NCT00949858

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
635

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2014

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

4.5 years

First QC Date

July 28, 2009

Last Update Submit

July 26, 2017

Conditions

Obstructive Sleep ApneaRestless Leg SyndromeInsomnia

Keywords

Sleep DisordersObstructive Sleep ApneaRestless Leg SyndromeInsomniaActigraphy

Outcome Measures

Primary Outcomes (1)

  • Define an object oriented data model for actigraphy and patient level data.

    6 months

Secondary Outcomes (1)

  • Apply existing and develop new advanced statistical and visualization methods for actigraphy data and include them in the data model listed above.

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients seen in clinic at the Washington University Sleep Medicine Center.

You may qualify if:

  • 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

You may not qualify if:

  • Inability to provide valid consent
  • Pregnancy
  • Night or rotating shift workers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University Sleep Medicine Center

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveRestless Legs SyndromeSleep Initiation and Maintenance DisordersSleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasNervous System DiseasesParasomniasMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William Shannon, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 30, 2009

Study Start

July 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 22, 2014

Last Updated

July 31, 2017

Record last verified: 2017-07

Locations

US(1)