Ocular Light Exposure for Circadian Rhythm and Sleep

(SCOPE Trial)

EK
Overseen ByElizabeth Klerman, MD PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how light exposure affects sleep, body clocks (circadian rhythms), and related hormones. Participants will wear a device to track sleep, complete health surveys, and undergo eye examinations. They will also measure pupil reactions to light at the hospital. Some participants might collect saliva at home to assess hormonal responses to light. This trial is open to individuals who are medically stable, have not undergone eye surgery, and can read and understand English well. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding of light's impact on health.

What prior data suggests that ocular light exposure is safe for participants?

Studies have shown that light therapy, using a light box like the one in this trial, is generally safe. Research indicates it is widely used for treating sleep and mood issues, such as sleep disorders related to body clock changes, with few side effects. Minor issues might include slight eye strain or headache, but these are rare.

Importantly, light therapy usually doesn’t cause serious problems. Sources consistently suggest it's well-tolerated by most people, making it a low-risk option for those considering joining this study.12345

Why are researchers excited about this trial?

Most treatments for circadian rhythm and sleep disorders focus on medications like melatonin supplements or sleep aids. However, this new approach of using ocular light exposure from a portable light box is unique because it directly targets the body's natural light response system. Researchers are excited about this technique because it offers a non-invasive way to potentially reset and improve the body's internal clock through controlled light exposure. This method could provide a more natural, side-effect-free alternative to traditional medications, with the possibility of delivering quick and noticeable improvements in sleep patterns.

What evidence suggests that ocular light exposure is effective for circadian rhythm and sleep?

This trial will investigate the effects of ocular light exposure from a portable light box on circadian rhythm and sleep. Studies have shown that light therapy effectively addresses various sleep and body clock issues. For instance, morning light exposure can increase alertness and focus early in the day. Research also indicates that light therapy can help individuals fall asleep earlier and reduce sleep problems. Bright light therapy often treats delayed sleep phase syndrome, characterized by sleeping and waking later than usual. Additionally, light therapy can assist with insomnia, jet lag, and seasonal affective disorder by regulating sleep patterns. Overall, these findings suggest that light exposure can be a valuable tool for improving sleep and adjusting the body clock.45678

Who Is on the Research Team?

EK

Elizabeth Klerman, MD PhD

Principal Investigator

MGB

Are You a Good Fit for This Trial?

This trial is for adults, both healthy and those with various medical conditions, who are willing to answer health questionnaires, have an eye exam, track their sleep at home for a week using a wearable device and diary, and attend a session measuring pupil response to light.

Inclusion Criteria

I am between 18 and 85 years old.
Medically stable
Ability to speak, understand and read English at a high school level

Exclusion Criteria

Shift- or night-work in past three months
Crossing more than 2 time zones in past three months
Pregnant or less than 6 months post-partum or breastfeeding
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants answer health questionnaires and receive an eye exam

1 day
1 visit (in-person)

Home Monitoring

Participants track their sleep and wake using actigraphy and an online sleep diary for one week

1 week

Pupillometry Session

Participants complete a pupillometry session to measure pupil size in response to different lighting

1 hour
1 visit (in-person)

Optional Saliva Collection

Participants may choose to collect saliva at home under dim and bright light conditions to analyze melatonin levels

2 nights

Follow-up

Participants are monitored for any additional data collection or analysis

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ocular light exposure from portable light box

Trial Overview

Researchers are studying how exposure to light affects the pupils, sleep patterns, circadian rhythms, and hormone levels. Participants use a portable light box at home and may provide saliva samples to measure melatonin changes after different lighting exposures.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Lighting interventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Elizabeth B Klerman MD PhD

Lead Sponsor

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Citations

Light therapy with boxes or glasses to counteract effects of ...

Morning light significantly improved sleepiness and sustained attention from 5 to 7 am. These effects were comparable between devices and significantly ...

Light therapies to improve sleep in intrinsic circadian ...

Meta-analysis showed improvements in sleep continuity (ES = −0.23, p = 0.000), self-reported sleep disturbance (ES = −0.32, p = 0.014), and advancement of ...

Bright Light Therapy

Bright light therapy is used to manage circadian rhythm disorders such as delayed sleep phase syndrome (DSPS), a condition which shifts the normal sleeping ...

Light Therapy: Can Light Combat Insomnia?

Light therapy can help relieve sleep issues associated with insomnia, circadian rhythm sleep disorders, jet lag, seasonal affective disorder, ...

Light Therapy to Improve Sleep Quality in Older Adults ...

Because light can regulate sleep rhythms, numerous studies have investigated whether light therapy can improve sleep disorders in older ...

Bright Light Therapy - Sleep Education by the AASM

Light therapy has a good record of safety. It does not seem to produce any major side effects. Minor side effects may include the following: ...

Adherence and acceptability of light therapies to improve ...

Here, we provide an analysis of user acceptability of light interventions to improve sleep in intrinsic circadian rhythm disorders and neuropsychiatric ...

Is Light Box Therapy Right for You?

Light box therapy is generally considered safe with minimal side effects. People with certain conditions, such as bipolar disorder or eye ...