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Sleep Length and Circadian Regulation in Humans (HAM)

Primary Purpose

Sleep Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bright light box
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Disorders focused on measuring Circadian Rhythms

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy adult volunteers

Exclusion Criteria:

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

Sites / Locations

  • Biological Rhythms Research Laboratory, RUMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

9 hour sleep, then 3 hour nap and 6 hour sleep

3 hour nap and 6 hour sleep, then 9 hour sleep

Arm Description

Outcomes

Primary Outcome Measures

Dim Light Melatonin Onset (Hours)
Gold standard marker of circadian timing

Secondary Outcome Measures

Psychomotor Vigilance
Fastest 10% reaction time (msec)

Full Information

First Posted
February 12, 2009
Last Updated
February 9, 2016
Sponsor
Rush University Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00843843
Brief Title
Sleep Length and Circadian Regulation in Humans
Acronym
HAM
Official Title
Sleep Length and Circadian Regulation in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders
Keywords
Circadian Rhythms

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
9 hour sleep, then 3 hour nap and 6 hour sleep
Arm Type
Active Comparator
Arm Title
3 hour nap and 6 hour sleep, then 9 hour sleep
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Bright light box
Intervention Description
Bright light of about 5000 lux, administered while sitting at a desk.
Primary Outcome Measure Information:
Title
Dim Light Melatonin Onset (Hours)
Description
Gold standard marker of circadian timing
Time Frame
12 days from baseline to final dim light melatonin onset
Secondary Outcome Measure Information:
Title
Psychomotor Vigilance
Description
Fastest 10% reaction time (msec)
Time Frame
after short or long nights

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy adult volunteers Exclusion Criteria: color blindness with the Ishihara test obese people (BMI > 30)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Burgess, PhD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biological Rhythms Research Laboratory, RUMC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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Sleep Length and Circadian Regulation in Humans

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