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New Data Analysis Methods for Actigraphy in Sleep Medicine

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ClinicalTrials.gov Identifier: NCT00949858
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : July 31, 2017
Sponsor:
Collaborator:
Utah State University
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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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.

Condition or disease
Obstructive Sleep Apnea Restless Leg Syndrome Insomnia

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 Design
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Study Type : Observational
Actual Enrollment : 635 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Data Analysis Methods for Actigraphy in Sleep Medicine
Study Start Date : July 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 22, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Define an object oriented data model for actigraphy and patient level data. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Apply existing and develop new advanced statistical and visualization methods for actigraphy data and include them in the data model listed above. [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen in clinic at the Washington University Sleep Medicine Center.
Criteria

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
Contacts and Locations
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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): NCT00949858


Locations
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United States, Missouri
Washington University Sleep Medicine Center
Saint Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Utah State University
Investigators
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Principal Investigator: William Shannon, PhD Washington University School of Medicine
More Information
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00949858    
Other Study ID Numbers: R01HL092347-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Keywords provided by Washington University School of Medicine:
Sleep Disorders
Obstructive Sleep Apnea
Restless Leg Syndrome
Insomnia
Actigraphy
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Initiation and Maintenance Disorders
Psychomotor Agitation
Restless Legs Syndrome
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Parasomnias