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

February 5, 2009 updated by: Memorial Health System
  • 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Memorial Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Orthopedic Total Hip or Knee Joint Replacement

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Perioperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of objective sleep data to standardized sleep questionnaires
Time Frame: Pre and Post Operative
Pre and Post Operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare Pre and Post Operative Objective sleep data
Time Frame: Pre and post operative
Pre and post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Health System

Collaborators

Nexan Inc

Investigators

  • Principal Investigator: Clayton B. Carr, M.D., Memorial Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

November 4, 2008

First Submitted That Met QC Criteria

November 4, 2008

First Posted (Estimate)

November 5, 2008

Study Record Updates

Last Update Posted (Estimate)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 5, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROSPECT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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