- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01102842
Unattended In-home Sleep Recording: A Pilot Study
September 4, 2013 updated by: University of Chicago
Laboratory studies have found that insufficient sleep duration and impaired sleep quality are associated with disease risk, including obesity, diabetes and heart disease.
The limitation to the laboratory studies is that they are conducted in artificial environments that do not reflect real-world behavior.
Although the epidemiologic studies do reflect habitual behavior, the vast majority of them rely on self-reported measures of sleep, which are only moderately correlated with objective measures of sleep..
The next logical step in the examination of sleep's role in cardiometabolic health is to conduct objective, detailed measures of sleep in people's homes.
This project is a pilot study that will develop ideal methodologies for recording sleep in the home environment.
Because there is currently is a gap between laboratory models of sleep loss and real world conditions, the ultimate goal of this research is to expand our work on sleep and cardiometabolic health outside of the laboratory.
Given the strong evidence for a link between impaired and insufficient sleep and increased disease risk, it is critical that we understand how people sleep in their daily lives and what factors can impact sleep.
This project will record sleep in people's homes using ambulatory polysomnography recordings and wrist actigraphy.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
165
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- The University of Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult volunteers (18 years of age and older) who have had a polysomnography recording in the laboratory at the University of Chicago.
Description
Inclusion Criteria:
- Must have had a polysomnography recording at the University of Chicago.
Exclusion Criteria:
- None.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Architecture
Time Frame: once
|
Sleep architecture (stages) from polysomnography
|
once
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kristen Knutson, PhD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
April 12, 2010
First Submitted That Met QC Criteria
April 12, 2010
First Posted (Estimate)
April 13, 2010
Study Record Updates
Last Update Posted (Estimate)
September 5, 2013
Last Update Submitted That Met QC Criteria
September 4, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 09-192-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep
-
University of Wisconsin, MadisonPhilips HealthcareCompletedSleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
-
Brain Electrophysiology Laboratory CompanyRecruiting
-
University GhentEuropean CommissionCompleted
-
Northumbria UniversityCompletedSleep | Mood | Poor Quality Sleep | Good Sleep HabitUnited Kingdom
-
Baylor College of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruiting
-
Brain Electrophysiology Laboratory CompanyCompletedSleep | Sleep HygieneUnited States
-
Koko Home, Inc.Stanford UniversityRecruitingSleep Disorder | Insomnia | Sleep Initiation and Maintenance Disorders | Sleep | Sleep Disturbance | Sleep HygieneUnited States
-
Medical College of WisconsinChildren's Hospital and Health System Foundation, Wisconsin; Divine Savior...Active, not recruitingSleep | Sleep HygieneUnited States
-
Aretaieion University HospitalRecruitingSleep Disorder | Sleep Initiation and Maintenance Disorders | Sleep | Sleep Disturbance | Surgery | Anesthesia | Sleep Fragmentation | Sleep Disorders, Circadian RhythmGreece
-
Brigham and Women's HospitalCharite University, Berlin, Germany; Stanford UniversityRecruitingSleep Disorders, Intrinsic | Sleep Wake Disorders | Sleep Disorders, Circadian Rhythm | Advanced Sleep Phase Syndrome (ASPS) | Delayed Sleep Phase Syndrome | Shift-Work Sleep Disorder | Delayed Sleep Phase | Non-24 Hour Sleep-Wake Disorder | Advanced Sleep Phase Syndrome | Advanced Sleep Phase | Irregular... and other conditionsUnited States