New Data Analysis Methods for Actigraphy in Sleep Medicine

Obstructive Sleep Apnea Clinical Trial

Official title:

New Data Analysis Methods for Actigraphy in Sleep Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949858
• Other study ID #: R01HL092347-01A1
• Status: Completed
• Phase: N/A
• First received: July 28, 2009
• Last updated: July 26, 2017
• Start date: July 2009
• Est. completion date: January 22, 2014

Study information

• Verified date: July 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 635
• Est. completion date: January 22, 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Obstructive Sleep Apnea
• Psychomotor Agitation
• Restless Leg Syndrome
• Restless Legs Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Initiation and Maintenance Disorders

Locations

Country	Name	City	State
United States	Washington University Sleep Medicine Center	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Utah State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define an object oriented data model for actigraphy and patient level data.		6 months
Secondary	Apply existing and develop new advanced statistical and visualization methods for actigraphy data and include them in the data model listed above.		6 months