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Improving Sleep in the Pediatric Intensive Care Unit

NCT00178321 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-04-30

No results posted yet for this study

Summary

Sleep is disrupted in the PICU. This disruption has been reported in studies that have used: (a) observation of sleep-wake cycles (b) self-reports by children themselves , and (c) objective measures (e.g., electroencephalograph( EEG). Noise and light levels have been correlated with profound sleep disruption in the PICU . Sleep disruption is known to have a profound impact on the overall health of a child, both from a physiological and a psychological standpoint . In addition, sleep disruption has been shown to change cortisol levels, cause impaired immune responses and impair cognitive function in both children and adults . Disruption in sleep also is known to impair healing through these many complex connections with other homeostatic processes in the human body. What is the effect of wearing earplugs in critically ill children admitted to the PICU on:

1. Sleep states
2. Physiological stability (e.g. melatonin, cortisol and immune status)
3. Sleep habits after discharge from the PICU (on the general pediatric unit, 2 weeks and 2 months after discharge), and
4. Child behavior at 2 weeks and 2 months after discharge from the PICU by parent report on the Child Behavior Checklist (CBCL).

Conditions

  • Critically Ill

Interventions

DEVICE

earplugs

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Principal Investigators

  • Margaret-Ann Carno, PhD, RN · University of Rochester

  • Heidi V. Connolly, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Completion
2006-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00178321 on ClinicalTrials.gov