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

NCT00928993 | Completed

• 1 other identifier: IRB00005369
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Monitoring

Keywords

actigraphy; polysomnography; pediatrics; sleep; To validate Actigraphy against polysomnography

Study Arms (1)

Main group

pediatric patients receiving overnight sleep study

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

pediatric patients receiving sleep study as part of their standard medical care

You may qualify if:

• 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)

You may not qualify if:

• 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 & Collaborators

• Oregon Health and Science University: lead
• Philips Respironics: collaborator

Study Sites (1)

Multnomah Pavilion, OHSU

Portland, Oregon, 97239, United States

Location

Study Officials

• Kyle Johnson, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2013
• Last Updated: December 27, 2019

Record last verified: 2019-12

Locations

US (1)