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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
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In conjunction with investigators at the Cecil G. Sheps Center for Health Services Research, University of North Carolina (UNC) at Chapel Hill, we propose to develop and evaluate a low-cost, minimally obtrusive device that delivers individualized light therapy to adults with early-awakening insomnia - the most common sleep disturbance in older adults, and a significant problem because of its relationship to daytime sleepiness, use of potentially hazardous sleep medication, and reduced quality of life. The proposed device will measure light/dark exposure data over 24 hours, estimate optimum timing for light delivery, and deliver an individualized light dosage while subjects are asleep. Light applied through closed eyelids in the early part of the night will delay the dim light melatonin onset, a marker of the circadian clock, and help those with early sleep onset to fall asleep later
We will recruit 50 subjects who report going to bed early and desiring later bedtimes and will ask them to wear an active and an inactive light mask for 8 consecutive weeks each. A 2-week washout period between active and inactive conditions will be applied. Outcome measures will be collected periodically throughout the 8 weeks. Baseline (no intervention) will be collected prior to the active and inactive lighting interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blue light | Experimental | The study protocol consisted of two 8-week intervention/control periods in which each participant wore either the intervention (blue light) or control (red light) mask every night, with the order of presentation of the two conditions randomized by the study's biostatistician. A light mask housing two blue Light Emitting Diodes (LED) arrays delivered a train of blue or red light pulses of 2 second duration that were presented every 30 s for no longer than 2 hr, resulting in a maximum total of approximately 240 pulses per night. the blue light mask was worn nightly for 8 weeks. There will be a two week washout period between each intervention |
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| Red light | Placebo Comparator | The study protocol consisted of two 8-week intervention/control periods in which each participant wore either the intervention (blue light) or control (red light) mask every night, with the order of presentation of the two conditions randomized by the study's biostatistician. A light mask housing two red Light Emitting Diodes (LED) arrays delivered a train of blue or red light pulses of 2 second duration that were presented every 30 s for no longer than 2 hr, resulting in a maximum total of approximately 240 pulses per night. the red light mask was worn nightly for 8 weeks, with a two week washout period between each intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue light | Other | After a two week baseline collection period, half of the subjects will initially be given light masks that deliver blue light through the closed eyelids, while subjects are sleeping. The light mask will always be turned on 120 min before estimated core body temperature minimum (CBTmin); it is expected that blue light exposure will delay the timing of the CBTmin. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Disturbance | Pittsburgh Sleep Quality Index. Score range 0 - 21. A score over 5 is indicative of sleep disturbance. Change in score from baseline to intervention is reported. A larger difference indicates a better outcome. | Baseline (week 0) and week 8 of lighting intervention |
| Total Sleep Time | The change in total amount of minutes spent sleeping at night from baseline week to the last week of intervention. A higher number is an improved outcome | baseline week (week 0) and the last week of intervention (week 8) |
| Sleep Efficiency | The change in sleep efficiency from baseline to last week of intervention. A higher number is a better outcome. Sleep efficiency is the percentage of time spent in bed sleeping. Scored total sleep time divided by interval duration minus total invalid time (sleep/wake) of the given rest interval multiplied by 100. This data was collected using actigraphy data. | baseline week (week 0) and the last week of intervention (week 8) |
| Sleep Start Time | Change in sleep start time, in minutes, from baseline week to the last week of intervention. A higher number is a better outcome. Based on actigraph data | baseline week (week 0) and the last week of intervention (week 8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariana G Figueiro, PhD | Rensselaer Polytechnic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rensselaer Polytechnic Institute | Troy | New York | 12180 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25506253 | Background | Figueiro MG, Plitnick B, Rea MS. Pulsing blue light through closed eyelids: effects on acute melatonin suppression and phase shifting of dim light melatonin onset. Nat Sci Sleep. 2014 Dec 2;6:149-56. doi: 10.2147/NSS.S73856. eCollection 2014. | |
| 24124400 | Background | Figueiro MG, Bierman A, Rea MS. A train of blue light pulses delivered through closed eyelids suppresses melatonin and phase shifts the human circadian system. Nat Sci Sleep. 2013 Oct 4;5:133-41. doi: 10.2147/NSS.S52203. eCollection 2013. |
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46 participants were enrolled into the study. These participants were randomized to begin the study with the active intervention, or the placebo intervention. After a 2 week washout period, participants were exposed to the opposite intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Intervention, Then Placebo | Participants started the study wearing the blue mask for 8 weeks. After a 2 week washout period, they wore the red mask for 8 weeks |
| FG001 | Placebo Intervention, Then Active | Participants started the study wearing the red mask every night for 8 weeks. After a 2 week washout period, they wore the blue mask every night for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (8 Weeks) |
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| Washout Period (2 Weeks) |
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| Second Intervention (8 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Intervention, Then Placebo Intervention | Participants started the study by wearing the blue mask every night for 8 weeks. After a washout period of 2 weeks, participants wore the red mask every night for 8 weeks |
| BG001 | Placebo Intervention, Then Active Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Sleep Disturbance | Pittsburgh Sleep Quality Index. Score range 0 - 21. A score over 5 is indicative of sleep disturbance. Change in score from baseline to intervention is reported. A larger difference indicates a better outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline (week 0) and week 8 of lighting intervention |
|
20 weeks
data was collected weekly during each 8 week intervention period
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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 | Blue Light | This within-subjects, randomized, two-treatment crossover design study consists of two 8-week periods in which each participant wore either the intervention (blue light) or control (red light) mask every night. Subjects will use each condition for eight weeks, with the intervention order counterbalanced across subjects, and a two-week washout period between the two study conditions. The blue mask delivered a flashing blue light for two hours beginning 1 hour after bedtime designed to result in a phase delay of the circadian response curve. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Burning | Eye disorders | Systematic Assessment |
We did not collect circadian marker data (e.g., DLMO) in this field study, it is not known whether any circadian phase shifting resulted. We did not control light during the day which could have counteracted the intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mariana Figueiro | Rensselaer Polytechnic Institute | (518)687-7142 | figuem@rpi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2018 | Nov 6, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 5, 2018 | Nov 6, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000095743 | Blue Light |
| D000095742 | Red Light |
| ID | Term |
|---|---|
| D008027 | Light |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
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Enrolled participants will be randomized to receive either the active intervention or placebo intervention and then crossed over to receive the opposite intervention. The study consisted of two intervention periods of 8 weeks separated by a two week washout period.
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| Red light | Other | After a two week baseline collection period, half of the subjects will initially be given light masks that deliver red light through the closed eyelids, while subjects are sleeping. The light mask will always be turned on 120 min before estimated core body temperature minimum (CBTmin); it is expected that red light exposure will have no effect on the timing of the CBTmin. |
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Participants started the study by wearing the red mask every night for 8 weeks. After a washout period of 2 weeks, participants wore the blue mask every night for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| early awakening insomnia | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Total Sleep Time | The change in total amount of minutes spent sleeping at night from baseline week to the last week of intervention. A higher number is an improved outcome | Posted | Mean | Standard Deviation | minutes | baseline week (week 0) and the last week of intervention (week 8) |
|
|
|
| Primary | Sleep Efficiency | The change in sleep efficiency from baseline to last week of intervention. A higher number is a better outcome. Sleep efficiency is the percentage of time spent in bed sleeping. Scored total sleep time divided by interval duration minus total invalid time (sleep/wake) of the given rest interval multiplied by 100. This data was collected using actigraphy data. | Posted | Mean | Standard Deviation | percentage of sleep | baseline week (week 0) and the last week of intervention (week 8) |
|
|
|
| Primary | Sleep Start Time | Change in sleep start time, in minutes, from baseline week to the last week of intervention. A higher number is a better outcome. Based on actigraph data | Posted | Mean | Standard Deviation | minutes | baseline week (week 0) and the last week of intervention (week 8) |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 13 |
| 34 |
| EG001 | Red Light | This within-subjects, randomized, two-treatment crossover design study consists of two 8-week periods in which each participant wore either the intervention (blue light) or control (red light) mask every night. Subjects will use each condition for eight weeks, with the intervention order counterbalanced across subjects, and a two-week washout period between the two study conditions. The red mask delivered a flashing red light for two hours beginning 1 hour after bedtime designed to have no effect on the circadian response curve. | 0 | 34 | 0 | 34 | 12 | 34 |
| Eye Redness | Eye disorders | Systematic Assessment |
|
| Eye strain | Eye disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
|
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| D055585 |
| Physical Phenomena |
| D055620 | Optical Phenomena |
| D011827 | Radiation |
| D011840 | Radiation, Nonionizing |