Circadian Light Exposure Adjustment for Restfulness

ConditionSleep Onset Latency

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60-83

SponsorUniversity of Arizona

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inclusion requires that children are aged 5.0-6.9 years at the time of enrollment with a parent-reported sleep onset of ≥ 60 min after parents' desired bedtime at least three nights per week.

Disqualifiers

All sleep disorders as indicated on the telephone screener or by clinical cut-off scores on the Children's Sleep Habits Questionnaire (CSHQ), except for insomnia or DSWPD as features of these disorders are directly targeted by the intervention. Secondary analyses will explore if outcomes differ among participants with or without parent-reported symptoms consistent with these diagnoses.

Physical abilities that interfere with assessments (e.g., visual impairment), developmental disabilities (e.g., autism, attention-deficit/hyperactivity disorder (ADHD), pervasive developmental disorder), epilepsy or other neurological disorders, metabolic disorders, medical conditions that commonly require treatments or assessments during the night (e.g., cancer, diabetes, active asthma), current infection or lead poisoning; a head injury involving loss of consciousness in the past 6 months.

Current use of medications affecting daytime sleepiness, the circadian system, or light sensitivity.

Eye disorders or color blindness (determined with Ishihara Color Vision Test); corrected vision with eyeglasses is permitted.

Trial design

Design model

Parallel

Treatments tested in this trial

Amber Tinted Glasses
Device
Children 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
Device
Children will wear clear glasses in the evening hours before bedtime. This sham intervention controls for wearing glasses without reducing light exposure.
Smart Lightbulbs
Device
Smart light bulbs will be installed in the child's home and programmed to reduce short-wavelength light exposure during evening hours before bedtime.

Treatment groups

60 Participants

are divided into 3 treatment groups

Group A: Amber Tinted GlassesExperimental treatment 1 intervention

Group B: Clear GlassesSham comparator 1 intervention

Group C: Smart LightbulbsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Intervention Feasibility

Feasibility will be assessed using adherence/compliance rates to assigned intervention protocols.

Time frame

Throughout the two-week intervention period.

Acceptability

Acceptability will be assessed using parent-reported qualitative interviews conducted post-intervention.

Time frame

Week 5

Secondary outcomes

Circadian Timing

Dim light melatonin onset, a measure of circadian timing, will be assessed via saliva samples.

Time frame

Assessed once in Week 2 and once in Week 5

Sleep Timing

Throughout the duration of the study, the child will wear a wrist actigraph which records sleep timing and light exposure. The actigraph is a watch-size monitor worn on the non-dominant wrist, providing continuous imputation of sleep-wake states via arm activity. These data will be used to examine changes in habitual sleep timing, sleep onset latency.

Time frame

Throughout the 5 week protocol

Light Exposure

Measured by the wrist-worn actigraph watch in 1-min epochs throughout data collection. These data provide an objective measure of the child's light exposure throughout the protocol (including compliance with the home lighting intervention) and will be used to examine changes in habitual light exposure.

Time frame

Throughout the 5 week protocol.

Sleep-Related Behaviors

Change in parent-reported sleep behaviors assessed via validated questionnaires.

Time frame

Assessed once in Week 1 and once in Week 5

Other outcomes

Pupillary Light Response

Baseline pupillary light response will be assessed as a measure of individual differences in photosensitivity.

Time frame

Baseline

Cognitive Functioning

Change in cognitive performance from pre- to post-intervention assessed using a standardized cognitive battery (NIH Toolbox).

Time frame

Assessed once in Week 1 and once in Week 5

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arizona

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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