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

August 29, 2023 updated by: University of Nebraska
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).

Study Overview

Status

Completed

Conditions

Detailed Description

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, a study performed by Harrison et al. and published in the December 2003 issue of The Journal of Arthroplasty. 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). The Berlin questionnaire is being used for screening.

Study Type

Observational

Enrollment (Actual)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

Inclusion Criteria:

  • 18 years old and older
  • Planned total hip or total knee arthroplasty
  • Referral to the internal medicine preoperative evaluation clinic

Exclusion Criteria:

• None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obstructive Sleep Apnea
Time Frame: 9 Months
The number patients with obstructive sleep apnea whether newly diagnosed or known at study entry.
9 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Jason F Shiffermiller, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2009

Primary Completion (Actual)

April 11, 2012

Study Completion (Actual)

April 11, 2012

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

April 1, 2009

First Posted (Estimated)

April 3, 2009

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0212-09-EP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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