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Sleep Length and Circadian Regulation in Humans

Sleep Length and Circadian Regulation in Humans

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00843843
Acronym
HAM
Enrollment
16
Registered
2009-02-13
Start date
2008-03-31
Completion date
2014-02-28
Last updated
2016-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorders

Keywords

Circadian Rhythms

Brief 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.

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.

Interventions

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy adult volunteers

Exclusion criteria

* color blindness with the Ishihara test * obese people (BMI \> 30)

Design outcomes

Primary

MeasureTime frameDescription
Dim Light Melatonin Onset (Hours)12 days from baseline to final dim light melatonin onsetGold standard marker of circadian timing

Secondary

MeasureTime frameDescription
Psychomotor Vigilanceafter short or long nightsFastest 10% reaction time (msec)

Countries

United States

Participant flow

Participants by arm

ArmCount
9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep
Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
8
3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap
Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
8
Total16

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPhysician Decision11
Overall StudyProtocol Violation11

Baseline characteristics

Characteristic9 Hour Sleep, Then 3 Hour Nap and 6 Hour SleepTotal3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap
Age, Continuous30.5 years
STANDARD_DEVIATION 9
28.5 years
STANDARD_DEVIATION 7.5
26.5 years
STANDARD_DEVIATION 5.8
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants2 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants14 Participants6 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
6 Participants8 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
2 Participants6 Participants4 Participants
Region of Enrollment
United States
8 participants16 participants8 participants
Sex: Female, Male
Female
4 Participants8 Participants4 Participants
Sex: Female, Male
Male
4 Participants8 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 80 / 8
serious
Total, serious adverse events
0 / 80 / 8

Outcome results

Primary

Dim Light Melatonin Onset (Hours)

Gold standard marker of circadian timing

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

ArmMeasureValue (MEAN)Dispersion
9 Hour SleepDim Light Melatonin Onset (Hours)1.93 hoursStandard Deviation 0.98
3 Hour Nap and 6 Hour SleepDim Light Melatonin Onset (Hours)0.80 hoursStandard Deviation 0.92
Secondary

Psychomotor Vigilance

Fastest 10% reaction time (msec)

Time frame: after short or long nights

Population: Means

ArmMeasureValue (MEAN)Dispersion
9 Hour SleepPsychomotor Vigilance215.15 msecStandard Deviation 32.57
3 Hour Nap and 6 Hour SleepPsychomotor Vigilance221.16 msecStandard Deviation 33.56

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026