Simulated Dawn Med Students
Primary Purpose
Depression, Anxiety, Fatigue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simulated Dawn Light Box
Sleep Hygiene instructions
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Medical Students
Eligibility 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
Sites / Locations
- University at Buffalo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DAWN simulation
Sleep hygiene instructions read aloud
Arm Description
Simulated Dawn Light box
Standard sleep hygiene instructions were read aloud.
Outcomes
Primary Outcome Measures
Sleep quality
Secondary Outcome Measures
Full Information
NCT ID
NCT02088593
First Posted
February 26, 2014
Last Updated
May 23, 2023
Sponsor
Medical University of South Carolina
Collaborators
University at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT02088593
Brief Title
Simulated Dawn Med Students
Official Title
The Effect of Improving Sleep and Circadian Rhythms on Affective Symptoms In First Year Medical Students
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
University at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Fatigue, Sleepiness, Sleep Disruption
Keywords
Medical Students
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DAWN simulation
Arm Type
Experimental
Arm Description
Simulated Dawn Light box
Arm Title
Sleep hygiene instructions read aloud
Arm Type
Active Comparator
Arm Description
Standard sleep hygiene instructions were read aloud.
Intervention Type
Device
Intervention Name(s)
Simulated Dawn Light Box
Other Intervention Name(s)
per3 model of Naturebright
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene instructions
Intervention Description
Sleep Hygiene instructions read aloud
Primary Outcome Measure Information:
Title
Sleep quality
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Sahlem, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14260
Country
United States
12. IPD Sharing Statement
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Simulated Dawn Med Students
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