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Clinical Trials/NCT00928993
NCT00928993
Completed
Not Applicable

An Evaluation of Actigraphy as an Indicator of Sleep and Wake in Children

Oregon Health and Science University1 site in 1 country48 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Monitoring
Sponsor
Oregon Health and Science University
Enrollment
48
Locations
1
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to learn how well an instrument called an Actiwatch-2 can determine whether a child is asleep or awake. The Actiwatch-2 (manufactured by Minimitter/Respironics of Bend, Oregon) is the brand name for an actigraphy monitor; that is, a motion sensor that is typically worn on the wrist and looks like a wrist watch. It measures and records the amount of movement a person makes each minute. After being worn overnight, data are transferred from the Actiwatch to a computer, and a program estimates whether a person is awake or asleep by analyzing the recorded movement data. The enrollment target is 80 participants. Although other actigraphy equipment has been used to monitor sleep in children, the Actiwatch-2 has not been validated in the pediatric population.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
June 2013
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children (ages 6 months to 18 years) who are undergoing a medically necessary sleep study \[polysomnography (PSG)\] in the OHSU Sleep Disorders Laboratory
  • ASA classification I and II (children in good health)

Exclusion Criteria

  • ASA classification III, IV (children with a chronic or severe disease).
  • Children with developmental delay.
  • Children born extremely prematurely (before 32 weeks gestation), as these children and their parents may react differently to experimental procedures
  • Children who do not speak English or whose parents do not speak English.

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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