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������������������������������������������������������������������������������������$�!:Title page

Increased risk of serious post-operative cardiopulmonary complications in undiagnosed severe obstructive sleep apnea.
1. Vincent D�ry, M.D., F.R.C.P.C.
Title: Professor
Affiliation: Universit� de Sherbrooke
Email:  HYPERLINK "mailto:vincent.dery@usherbrooke.ca" vincent.dery@usherbrooke.ca
Role: This author helped design the study, conduct the study, analyze the data, and write the manuscript
Conflicts: Vincent D�ry reported no conflicts of interest
Attestation: Vincent D�ry has seen the original study data, reviewed the analysis of the data, approved the final manuscript, and is the author responsible for archiving the study files

2. Luc Lanthier, M.D. F.R.C.P.C. M.Sc.
Title: Professor
Affiliation: Universit� de Sherbrooke
Email: luc.lanthier@usherbrooke.ca
Role: This author helped design the study, conduct the study, analyze the data, and write the manuscript
Conflicts: Luc Lanthier reported no conflicts of interest
Attestation: Luc Lanthier has seen the original study data, reviewed the analysis of the data, and approved the final manuscript

3. Matthieu Touchette, M.D. F.R.C.P.C.
Title: Professor
Affiliation: Universit� de Sherbrooke
Email: matthieu.touchette@usherbrooke.ca
Role: This author helped design the study, conduct the study, analyze the data, and write the manuscript
Conflicts: Matthieu Touchette reported no conflicts of interest
Attestation: Matthieu Touchette has seen the original study data, reviewed the analysis of the data, and approved the final manuscript

Institution: Universit� de Sherbrooke
Short Title: Postoperative cardiopulmonary complications in OSA
Funding: No external funding
Corresponding Author:
Vincent D�ry, M.D.
Universit� de Sherbrooke
1660 Ernest-Therriault, Sherbrooke, Qc, CanadaJ1E4L3
Phone: 819-812-4713
FAX: 819-829-6295
Email: vincent.dery@usherbrooke.ca

Information for LWW regarding depositing manuscript into PubMed Central: This paper does not need to be deposited in PubMed Central.

For Editorial Office:
This report was previously presented, in part, at the Canadian Society of Internal Medecine congress 2012

Submitted as a Research Report

This manuscript was screened for plagiarism using Dupli Checker.
Link to Title Page: http://www.aaauthor.org/pages/7096-2013-Apr-20


Abstract 
Background
Previous trials suggest that OSA (obstructive sleep apnea)  is associated with an increased rate of postoperative complications. Our objective was to determine whether OSA is an independent risk factor for serious cardiopulmonary complications and to assess the possible role of OSA severity.
Methods
We analysed 5133 polysomnograms conducted between 2002 and 2011 for suspicion of OSA. We reviewed medical charts to assess the occurrence of postoperative complications in patients who had undergone elective or urgent surgery in the three years preceding the polysomnogram study. Patients with OSA were compared to patients who had a normal polysomnogram. The primary outcome was a composite of serious cardiac or respiratory complications and unplanned admission to intensive care unit. Multivariate analysis with risk stratification according to OSA severity and apnea-hypopnea index were planned to the protocol.                              
Results	
	The primary outcome was met in 45 patients (45/241; 18.7%) in the OSA group and 8 patients in the control group (8/82; 9.8%). Univariate analysis showed the following factors were associated with the primary outcome (P < 0.1): age, BMI, chronic pulmonary obstructive disease, type of surgery and OSA. Multivariate analysis showed an increased rate of complications in severe OSA (odds ratio (OR) 3.293, P = 0.015; 95%), but not for mild and moderate OSA (OR 1.276, P = 0,656; and OR 1.284, P = 0,653; respectively).
Conclusion	
	Our results suggest that severe OSA is a significant risk factor for the development of serious and clinically significant postoperative cardiopulmonary complications. Mild to moderate OSA was not associated to a higher rate of complications in our study. Future research should aim at defining whether population screening and preventive measures can be applied to decrease the incidence of postoperative complications in these patient.
Number of words: 285

Introduction 
Obstructive sleep apnea (OSA) is common on surgical wards, affecting 9-24% of patients.ADDIN RW.CITE{{36 Young,T. 2002; 47 Finkel,K.J. 2009}}(1,2) Based on the rising rate of obesity ADDIN RW.CITE{{74 deOnis,M. 2010}}(3) and its demonstrated link to OSA (obstructive sleep apnea) ADDIN RW.CITE{{75 Young,T. 2004}}(4), it is likely that as the number of obese patients undergoing surgery increase there will be a concomitant rise in OSA rates on surgical wards. Of greatest concern is the estimation that more than 80% of moderate to severe OSA cases currently go undiagnosed.ADDIN RW.CITE{{57 Young,T. 1997}}(5) Earlier reports have pointed to OSA as a possible cause of increased postoperative complications ADDIN RW.CITE{{8 Gupta,R.M. 2001; 42 Ghamande,S.A 2002; 5 Kaw,R. 2006; 6 Hwang,D. 2008; 7 Liao,P. 2009; 61 Rotenberg,B. 2010; 62 Mador,M.J. 2011; 63 Flink,B.J. 2012}}(6-13), including cardiorespiratory arrest.ADDIN RW.CITE{{43 Ostermeier,A.M. 1997}}(14)
Despite these concerns, robust clinical data are still lacking. The few studies on postoperative complications in patients with OSA showed mixed results.ADDIN RW.CITE{{8 Gupta,R.M. 2001; 42 Ghamande,S.A 2002; 5 Kaw,R. 2006; 6 Hwang,D. 2008; 7 Liao,P. 2009; 61 Rotenberg,B. 2010; 62 Mador,M.J. 2011; 63 Flink,B.J. 2012}}(6-13) Most publications included surrogate end-points or complications unlikely to be directly related to OSA in their analysis. Although earlier studies were also conflicting as to the impact of OSA severityADDIN RW.CITE{{8 Gupta,R.M. 2001}}(6), one study demonstrated a correlation between the oxygen desaturation index and the rate of postoperative complications.ADDIN RW.CITE{{6 Hwang,D. 2008}}(9)
The aim of our study was to determine whether OSA was an independent risk factor for serious and clinically significant cardiopulmonary complications in the postoperative period. Of particular interest was to the determine whether OSA severity had an impact on the rate of postoperative complications. Our secondary objectives were to determine whether OSA had an effect on hospitalization duration and describe the timing of post-operative complications. 
Methods 
The study protocol was reviewed and approved by our  institution�s Ethics Review Board. We conducted the study retrospectively though patient chart review and analyses of  polysomnograms recorded in the Pulmonology Service at the Centre Hospitalier Universitaire de Sherbrooke (Quebec, Canada). 
Patient characteristics
	Inclusion criteria were as follows: e" 18 years of age, having undergone polysomnographic investigation for clinical suspicion of OSA between 2002 and 2011, and having undergone surgery at our institution in the three years preceding the polysomnographic investigation. Surgeries performed under local anesthesia, surgical procedures for OSA, and surgeries with discharge on the same day were excluded. Other exclusion criteria were: a diagnosis of OSA before surgery, use of a continuous positive airway pressure device any time before surgery, and having a major sleep disorder other than OSA (e.g. central sleep apnea and obesity hypoventilation syndrome).
	Patients meeting the inclusion criteria were divided into two groups. The OSA group included patients whose polysomnogram yielded a primary diagnosis of OSA and an apnea-hypopnea index equal to or greater than 5 events per hour. We consider that these patients likely had undiagnosed OSA when they previously underwent surgery (within three years of the polysomnogram). The control group consisted of patients with normal polysomnograms and were thus unlikely to have had OSA at the time of surgery. Figure 1 presents patient selection details.
Data source
	The primary investigators were blinded when reviewing the medical charts. This was done by assigning an automated number to each patient with a corresponding number linking it to the results of the sleep study. Outcomes were assigned using a standardized collection grid using the chart review data including, but not limited to, the discharge summary, nursing and medical progress notes, vital signs, laboratory investigations, radiologic procedures, and electrocardiogram. Demographic and anthropometric data as well as underlying medical conditions at the time of surgery were collected. Type of surgery, mode of anesthesia (general or spinal), admission to intensive care unit, and duration of hospitalization were also recorded. Complications encountered during the postoperative period were recorded in the chart by the attending medical staff and were reviewed by the investigators. Admisssion to intensive care unit was assumed un-planned if the primary physician didn�t ask an admission to ICU before starting the surgical procedure.
	Polysomnographic data were collected manually by reviewing each polysomnogram included in the study and recording the apnea-hypopnea index. Polysomnograms done in-hospital were complete sleep studies (level-1 polysomnograms) under the supervision of a qualified technologist in one of the two sleep study laboratories in our center. Polysomnogram done in the community were 4 channels polysmnography studies (level-3 polysomnograms). Interpretation of sleep studies were all centralized and performed by the pulmonologists in our center.
Outcomes 
	A strict definition of endpoints was agreed upon prior to chart analysis in order to detect only complications that were both clinically relevant and potentially attributable to OSA. The composite primary end-point was considered met when a patient was admitted to the intensive care unit or when at least on of the following complications was identified: pulmonary complications � specifically pneumonia, aspiration pneumonitis, atelectasia requiring bronchoscopy, respiratory distress requiring re-intubation, respiratory distress requiring non-invasive ventilation, respiratory acidosis documented by arterial blood gas requiring urgent treatment, or alteration in consciousness or symptomatic bradypnea necessitating urgent treatment; or cardiac complications � specifically acute coronary syndrome, pulmonary edema requiring urgent treatment, arrhythmia requiring urgent cardioversion or intravenous medication, ventricular tachycardia, symptomatic bradycardia, or stroke. Secondary outcomes measures were duration of hospitalization and timing of post-operative complications. Were accounted for only complications that occured before discharge of hospital.
Data analysis
	Sample size estimates indicated we needed 493 patients in each group to achieve 80% statistical power with two-tailed P-value of < 0.05, assuming a 25% complication rate in the OSA group and an increase of 30% in complications rate compared to the control group.
Comparison of OSA and control groups	
	The OSA and control groups were compared based on demographics, comorbidities, type of surgery, type of anesthesia, and type of postoperative using Chi-squared or Fisher�s Exact tests for qualitative data and t-tests for quantitative data. Hospital stay duration was compared between two groups, patients with severe OSA vs. all other levels of OSA severity and control group (mild, moderate and no OSA pooled), using Mann-Whitney U test for independent samples. 
Analysis of primary end-point
	OSA status, demographics, surgery type, comorbidities, and the type of anesthesia were tested for significance individually using univariate binary logistic regression of the primary endpoint (complications or unplanned transfer to the intensive care unit). In addition to OSA status, which was forced into the model, variable attaining a P-value of 0.1 or less in univariate analysis were retained as variables of interest for the multivariate logistic regression of the composite primary end-point (forward stepwise procedure). Moreover, OSA status was taken into consideration in three ways (three separate analyses): as a binominal variable (presence or absence of OSA based on above criteria), stratified by severity (mild: apnea-hypopnea index of 5-14.9 events/hour, moderate: 15-29.9 events/hour or severe: e" 30 events/hour), and based on the apnea-hypopnea index of patients (number of events per hour). The latter analysis was performed solely on patients in the OSA group (i.e. excluding patients without OSA).
Results 
Patient characteristics
We identified 5133 patients who had undergone polysomnography studies between 2002 and 2011, of which 323 met the inclusion criteria. Additional patient inclusion and exclusion information is provided in figure 1. A comparison of baseline patient characteristics between the control and OSA groups, including demographics, comorbidities, type of surgery, and type of anesthesia is presented in table 1. Patients in the OSA group were significantly older, had a higher body mass index, and were more likely to be males and smokers. Table 2 shows the distribution of the observed adverse outcomes by study group; the frequency of each type of complication did not differ significantly between the OSA and control groups.
Study outcomes
The primary end-point was met in 8 of 82 patients (9.8%) in the control group and 45 of 241 patients (18.7%) in the OSA group. Variables considered significant in the univariate logistic regression analysis (P < 0.1) of the primary outcome were age (P = 0.326, OR = 1.034, 95% CI = 1.009-1.060), body mass index (P = 0.030, OR = 1.029, 95% CI = 1.003-1.056), chronic obstructive pulmonary disease (P = 0.017, OR = 2.417, 95% CI = 1.169-4.998), OSA status (binary variable; P = 0.064, OR 2.124, 95% CI = 0.956-4.718), OSA severity (P = 0.042), apnea-hypopnea index (P = 0.049) and type of surgery (P < 0.001) (see Table 3). These variables were subsequently used in the multivariate analyses.
In the first multivariate analysis, where OSA was taken into account as a binary variable, it was not retained as an independent predictor of post-operative complications (Table 4). However, for each one unit increase in a patient�s body mass index, the odds of meeting the primary endpoint increased by 3.7% (P = 0.014, OR = 1.037, 95% CI 1.007-1.067) and patients undergoing cardiac or thoracic surgery were 5.282 (P = 0.001, 95% CI = 1.922-14.515) and 7.581 (P = 0.002, 95% CI = 2.054-27.975) times more likely, respectively, to experience complications than patients undergoing orthopedic surgery (Table 4).
In the second multivariate analysis, where OSA was stratified by severity, patients with severe OSA were 3.293 times more likely to experience post-operative complications than patients without OSA (P = 0.015, 95% CI = 1.259-8.615) (Table 4, Figure 2). Mild and moderate OSA did not significantly increase the odds of post-operative complications. As per the previous multivariate analysis, body mass index, cardiac and thoracic surgeries were also retained as significant risk factors for post-operative complications (Table 4).
In the final multivariate analysis, where OSA was considered using the apnea-hypopnea index directly, for every one point increase in the index score, a patient�s odds of experiencing post-operative complications increased by 1.7% (P = 0.029, OR = 1.017, 95% CI = 1.002-1.032) (Table 4). Furthermore, only cardiac surgery carried a significantly higher risk than orthopedic surgery with respect to meeting the primary end-point (P = 0.019, OR 3.531, 95% CI 
There was no statistically significant difference in the length of hospital stay between patients with severe OSA and patients without OSA (control patients) (mean = 8.54 vs 6.35 days respectively, P = 0.215). Patients that met the primary endpoint generally did so within the first 24 hours after surgery (30/53 patients, 56.6%). However, 17 more patients met the primary endpoint after 48 hours (17/53 patients, 32.1%; Figure 3).

Discussion
Our multivariate models suggest that severe OSA is a significant risk factor for serious and clinically significant adverse events in the postoperative period, specifically when it is considered in terms of the apnea-hypopnea index (e.g. OSA stratified by severity based on the index and using the index score itself as a variable). However, our primary analysis could not detect a statistically significant difference in complication rate when a pool of all OSA patients was compared to the control group. We attribute this primarily to a lower than expected rate of complications observed in patients with mild and moderate OSA. 
Previously published studies on postoperative complications in this population are typically retrospective, have heterogeneous designs and varying definitions of complications. Most studies report a higher rate of complications at all levels of OSA, include complications such as atrial fibrillation ADDIN RW.CITE{{30 Mooe,T. 1996}}(15), encephalopathy or delirium ADDIN RW.CITE{{5 Kaw,R. 2006; 63 Flink,B.J. 2012}}(8,13), and often use composite end-points with a wide array of different complications such as bleeding events and infectious complications.ADDIN RW.CITE{{6 Hwang,D. 2008; 7 Liao,P. 2009; 8 Gupta,R.M. 2001}}(6,9,10) A study by Gupta et al.ADDIN RW.CITE{{8 Gupta,R.M. 2001}}(6) also demonstrated an increase in serious complications and longer hospital stays, but did not find an interaction with the severity of OSA. Hwang et al.ADDIN RW.CITE{{6 Hwang,D. 2008}}(9) observed an increase in the rate of complications in OSA patients with OSA, with a higher oxygen desaturation index being associated to higher rate of adverse events. However, most outcomes in the latter study could not be attributed to OSA or were not clinically significant (e.g. gastrointestinal bleeding, wheezing and non-coronary chest pain).ADDIN RW.CITE{{6 Hwang,D. 2008}}(9) We elected to include only clinically relevant complications that we judged likely to be related to OSA. This could explain why the rate of adverse events in patients with mild and moderate OSA was lower than reported suggested by previous authors. 
Overall, 50% or more of patients meeting the primary endpoint in each group did so early, within the first 24 hour period after surgery. The higher incidence of earlier complications could be attributed to the perioperative use of narcotics, sedatives and residual anesthetic effect, to which patients with OSA are particularly sensitive.ADDIN RW.CITE{{69 Strauss,S.G. 1999; 72 Brown,K.A. 2004; 71 Brown,K.A. 2006}}(16-18) These factors are known to decrease pharyngeal tone, increase airway obstruction and diminish the arousal response to obstruction leading to hypercarbia and hypoxemia.ADDIN RW.CITE{{33 Kaw,R. 2006}}(19)
However, a substantial number of complications also occurred later in the post-operative period (32.1% after 48 hours after surgery; Figure 3). These later complications may have a different basis, namely rapid eye movement (REM) sleep because of pain and physiologic stress, but the subsequent sleeping periods are characterized by a rebound in REM sleep.ADDIN RW.CITE{{37 Knill,R.L. 1990}}(20) More intense REM sleep (REM rebound phenomenon) leads to reduced pharyngeal tone and is associated with increasing hypoxic events in patients with OSA.ADDIN RW.CITE{{33 Kaw,R. 2006}}(19) This effect is additive to the depressive effect of narcotics and sedative drugs on the central nervous system. It has been observed that hypoxemic events during sleep are associated with an increase in catecholaminergic output with fluctuation in arterial blood pressure and increased cardiac arrhythmogenicity hereby potentially producing the predisposing conditions for an increased risk of arrhythmia, heart failure, and coronary ischemia in patients with OSA.ADDIN RW.CITE{{60 Shepard,J.W.,Jr 1985; 30 Mooe,T. 1996}}(15,21) 
These findings highlight the importance of screening patients in the pre-operative period, so that severe OSA might be detected before surgery. Validated screening tools for OSA like the STOP-BANG questionnaire are easily used at the bedside.ADDIN RW.CITE{{68 Chung,F. 2008}}(22) In fact, meta-analysis of different screening tools found that the STOP-BANG questionnaire had the best sensitivity for moderate to severe OSA (92.9% and 100% respectively) and reported that the studies validating this questionnaire were of higher methodological quality than those on other questionnaires.ADDIN RW.CITE{{64 Abrishami,A. 2010}}(23) However, using the STOP-BANG questionnaire might wrongly classify many patients at risk of severe OSA as the specificity decreases to 37% when the sensitivity cut-off is set at 100%. 
The best strategy for monitoring patients with established or suspected sleep apnea is still subject for debate. In patients with known OSA, retrospective data suggest that using a continuous positive airway pressure device at home before surgery, and continuing its use after surgery, lowers the rate of complications to that of patients without OSA.ADDIN RW.CITE{{8 Gupta,R.M. 2001}}(6) However, there are no prospective, randomized, interventional trials that actually demonstrate any beneficial effect of continuous positive airway pressure device on post-operative complications. For patients who do not use a continuous positive airway pressure device and in whom OSA is suspected, experts have suggested different strategies for reducing post-operative complications. These include surveillance with prolonged monitoring in the recovery room, pulse oximetry monitoring, careful administration of narcotics and sedatives, and semi-upright positioning.ADDIN RW.CITE{{73 Seet,E. 2010; 9 Adesanya,A.O. 2010; 17 Bapoje,S.R. 2007; 13 Seet,E. 2010}}(24-27) It is unclear whether these interventions improve postoperative outcomes or whether it is clinically useful to document OSA with a polysomnogram before surgery. 
Strengths, limits and bias
Although both univariate and multivariate analyses showed a positive relationship between the apnea-hypopnea index (as a measure of OSA severity) and the likelihood of experiencing complications, the effect was fairly small. This is partially the result of having excluded control patients from this analysis (apnea-hypopnea index less than 5). Furthermore, patients with mild and moderate OSA had lower than expected rates of adverse events compared to earlier publications, due to a narrower definition of �complication� in our study. Finally, fewer patient charts were available for review than initially expected. We identified only 323 patients who met the inclusion criteria, falling below our sample size calculation. The most frequent cause for exclusion was the absence of surgery in the three years preceding the polysomnogram. With a larger sample size, we may also have detected a graded response in complication rate with mild and moderate OSA.
The retrospective design of this study may have resulted in an overestimation of the rate of complications in both groups, as the attending physician was possibly more likely to request a diagnostic polysomnogram after surgery if a patient had a complication felt to be related to OSA. However, this effect applies to both the control and OSA groups and, despite this, our rate of complications was still lower than what has been reported previously. Although we demonstrated that patients with OSA are more likely to experience post-operative complications, the retrospective nature of our study prevents us from ascertaining causality. 
Conclusion
Severe OSA appears to be a significant and independent risk factor for serious and clinically significant postoperative complications. Mild to moderate OSA was not associated to a higher rate of complications in our study. These findings are relevant to the care of the general surgical population as 80% of patients who suffer from OSA are unaware of their pathology and are therefore untreated at the time of surgery. Growing evidence, including the present study, suggests that these patients are at greater risk of complications in the postoperative period. As such, future research should aim to determine whether population screening and preventive measures can be applied effectively to decrease the incidence of postoperative complications in patients with suspected severe OSA. 
 
Figures and  llustrations (2)















Figure 1. Patient selection flow chart.
Abbreviation: PSG, polysomnogram; OSA, obstructive sleep apnea; AHI, apnea-hypopnea index; CPAP, continuous positive airway pressure. 









Figure 2. Primary endpoint by study group
Multivariate analysis with OSA stratified by severity with comparison to control.
Abbreviation: OSA, obstructive sleep apnea.




 









Figure 3. Timing of patients meeting primary endpoint by study group.
Abbreviation: OSA, obstructive sleep apnea.
Figure Legends
Table 1: Baseline characteristics
Abbreviations: AHI, apnea-hypopnea index; BMI, body mass index; ENT, ear, nose, throat; OSA, obstructive sleep apnea; SD, standard deviation.
Data is presented as number of patients (%), unless otherwise specified.
* High risk surgeries include cardiac and thoracic surgeries; low risk surgeries include all the other types of surgery.
P value using Chi-square.
Table 2: Study outcome
Abbreviations: OSA, obstructive sleep apnea; ICU, intensive care unit.
*Patients that met the primary endpoint.
Data is presented as [number of a given type of complication observed (% of total number of complications)], unless otherwise specified. Some patients had more than one complication.
P value using Chi-square.
Table  3: Results of univariate analysis
Abbreviations: AHI, apnea-hypopnea index; OSA, obstructive sleep apnea.
Variables with P<0.1 and/or in the obstructive sleep apnea category (bold type) were retained for multiple logistic regression analyses of the primary endpoint.
* High risk surgeries include cardiac and thoracic surgeries; low risk surgeries include all the other types of surgery.
Table  4: Results of multivariate analysis
Abbreviations: �-� refers to variables that never met the model entrance criteria; AHI, apnea-hypopnea index; OSA, obstructive sleep apnea.
*Only patients with an OSA diagnosis were used in this analysis (n=241 i.e. no Control group patients).
Bold character highlights variables considered significant and independent predictors of the primary endpoint. 
Figure 1 : Patient selection flow chart.
Abbreviation: PSG, polysomnogram; OSA, obstructive sleep apnea; AHI, apnea-hypopnea index; CPAP, continuous positive airway pressure. 
Figure 2: Primary endpoint by study group.
Abbreviation: OSA, obstructive sleep apnea.
Figure 3: Timing of patients meeting primary endpoint by study group.
Abbreviation: OSA, obstructive sleep apnea. 





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Manuscript Title: 	Increased risk of serious post-operative cardiopulmonary complications in undiagnosed severe obstructive sleep apnea.
First Author:		Vincent D�ry
Disclosing Author:	Vincent D�ry

1.	Have you or a close relative received money, gifts, or other compensation from any organization, institution, or business that may be affected financially by your publication? Examples include speaker fees, consulting fees, honoraria, travel, gifts, or research funding. Yes o�   No X
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h�RaJ.Do you or a close relative hold stocks, investments, or other financial interests (excluding diversified mutual funds) in an organization, institution, or business that may be affected financially by your publication? Yes o�   No X
5.	Could the findings of this publication directly or indirectly affect your compensation?  Yes o�   No X
6.	Are there any other potential conflicts or relevant competing interests that should be known by the Editor? Yes o�   No X

















PAGE   \* MERGEFORMAT3











Polysomnograms available for review : 5133

Included in the study
323 patients

Exclusions:
No surgery in the three years preceding PSG: 4368 patients
Inconclusive PSG: 100 patients
Central sleep apnea: 36 patients
Obesity hypoventilation syndrome: 59 patients
Patient already on CPAP device before surgery: 247 patients


OSA group
241 patients
(primary diagnosis was OSA, AHI > 5 events/hr)


Control group
82 patients
(not diagnosed with OSA)

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p=0.653

p=0.015

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