Trial Outcomes & Findings for Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors (NCT NCT03304587)
NCT ID: NCT03304587
Last Updated: 2025-06-10
Results Overview
Study participants kept a daily log where they listed the dates and times they used the light visor - noting time they put it on, and the time they took it off. The light exposure were recorded to assess adherence to the treatment protocol. Adherence: percentage that the study participant used the light visor for 30 minutes per day during the 14-day light therapy intervention (based on the daily log that reported use or not use of the light visor for 30 minutes for the 14 days of the intervention and the time they put it on each day and took it off each day) Attrition: study participants withdrew from the study prior to completing the intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Up to 3 weeks from registration
Results posted on
2025-06-10
Participant Flow
10 participants withdrew prior to assignment for: schedule coordination issues (n=8); loss of contact after 3 attempts (n=2)
Participant milestones
| Measure |
Arm 1: Bright Blue-green Light
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
Withdrawal
|
1
|
1
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1: Bright Blue-green Light
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Overall Study
Headache after intervention
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Effects of Bright Light on Co-occurring Cancer-related Symptoms in Breast Cancer Survivors
Baseline characteristics by cohort
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
52.4 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Greater Lansing, Michigan
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States · St Louis Metro., Illinois/Missouri
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education
|
15.6 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
16.5 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
16.1 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Marital Status
Single
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital Status
Married/Partnered
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Employment
Full time
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Employment
Part time
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Employment
Self employed
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Employment
Retired
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Living Arrangement
Lives alone
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Living Arrangement
Lives with others
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Tumor Stage
Stage I
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Tumor Stage
Stage II
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Tumor Stage
Stage III
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Previous Treatment
Chemotherapy
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Previous Treatment
Radiation
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Previous Treatment
Both (chemotherapy & radiation)
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Number of Comorbidities
0
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Number of Comorbidities
1
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Number of Comorbidities
2
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Number of Comorbidities
3 or more
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Chronotype
Eveningness
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Chronotype
Morningness
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 weeks from registrationStudy participants kept a daily log where they listed the dates and times they used the light visor - noting time they put it on, and the time they took it off. The light exposure were recorded to assess adherence to the treatment protocol. Adherence: percentage that the study participant used the light visor for 30 minutes per day during the 14-day light therapy intervention (based on the daily log that reported use or not use of the light visor for 30 minutes for the 14 days of the intervention and the time they put it on each day and took it off each day) Attrition: study participants withdrew from the study prior to completing the intervention
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Study Attrition and Adherence
Attrition
|
1 Participants
|
1 Participants
|
|
Study Attrition and Adherence
Adherence to light therapy
|
14 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep disturbance T-Score. A higher PROMIS-Sleep disturbance T-score represents greater\\worse sleep disturbance. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean worse sleep disturbance Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance
Baseline
|
56 T-score
Standard Deviation 6
|
57.3 T-score
Standard Deviation 7.5
|
|
Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance
Post-Test
|
49.6 T-score
Standard Deviation 5.3
|
50.4 T-score
Standard Deviation 6
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Pittsburgh Sleep Quality Index (PSQI) Global score: The PSQI has 7 components, with each component self-rated from 0-3, with 3 being worse sleep quality. Global PSQI sleep score is the sum of all 7 components, with score range from 0-21, with higher score meaning worse sleep quality.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Sleep Disturbance as Measured by the PSQI
Baseline
|
9.3 score on a scale
Standard Deviation 3.2
|
9.6 score on a scale
Standard Deviation 3.2
|
|
Effects of Bright Light on Sleep Disturbance as Measured by the PSQI
Post-Test
|
7.8 score on a scale
Standard Deviation 2.4
|
6.0 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue T-Score. A higher PROMIS-Cancer-Fatigue T-score represents greater\\worse fatigue. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean worse fatigue Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue
Baseline
|
55.8 T-score
Standard Deviation 6.8
|
56.3 T-score
Standard Deviation 7.9
|
|
Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue
Post Test
|
48.3 T-score
Standard Deviation 4.4
|
50.5 T-score
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Kept throughout the approx 3 weeks of the studyFatigue self-report is rated numerically from 1-5, with greater score meaning more fatigue
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Fatigue as Measured by the Daily Log
Baseline self-reported fatigue
|
3.54 score on a scale
Standard Deviation 2.03
|
4.57 score on a scale
Standard Deviation 2.41
|
|
Effects of Bright Light on Fatigue as Measured by the Daily Log
Post-Test self-reported fatigue
|
1.92 score on a scale
Standard Deviation 1.44
|
2.86 score on a scale
Standard Deviation 2.35
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression T-Score. A higher PROMIS-Depression T-score represents greater\\worse Depression. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean worse worse depression. Note: For negatively-worded concepts like Fatigue, a T-score of 60 is one SD worse than average. By comparison, a Fatigue T-score of 40 is one SD better than average.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Depression as Measured by the PROMIS-Depression
Baseline
|
50.4 T-score
Standard Deviation 7.9
|
51.1 T-score
Standard Deviation 6.4
|
|
Effects of Bright Light on Depression as Measured by the PROMIS-Depression
Post-Test
|
45.2 T-score
Standard Deviation 5.9
|
46.5 T-score
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Center for Epidemiologic Studies Depression Scale (CES-D) score: Total CES-D range is 0-60, with higher score meaning more depressed.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Depression as Measured by the CES-D
Baseline
|
14.7 score on a scale
Standard Deviation 8.3
|
16.3 score on a scale
Standard Deviation 4.1
|
|
Effects of Bright Light on Depression as Measured by the CES-D
Post-Test
|
6.0 score on a scale
Standard Deviation 3.8
|
8.9 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)MoCA (Montreal Cognitive Assessment): Test conducted by researcher, with total score range 0-30. Higher score means less cognitive dysfunction.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA
Baseline
|
27.9 score on a scale
Standard Deviation 1.7
|
26.6 score on a scale
Standard Deviation 2.2
|
|
Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA
Post-Test
|
28.0 score on a scale
Standard Deviation 2.0
|
27.1 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function T-Score. A higher PROMIS-Physical Function T-score represents greater\\better Physical Function. PROMIS measures provide a common metric: the T-score (mean = 50, standard deviation = 10). A mean of 50 equals the mean in the U.S. general population. Higher scores mean better functioning. Note: A T-score of 60 is one SD greater than average; A T-Score of 40 is one SD lower than average.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function
Baseline
|
47.5 T-score
Standard Deviation 10.2
|
48.6 T-score
Standard Deviation 8.1
|
|
Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function
Post-Test
|
48.7 T-score
Standard Deviation 9.2
|
51.3 T-score
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Quality of Life (QOL)-Global Health score: Range 0-100, higher score is better global health quality of life Quality of Life (QOL) Symptom score: Range 0-100, Higher score is worse symptoms quality of life Quality of Life (QOL)-Function: Range 0-100, Higher score is better functional quality of life
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30
Baseline QOL-Global
|
65.6 score on a scale
Standard Deviation 16.6
|
76.1 score on a scale
Standard Deviation 16.0
|
|
Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30
Post-Test QOL-Global
|
76.2 score on a scale
Standard Deviation 7.9
|
81.0 score on a scale
Standard Deviation 11
|
|
Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30
Baseline QOL-Symptom
|
20.7 score on a scale
Standard Deviation 13.0
|
19.5 score on a scale
Standard Deviation 9.0
|
|
Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30
Post-Test QOL-Symptom
|
13.4 score on a scale
Standard Deviation 7.1
|
12.1 score on a scale
Standard Deviation 7.3
|
|
Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30
Baseline QOL-Function
|
76.7 score on a scale
Standard Deviation 15.7
|
80.4 score on a scale
Standard Deviation 10.4
|
|
Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30
Post-Test QOL-Function
|
87.0 score on a scale
Standard Deviation 6.6
|
87.6 score on a scale
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes of total sleep time is reported.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time
Post-Test
|
386.1 minutes
Standard Deviation 84.8
|
415.9 minutes
Standard Deviation 71.5
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time
Baseline
|
394.2 minutes
Standard Deviation 68.9
|
393.53 minutes
Standard Deviation 59.35
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Sleep efficiency is reported as percentage of total sleep time.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency
Baseline
|
81.9 percentage of sleep time
Standard Deviation 7.9
|
82.7 percentage of sleep time
Standard Deviation 8.08
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency
Post-Test
|
81.0 percentage of sleep time
Standard Deviation 14.3
|
82.4 percentage of sleep time
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes of latency to sleep onset is reported.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency
Post-Test
|
35.7 minutes
Standard Deviation 33.1
|
52.4 minutes
Standard Deviation 55.4
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency
Baseline
|
58.6 minutes
Standard Deviation 64.8
|
43.9 minutes
Standard Deviation 49.5
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Minutes of awakenings during sleep is recorded.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings
Baseline
|
20.5 minutes
Standard Deviation 8.6
|
16.4 minutes
Standard Deviation 7.1
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings
Post-Test
|
15.6 minutes
Standard Deviation 5.2
|
15.2 minutes
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Objective testing using in-lab polysomnography (PSG)is used to measure the effects of bright light on level of stress. Arousal minutes during sleep are recorded
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals
Baseline
|
53.4 minutes
Standard Deviation 20.4
|
64.6 minutes
Standard Deviation 40.7
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals
Post-Test
|
45.8 minutes
Standard Deviation 17.9
|
58.0 minutes
Standard Deviation 32.2
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Arousal index is total number of arousals per hour of sleep.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index
Baseline
|
8.4 Total number of arousals per hr of sleep
Standard Deviation 3.5
|
9.6 Total number of arousals per hr of sleep
Standard Deviation 5.3
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index
Post-Test
|
7.8 Total number of arousals per hr of sleep
Standard Deviation 2.8
|
8.1 Total number of arousals per hr of sleep
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Minutes till wake after sleep onset is reported.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO)
Baseline
|
51.6 minutes
Standard Deviation 19.9
|
47.8 minutes
Standard Deviation 22.7
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO)
Post-Test
|
72.8 minutes
Standard Deviation 41.5
|
48.2 minutes
Standard Deviation 31.4
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Objective testing using in-lab polysomnography (PSG) used to measure effects of bright light on level of stress. Minutes spent in each sleep stage is reported. Stage 1 is when a person first falls asleep, normally lasts 1-7minutes. Body has not fully relaxed, though body and brain activities start to slow with periods of brief movements. Stage 2 the body enters a more subdued state including a drop in temperature, relaxed muscles and slowed breathing and heart rate. Stage 3 muscle tone, pulse and breathing rate decrease as body relaxes. REM brain activity picks up, body experiences atonia-a temporary paralysis of muscles except for eyes and muscles that control breathing. Usually takes 90 minutes to reach REM stage.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)
Post-Test Stage 1
|
24.7 minutes
Standard Deviation 7.9
|
26.1 minutes
Standard Deviation 14.5
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)
Baseline Stage 2
|
236.7 minutes
Standard Deviation 49.1
|
241.2 minutes
Standard Deviation 55.4
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)
Post-Test Stage 2
|
250.3 minutes
Standard Deviation 61.3
|
279.9 minutes
Standard Deviation 74.3
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)
Baseline Stage 3
|
37.7 minutes
Standard Deviation 40.0
|
32.5 minutes
Standard Deviation 23.4
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)
Baseline REM
|
93.9 minutes
Standard Deviation 30.7
|
91.7 minutes
Standard Deviation 28.9
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)
Post-Test REM
|
84.0 minutes
Standard Deviation 28.9
|
86.5 minutes
Standard Deviation 33.9
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)
Baseline Stage 1
|
26.0 minutes
Standard Deviation 12.6
|
28.2 minutes
Standard Deviation 13.9
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min)
Post-Test Stage 3
|
27.1 minutes
Standard Deviation 30.2
|
23.4 minutes
Standard Deviation 27.4
|
SECONDARY outcome
Timeframe: Baseline (day 2 of study) and Post-treatment (approx day 17 of study)Objective testing using in-lab polysomnography (PSG) is used to measure the effects of bright light on level of stress. Percentage of time in each sleep stage is reported. Stage 1 is when a person first falls asleep, normally lasts 1-7minutes. Body has not fully relaxed, though body and brain activities start to slow with periods of brief movements. Stage 2 the body enters a more subdued state including a drop in temperature, relaxed muscles and slowed breathing and heart rate. Stage 3 muscle tone, pulse and breathing rate decrease as body relaxes. REM brain activity picks up, body experiences atonia-a temporary paralysis of muscles except for eyes and muscles that control breathing. Usually takes 90 minutes to reach REM stage.
Outcome measures
| Measure |
Arm 1: Bright Blue-green Light
n=15 Participants
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 Participants
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)
Baseline Stage 1
|
6.9 percentage of sleep time
Standard Deviation 4.0
|
7.4 percentage of sleep time
Standard Deviation 4.4
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)
Post-Test Stage 1
|
6.7 percentage of sleep time
Standard Deviation 2.9
|
6.3 percentage of sleep time
Standard Deviation 3.3
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)
Baseline Stage 2
|
60.6 percentage of sleep time
Standard Deviation 10.7
|
61.0 percentage of sleep time
Standard Deviation 7.7
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)
Baseline Stage 3
|
9.2 percentage of sleep time
Standard Deviation 9.0
|
8.5 percentage of sleep time
Standard Deviation 6.6
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)
Post-Test Stage 3
|
7.3 percentage of sleep time
Standard Deviation 7.5
|
6.4 percentage of sleep time
Standard Deviation 8.4
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)
Baseline REM
|
23.4 percentage of sleep time
Standard Deviation 5.4
|
23.2 percentage of sleep time
Standard Deviation 6.5
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)
Post-Test REM
|
21.2 percentage of sleep time
Standard Deviation 5.8
|
20.7 percentage of sleep time
Standard Deviation 6.9
|
|
Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%)
Post-Test Stage 2
|
64.8 percentage of sleep time
Standard Deviation 7.7
|
66.7 percentage of sleep time
Standard Deviation 11.0
|
Adverse Events
Arm 1: Bright Blue-green Light
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Dim Red Light
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1: Bright Blue-green Light
n=15 participants at risk
* Bright blue-green light (\~515nm; 12,000 lux) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Bright blue-green light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
Arm 2: Dim Red Light
n=15 participants at risk
-Dim red light (5 lux) (control group) for 30 minutes once a day.
* For those who have scores of ≤41 (evening types) on Horne-Ostberg Morningness-Eveningness Questionnaire (MEQ), light will be delivered within 30 minutes of waking for 14 consecutive mornings. For those who receive scores of ≥59 (morning types), light will be delivered between 1900-2000 hours for 14 consecutive evenings.
* Light therapy will be self-administered using a light visor cap
* Each participant will make (3) overnight visits to the sleep laboratory
* On 2 randomly selected days, the participants will wear a light meter during wake time
Dim red light: -The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
\*\*See study protocol for measurement details
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Baseline assessment through post-assessment (up to 3 weeks)
Self-reported symptoms following intervention
|
6.7%
1/15 • Number of events 1 • Baseline assessment through post-assessment (up to 3 weeks)
Self-reported symptoms following intervention
|
Additional Information
Dr. Horng-Shiuann Wu, Associate Professor
Michigan State University College of Nursing
Phone: 517-884-4643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place