New Data Analysis Methods for Actigraphy in Sleep Medicine

Completed

• Conditions: Restless Leg Syndrome; Insomnia; Obstructive Sleep Apnea

• Registration Number: NCT00949858
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this study is to develop statistical and informatics tools for analyzing and visualizing Actical™ (actigraphy) data linked to fatigue in Sleep Medicine Center patients.

Detailed Description

An Actical™ is a watch-like device attached to the wrist that uses an accelerometer to measure movement nearly continuously over several days. The American Academy of Sleep Medicine practice parameters report that actigraphy is a useful tool for detecting sleep in healthy individuals, assessing specific aspects in insomnia and restless legs syndrome, circadian-rhythm disorders, and excessive sleepiness. Concurrent with these recommendations is an increased interest in the use of actigraphy as a tool for objectively measuring fatigue. With improved high-end statistical methods for analyzing this data, actigraphy has the potential to become more important as an objective diagnostic tool for determining fatigue, sleep abnormalities and assessing response to treatment.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-28
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-30
• Primary Completion: 2014-01
• Study Completion: 2014-01-22
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 635

Inclusion Criteria

• Patient presenting to the Washington University Sleep Medicine Center for evaluation of obstructive sleep apnea syndrome, restless legs syndrome, or insomnia
• Older than 18 years of age
• Ability to consent to participation in the study
• Willingness to wear the Actical™ for two 7 day periods and to return the equipment promptly

Exclusion Criteria

• Inability to provide valid consent
• Pregnancy
• Night or rotating shift workers

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Define an object oriented data model for actigraphy and patient level data.	6 months

Secondary Outcome Measures

Name	Time	Method
Apply existing and develop new advanced statistical and visualization methods for actigraphy data and include them in the data model listed above.	6 months

Trial Locations

Locations (1)

Washington University Sleep Medicine Center; 🇺🇸 Saint Louis, Missouri, United States