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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berlin | Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire. |
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| Measure | Description | Time Frame |
|---|---|---|
| Obstructive Sleep Apnea | The number patients with obstructive sleep apnea whether newly diagnosed or known at study entry. | 9 Months |
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Inclusion Criteria:
Exclusion Criteria:
• None
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Subjects are all patients referred to an academic internal medicicine preoperative evaluation clinic prior to hip or knee arthroplasty.
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| Name | Affiliation | Role |
|---|---|---|
| Jason F Shiffermiller, MD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-3331 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16424433 | Background | 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. | |
| 1798880 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Berlin | Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Berlin | Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Obstructive Sleep Apnea | The number patients with obstructive sleep apnea whether newly diagnosed or known at study entry. | Posted | Number | participants | 9 Months |
|
|
9 months
Serious and other (nonserious) adverse events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Berlin | Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Shiffermiller, MD, MPH | University of Nebraska Medical Center | 402-559-7299 | jshiffermiller@unmc.edu |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 9406321 | Background | 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. |
| 11560300 | Background | 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. |
| 14658110 | Background | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 216 |
| 0 |
| 216 |
| 0 |
| 216 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |