NCT02088593

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

2.5 years

First QC Date

February 26, 2014

Last Update Submit

May 23, 2023

Conditions

Keywords

Medical Students

Outcome Measures

Primary Outcomes (1)

  • Sleep quality

    3 months

Study Arms (2)

DAWN simulation

EXPERIMENTAL

Simulated Dawn Light box

Device: Simulated Dawn Light BoxBehavioral: Sleep Hygiene instructions

Sleep hygiene instructions read aloud

ACTIVE COMPARATOR

Standard sleep hygiene instructions were read aloud.

Behavioral: Sleep Hygiene instructions

Interventions

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.

Also known as: per3 model of Naturebright
DAWN simulation

Sleep Hygiene instructions read aloud

DAWN simulationSleep hygiene instructions read aloud

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14260, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersFatigueSleepiness

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gregory Sahlem, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2014

First Posted

March 17, 2014

Study Start

July 1, 2007

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations