Circadian Light Exposure Adjustment for Sleep Onset Insomnia
(CLEAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to help young children who struggle to fall asleep by testing different methods to reduce evening light exposure. Researchers will evaluate whether adjusting home lighting, using amber-tinted glasses, or using clear glasses can improve sleep and reset children's biological clocks. The trial targets kids aged 5-6 who usually take an hour or more to fall asleep after bedtime. Participants will try one of the three interventions for two weeks. As an unphased trial, this study provides families with a unique opportunity to explore innovative sleep solutions for their children.
Do I need to stop taking my current medications to join the trial?
Yes, if your child is currently using medications that affect daytime sleepiness, the circadian system, or light sensitivity, they would not be eligible to participate in the trial.
What prior data suggests that these strategies are safe for children?
Research has shown that wearing amber-tinted glasses in the evening can safely help adjust sleep patterns. These glasses block blue light, making it easier to fall asleep. Studies have found that amber lenses help maintain normal melatonin levels. Melatonin, a hormone that promotes sleep, remains unaffected by these glasses, and users generally do not report serious side effects.
Research indicates that smart lightbulbs can also improve sleep by reducing blue light in the evening. These bulbs can be dimmed and change color, helping to regulate the body's natural clock. While concerns exist about blue light from regular LED bulbs affecting sleep, using smart bulbs to lower this exposure is considered safe and effective.
Overall, both amber-tinted glasses and smart lightbulbs are well-tolerated and can help improve sleep by managing evening light exposure.12345Why are researchers excited about this trial?
Researchers are excited about the Circadian Light Exposure Adjustment trial because it explores innovative ways to help children with sleep onset insomnia. Traditional treatments for insomnia often involve medication or behavioral therapy, but this trial looks at how tweaking light exposure can influence sleep patterns. The use of amber-tinted glasses filters out blue light, which is known to suppress melatonin, helping to naturally shift the sleep cycle earlier. Meanwhile, smart lightbulbs adjust the home lighting environment to be less stimulating in the evening, potentially aligning children's circadian rhythms more closely with natural sleep times. These interventions offer a non-invasive, drug-free alternative to existing sleep treatments, which could be especially beneficial for young children.
What evidence suggests that this trial's treatments could be effective for sleep onset insomnia in children?
This trial will compare different methods to improve sleep onset insomnia in children. Research has shown that amber-tinted glasses, also called "blue-blockers," may help improve sleep. Studies have found that these glasses can help people with insomnia sleep longer by blocking blue light, which can reduce melatonin, a hormone that aids sleep. By blocking this light, falling asleep and sleeping better overall becomes easier. Participants in this trial may receive amber-tinted glasses as part of their treatment.
Another treatment arm in this trial involves using smart lightbulbs, which can change color and brightness to create a sleep-friendly environment. By reducing blue light in the evening, these bulbs can help the body's internal clock align with natural sleep patterns. Both methods aim to lessen the effects of evening light, which can make it harder for children to fall asleep.23467Who Is on the Research Team?
Lauren E Hartstein, PhD
Principal Investigator
University of Arizona
Are You a Good Fit for This Trial?
This trial is for children aged 5-6 with difficulties falling asleep, as reported by their parents. The study aims to help these kids sleep better by testing three different methods of reducing light exposure before bedtime.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessments of children's sleep timing, light exposure, cognition, and circadian rhythms
Intervention
Participants are randomly assigned to one of three interventions to reduce evening light exposure for two weeks
Post-Intervention Assessment
Repeat of baseline measures and parent interviews about the intervention experience
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Circadian Light Exposure Adjustment
Trial Overview
The trial is examining the effectiveness of amber-tinted glasses, clear glasses, and smart lightbulbs in improving sleep onset in young children. Participants will be randomly assigned to one of these interventions for two weeks.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
The presence of more blue light in the home is associated with later circadian timing in both school-aged children and adults. This intervention will adjust the evening home lighting environment to be less stimulating to children's circadian clocks. Smart light bulbs (dimmable and color tunable LED bulbs) will be installed in participants' homes light fixtures, or in the child's bedroom, bathroom, as well as areas the child is likely to spend time in after dinner (i.e., living room, playroom). The researchers will program the lights to transition to a lower CCT and dimmer intensity to achieve the recommended evening mEDI of 10 lux starting 1 h before the child's parent-selected bedtime.
Wearing "blue-blocker" glasses (lenses that filter out the blue portion of the visible spectrum) can reduce the melatonin suppression and alertness effects of evening light exposure in both adults and adolescents, as well as advance the timing of the circadian clock and sleep onset, compared with participants wearing placebo lenses. This intervention will examine their efficacy in advancing young children's sleep and circadian timing. Children will be given a pair of glasses (Block Blue Light), with amber-tinted lenses (advertised as blocking 100% of light from 380-550 nm. Children will wear the glasses starting 1 h before parent's selected bedtime each evening across the two-week intervention. Parents will also complete a daily diary detailing when the glasses are worn.
The sham comparator consists of the same protocols for the amber-tinted glasses, except that children will wear a pair of glasses with clear lenses (advertised as blocking 50% of light from 400-500 nm), which are significantly less effective at blocking short-wavelength light.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arizona
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Citations
Efficacy of blue-light blocking glasses on actigraphic sleep ...
Evening exposure to blue light suppresses melatonin, delays circadian phase, and prolongs sleep onset latency, impairing sleep quality.
Blue-blockers' resurgence as a sleep aid?
A study from the Columbia University Medical Center found amber-tinted lenses worn two hours preceding bedtime helped insomniacs gain an extra 30 minutes of ...
Optimizing the Potential Utility of Blue-Blocking Glasses for ...
Overall, there is robust evidence from both basic and applied research for the efficacy of blue-blocking glasses to increase circadian health.
Dark therapy for bipolar disorder using amber lenses ...
Amber-tinted safety glasses, which block transmission of these wavelengths, have already been shown to preserve normal nocturnal melatonin levels in a light ...
Amber lenses to block blue light and improve sleep
Results demonstrated that sleep quality at study outset was poorer in the amber lens than the control group. Two- by three-way ANOVA revealed significant (p < .
Wearing blue light-blocking glasses in the evening ...
These data suggest that wearing amber lenses may be an effective and safe intervention for the patients with DSPD.
AMBER LENSES TO BLOCK BLUE LIGHT AND IMPROVE ...
Sleep-onset insomnia (difficulty falling asleep) and mid-sleep insomnia ... Dark therapy for bipolar disorder using amber lenses for blue light blockade.
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