- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01057823
Understanding Sleep in Hospitalized Older Patients
Environment and Perceived Control: Improving Sleep in Hospitalized Older Patients
The overall goal of this research is to elucidate how environmental, healthcare, and patient-level factors and patients' level of perceived control impact sleep duration and quality in hospitalized older patients and to assess whether better in-hospital sleep is associated with improved physical activity and health outcomes.
We hypothesize that environment, healthcare disruptions and patient symptoms will be significantly associated with objective and subjective sleep duration and sleep quality in hospitalized older patients.
We also hypothesize that a high level of perceived control will be associated with improved sleep duration and quality in hospitalized older patients.
We further hypothesize that shorter sleep duration and quality in hospitalized older adults will be associated with adverse health outcomes, namely higher blood pressure and blood sugar.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- The University of Chicago Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 50 or above
- Hospitalized on General Medicine service
- Ambulatory
- Community Dwelling
- MMSE >17
Exclusion Criteria:
- transfer from the ICU or another hospital
- cognitively impaired
- not ambulatory
- residents of a nursing home or skilled nursing facility
- on bedrest
- documented sleep disorder in their medical history
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Inpatient Elders Age 50 and up
The study population is community-dwelling ambulatory patients age 50 or above hospitalized on the University of Chicago general medicine service.
Exclusion criteria include: (1) transfer from the ICU or another hospital; (2) cognitively impaired; (3) not ambulatory; (4) residents of a nursing home or skilled nursing facility; (5) on bedrest; (6)documented sleep disorder in their medical history (i.e.
obstructive sleep apnea, narcolepsy, etc).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sleep will be measured using subjective reports (Karolinska Sleep Diary on Daily Sleep Assessment).
Time Frame: January 2010-January 2015
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January 2010-January 2015
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Sleep will also be measured objectively using actigraphy.
Time Frame: January 2010-January 2015
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January 2010-January 2015
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vineet M Arora, MD, MA, University of Chicago
Publications and helpful links
General Publications
- Arora VM, Chang KL, Fazal AZ, Staisiunas PG, Meltzer DO, Zee PC, Knutson KL, Van Cauter E. Objective sleep duration and quality in hospitalized older adults: associations with blood pressure and mood. J Am Geriatr Soc. 2011 Nov;59(11):2185-6. doi: 10.1111/j.1532-5415.2011.03644.x. No abstract available.
- Yoder JC, Staisiunas PG, Meltzer DO, Knutson KL, Arora VM. Noise and sleep among adult medical inpatients: far from a quiet night. Arch Intern Med. 2012 Jan 9;172(1):68-70. doi: 10.1001/archinternmed.2011.603. No abstract available.
- Adachi M, Staisiunas PG, Knutson KL, Beveridge C, Meltzer DO, Arora VM. Perceived control and sleep in hospitalized older adults: a sound hypothesis? J Hosp Med. 2013 Apr;8(4):184-90. doi: 10.1002/jhm.2027. Epub 2013 Mar 18.
- DePietro RH, Knutson KL, Spampinato L, Anderson SL, Meltzer DO, Van Cauter E, Arora VM. Association Between Inpatient Sleep Loss and Hyperglycemia of Hospitalization. Diabetes Care. 2017 Feb;40(2):188-193. doi: 10.2337/dc16-1683. Epub 2016 Nov 30.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16685B
- 1K23AG033763-01 (U.S. NIH Grant/Contract)
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.
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