NCT00874822

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 26, 2009

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

January 20, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2012

Completed
Last Updated

September 18, 2023

Status Verified

August 1, 2023

Enrollment Period

2.9 years

First QC Date

March 26, 2009

Results QC Date

October 27, 2011

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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: 16424433BACKGROUND
  • 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. doi: 10.1093/sleep/14.6.486.

    PMID: 1798880BACKGROUND
  • 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. doi: 10.1093/sleep/20.9.705.

    PMID: 9406321BACKGROUND
  • 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. doi: 10.4065/76.9.897.

    PMID: 11560300BACKGROUND
  • 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. doi: 10.1016/s0883-5403(03)00459-5.

    PMID: 14658110BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

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

  • Jason F Shiffermiller, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

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

Locations