DepressionNCT02088593
Simulated Dawn Med Students
A study testing Simulated Dawn Light Box and Sleep Hygiene instructions in people with Depression and Anxiety, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Fatigue
- What is being tested?
- Simulated Dawn Light Box and Sleep Hygiene instructions
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being a first year medical student
- Good academic standing after the first module
- Reporting attending morning lectures regularly.
Who cannot join
- No reported history of psychiatric illness,sleep illness, ophthalmic illness
- No current use of photosensitizing medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Improving Sleep and Circadian Rhythms on Affective Symptoms In First Year Medical Students
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.
Read the 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.
- Conditions
- Depression, Anxiety, Fatigue, Sleepiness, Sleep Disruption
- Being tested
- Simulated Dawn Light Box, Sleep Hygiene instructions
- Keywords
- Medical Students
- Medical subject headings
- Depression, Anxiety Disorders, Fatigue, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated Dawn Light BoxDevice
Also called per3 model of Naturebright
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.
Sleep Hygiene instructionsBehavioural
Sleep Hygiene instructions read aloud
| Study group | Role | What they receive |
|---|---|---|
| DAWN simulation | Experimental | Simulated Dawn Light box Receives: Device: Simulated Dawn Light Box; Behavioral: Sleep Hygiene instructions |
| Sleep hygiene instructions read aloud | Active comparator | Standard sleep hygiene instructions were read aloud. Receives: Behavioral: Sleep Hygiene instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startJul 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo
- Responsible party
- Sponsor
- Investigators
- Gregory Sahlem, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088593
- Sponsor's protocol ID
- Dawn
- Status last verified
- May 2023
- First submitted
- 26 Feb 2014
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Improving Sleep and Circadian Rhythms on Affective Symptoms In First Year Medical Students
- ClinicalTrials.gov ID
- NCT02088593
- Acronym / sponsor ID
- Dawn
- Conditions
- Depression, Anxiety, Fatigue, Sleepiness, Sleep Disruption
- Keywords
- Medical Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- University at Buffalo
- Study start
- Jul 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAWN simulation | Experimental | Device: Simulated Dawn Light Box, Behavioral: Sleep Hygiene instructionsSimulated Dawn Light box |
| Sleep hygiene instructions read aloud | Active comparator | Behavioral: Sleep Hygiene instructionsStandard sleep hygiene instructions were read aloud. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being a first year medical student
- Good academic standing after the first module
- Reporting attending morning lectures regularly.
Key exclusion criteria (2 listed)
- No reported history of psychiatric illness,sleep illness, ophthalmic illness
- No current use of photosensitizing medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated Dawn Light BoxAlso: per3 model of Naturebrightper3 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. | Device | DAWN simulation |
| Sleep Hygiene instructionsSleep Hygiene instructions read aloud | Behavioural | DAWN simulation, Sleep hygiene instructions read aloud |
Primary outcome
Sleep quality
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Sahlem, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated Dawn Light Box and Sleep Hygiene instructions in people with Depression and Anxiety, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.