Prevalence of Sleep Apnea in Patients Presenting for Hip or Knee Replacement Surgery
1 other identifier
observational
216
1 country
1
Brief Summary
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. Participants referred 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2009
CompletedFirst Posted
Study publicly available on registry
April 3, 2009
CompletedStudy Start
First participant enrolled
May 26, 2009
CompletedResults Posted
Study results publicly available
January 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2012
CompletedSeptember 18, 2023
August 1, 2023
2.9 years
March 26, 2009
October 27, 2011
August 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Obstructive Sleep Apnea
The number patients with obstructive sleep apnea whether newly diagnosed or known at study entry.
9 Months
Study Arms (1)
Berlin
Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
Eligibility Criteria
Subjects are all patients referred to an academic internal medicicine preoperative evaluation clinic prior to hip or knee arthroplasty.
You may qualify if:
- years old and older
- Planned total hip or total knee arthroplasty
- Referral to the internal medicine preoperative evaluation clinic
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3331, United States
Related Publications (5)
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. doi: 10.1378/chest.129.1.198.
PMID: 16424433BACKGROUNDAncoli-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. doi: 10.1093/sleep/14.6.486.
PMID: 1798880BACKGROUNDYoung 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. doi: 10.1093/sleep/20.9.705.
PMID: 9406321BACKGROUNDGupta 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. doi: 10.4065/76.9.897.
PMID: 11560300BACKGROUNDHarrison 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. doi: 10.1016/s0883-5403(03)00459-5.
PMID: 14658110BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Obstructive sleep apnea was diagnosed in only four patients due to a high rate of failure to undergo PSG by patients for whom it was indicated. A second major weakness is the use of a literature control group.
Results Point of Contact
- Title
- Jason Shiffermiller, MD, MPH
- Organization
- University of Nebraska Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jason F Shiffermiller, MD
University of Nebraska
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2009
First Posted
April 3, 2009
Study Start
May 26, 2009
Primary Completion
April 11, 2012
Study Completion
April 11, 2012
Last Updated
September 18, 2023
Results First Posted
January 20, 2012
Record last verified: 2023-08