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

Sleep Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928993
• Other study ID #: IRB00005369
• Status: Completed
• Start date: June 2009
• Est. completion date: June 2013

Study information

• Verified date: December 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Monitoring

Locations

Country	Name	City	State
United States	Multnomah Pavilion, OHSU	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Philips Respironics

Country where clinical trial is conducted

United States,