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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Monitoring

Keywords

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actigraphy polysomnography pediatrics sleep To validate Actigraphy against polysomnography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Main group

pediatric patients receiving overnight sleep study

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyle Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Multnomah Pavilion, OHSU

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00005369

Identifier Type: -

Identifier Source: org_study_id