| Primary | Study Attrition and Adherence | 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 | | Posted | | Count of Participants | | Participants | | Up to 3 weeks from registration | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
|---|
| Attrition | | | | Adherence to light therapy | | |
| |
| Secondary | Effects of Bright Light on Sleep Disturbance as Measured by the PROMIS-Sleep Disturbance | 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. | | Posted | | Mean | Standard Deviation | T-score | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | |
|
| Secondary | Effects of Bright Light on Sleep Disturbance as Measured by the PSQI | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Effects of Bright Light on Fatigue as Measured by the PROMIS-Cancer-Fatigue | 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. | | Posted | | Mean | Standard Deviation | T-score | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| Secondary | Effects of Bright Light on Fatigue as Measured by the Daily Log | Fatigue self-report is rated numerically from 1-5, with greater score meaning more fatigue | | Posted | | Mean | Standard Deviation | score on a scale | | Kept throughout the approx 3 weeks of the study | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Effects of Bright Light on Depression as Measured by the PROMIS-Depression | 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. | | Posted | | Mean | Standard Deviation | T-score | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 |
|
| Secondary | Effects of Bright Light on Depression as Measured by the CES-D | Center for Epidemiologic Studies Depression Scale (CES-D) score: Total CES-D range is 0-60, with higher score meaning more depressed. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Effects of Bright Lights on Cognitive Dysfunction as Measured by the MoCA | MoCA (Montreal Cognitive Assessment): Test conducted by researcher, with total score range 0-30. Higher score means less cognitive dysfunction. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Effect of Bright Light on Quality of Life as Measured by the PROMIS-Physical Function | 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. | | Posted | | Mean | Standard Deviation | T-score | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Arm 2: Dim Red Light |
|
| Secondary | Effect of Bright Light on Quality of Life as Measured by EORTC QLQ-30 | 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 | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Effects of Bright Light on Level of Stress as Measured by the PSG-Total Sleep Time | 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. | | Posted | | Mean | Standard Deviation | minutes | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Efficiency | 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. | | Posted | | Mean | Standard Deviation | percentage of sleep time | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Effects of Bright Light on Level of Stress as Measured by the PSG-Sleep Onset Latency | 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. | | Posted | | Mean | Standard Deviation | minutes | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Effects of Bright Light on Level of Stress as Measured by the PSG-Awakenings | 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. | | Posted | | Mean | Standard Deviation | minutes | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Effects of Bright Light on Level of Stress as Measured by the PSG-Arousals | 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 | | Posted | | Mean | Standard Deviation | minutes | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Effects of Bright Light on Level of Stress as Measured by the PSG-Arousal Index | 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. | | Posted | | Mean | Standard Deviation | Total number of arousals per hr of sleep | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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
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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 |
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| Secondary | Effects of Bright Light on Level of Stress as Measured by the PSG-Wake After Sleep Onset (WASO) | 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. | | Posted | | Mean | Standard Deviation | minutes | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (Min) | 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. | | Posted | | Mean | Standard Deviation | minutes | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 |
|
| Secondary | Effects of Bright Light on Level of Stress as Measured by the PSG-sleep Stages (%) | 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. | | Posted | | Mean | Standard Deviation | percentage of sleep time | | Baseline (day 2 of study) and Post-treatment (approx day 17 of study) | | | | ID | Title | Description |
|---|
| OG000 | 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 |
|