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

This study is currently recruiting participants.

Verified by Memorial Health System, September 2008

Sponsors and Collaborators:	Memorial Health System Nexan Inc
Information provided by:	Memorial Health System
ClinicalTrials.gov Identifier:	NCT00785070

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 I

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Observational
Study Design:	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 ] [ 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	April 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 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

Contacts

Contact: Carla A. Lickteig, BSN	719-351-4908	carlalickteig@msn.com
Contact: Robyn Woidtke, RN, BSHS	510-728-0828	robyn@nexanusa.com

Locations

United States, Colorado
Memorial Health System	Recruiting
Colorado Springs, Colorado, United States, 80909
Principal Investigator: Clayton B. Carr, M.D.
Sub-Investigator: Carla A. Lickteig, BSN
Sub-Investigator: Timothy Rummel, M.D.
Sub-Investigator: Jenenne Nelson, PhD

Sponsors and Collaborators

Memorial Health System

Nexan Inc

Investigators

Principal Investigator:

Clayton B. Carr, M.D.

Memorial Health System

More Information

Responsible Party:	Memorial Health System ( C. Bryan Carr, M.D. )
Study ID Numbers:	PROSPECT
Study First Received:	November 4, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00785070
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Health System:

Perioperative
Obstructive Sleep Apnea
Screening
Home Sleep Testing

Study placed in the following topic categories:

Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009