Effects of Litebook EDGE™ Phototherapy on Academic Performance and Brain Activity

NCT05383690 | Completed

• 1 other identifier: 2016D003724
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

As children pass through puberty the timing of their sleep-wake cycle shifts and they experience a strong urge to stay up and awaken late. High school typically starts early in the morning and a significant percentage of normal adolescents arrive at school each day with an insufficient amount of sleep, which can take a substantial toll on their academic performance. As the primary reason for insufficient sleep is a naturally occurring propensity to stay up later in the evening it seems plausible that bright light treatment (BLT) at the appropriate time may phase advance biological clocks and potentially reverse this problem. Hence, the investigators are testing the hypothesis that consistent morning use of a light emitting diode (LED) BLT device (LiteBook Edge™) by healthy adolescents will shift the phase of their sleep wake cycle and enable them to receive an increased amount of sleep during the school week and perform better on tests of attention and academic performance and evidence signs of improved alertness. Alternatively, BLT could potentially enhance alertness through other mechanisms, such as a direct arousing effect, without exerting a discernible effect on circadian phase or sleep duration.

Conditions

Sleepiness, Daytime

Outcome Measures

Primary Outcomes (4)

• Beta electroencephalographic (EEG) activity

  Primary outcome measure one is the degree of increase in beta EEG activity, which is indicative of wakefulness and arousal. Change in beta EEG power will be compared to degree of use of the bright light treatment device.

  Baseline and week 4 (or last observation after baseline)

• Theta electroencephalographic (EEG) activity

  Primary outcome measure two is the degree of decease in theta EEG activity, which is indicative of drowsiness. Change in theta EEG power will be compared to degree of use of the bright light treatment device.

  Baseline and week 4 (or last observation after baseline)

• Sleep onset

  Primary outcome measure three is the change in actigraph-assessed sleep onset to an earlier hour. Change in sleep onset time will be compared to degree of use of the bright light treatment device.

  Baseline and week 4 (or last observation after baseline)

• Sleep duration

  Primary outcome measure four is the increase in actigraph-assessed sleep duration. Change in sleep duration will be compared to degree of use of the bright light treatment device.

  Baseline and week 4 (or last observation after baseline)

Secondary Outcomes (6)

• Errors of omission

  Baseline and week 4 (or last observation after baseline)

• Response variability

  Baseline and week 4 (or last observation after baseline)

• Mathematical ability

  Baseline and week 4 (or last observation after baseline)

• Simple computational speed

  Baseline and week 4 (or last observation after baseline)

• Dentate gyrus volume

  Baseline and week 4 (or last observation after baseline)

Other Outcomes (1)

• Functional connectivity during Go/No Go task

  Baseline and week 4 (or last observation after baseline)

Study Arms (1)

Bright Light Arm

EXPERIMENTAL

This is a one-arm study. Subjects will be provided with the LiteBook Edge™ (LiteBook Company LTD), which is a patented smart phone sized BLT device that provides 10,000 lux illumination at a recommended distance of 61 cm from an LED panel with peak spectral radiance in the blue color spectrum that closely corresponds to the peak spectral frequency (480 nm) of melanopsin photoreceptors that project to the suprachiasmatic nucleus and entrain the circadian clock (Hatori \& Panda, 2010).

Device: LED bright light treatment device

Interventions

LED bright light treatment device DEVICE

Subjects will be instructed to use the bright light treatment device, as early as possible, for 30 minutes each morning. These devices will be equipped with monitoring electronics that will enable us to download their daily degree of use. Participants will also be provided with yellow-tinted blue light blocking glasses and will be instructed to wear them starting 2 hours before bedtime if they are viewing LED or liquid-crystal display screens.

Also known as: LiteBook Edge™

Bright Light Arm

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Enrolled in school, drowsiness/sleepiness during morning classes which interferes to some degree with academic performance but able to wake up and be on time for said classes, willingness to use a device in the morning to enhance alertness, Intelligence Quotient greater than 80

You may not qualify if:

• Symptoms of psychiatric disorder on screening, current use of medications, home schooled, involved in morning activities, like athletics, that can alter morning alertness

Sponsors & Collaborators

• Mclean Hospital: lead
• LiteBook Company Ltd: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Related Publications (37)

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MeSH Terms

Conditions

Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Martin H Teicher, MD,PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist

Model Details: Single arm, with independent variable being percent device use.

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 20, 2022
• Study Start: March 27, 2017
• Primary Completion: June 23, 2017
• Study Completion: June 23, 2017
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)