Clinical trial NCT00874822: Prevalence of Sleep Apnea in Patients Presenting for Hip or Knee Replacement Surgery
Official title: Prevalence of Sleep Apnea in Patients Presenting for Hip or Knee Replacement Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2009-04-03
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Obstructive Sleep Apnea
timeFrame: 9 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Jason F Shiffermiller, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.