NCT01057823

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
771

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 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

January 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2020

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

9.6 years

First QC Date

January 26, 2010

Last Update Submit

May 13, 2021

Conditions

Keywords

agedsleep deprivationactigraphyambulatory monitoring

Outcome Measures

Primary Outcomes (1)

  • Sleep will be measured using subjective reports (Karolinska Sleep Diary on Daily Sleep Assessment).

    January 2010-January 2015

Secondary Outcomes (1)

  • Sleep will also be measured objectively using actigraphy.

    January 2010-January 2015

Study Arms (1)

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).

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Age 50 or above
  • Hospitalized on General Medicine service
  • Ambulatory
  • Community Dwelling
  • MMSE \>17

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Vineet M Arora, MD, MA

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 27, 2010

Study Start

January 1, 2010

Primary Completion

July 19, 2019

Study Completion

July 19, 2020

Last Updated

May 17, 2021

Record last verified: 2021-05

Locations