NCT01102842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

2.3 years

First QC Date

April 12, 2010

Last Update Submit

September 4, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sleep Architecture

    Sleep architecture (stages) from polysomnography

    once

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Study Officials

  • Kristen Knutson, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 13, 2010

Study Start

April 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations