Pre and Post Orthopedic Surgery Sleep and Cardiac Testing (PROSPECT)

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT00785070
• Lead Sponsor: Memorial Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2009-01
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-05
• Last Update Posted: 2009-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Tape Allergy
• Previous Diagnosis Of Obstructive Sleep Apnea

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of objective sleep data to standardized sleep questionnaires	Pre and Post Operative

Secondary Outcome Measures

Name	Time	Method
Compare Pre and Post Operative Objective sleep data	Pre and post operative

Trial Locations

Locations (1)

Memorial Health System; 🇺🇸 Colorado Springs, Colorado, United States