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

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ClinicalTrials.gov Identifier: NCT00928993
Recruitment Status : Unknown
Verified September 2009 by Oregon Health and Science University.
Recruitment status was:  Not yet recruiting
First Posted : June 26, 2009
Last Update Posted : September 15, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease
Sleep Monitoring

Study Design

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation of Actigraphy as an Indicator of Sleep and Wake in Children
Study Start Date : June 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2012
Groups and Cohorts

Group/Cohort
Main group
pediatric patients receiving overnight sleep study


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

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