Circadian Light Exposure Adjustment for Restfulness
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- University of Arizona
- Study ID
- NCT07391852
- Status
- Not Yet Recruiting
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Conditions
- Sleep Onset Latency
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Months - 83 Months
- Healthy Volunteers
- Not accepted
Interventions
- Amber Tinted Glasses — DEVICEChildren will wear amber-tinted glasses in the evening hours before bedtime to reduce exposure to short-wavelength (blue) light. The glasses are intended to reduce circadian disruption associated with evening light exposure.
- Clear Glasses — DEVICEChildren will wear clear glasses in the evening hours before bedtime. This sham intervention controls for wearing glasses without reducing light exposure.
- Smart Lightbulbs — DEVICESmart light bulbs will be installed in the child's home and programmed to reduce short-wavelength light exposure during evening hours before bedtime.
Study Details
Many young children are exposed to light int he evening hours before bedtime. Children's biological clocks are highly sensitive to evening light exposure, which can delay the timing of the clock and make it harder to fall asleep. The purpose of this study is to test three strategies (adjustment to home lighting, amber-tinted glasses, clear glasses) to reduce evening light exposure in children ages 5-6 years with parent-reported sleep onset difficulties in order to improve their sleep and the timing of their biological clock. This study takes place over approximately 5 weeks. After baseline assessments of children's sleep timing, light exposure, cognition, and circadian rhythms, they will be randomly assigned to one of three interventions to reduce evening light exposure for two weeks. After the two-week intervention period, the baseline measures are repeated and parents are interviewed about their and their child's experiences with the intervention.
Key Dates
- Start date
- Jan 15, 2026
- Status verified
- Jan 2026
- Primary completion
- Dec 1, 2029
- Completion
- Jul 31, 2030
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Amber Tinted GlassesWearing "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.
- Sham Comparator: Clear GlassesThe 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.
- Experimental: Smart LightbulbsThe 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.
Primary Outcome Measure
Intervention Feasibility [ Time Frame: Throughout the two-week intervention period. ]
Central Contacts
- Lauren E Hartstein, PhD520-621-1360
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 |