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

This study has been completed.
Sponsor:
Collaborator:
Nexan Inc
Information provided by:
Memorial Health System
ClinicalTrials.gov Identifier:
NCT00785070
First received: November 4, 2008
Last updated: February 5, 2009
Last verified: February 2009
History of Changes
  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)

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Compare Pre and Post Operative Objective sleep data [ Time Frame: Pre and post operative ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: C. Bryan Carr, M.D., Memorial Health System
ClinicalTrials.gov Identifier: NCT00785070     History of Changes
Other Study ID Numbers: PROSPECT
Study First Received: November 4, 2008
Last Updated: February 5, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013