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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 19, 2014