Prevalence of Sleep Apnea in Patients Presenting for Hip or Knee Replacement Surgery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Jason Shiffermiller, MD, University of Nebraska

ClinicalTrials.gov Identifier:

NCT00874822

First received: March 26, 2009

Last updated: January 18, 2012

Last verified: January 2012

History of Changes

Purpose

The study hypothesis is that the prevalence of obstructive sleep apnea in patients presenting for total knee or total hip arthroplasty is higher than generally suspected. The study will include just one arm and results will be compared to a literature control group. Patients refered for preoperative evaluation will be screened using a standard questionnaire. Those at high risk of obstructive sleep apnea will then undergo a formal overnight sleep study (polysomnography).

Condition
Sleep Apnea, Obstructive

Study Type:	Observational
Study Design:	Time Perspective: Retrospective
Official Title:	Prevalence of Sleep Apnea in Patients Presenting for Hip or Knee Replacement Surgery

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Sleep Apnea

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:

Obstructive Sleep Apnea [ Time Frame: 9 Months ] [ Designated as safety issue: Yes ]
The number patients with obstructive sleep apnea whether newly diagnosed or known at study entry.

Enrollment:	216
Study Start Date:	September 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Berlin Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.

Detailed Description:

All patients seen by academic orthopedic surgeon for total hip or total knee arthroplasty are referred for preoperative evaluation. The historical control group comes from a study performed by Harrison et al. and published in the December 2003 issue of The Journal of Arthroplasty. The Berlin questionnaire is being used for screening.

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

Subjects are all patients referred to an academic internal medicicine preoperative evaluation clinic prior to hip or knee arthroplasty.

Criteria

Inclusion Criteria:

Planned total hip or total knee arthroplasty
Referral to the internal medicine preoperative evaluation clinic

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874822

Locations

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3331

Sponsors and Collaborators

University of Nebraska

Investigators

Principal Investigator:

Jason F Shiffermiller, MD

University of Nebraska

More Information

Publications:

Kaw R, Michota F, Jaffer A, Ghamande S, Auckley D, Golish J. Unrecognized sleep apnea in the surgical patient: implications for the perioperative setting. Chest. 2006 Jan;129(1):198-205. Review.

Ancoli-Israel S, Kripke DF, Klauber MR, Mason WJ, Fell R, Kaplan O. Sleep-disordered breathing in community-dwelling elderly. Sleep. 1991 Dec;14(6):486-95.

Young T, Evans L, Finn L, Palta M. Estimation of the clinically diagnosed proportion of sleep apnea syndrome in middle-aged men and women. Sleep. 1997 Sep;20(9):705-6.

Gupta RM, Parvizi J, Hanssen AD, Gay PC. Postoperative complications in patients with obstructive sleep apnea syndrome undergoing hip or knee replacement: a case-control study. Mayo Clin Proc. 2001 Sep;76(9):897-905.

Harrison MM, Childs A, Carson PE. Incidence of undiagnosed sleep apnea in patients scheduled for elective total joint arthroplasty. J Arthroplasty. 2003 Dec;18(8):1044-7.

Responsible Party:	Jason Shiffermiller, MD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier:	NCT00874822 History of Changes
Other Study ID Numbers:	212-09-EP
Study First Received:	March 26, 2009
Results First Received:	October 27, 2011
Last Updated:	January 18, 2012
Health Authority:	United States: Institutional Review Board

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 June 18, 2013

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