (21.12)	90.55 (18.56)
End-of-intervention	89.04 (19.69)	88.90 (19.08)
8 weeks later	87.29 (21.58)	92.78 (19.47)

7. Secondary Outcome

Title	Quality of Life (FACT-BMT)
Description	This 50-item scale is a commonly used and well-validated measure of the functional status of cancer patients who have undergone BMT (SCT).
Time Frame	Baseline, End of intervention, 8 weeks post-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Light	Comparison Light
Arm/Group Description	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.	30 minutes of comparison systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.
Measure Participants	23	20
Baseline	110.27 (4.1870)	109.66 (4.2157)
End of intervention	116.88 (3.5606)	111.94 (4.9821)
8 weeks post-intervention	112.68 (4.4154)	110.92 (5.0970)

8. Secondary Outcome

Title	Interleukin-6
Description	Serum cytokine IL-6 in pg/mL
Time Frame	Baseline and end-of-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comparison Light	Intervention Light
Arm/Group Description	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.
Measure Participants	23	18
Baseline	3.24 (2.72)	3.24 (1.79)
End-of-intervention	3.98 (4.87)	3.28 (2.60)

9. Secondary Outcome

Title	Pro-inflammatory Cytokine - TNF Alpha
Description	Serum cytokine TNF-α in pg/mL
Time Frame	Baseline and end-of-intervention

Outcome Measure Data

Analysis Population Description

Two participants did not provide blood samples at the end-of-intervention

Arm/Group Title	Comparison Light	Intervention Light
Arm/Group Description	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.
Measure Participants	23	18
Baseline	7.55 (2.49)	7.00 (2.13)
End-of-intervention	7.44 (3.26)	7.30 (2.36)

10. Secondary Outcome

Title	C-Reactive Protein
Description	C-reactive protein in mg/L
Time Frame	Baseline and end-of-intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comparison Light	Intervention Light
Arm/Group Description	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.
Measure Participants	23	18
Baseline	5.67 (10.11)	3.68 (3.09)
End-of-intervention	5.95 (15.29)	3.53 (2.61)

11. Secondary Outcome

Title	Self-reported Cognitive Function (Patient Assessment of Own Functioning Inventory)
Description	The 33-item Patient Assessment of Own Functioning Inventory (PAOFI) is a reliable and valid measure of perceptions of cognitive functioning (Bell et al., 2013; Chelune et al., 1986). Using a Likert scale from 1 (Almost Always) to 6 (Almost Never), ratings of 1-3 were scored "1" indicating impairment, and ratings from 4 to 6 were scored "0" indicating no impairment. Total impairment was calculated by summing the number of impaired items.
Time Frame	Baseline, mid-intervention, end of intervention, 8 weeks after intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Light	Comparison Light
Arm/Group Description	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.
Measure Participants	19	18
Baseline	8.5217 (1.219)	7.9703 (1.2023)
Mid-intervention	6.5927 (1.2457)	6.9583 (1.1934)
End of intervention	4.7065 (1.258)	5.5905 (1.2023)
8 weeks after intervention	7.0445 (1.284)	6.2142 (1.2023)

12. Other Pre-specified Outcome

Title	Treatment Satisfaction (FACT-TS)
Description	Range between 0 and 5, with 5 meaning higher treatment satisfaction
Time Frame	During the 4th week of the intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Light	Comparison Light
Arm/Group Description	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.
Measure Participants	23	24
Mean (Standard Deviation) [units on a scale]	2.5 (0.8)	2.0 (1.0)

13. Other Pre-specified Outcome

Title	Credibility/Expectancy (Credibility/Expectancy Questionnaire)
Description	Treatment credibility and outcome expectancy were assessed at baseline with the mean of the first 3 items of the Credibility/Expectancy Questionnaire. Items are scored on a Likert scale from 1 to 9, and the term "symptoms" was replaced with "thinking, memory and concentration problems." Higher scores represent greater credibility and outcome expectancy.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comparison Light	Intervention Light
Arm/Group Description	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.
Measure Participants	24	23
Mean (Standard Deviation) [units on a scale]	6.9 (1.5)	6.3 (1.4)

14. Other Pre-specified Outcome

Title	Usage of Light Box (Integrated Meter Measurement and Litebook Log)
Description	Length of time light box has been used.
Time Frame	Throughout intervention period (4 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comparison Light	Intervention Light
Arm/Group Description	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.
Measure Participants	24	23
Mean (Standard Deviation) [days]	21.1 (7.5)	21.0 (8.7)

15. Other Pre-specified Outcome

Title	Chronotype (Morningness-eveningness Questionnaire)
Description	Measure determines chronotype with a lower score indicating an evening type and a higher score indicating a morning type.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comparison Light	Intervention Light
Arm/Group Description	30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.
Measure Participants	23	20
Mean (Standard Deviation) [score on a scale]	17.91 (3.15)	15.65 (4.11)

Adverse Events

Time Frame	13 to 16 weeks
Arm/Group Title	Intervention Light		Comparison Light
Arm/Group Description	30 minutes of intervention systematic light exposure daily for 4 weeks. Intervention systematic light exposure: Bright light using Litebook device.		30 minutes of comparison long wavelength systematic light exposure daily for 4 weeks. Comparison systematic light exposure: Dim light using modified Litebook device.
All Cause Mortality
	Intervention Light		Comparison Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)
Serious Adverse Events
	Intervention Light		Comparison Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Light		Comparison Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.