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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Oregon Health and Science University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Philips/Respironics Mini-Mitter
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00928993
First received: June 25, 2009
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition
Sleep Monitoring

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation of Actigraphy as an Indicator of Sleep and Wake in Children

Further study details as provided by Oregon Health and Science University:

Estimated Enrollment: 80
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Main group
pediatric patients receiving overnight sleep study

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928993

Contacts
Contact: Caitlin Murray, BA 503-494-7760 murray@ohsu.edu

Locations
United States, Oregon
Multnomah Pavilion, OHSU Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Caitlin Murray, BA     503-494-7760     murray@ohsu.edu    
Principal Investigator: Kyle Johnson, MD            
Sponsors and Collaborators
Oregon Health and Science University
Philips/Respironics Mini-Mitter
Investigators
Principal Investigator: Kyle Johnson, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Susan Bankowski, M.S., J.D., Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00928993     History of Changes
Other Study ID Numbers: IRB00005369
Study First Received: June 25, 2009
Last Updated: September 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
actigraphy
polysomnography
pediatrics
sleep
To validate Actigraphy against polysomnography

ClinicalTrials.gov processed this record on June 18, 2013