Light Sensitization Study

NCT01327040 | Completed

• 2 other identifiers: 2010-P-000346R01HL094654
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

light; melatonin; circadian; delayed sleep phase disorder; circadian light sensitivity; circadian timing system

Outcome Measures

Primary Outcomes (1)

• circadian phase timing

  timing of circadian phase as assessed using melatonin and temperature data

  During inpatient study, on days 6-7 and 11-12

Secondary Outcomes (1)

• melatonin suppression

  During inpatient study, on days 6-7 and 11-12

Study Arms (4)

sensitization duration 1.375h

EXPERIMENTAL

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

Other: light exposure

sensitization duration 5.5h

EXPERIMENTAL

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

Other: light exposure

sensitization duration 22h

EXPERIMENTAL

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

Other: light exposure

sensitization duration 0.33h

EXPERIMENTAL

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

Other: light exposure

Interventions

light exposure OTHER

12-hour light exposure of approximately 200 lux

sensitization duration 0.33h; sensitization duration 1.375h; sensitization duration 22h; sensitization duration 5.5h

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Chronobiology Disorders; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders

Study Officials

• Charles A Czeisler, PhD, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Jeanne F Duffy, PhD

  Brigham and Women's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Neuroscientist

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 1, 2011
• Study Start: October 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2020
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)