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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00785070
First Posted: November 5, 2008
Last Update Posted: February 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nexan Inc
Information provided by:
Memorial Health System
  Purpose
  • 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.

Condition Phase
Obstructive Sleep Apnea Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pre and Post Orthopedic Surgery Sleep and Cardiac Testing (PROSPECT)

Further study details as provided by Memorial Health System:

Primary Outcome Measures:
  • Comparison of objective sleep data to standardized sleep questionnaires [ Time Frame: Pre and Post Operative ]

Secondary Outcome Measures:
  • Compare Pre and Post Operative Objective sleep data [ Time Frame: Pre and post operative ]

Estimated Enrollment: 100
Study Start Date: April 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Perioperative

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Orthopedic Total Hip or Knee Joint Replacement
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785070


Locations
United States, Colorado
Memorial Health System
Colorado Springs, Colorado, United States, 80909
Sponsors and Collaborators
Memorial Health System
Nexan Inc
Investigators
Principal Investigator: Clayton B. Carr, M.D. Memorial Health System
  More Information

Responsible Party: C. Bryan Carr, M.D., Memorial Health System
ClinicalTrials.gov Identifier: NCT00785070     History of Changes
Other Study ID Numbers: PROSPECT
First Submitted: November 4, 2008
First Posted: November 5, 2008
Last Update Posted: February 9, 2009
Last Verified: February 2009

Keywords provided by Memorial Health System:
Perioperative
Obstructive Sleep Apnea
Screening
Home Sleep Testing

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases