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Simulated Dawn Med Students

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088593
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
University at Buffalo
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
Medical students score higher than the general population on measures of depression, anxiety, fatigue, poor sleep and sleepiness. Data suggest that disparages in circadian phase might contribute to these problems. From an internal validity standpoint, first year medical students are an ideal group to study. The majority of the students will be matched on variables such as education, age, and intelligence. However, more importantly, they have a nearly identical life style when it comes to factors such as schedule, living conditions, level of stress, and timing of stressors. The specific aim and hypothesis is:Medical students randomized to sleep hygiene counseling plus simulated dawn will report less depression, anxiety, fatigue, sleepiness, and sleep disruption (as measured by standardized questionnaires) than students randomized to just sleep hygiene counseling.

Condition or disease Intervention/treatment Phase
Depression Anxiety Fatigue Sleepiness Sleep Disruption Device: Simulated Dawn Light Box Behavioral: Sleep Hygiene instructions Not Applicable

Detailed Description:

There is a substantial and growing body of literature that has identified medical students as a group that suffers from increased levels of depression, anxiety, and other markers of "psychological distress". Other studies have demonstrated that in conjunction with the "psychological distress", medical students suffer from sleep deprivation, sleep disruption, and daytime sleepiness. Finally there is some preliminary evidence that residents and interns show increased symptoms of fatigue. It might reasonably be assumed that all of these symptoms are inter-related and more importantly detrimental to both the student and those patients under their care. There have been interventional studies aimed at educating participants on stress management, however these attempts have had only limited success.

Circadian rhythms are biological rhythms that contribute to most of our bodies' physiological processes. It has been determined that light is the major environmental cue that influences the setting of our circadian rhythm. Under ideal circumstances exposure to natural sunlight is sufficient to maintain a consistent and synchronized circadian rhythm. Often times this is not the case. Reduced exposure to natural light and increased exposure to artificial light are just two influencing factors.

Artificial light therapy has been successfully applied to the treatment of disorders of circadian rhythms as well as the treatment of some affective disorders. Most notably, light therapy has been shown to be effective in treating symptoms of depression and sleep disruption, specifically in patients with seasonal affective disorder, non-seasonal major depression, delayed sleep phase syndrome, advanced sleep phase syndrome, and sub-syndromal levels of each of these.

The theoretical mechanism of action is reviewed by Terman et al and asserts that morning bright light therapy advances and stabilizes the circadian rhythm of individuals who have delayed or drifting rhythms. There is subsequent synchronization and entrainment of the individual's endogenous rhythm with the environmental rhythm of daily life as reviewed in.

The timing, duration, and type of light delivered are of paramount concern, as improper delivery of therapy has been shown to have no advantage over placebo. One method of light delivery is simulated dawn light therapy. Simulated dawn light therapy works by gradually increasing light exposure over a specified period of time at the end of the sleep period. This gradually increasing light exposure during the sleep period is in contrast to traditional light therapy, which is delivered at full intensity after wake time. Simulated dawn has shown great promise as being just as effective as traditional light therapy but with the additional advantages of being more time efficient, easier to use, and more easily tolerated. All of these factors are important considerations in the application of this intervention to medical students, as being short on time and under significant stress are both hallmarks of medical education. The following proposal is a novel approach, using light therapy, to improve the mental well-being of first year medical students.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Improving Sleep and Circadian Rhythms on Affective Symptoms In First Year Medical Students
Study Start Date : July 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep

Arm Intervention/treatment
Experimental: DAWN simulation
Simulated Dawn Light box
Device: Simulated Dawn Light Box
per3 model of Naturebright It was set at the participants habitual wake time, and automatically began ramping between 30 and 90 minutes prior to that time (based upon participant preference). The ramp increased in a curvilinear fashion, mimicking sunrise during the summer at 45 degrees North latitude and reached a maximum light intensity of 300lux. They were allowed to switch the lamp off during the ramp period, and sleep in on off days, but were asked to allow the light to begin its ramp.
Other Name: per3 model of Naturebright

Behavioral: Sleep Hygiene instructions
Sleep Hygiene instructions read aloud

Active Comparator: Sleep hygiene instructions read aloud
Standard sleep hygiene instructions were read aloud.
Behavioral: Sleep Hygiene instructions
Sleep Hygiene instructions read aloud




Primary Outcome Measures :
  1. Sleep quality [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Being a first year medical student
  • Good academic standing after the first module
  • Reporting attending morning lectures regularly.

Exclusion Criteria:

  • No reported history of psychiatric illness,sleep illness, ophthalmic illness
  • No current use of photosensitizing medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088593


Locations
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United States, New York
University at Buffalo
Buffalo, New York, United States, 14260
Sponsors and Collaborators
Medical University of South Carolina
University at Buffalo
Investigators
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Principal Investigator: Gregory Sahlem, MD Medical University of South Carolina
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02088593    
Other Study ID Numbers: Dawn
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of South Carolina:
Medical Students
Additional relevant MeSH terms:
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Sleepiness