Light Sensitization Study

NCT ID: NCT01327040

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2020-12-31

Brief Summary

Circadian rhythm disorders are a class of sleep disorders characterized by misalignment between the timing of sleep and the timing of rhythms driven by the biological clock. Light therapy can effectively treat these disorders, but the intensity and duration of light exposure required to do so has limited its practical use. In this study the investigators will test whether pre-exposure to dim light may enhance the response of the circadian system to light therapy. If so, this could result in shorter treatments that would have greater practical applications.

Detailed Description

Sleep disorders affect 35-40% of adults, resulting in diminished quality of life, and increased morbidity, mortality, and risk of automobile and occupational accidents. Circadian rhythm sleep disorders form a distinct class of sleep disorders characterized by misalignment between the timing of sleep and the circadian pacemaker. While light therapy can be an effective treatment of circadian rhythm sleep disorders, there are numerous practical limitations.

Light is the most powerful signal from the environment that influences and regulates daily biological rhythms. It is well-established that the irradiance, duration, and timing of light exposure all affect the response of the circadian system. While it was once thought that these responses were mediated through the visual system, it is now known that there is a network of intrinsically photosensitive retinal ganglion cells (ipRGCs) that mediate circadian responses to light. Other new studies have demonstrated that recent light exposure history affects the circadian response to light in humans.

These recent findings have important implications for the use of light to treat circadian rhythm disorders, including delayed and advanced sleep phase disorders, shift work sleep disorder, and jet lag, and they may also have relevance for the use of light to treat seasonal affective disorder. Up to now, little attention has been paid to the duration or intensity of light exposure prior to such light treatments. The investigators now have evidence that the human circadian system can become desensitized to light during long exposures and evidence that it can be sensitized to light by prior exposure to dim light. These recent findings suggest that light treatment protocols that sensitize the circadian system prior to the light treatment will be more effective than those currently in use.

The 13-day inpatient studies the investigators propose will examine the effect on the human circadian system of different durations of dim-light sensitization prior to a standardized light treatment. These results will be compared within subjects in a randomized cross-over design study in which each subject will receive a control treatment and a light treatment with prior dim-light sensitization. The investigators will also include circadian phase disorder patients to test these mechanisms in the target patient population. Our findings will provide an important step in understanding how new knowledge about the circadian photoreceptive system can be used to refine and provide better treatment options for circadian rhythm disorders.

Conditions

Chronobiology Disorders; Circadian Rhythm Disorders; Sleep Disorders, Circadian Rhythm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

sensitization duration 1.375h

This group will experience a 1.375h sensitization duration prior to the 12h light exposure

Group Type: EXPERIMENTAL

light exposure

Intervention Type: OTHER

12-hour light exposure of approximately 200 lux

sensitization duration 5.5h

This group will experience a 5.5h sensitization duration prior to the 12h light exposure

Group Type: EXPERIMENTAL

light exposure

Intervention Type: OTHER

12-hour light exposure of approximately 200 lux

sensitization duration 22h

This group will experience a 22h sensitization duration prior to the 12h light exposure

Group Type: EXPERIMENTAL

light exposure

Intervention Type: OTHER

12-hour light exposure of approximately 200 lux

sensitization duration 0.33h

This group will experience a 0.33h sensitization duration prior to the 12h light exposure

Group Type: EXPERIMENTAL

light exposure

Intervention Type: OTHER

12-hour light exposure of approximately 200 lux

Interventions

light exposure

12-hour light exposure of approximately 200 lux

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• healthy adults with conventional and regular sleep-wake timing
• non-smokers
• completion of medical, psychological, ophthalmological, and sleep screening tests
• able to spend 13 consecutive days/nights in the laboratory

Exclusion Criteria

• history of neurological or psychiatric disorder
• history of eye injury, eye surgery, or visual disorder (corrective lenses are acceptable)
• history of sleep disorder or regular use of sleep-promoting medication
• current prescription, herbal, or over-the-counter medication use (oral contraceptives are acceptable)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeanne Duffy

Associate Neuroscientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles A Czeisler, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Jeanne F Duffy, PhD

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

R01HL094654

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010-P-000346

Identifier Type: -

Identifier Source: org_study_id