Understanding Sleep in Hospitalized Older Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01057823
First received: January 26, 2010
Last updated: September 4, 2013
Last verified: December 2012
  Purpose

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.


Condition
Sleep Deprivation
Sleep Fragmentation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Environment and Perceived Control: Improving Sleep in Hospitalized Older Patients

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Sleep will be measured using subjective reports (Karolinska Sleep Diary on Daily Sleep Assessment). [ Time Frame: January 2010-January 2015 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep will also be measured objectively using actigraphy. [ Time Frame: January 2010-January 2015 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2010
Estimated Study Completion Date: January 2015
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Community-dwelling ambulatory patients age 50 or above hospitalized on the University of Chicago general medicine service.

Criteria

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
  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: NCT01057823

Locations
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Vineet M Arora, MD, MA University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01057823     History of Changes
Other Study ID Numbers: 16685B, 1K23AG033763-01
Study First Received: January 26, 2010
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
aged
sleep deprivation
actigraphy
ambulatory monitoring

Additional relevant MeSH terms:
Sleep Deprivation
Dyssomnias
Sleep Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014