Unattended In-home Sleep Recording: A Pilot Study
| Tracking Information | |||||
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| First Received Date ICMJE | April 12, 2010 | ||||
| Last Updated Date | December 17, 2012 | ||||
| Start Date ICMJE | April 2010 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Sleep Architecture [ Time Frame: once ] [ Designated as safety issue: No ] Sleep architecture (stages) from polysomnography |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01102842 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Unattended In-home Sleep Recording: A Pilot Study | ||||
| Official Title ICMJE | Unattended In-home Sleep Recording: A Pilot Study | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Sleep | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 165 | ||||
| Completion Date | August 2012 | ||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01102842 | ||||
| Other Study ID Numbers ICMJE | 09-192-A | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Kristen Knutson, University of Chicago | ||||
| Study Sponsor ICMJE | University of Chicago | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Chicago | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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