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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG064198-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This two-phase pilot study will test the feasibility of a "combined chronotherapy" (CC) intervention consisting of morning bright light therapy (BLT) and evening blue light blocking (BLB), administered daily for 4 weeks in patients who experienced acute coronary syndrome (ACS). Phase A of the study will be a single-arm open-label study of the home-based CC intervention in 5 post-ACS patients. Phase B of the study will be a parallel-arm randomized clinical trial (RCT) in which 15 post-ACS patients will be randomized (using a 2:1 allocation) to active CC treatment or sleep hygiene education control group. In Phase A and Phase B, the primary aims are study feasibility, acceptability, appropriateness, and usability. In Phase B, the investigator will additionally assess whether the intervention engages its proposed proximal target mechanism - sleep.
Survivors of acute medical events often experience psychological distress including post-traumatic stress disorder (PTSD). The goal of this project is to conduct preliminary testing of a chronotherapeutic intervention targeting disturbed sleep in survivors of ACS.
There are many ways to try and improve sleep. Some of these include taking medications or working with a trained sleep specialist. The goal of this research study is to investigate the usefulness of a new way of trying to improve sleep (an "intervention") that does not involve taking medications or working with a specialist or therapist. Chronotherapeutic interventions are non-pharmacologic approaches that target the circadian or sleep-wake cycle to improve behavioral or health outcomes. Light is the strongest external signal for the human circadian system and manipulations of the light environment (e.g., morning bright light exposure and evening light avoidance) are effective in improving sleep and mood.
Participants in Phase A of this study will be asked to use a light visor to administer light to the eye each morning (BLT component of the CC) and orange-colored glasses to block out short wavelength ("blue") light to the eye each night before going to bed (BLB component of the CC) for 4 weeks. Participants are also asked to wear an activity/sleep monitor throughout the 4-week period and complete questionnaires about their sleep. Participants will also receive a sleep hygiene education by watching educational videos.
In Phase B of the study, participants will be randomized to either the active CC intervention condition (consisting of both the BLT and BLB components along with sleep hygiene education) or a sleep hygiene education only control condition. Participants will be randomized in a 2:1 ratio to CC condition or control condition. All participants (i.e., those in the CC and control groups) will wear an activity/sleep monitor throughout the 4-week period and complete questionnaires about their sleep. There will also be a 3 month follow up after the end of the 4-week intervention period for both groups where we assess sleep outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase A - open label single-arm | Experimental | All Phase A participants randomized to the home-based CC intervention will be use a light visor to administer "bright light therapy" in the morning for 30 minutes after waking up (BLT), and use orange-colored glasses for "blue light blocking" at night from 8:00 pm until going to sleep (BLB). |
|
| Phase B - active CC treatment | Experimental | For all Phase B participants randomized to the active CC group, BLT will occur each morning after awakening and will last 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 will also receive a sleep hygiene education. |
|
| Phase B - sleep hygiene education control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLT Intervention | Behavioral | BLT will be 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Complete 100% of the Outcome Assessments at Study Conclusion | The 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. | At end of 4-week intervention period |
| Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility | 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. | At end of 4-week intervention period |
| Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability | 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. | At end of 4-week intervention period |
| Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Sleep | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the Total Score of Insomnia Severity Index | This 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). |
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Patients will be eligible for PHASE A if they meet the following criteria
Inclusion Criteria:
Exclusion Criteria:
Patients will be eligible for PHASE B if they meet the following criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ari Shechter, PhD | Associate Professor of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CUIMC | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40028185 | Derived | Mendieta M, Cumella R, Fray N, Lopez-Veneros D, Hiti D, Franqui C, D'Agostino C, Kronish IM, Shechter A. Combined Chronotherapy for Poor Sleep Following Acute Coronary Syndrome: A Pilot Randomized Trial. J Circadian Rhythms. 2025 Feb 25;23:1. doi: 10.5334/jcr.250. eCollection 2025. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| FG002 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two patients from the Phase B CC intervention group withdrew from the study after randomization but before the start of study procedures.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase A - Open Label Single-arm | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Complete 100% of the Outcome Assessments at Study Conclusion | The 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. | Posted | Count of Participants | Participants | At end of 4-week intervention period |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ari Shechter | Columbia University Irving Medical Center | 212-342-1335 | as4874@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2023 | Nov 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2023 | Dec 12, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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This will be a two-phase pilot study.
Phase A of the study will be a single-arm open-label study of the home-based CC intervention in n=5 post-ACS patients. Please note that as Phase A is a single-arm open-label study, there will be no randomization of participants.
Phase B of the study will be a parallel-arm randomized clinical trial (RCT) in which n=15 post-ACS patients will be randomized (using a 2:1 allocation) to active CC treatment or sleep hygiene education control group.
The "Allocation" scheme below refers to Phase B.
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|
|
| BLB Intervention | Behavioral | BLB will be 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 | Behavioral | 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). |
|
| At end of 4-week intervention period |
| Percentage of Participants Who Report Total Scores ≥68 for Their Final Rating of the Intervention's Usability | 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. | At end of 4-week intervention period |
| Percentage of Who Report Administering the BLT Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period | 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. | At end of 4-week intervention period |
| Percentage of Who Report Administering the BLT Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period | 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. | At end of 4-week intervention period |
| Percentage of Who Report Administering the BLB Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period | 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. | At end of 4-week intervention period |
| Percentage of Who Report Administering the BLB Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period | 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. | At end of 4-week intervention period |
| Baseline, 4 weeks |
| Difference in the Total Global Score of Pittsburgh Sleep Quality Index | This 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. | Baseline, 4 weeks |
| Difference in the Sleep Duration Item of the Pittsburgh Sleep Quality Index (i.e., Question #4). | This 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.)" | Baseline, 4 weeks |
| BG001 | Phase B - Active CC Treatment | 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). |
| BG002 | 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). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Insomnia Severity Index score | The ISI consists of 5 questions rating presence and severity of insomnia using a 5-point Likert scale (0 through 4, with higher scores indicating worse severity). The ISI score is computed by adding up the score son each of the 5 questions. The score ranges from 0 to 28. Higher scores indicate worse severity insomnia symptoms | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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). |
| OG002 | 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). |
|
|
| Primary | Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Feasibility | 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. | Phase B participants in the sleep hygiene education group did not complete the FIM scale. Only those who used the intervention completed ratings. | Posted | Count of Participants | Participants | At end of 4-week intervention period |
|
|
|
| Primary | Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Acceptability | 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. | Phase B participants in the sleep hygiene education group did not complete the AIM scale. Only those who used the intervention completed ratings. | Posted | Count of Participants | Participants | At end of 4-week intervention period |
|
|
|
| Primary | Percentage of Participants Who Report Scores ≥4 for Their Final Rating of the Intervention's Appropriateness for Improving Sleep | 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. | Phase B participants in the sleep hygiene education group did not complete the IAM scale. Only those who used the intervention completed ratings. | Posted | Count of Participants | Participants | At end of 4-week intervention period |
|
|
|
| Primary | Percentage of Participants Who Report Total Scores ≥68 for Their Final Rating of the Intervention's Usability | 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. | Phase B participants in the sleep hygiene education group did not complete the FIM scale. Only those who used the intervention completed ratings. | Posted | Count of Participants | Participants | At end of 4-week intervention period |
|
|
|
| Primary | Percentage of Who Report Administering the BLT Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period | 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. | Phase B participants in the sleep hygiene education group did not use the devices. | Posted | Count of Participants | Participants | At end of 4-week intervention period |
|
|
|
| Secondary | Difference in the Total Score of Insomnia Severity Index | This 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). | Posted | Mean | Standard Deviation | pre-to-post change score on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Difference in the Total Global Score of Pittsburgh Sleep Quality Index | This 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. | Posted | Mean | Standard Deviation | pre-to-post change score on a scale | Baseline, 4 weeks |
|
|
|
| Secondary | Difference in the Sleep Duration Item of the Pittsburgh Sleep Quality Index (i.e., Question #4). | This 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.)" | Posted | Mean | Standard Deviation | pre-to-post change in hours | Baseline, 4 weeks |
|
|
|
| Primary | Percentage of Who Report Administering the BLT Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period | 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. | Phase B participants in the sleep hygiene education group did not use the devices. | Posted | Count of Participants | Participants | At end of 4-week intervention period |
|
|
|
| Primary | Percentage of Who Report Administering the BLB Intervention on ≥50% of the Days Throughout the 4-wk Treatment Period | 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. | Phase B participants in the sleep hygiene education group did not use the devices. | Posted | Count of Participants | Participants | At end of 4-week intervention period |
|
|
|
| Primary | Percentage of Who Report Administering the BLB Intervention on ≥75% of the Days Throughout the 4-wk Treatment Period | 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. | Phase B participants in the sleep hygiene education group did not use the devices. | Posted | Count of Participants | Participants | At end of 4-week intervention period |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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). | 0 | 8 | 0 | 8 | 2 | 8 |
| EG002 | 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). | 0 | 5 | 0 | 5 | 0 | 5 |
| eyestrain / eye sensitivity | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
| D020920 | Dyssomnias |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |