Sleep Apnea, Obstructive
Conditions
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.
Interventions
None listed
Sponsors
University of Nebraska
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Obstructive Sleep Apnea | 9 Months | The number patients with obstructive sleep apnea whether newly diagnosed or known at study entry. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Berlin Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire. | 216 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | excluded by criteria | 8 |
Baseline characteristics
| Characteristic | Berlin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 117 Participants |
| Age, Categorical Between 18 and 65 years | 99 Participants |
| Age, Continuous | 62.88 years STANDARD_DEVIATION 0.86 |
| Region of Enrollment United States | 216 participants |
| Sex: Female, Male Female | 118 Participants |
| Sex: Female, Male Male | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 216 |
| other Total, other adverse events | 0 / 216 |
| serious Total, serious adverse events | 0 / 216 |
Outcome results
Primary
Obstructive Sleep Apnea
The number patients with obstructive sleep apnea whether newly diagnosed or known at study entry.
Time frame: 9 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Berlin | Obstructive Sleep Apnea | 41 participants |
Comparison: Ho: The Prevalence of obstructive sleep apnea in patients planning hip or knee arthroplasty will be no different using current screening techniques than it was in a historical control group.~The prevalence of OSA in the study population is hypothesized to be at least 10% higher than the best previous estimate of 6.7%. Employing a two-sided hypothesis test with α of 0.05 and power of 0.85 yields a sample size of 163.p-value: <0.000195% CI: [13.6, 24.4]Chi-squared, Corrected