New Data Analysis Methods for Actigraphy in Sleep Medicine

NCT ID: NCT00949858

Last Updated: 2017-07-31

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

635 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2014-01-22

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea Restless Leg Syndrome Insomnia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Utah State University

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Shannon, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University Sleep Medicine Center

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL092347-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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