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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01057823
Other study ID # 16685B
Secondary ID 1K23AG033763-01
Status Completed
Phase
First received
Last updated
Start date January 2010
Est. completion date July 19, 2020

Study information

Verified date May 2021
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

This research can lead to a better understanding of the effects of inpatient sleep on health outcomes for hospitalized older patients and can help inform the design and evaluation of interventions designed to improve sleep in hospitalized older patients. This work can also form the foundation for understanding the longer term health effects of inpatient sleep loss for older patients that are potentially modifiable.


Recruitment information / eligibility

Status Completed
Enrollment 771
Est. completion date July 19, 2020
Est. primary completion date July 19, 2019
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States The University of Chicago Medical Center Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Chicago National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep will be measured using subjective reports (Karolinska Sleep Diary on Daily Sleep Assessment). January 2010-January 2015
Secondary Sleep will also be measured objectively using actigraphy. January 2010-January 2015
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