Unattended In-home Sleep Recording: A Pilot Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01102842
First received: April 12, 2010
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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.


Condition
Sleep

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Unattended In-home Sleep Recording: A Pilot Study

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Sleep Architecture [ Time Frame: once ] [ Designated as safety issue: No ]
    Sleep architecture (stages) from polysomnography


Enrollment: 165
Study Start Date: April 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • Must have had a polysomnography recording at the University of Chicago.

Exclusion Criteria:

  • None.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102842

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Kristen Knutson, PhD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01102842     History of Changes
Other Study ID Numbers: 09-192-A
Study First Received: April 12, 2010
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 26, 2014