Trial Outcomes & Findings for The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS (NCT NCT05299723)
NCT ID: NCT05299723
Last Updated: 2025-01-07
Results Overview
Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥75% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
At end of 4-week intervention period
Results posted on
2025-01-07
Participant Flow
Participant milestones
| Measure |
Phase A - Open Label Single-arm
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
10
|
5
|
|
Overall Study
COMPLETED
|
4
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Phase A - Open Label Single-arm
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
Baseline characteristics by cohort
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC intervention used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=10 Participants
For all Phase B participants randomized to the active CC group, BLT occured each morning after awakening and lasted for 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received a sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
n=5 Participants
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
54.4 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
5 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Baseline Insomnia Severity Index score
|
14 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 6.9 • n=7 Participants
|
19.2 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
13.5 units on a scale
STANDARD_DEVIATION 6.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: At end of 4-week intervention periodThe total number of participants who complete all endpoint questionnaire assessments will be documented and the proportion of participants who fully complete outcome assessments will be computed.
Outcome measures
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=8 Participants
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
n=5 Participants
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Percentage of Participants Who Complete 100% of the Outcome Assessments at Study Conclusion
|
4 Participants
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: At end of 4-week intervention periodPopulation: Phase B participants in the sleep hygiene education group did not complete the FIM scale. Only those who used the intervention completed ratings.
Participants in Phase A and those participants in Phase B who were randomized to the intervention group will complete the Feasibility of Intervention Measure (FIM). The FIM is a 4-item questionnaire, with each question having a 5-point Likert scale (1=completely disagree to 5= completely agree). The score is calculated by adding up the selections on each of the 4 questions. The total score on the FIM can range from 4 to 20, with higher scores indicating greater feasibility of the intervention.
Outcome measures
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=7 Participants
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility
|
4 Participants
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At end of 4-week intervention periodPopulation: Phase B participants in the sleep hygiene education group did not complete the AIM scale. Only those who used the intervention completed ratings.
Participants in Phase A and those participants in Phase B who were randomized to the intervention group will complete the Acceptability of Intervention Measure (AIM). The AIM is a 4-item questionnaire, with each question having a 5-point Likert scale (1=completely disagree to 5= completely agree). The score is calculated by adding up the selections on each of the 4 questions. The total score on the AIM can range from 4 to 20, with higher scores indicating greater acceptability of the intervention.
Outcome measures
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=7 Participants
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability
|
2 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At end of 4-week intervention periodPopulation: Phase B participants in the sleep hygiene education group did not complete the IAM scale. Only those who used the intervention completed ratings.
Participants in Phase A and those participants in Phase B who were randomized to the intervention group will complete the Intervention Appropriateness Measure (IAM). The IAM is a 4-item questionnaire, with each question having a 5-point Likert scale (1=completely disagree to 5= completely agree). The score is calculated by adding up the selections on each of the 4 questions. The total score on the IAM can range from 4 to 20, with higher scores indicating greater feasibility of the intervention.
Outcome measures
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=7 Participants
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Sleep
|
3 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At end of 4-week intervention periodPopulation: Phase B participants in the sleep hygiene education group did not complete the FIM scale. Only those who used the intervention completed ratings.
Participants in Phase A and those participants in Phase B who were randomized to the intervention group will complete the System Usability Scale (SUS). The SUS is a 10-item questionnaire with a 5-point Likert scale (1= strongly disagree to 5 = strongly agree). The score is calculated by subtracting 1 from each question's raw score then using the following equation: SUS = 2.5 (20 + \[sum of scores on SUS1, SUS3, SUS5, SUS7, SUS9\] - \[sum of scores on SUS2, SUS4, SUS6, SUS8, SUS10\]). The SUS total score can range from 0 to 100, with higher scores indicating better system usability of the intervention.
Outcome measures
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=7 Participants
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Percentage of Participants Who Report Total Scores ≥68 for Their Final Rating of the Intervention's Usability
|
4 Participants
|
7 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At end of 4-week intervention periodPopulation: Phase B participants in the sleep hygiene education group did not use the devices.
Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥50% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.
Outcome measures
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=8 Participants
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Percentage of Who Report Administering the BLT Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period
|
4 Participants
|
7 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At end of 4-week intervention periodPopulation: Phase B participants in the sleep hygiene education group did not use the devices.
Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥75% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.
Outcome measures
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=8 Participants
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Percentage of Who Report Administering the BLT Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period
|
4 Participants
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At end of 4-week intervention periodPopulation: Phase B participants in the sleep hygiene education group did not use the devices.
Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥50% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.
Outcome measures
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=8 Participants
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Percentage of Who Report Administering the BLB Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period
|
4 Participants
|
8 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At end of 4-week intervention periodPopulation: Phase B participants in the sleep hygiene education group did not use the devices.
Participants will complete a daily use log where the times of use of the intervention devices will be documented. Adherence to the protocol will be calculated as using the devices on ≥75% of days. The proportion of participants who meet adherence criteria at 4 week endpoint will be computed.
Outcome measures
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=8 Participants
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Percentage of Who Report Administering the BLB Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period
|
4 Participants
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksThis is to measure the baseline-to-study conclusion change in insomnia symptom severity. The range of values is 0-28, with higher values indicating worsened severity of insomnia symptoms. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Outcome measures
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=7 Participants
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
n=5 Participants
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Difference in the Total Score of Insomnia Severity Index
|
-8.25 pre-to-post change score on a scale
Standard Deviation 7.3
|
-5.7 pre-to-post change score on a scale
Standard Deviation 9.3
|
-3.0 pre-to-post change score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksThis is to measure the baseline-to-study conclusion change in global sleep quality. The Pittsburgh Sleep Quality Index is a 19-item questionnaire that is completed by the participant. The score range is 0-21. Higher score indicates poorer sleep quality. A cutoff value of a total score \> 5 is often used to indicate the presence of poor sleep quality.
Outcome measures
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=7 Participants
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
n=5 Participants
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Difference in the Total Global Score of Pittsburgh Sleep Quality Index
|
-5 pre-to-post change score on a scale
Standard Deviation 2.9
|
-3.6 pre-to-post change score on a scale
Standard Deviation 3.8
|
-3.2 pre-to-post change score on a scale
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksThis is to measure the baseline-to-study conclusion change in self-reported sleep duration (hours spent asleep). Participants enter a value as a whole number in response to the question: "During the past month, how many hours of actual sleep did you get at night? (This may be different than the number of hours you spend in bed.)"
Outcome measures
| Measure |
Phase A - Open Label Single-arm
n=4 Participants
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=7 Participants
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
n=5 Participants
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Difference in the Sleep Duration Item of the Pittsburgh Sleep Quality Index (i.e., Question #4).
|
1 pre-to-post change in hours
Standard Deviation 1.1
|
1 pre-to-post change in hours
Standard Deviation 1.1
|
0.3 pre-to-post change in hours
Standard Deviation 1.6
|
Adverse Events
Phase A - Open Label Single-arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase B - Active CC Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase B - Sleep Hygiene Education Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase A - Open Label Single-arm
n=4 participants at risk
All Phase A participants randomized to the CC used a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and used orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB).
BLT Intervention: BLT was administered via a Luminette 3 light therapy visor. The Luminette 3 is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina at 1,000 lux via a holographic system in order to ensure correct penetration into the eye without impeding vision. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. BLB lenses reduce melanopic irradiance (i.e., the light that affects sleep) of about 85%. BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (overview of sleep hygiene approaches).
|
Phase B - Active CC Treatment
n=8 participants at risk
For all Phase B participants randomized to the active CC group, BLT occurred each morning after awakening and lasted 30 minutes and BLB at night from 8:00 pm until going to sleep throughout the 4-week intervention period. Participants in the CC group also received sleep hygiene education.
BLT Intervention: BLT was administered via a Luminette light therapy visor. Luminette is a visor worn above the eyes containing light emitting diode (LEDs) emitting a blue-enriched white light reflecting to the retina. This range of light and intensity is sufficient to synchronize the circadian clock.
BLB Intervention: BLB was administered via orange lenses that filter out short-wavelength blue light, while allowing the other visible spectrum light to pass. The BLB lenses result in a reduction in melanopic irradiance (i.e., the light that affects sleep) of about 85%. The BLB lenses only make the overall light environment about 30% dimmer. Therefore, the BLB lenses are effective in blocking out most of the blue light in the visible environment that impacts sleep, but do not result in drastic overall dimming/darkening of the light environment.
Sleep Hygiene Education: The sleep hygiene education consisted of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
Phase B - Sleep Hygiene Education Control Group
n=5 participants at risk
All Phase B participants randomized to the control group will receive a sleep hygiene education alone at the start of the 4 week monitoring period.
Sleep Hygiene Education: The sleep hygiene education will consist of watching a sleep education video (background on the regulation of sleep, the impacts of insufficient sleep on mental and physical health, etc.) and a sleep hygiene video (providing overview of sleep hygiene approaches).
|
|---|---|---|---|
|
Nervous system disorders
headache
|
0.00%
0/4 • 4 weeks
|
25.0%
2/8 • Number of events 2 • 4 weeks
|
0.00%
0/5 • 4 weeks
|
|
Eye disorders
eyestrain / eye sensitivity
|
0.00%
0/4 • 4 weeks
|
12.5%
1/8 • Number of events 1 • 4 weeks
|
0.00%
0/5 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place