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OpenTrials
Completed

NCT Number: NCT00928993

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

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.

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Key information

Conditions

Sleep Monitoring

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Multnomah Pavilion, OHSU

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Philips Respironics

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Jun 26, 2009
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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