NCT01280097

Brief Summary

The investigators will perform a prospective, cohort study of 100 older intensive care unit (ICU) patients, to investigate the association between sleep disruption and ICU delirium.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2010

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

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

1.9 years

First QC Date

January 18, 2011

Last Update Submit

July 13, 2015

Conditions

DeliriumSleep Disorders, Circadian Rhythm

Keywords

Intensive care unit deliriumSleep disruptionSleep hygieneEarly mobilization in the Intensive care unitSedative agents and sleepCircadian rhythmCognitive disorderElectroencephalography (EEG) to measure sleepConfusion Assessment Method in the Intensive Care UnitImmune functionREM sleep

Outcome Measures

Primary Outcomes (1)

  • ICU delirium

    ICU delirium will be measured using the CAM-ICU. This measurement will be done twice daily.

    Daily measurement during study

Secondary Outcomes (5)

  • Intensive Care Unit (ICU) length of stay

    Assessed at discharge from ICU

  • Hospital Length of Stay

    Assesses at discharge from hospital

  • ICU mortality

    Assessed at discharge from ICU

  • Hospital mortality

    Assessed at discharge from hospital

  • One year mortality

    Assessed at 1 year from admission to hospital

Study Arms (1)

Prospective cohort study

Observational only

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include elderly patients admitted to the intensive care unit at UCSF.

You may qualify if:

  • patients ≥ 45 years of age admitted to the ICU, and remain for at least 24 hours.

You may not qualify if:

  • status post craniotomy,
  • moribund state with planned withdrawal of life support,
  • severe dementia,
  • substantial hearing impairment or inability to understand English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143-0648, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be collected as part of the study. It will be used to measure circadian markers that will include core body temperature, cortisol and melatonin rhythms. If subjects agree, some will be stored in a bank for future research.

MeSH Terms

Conditions

DeliriumSleep Disorders, Circadian RhythmSleep HygieneCognitive Dysfunction

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersChronobiology DisordersDyssomniasSleep Wake DisordersOccupational DiseasesHealth BehaviorBehaviorCognition Disorders

Study Officials

  • Jacqueline M Leung, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 20, 2011

Study Start

December 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

July 15, 2015

Record last verified: 2015-07

Locations

US(1)