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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874822
• Other study ID #: 0212-09-EP
• Status: Completed
• Start date: May 26, 2009
• Est. completion date: April 11, 2012

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: April 11, 2012
• Est. primary completion date: April 11, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obstructive Sleep Apnea	The number patients with obstructive sleep apnea whether newly diagnosed or known at study entry.	9 Months