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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

Tracking Information
First Submitted Date July 28, 2009
First Posted Date July 30, 2009
Last Update Posted Date July 31, 2017
Study Start Date July 2009
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 28, 2009)
Define an object oriented data model for actigraphy and patient level data. [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 28, 2009)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title New Data Analysis Methods for Actigraphy in Sleep Medicine
Official Title New Data Analysis Methods for Actigraphy in Sleep 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients seen in clinic at the Washington University Sleep Medicine Center.
Condition
  • Obstructive Sleep Apnea
  • Restless Leg Syndrome
  • Insomnia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 26, 2017)
635
Original Estimated Enrollment
 (submitted: July 28, 2009)
750
Actual Study Completion Date January 22, 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00949858
Other Study ID Numbers R01HL092347-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators Utah State University
Investigators
Principal Investigator: William Shannon, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date July 2017