New Data Analysis Methods for Actigraphy in Sleep Medicine

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Utah State University
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00949858
First received: July 28, 2009
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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
Obstructive Sleep Apnea
Restless Leg Syndrome
Insomnia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Data Analysis Methods for Actigraphy in Sleep Medicine

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Define an object oriented data model for actigraphy and patient level data. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: July 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949858

Locations
United States, Missouri
Washington University Sleep Medicine Center
St Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Utah State University
Investigators
Principal Investigator: William Shannon, PhD Washington University Early Recognition Center
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00949858     History of Changes
Other Study ID Numbers: RO1 HL092347-01a1
Study First Received: July 28, 2009
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Sleep Disorders
Obstructive Sleep Apnea
Restless Leg Syndrome
Insomnia
Actigraphy

Additional relevant MeSH terms:
Apnea
Restless Legs Syndrome
Sleep Apnea Syndromes
Psychomotor Agitation
Sleep Apnea, Obstructive
Sleep Initiation and Maintenance Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations

ClinicalTrials.gov processed this record on July 26, 2014