NCT00785070

Brief Summary

  • Evaluate sleep disordered breathing before and after orthopedic surgery utilizing a FDA cleared to market (510k) home sleep study device (Nexan Inc., ClearPath System)
  • Compare Berlin Questionnaire and Epworth Sleep Scale questionnaires to the home sleep study device results.
  • Evaluate effectiveness of the home sleep study testing in the orthopedic presurgical population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 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

April 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 9, 2009

Status Verified

February 1, 2009

Enrollment Period

9 months

First QC Date

November 4, 2008

Last Update Submit

February 5, 2009

Conditions

Obstructive Sleep Apnea

Keywords

PerioperativeObstructive Sleep ApneaScreeningHome Sleep Testing

Outcome Measures

Primary Outcomes (1)

  • Comparison of objective sleep data to standardized sleep questionnaires

    Pre and Post Operative

Secondary Outcomes (1)

  • Compare Pre and Post Operative Objective sleep data

    Pre and post operative

Study Arms (1)

1

Perioperative

Eligibility Criteria

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

Orthopedic Total Hip or Knee Joint Replacement

You may qualify if:

  • Undergoing knee or hip total joint replacement
  • Answer Yes to any PROSPECT health history questions and/or score Positive on the sleep questionnaires

You may not qualify if:

  • Tape Allergy
  • Previous Diagnosis Of Obstructive Sleep Apnea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Health System

Colorado Springs, Colorado, 80909, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Clayton B. Carr, M.D.

    Memorial Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 5, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

February 9, 2009

Record last verified: 2009-02

Locations

US(1)