CClinicalTrials.gg
CompletedNCT00843843HAMUpdated Mar 8, 2016Results posted

Sleep Length and Circadian Regulation in Humans

An interventional study of Bright light box in Sleep Disorders, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-08.

Sponsored by Rush University Medical Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This research will examine why sleep restriction reduces the body clock's response to bright light. The results will enable the optimization of the bright light treatment of people who suffer from circadian rhythm sleep disorders, which include shift work sleep disorder, jet lag, delayed sleep phase syndrome and winter depression, thereby improving public health and safety, well-being, mood, mental function, and quality of life.

Read the detailed description

Millions of Americans suffer from circadian rhythm sleep disorders, which include shift work sleep disorder, jet lag, delayed sleep phase syndrome and possibly winter depression. These conditions are typically characterized by persistent insomnia and/or excessive daytime sleepiness, impaired performance, and gastrointestinal distress. These negative symptoms result from a misalignment between the timing of the external social world and the timing of the internal circadian (body) clock. Circadian rhythm sleep disorders are effectively treated with bright light, which phase shifts the circadian clock, thereby realigning it with the timing of the external social world.

It is widely recognized that social influences have led to an increasing prevalence of sleep restriction in modern society. We recently demonstrated for the first time that short sleep episodes, when compared to long sleep episodes, markedly reduce phase advances to bright light. Thus when people cut their sleep short, they inadvertently reduce their circadian responsiveness to bright light. The mechanism(s) behind these reduced phase shifts to light are unknown. However, there are at least two aspects of short sleep episodes that could be responsible for this effect. First, short sleep episodes are associated with partial sleep deprivation. Second, as humans sleep with their eyes closed and are usually exposed to light when awake, short sleep episodes are also associated with short dark lengths. Our overall goal is to determine the biobehavioral mechanisms by which short sleep episodes impair phase shifts to bright light. Specific Aim 1 is to determine the effect of partial sleep deprivation on phase advances to light, while controlling for dark length. Specific Aim 2 is to determine the effect of short dark lengths on phase advances to light while minimizing sleep deprivation. We will estimate the timing of the human circadian clock by measuring salivary melatonin, a neuroendocrine hormone released from the pineal gland, and collecting measures of sleep via actigraphy, and sleepiness, mood, gastrointestinal distress and cognitive performance via computerized assessment.

Characterization of the separate effects of sleep deprivation and dark length on circadian phase shifts to light in humans is critical to understanding how humans respond to light during their daily life activities. Furthermore, the findings of this research will produce important and practical recommendations for avoiding decrements to phase shifts to light, thereby optimizing the bright light treatment of circadian rhythm sleep disorders, and thus improving public health and safety, well-being, mood, cognitive function, and quality of life.

02

Conditions studied

  • Sleep Disorders

Browse trials for

Keywords

  • Circadian Rhythms
03

In context

Sleep Wake Disorders

788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.

This study's enrollment of 16 is below the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.

Browse Sleep Wake Disorders studies →

Lead sponsor

Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy adult volunteers

Exclusion criteria

Exclusion Criteria:

  • color blindness with the Ishihara test
  • obese people (BMI > 30)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    9 hour sleep, then 3 hour nap and 6 hour sleep

    Device: Bright light box

  • Active comparator
    3 hour nap and 6 hour sleep, then 9 hour sleep

    Device: Bright light box

Interventions

  • DeviceBright light box

    Bright light of about 5000 lux, administered while sitting at a desk.

06

What researchers measure

Primary outcomes

  1. Dim Light Melatonin Onset (Hours)

    Gold standard marker of circadian timing

    Time frame: 12 days from baseline to final dim light melatonin onset

Secondary outcomes

  1. Psychomotor Vigilance

    Fastest 10% reaction time (msec)

    Time frame: after short or long nights

07

Results

Posted Mar 8, 2016

Participant flow

Participant flow — Overall Study
Milestone9 Hour Sleep (3days), Then 3 Hour Nap and 6 Hour Sleep (3days)3 Hour Nap and 6 Hour Sleep (3days), Then 9 Hour Sleep (3days)
Started88
Completed66
Not completed22
Withdrew: Physician decision11
Withdrew: Protocol violation11

Outcome measures

PrimaryDim Light Melatonin Onset (Hours)

Gold standard marker of circadian timing

Time frame:
12 days from baseline to final dim light melatonin onset
Reported as:
Mean · hours
Dim Light Melatonin Onset (Hours)
hours9 Hour Sleep3 Hour Nap and 6 Hour Sleep
Dim Light Melatonin Onset (Hours)1.93 ± 0.980.80 ± 0.92
SecondaryPsychomotor Vigilance

Fastest 10% reaction time (msec)

Time frame:
after short or long nights
Reported as:
Mean · msec
Psychomotor Vigilance
msec9 Hour Sleep3 Hour Nap and 6 Hour Sleep
Psychomotor Vigilance215.15 ± 32.57221.16 ± 33.56

Adverse events

Collected over Duration of study = 48 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
9 Hour Sleep—0/8 (0%)0/8 (0%)
3 Hour Nap and 6 Hour Sleep—0/8 (0%)0/8 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep3 Hour Nap and 6 Hour Sleep, Then 9 Hour NapTotal
Mean30.5 ± 9.026.5 ± 5.828.5 ± 7.5
Sex: Female, Male
Sex: Female, Male(Participants)9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep3 Hour Nap and 6 Hour Sleep, Then 9 Hour NapTotal
Female448
Male448
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep3 Hour Nap and 6 Hour Sleep, Then 9 Hour NapTotal
Hispanic or Latino022
Not Hispanic or Latino8614
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep3 Hour Nap and 6 Hour Sleep, Then 9 Hour NapTotal
American Indian or Alaska Native000
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American628
White246
More than one race000
Unknown or Not Reported011
Region of Enrollment
Region of Enrollment(participants)9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep3 Hour Nap and 6 Hour Sleep, Then 9 Hour NapTotal
United States8816
08

Study locations

1 site
  • Biological Rhythms Research Laboratory, RUMC
    Chicago, Illinois 60612, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00843843
Lead sponsor
Rush University Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Helen Burgess (Associate Professor, Rush University Medical Center) — Principal investigator
First posted
Feb 13, 2009
Start date
Mar 2008
Primary completion
Feb 2014
Completion
Feb 2014
Results posted
Mar 8, 2016
Last update
Mar 8, 2016

Study contacts

Helen Burgess, PhD
principal investigator · Rush University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion