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- W2890106031 abstract "Free AccessCPAPThe Association Between Adherence to Positive Airway Pressure Therapy and Long-Term Outcomes in Patients With Obesity Hypoventilation Syndrome: A Prospective Observational Study Izolde Bouloukaki, MD, PhD, Charalampos Mermigkis, MD, PhD, Stylianos Michelakis, MD, Violeta Moniaki, RN, Eleni Mauroudi, RN, Nikolaos Tzanakis, MD, PhD, Sophia E. Schiza, MD, PhD Izolde Bouloukaki, MD, PhD Address correspondence to: Izolde Bouloukaki, MD, PhD, Sleep Disorders Center, Dept. of Thoracic Medicine, University of Crete, 71110 Heraklion Crete, Greece E-mail Address: [email protected] Sleep Disorders Center, Department of Thoracic Medicine, University of Crete, Heraklion, Greece Search for more papers by this author , Charalampos Mermigkis, MD, PhD Sleep Disorders Center, Department of Thoracic Medicine, University of Crete, Heraklion, Greece Search for more papers by this author , Stylianos Michelakis, MD Sleep Disorders Center, Department of Thoracic Medicine, University of Crete, Heraklion, Greece Search for more papers by this author , Violeta Moniaki, RN Sleep Disorders Center, Department of Thoracic Medicine, University of Crete, Heraklion, Greece Search for more papers by this author , Eleni Mauroudi, RN Sleep Disorders Center, Department of Thoracic Medicine, University of Crete, Heraklion, Greece Search for more papers by this author , Nikolaos Tzanakis, MD, PhD Sleep Disorders Center, Department of Thoracic Medicine, University of Crete, Heraklion, Greece Search for more papers by this author , Sophia E. Schiza, MD, PhD Sleep Disorders Center, Department of Thoracic Medicine, University of Crete, Heraklion, Greece Search for more papers by this author Published Online:September 15, 2018https://doi.org/10.5664/jcsm.7332Cited by:27SectionsAbstractPDFSupplemental Material ShareShare onFacebookTwitterLinkedInRedditEmail ToolsAdd to favoritesDownload CitationsTrack Citations AboutABSTRACTStudy Objectives:To assess the role of different levels of adherence and long-term effects of positive airway pressure (PAP) therapy on gas exchange, sleepiness, quality of life, depressive symptoms, and all-cause mortality in patients with obesity hypoventilation syndrome (OHS).Methods:A total of 252 patients with newly diagnosed OHS were followed up for a minimum of 2 years after PAP initiation. PAP adherence (h/night) was monitored. Arterial blood gas samples were taken with patients being alert for more than 4 hours after morning awakening. Subjective daytime sleepiness (Epworth Sleepiness Scale [ESS]), quality of life (Short Form 36 [SF-36]) and patient's depressive symptoms (Beck Depression Inventory [BDI]) were assessed before and at the end of the follow-up period, along with all-cause mortality.Results:At the end of the follow-up period (median duration [25th–75th percentile], 30 [24–52] months), PaO2 increased from baseline (72.7 ± 10.3 versus 63.2 ± 10.6, P < .001) and both PaCO2 and HCO3− decreased (43.0 [39.2–45.0] versus 50.0 [46.7–55.4] and 27.5 ± 3.2 versus 31.4 ± 4.2, respectively, P < .001). In addition, PAP therapy significantly improved ESS (7 [4–9] versus 14 [11–16], P < .001), BDI (8.8 ± 4.9 versus 15.5 ± 7.3, P < .001) and SF-36 (82 [78–87] versus 74 [67–79], P < .001) scores. Over the follow-up period 11 patients died. Patients who used PAP for > 6 h/night had significant improvements (P < .05) in blood gases and SF-36 scores than less adherent patients.Conclusions:Increased hours of use and long-term therapy with PAP are effective in the treatment of patients with OHS. Clinicians should encourage adherence to PAP therapy in order to provide a significant improvement in clinical status and gas exchange in these patients.Commentary:A commenary on this article appears in this issue on page 1455.Clinical Trial Registration:Title: PAP Therapy in Patients With Obesity Hypoventilation Syndrome, Registry: ClinicalTrials.gov, Identifier: NCT03449641, URL: https://clinicaltrials.gov/ct2/show/NCT03449641Citation:Bouloukaki I, Mermigkis C, Michelakis S, Moniaki V, Mauroudi E, Tzanakis N, Schiza SE. The association between adherence to positive airway pressure therapy and long-term outcomes in patients with obesity hypoventilation syndrome: a prospective observational study. J Clin Sleep Med. 2018;14(9):1539–1550.BRIEF SUMMARYCurrent Knowledge/Study Rationale: There are limited data concerning the effect of long-term effects of positive airway pressure (PAP) therapy on survival and functional status in individuals with obesity hypoventilation syndrome (OHS). This study aimed to assess the role of different levels of adherence and long-term effects of PAP therapy on gas exchange, sleepiness, quality of life, depressive symptoms, and all-cause mortality in patients with OHS after 2 years of PAP therapy.Study Impact: Our results show that PAP therapy for ≥ 6 h/night, at least for a 2-year period in patients with OHS, resulted in significant improvements of arterial blood gases, quality of life, cardiovascular morbidity, and mortality. Clinicians should encourage PAP adherence to provide a significant improvement in clinical status and gas exchange of these patients.INTRODUCTIONObesity is the main risk factor for obstructive sleep apnea (OSA)1 and a determining factor for obesity hypoventilation syndrome (OHS).2 As the prevalence of obesity is increasing rapidly, chronic alveolar hypoventilation resulting in chronic hypercapnic respiratory failure develops in a considerable percentage of severely obese patients.3 Although the prevalence of OHS is currently unknown, 0.3% to 0.48% in the general population are estimated to be affected, whereas in obese patients referred to sleep clinics the prevalence of OHS ranges from 8% to 20%.4,5Patients with OHS have decreased quality of life, tend to have more comorbidities and increased health care expenses, and are at higher risk of the development of serious cardiovascular disease leading to early mortality, compared to normocapnic morbidly obese patients and normocapnic patients with OSA.6 Despite these worse outcomes, the diagnosis of OHS is typically established late, in the fifth or sixth decade of life; therefore, clinicians need to maintain a high index of suspicion, particularly given that early diagnosis and therapy are considered important to avoid the adverse effects of OHS and reduce the high burden of morbidity and mortality associated with this syndrome.7Treatment of OHS is based on the underlying pathophysiology of the condition. The upper airway obstruction is an important factor in the pathogenesis of OHS, with 90% of patients exhibiting coexistent OSA. There is evidence that strategies for reversing upper airway obstruction, such as positive airway pressure (PAP), are effective in most patients with stable OHS, particularly in the subgroup with severe OSA. PAP therapy improves blood gases, morning headaches, excessive daytime sleepiness and vigilance, dyspnea, pulmonary hypertension, and secondary erythrocytosis.8–11 Improvements in symptoms and blood gases are directly related to adherence to therapy and maximal improvement in blood gases can be achieved as early as 2 to 4 weeks after initiation of PAP therapy.12Various forms of PAP therapy are effective in providing short- and long-term benefits in these patients with or without OSA. However, there are limited data concerning the long-term effects of PAP therapy on survival and functional status in individuals with OHS and OSA. Therefore, we aimed to assess the role of different levels of adherence and long-term effects of PAP therapy on gas exchange, sleepiness, quality of life, depressive symptoms, and all-cause mortality in patients with OHS.METHODSWe conducted a single-center, prospective, long-term follow-up study of patients with a new diagnosis and who fulfilled OHS diagnostic criteria. Between June 2009 and June 2012, consecutive patients aged between 18 and 80 years, who were admitted to the Sleep Disorders Center, Department of Thoracic Medicine, University of Crete Medical School, for evaluation of suspected sleep-disordered breathing, were considered as potential recruits for this study. OHS was determined by an arterial blood gas with partial pressure of carbon dioxide in the arterial blood (PaCO2) at rest > 45 mmHg and a body mass index (BMI) > 30 kg/m2 in the absence of other causes of hypoventilation, such as neuromuscular, chest wall disorders, and chronic obstructive pulmonary disease. To be included in the study, patients had to be clinically stable for at least 4 weeks prior to enrollment. In addition, all included patients had to have achieved higher than elementary-school education. The exclusion criteria were: refusal to participate, refusal of PAP therapy, central sleep apnea syndromes, chronic obstructive pulmonary disease or asthma, restrictive ventilation syndromes, severe congestive heart failure, a history of life-threatening arrhythmias, severe cardiomyopathy, significant chronic kidney disease, untreated hypothyroidism, family or personal history of mental illness, drug or alcohol abuse, sedative use, severe cognitive impairment, concurrent oncological diseases, and history of narcolepsy or restless legs syndrome.All subjects provided written informed consent and ethical approval was provided by the University Hospital Ethics Committee.Initial Visit/Evaluation Data CollectionAll patients underwent a detailed evaluation that included age, measurement of BMI, medical history focused on sleep-related symptoms, associated conditions and comorbidities, menopausal status, smoking history, and alcohol intake. In addition, we performed spirometry and overnight attended polysomnography (PSG) and collected arterial blood gas (ABG) samples. Furthermore, patients were classified into three groups according to PaCO2 values: (1) mild (PaCO2 46–50 mmHg), moderate (PaCO2 51–55 mmHg), severe (PaCO2 ≥ 56 mmHg), based on the suggestions of Damiani et al.13 Subjective daytime sleepiness was assessed by the Epworth Sleepiness Scale (ESS),14 quality of life by Short Form 36 Health Survey (SF-36), and patient's depressive symptoms by the Beck Depression Inventory (BDI) at baseline and at 2 years after initiation of PAP therapy.Short Form 36 Health SurveyThe SF-36 is a reliable and validated 36-item questionnaire for the assessment of general (physical and mental) health and quality of life, each of which is scored separately from 0 (worst) to 100 (best).15–17Beck Depression InventoryThe BDI is a 21-item questionnaire that is a widely used and well-validated self-reported inventory of depressive symptoms.18–20 Total scores range from 0 to 63 and represent the sum of the highest levels endorsed on each item. Scores lower than 10 are considered normal.SpirometrySpirometry was performed with the patient in the seated position, according to approved standards.21ABG SamplesABG samples were taken with patients being alert for more than 4 hours after morning awakening, seated and breathing room air, and having remained at rest for 10 minutes. In patients on long-term oxygen therapy, supplemental oxygen was removed 30 minutes before the measurement of blood gases.Sleep Study and PAP TreatmentPolysomnographyIn-laboratory PSG was performed in clinically stable patients at a median (25th–75th percentile) 58.9 (28.2–47.3) days after the diagnosis. All patients underwent a single-night full diagnostic PSG study (Alice 5, Diagnostics System, Respironics, Murrysville, Pennsylvania, United States) according to standard techniques, with monitoring of the electroencephalogram, electro-oculogram, electromyogram, flow (by oronasal thermistor and nasal air pressure transducer), thoracic and abdominal respiratory effort (by respiratory inductance plethysmography), pulse oximetry (SpO2), and body position. Snoring was recorded by a microphone placed on the anterior neck. In addition, we performed sleep capnography, (CO2SMO, Respironics Novametrix, Wallingford, Connecticut, United States) with transcutaneous carbon dioxide (PtcCO2) monitoring, in order to identify sleep hypoventilation and to guide the titration of PAP therapy, ensuring that ventilation is adequately maintained.22 We identified the average PtcCO2 values by downloading the overnight records. We excluded unreliable records (n = 18) (inexplicable, abrupt, and excessive increases in PtcCO2). PSG recordings were manually interpreted over 30-second periods by experienced staff in accordance with the 2007 American Academy of Sleep Medicine (AASM) guidelines.23 The scorer was blinded to the origin of the data. The definition of apnea and hypopnea followed the AASM standard criteria.23 The apnea-hypopnea index (AHI), calculated as the number of apnea and hypopnea events per hour of sleep, was used to diagnose OSA and assess its severity. OSA was categorized as mild (AHI 5 to < 15 events/h), moderate (AHI 15 to < 30 events/h), and severe (AHI ≥ 30 events/h).PAP TitrationDuring in-laboratory PAP titration with full PSG, performed 11.8 ± 8.9 days after the diagnostic PSG, the appropriate PAP settings were established. Continuous positive airway pressure (CPAP) was initially tested in all patients, and manually titrated in order to abolish all nocturnal respiratory events. If oxygen desaturation persisted after obstructive apneas and hypopneas had been eliminated with CPAP, we changed to bilevel PAP ventilation in spontaneous mode (ie, no backup respiratory rate). The level of CPAP that eliminated obstructive apneas and hypopneas was used as the expiratory positive pressure and positive inspiratory pressure was gradually increased until oxygen saturation was steadily over 90% or high inspiratory pressures (equal or above 20 cmH2O) were reached. Oxygen was added when significant oxygen desaturation persisted (SpO2 ≤ 88% for ≥ 5 minutes in the absence of obstructive respiratory events) despite the use of these high inspiratory pressures. In addition, oxygen therapy was added if, prior to the PAP titration, the patient's awake supine SpO2 while breathing room air was ≤ 88%.24 All patients received education prior to the PAP titration night and completed a questionnaire at the end of the first night, reporting their quality of sleep under PAP titration and any side effects.Follow-UpAll study groups received individual counseling during scheduled clinic appointments, at their initial sleep clinic consultation, and after the completion of overnight in-laboratory polysomnography. After PAP therapy was started, patients were followed up in the outpatient sleep clinic at 1 month, then at 3-month intervals during the first year, and every 6 months thereafter. Patients were advised to bring their PAP device and interface to every sleep clinic visit. The importance of good adherence to PAP therapy was emphasized, encouraging the patients to use PAP therapy throughout the entire sleep period every day. This format adhered to a standardized approach according to our PAP clinic procedures.25 In the first month, separate from treatment adherence encouragement, an ABG analysis was performed, and changes to oxygen therapy or PAP settings were made if necessary. At each visit a clinical nurse, under the supervision of a sleep physician, re-evaluated the exclusion criteria and recorded anthropometric variables, weight, PAP adherence, medications, alcohol and tobacco consumption, and other clinically relevant events. Furthermore, in patients requiring supplemental oxygen, oxygen was withdrawn based on awake ABG levels, effective PAP therapy (PAP adherence), and nocturnal oximetry results.The study was designed to follow patients for at least 2 years. However, in some patients, follow-up stopped when the patient withdrew informed consent or was unable to complete follow-up.PAP AdherencePAP usage data included mask type (nasal or full face), number of nights on PAP, average use (h/night), air leakage, and air pressure delivered. Regular PAP adherence was defined as using PAP therapy for an average of 4 h/night for and at least 70% of the nights.26 However, we used the cutoff point of 6 h/ night of PAP use for subgroup analysis, as studies in patients with eucapnic OSA indicate that with use more than 6 h/night a greater percentage of patients will achieve normal levels of objectively measured and self-reported daytime sleepiness, as well as significantly improved memory, daily functioning, and improved survival rates.25,27Statistical AnalysisAll continuous variables were tested for normality using several methods (skewness and kurtosis, the proximity of the mean to the median, visual inspection of their histograms, Q-Q plots, and box plots). Results are presented as mean ± standard deviation (SD) for continuous variables if normally distributed and as median (25th–75th percentile) if not. Qualitative variables are presented as absolute number (percentage). Variables that were normally distributed were compared among the three groups (mild, moderate and severe OHS) using analysis of variance. If analysis of variance was significant, we used Tukey-Kramer post hoc test to compare each pair (moderate versus mild, severe versus mild, and moderate versus mild OHS groups). For variables that are not normally distributed, we used the Kruskal-Wallis test to compare the three groups. If Kruskal-Wallis test results were significant, we used the Mann-Whitney U test to compare each pair. For categorical variables, we used the chi-square test to compare the three groups. To compare changes from baseline to follow-up, the paired samples t test (for normally distributed data) and the Wilcoxon signed-rank test (for non-normally distributed data) were used. Changes of continuous variables from baseline to follow-up were defined as follow-up minus baseline values. Correlation coefficients were calculated using the Pearson or Spearman (for non-normally distributed data) correlation test for all the independent predictors of mean change of PaO2, PaCO2, HCO3−, and questionnaire scores. As independent variables we included clinically relevant variables such as age, sex, BMI, ESS, smoking history, comorbidities, AHI, oxygen desaturation index, mean SpO2 and minimum SpO2 during sleep, awake and asleep transcutaneous CO2 (PtcCO2), sleep time with SpO2 < 90%, ABG, spirometric measurements, h/ night of PAP use, percentage of nights PAP was used, type of PAP (bilevel PAP or fixed CPAP and auto-PAP) mode. Only the variables that were found to be significant were further analyzed. Multivariate linear regression analysis was used to examine any association of PAP treatment with changes in PaO2, PaCO2, HCO3−, and questionnaires scores at follow-up, after controlling for the potential confounders that were found to be significant. Furthermore, we applied a binary logistic regression analysis model to assess the ability of the previous variables to predict the prescription of O2 supplementation to PAP therapy and mortality. As a large proportion of patients were smokers and obesity can falsely increase the forced expiratory volume in one second/forced vital capacity ratio leading to probable false-negative results for the presence of obstructive airways disease, we performed our analysis separately in patients who never smoked. A value of P < .05 was considered statistically significant. Data were analyzed using PAWP 17.0 software (SPSS Inc, Chicago, Illinois, United States).RESULTSBaseline CharacteristicsDuring the study period, 1,855 patients were referred to the sleep disorders clinic for clinical suspicion of OSA. Most were obese (BMI > 30 kg/m2) and had an AHI ≥ 5 events/h (1,623, 87.5%). Among the 1,855 patients, 241 received a diagnosis of OHS and OSA, 11 OHS without OSA (ie, AHI < 5 events/h), 1,227 OSA without hypercapnia, 211 OSA with hypercapnia (mainly due to COPD diagnosis), and 165 no OSA. The overall prevalence of OHS among the 1,855 patients referred was 13.6% and among obese patients with OSA it was 15.5%. All 252 patients with OHS participated, of whom 7 patients abandoned PAP therapy before the 24-month period and 20 did not show up for the final assessment (Figure 1). Thus, the final study sample comprised 225 patients, 108 men (48%) and 117 women (52%). These patients did not differ from those who did not complete the study regarding age, sex, BMI, comorbidities, AHI, mean nighttime SpO2, baseline PaCO2 and PaO2 and type of PAP therapy prescribed (data not shown).Figure 1: Study flow diagram illustrating how the final group of patients were obtained.Download FigureDemographics, spirometric measurements, and ABG analysis of the final sample at baseline are shown in Table 1. PSG data and questionnaires scores are shown in Table 2. Time that PtcCO2 was above 50 mmHg was 72.3 ± 30.1 minutes. None of the patients included in the study had a significant number of central apneas during sleep. Based on OHS grading according to PaCO2 level, 123 patients (55%) were categorized as mild, 46 (20%) as moderate, and 56 (25%) as severe. No difference was found among groups in terms of BMI, current smoking, spirometry results, BDI, and ESS scores (Table 1 and Table 2).Table 1 Baseline demographics, spirometric measurements, and ABG analysis results of the study population.Table 1 Baseline demographics, spirometric measurements, and ABG analysis results of the study population.Table 2 Baseline PSG data and questionnaires scores of the final sample.Table 2 Baseline PSG data and questionnaires scores of the final sample.At baseline, 100 patients (45%) required daytime and/ or nocturnal supplemental oxygen (flow 1–3 L/min) therapy (Table S1 in the supplemental material). These patients were older and mostly female, had more comorbidities, higher baseline PaCO2, and lower AHI. In logistic regression models, the prescription of O2 supplementation with PAP therapy was associated with the moderate to severe OHS group (14.1; 95% CI 4.4, 45.4, P < .001) after controlling for the potential confounders.Adherence With PAP TherapyOf 225 patients with OHS, 84 (37.3%) used PAP (either fixed CPAP [17.8%] or auto-PAP [82.2%] with the mean CPAP pressure of 10.5 ± 2.5 cmH2O) and 141 (62.6%) used bilevel PAP (mean IPAP of 13.9 ± 2.7 cmH2O and mean EPAP of 9.2 ± 2.1 cmH2O). In the mild OHS group, 55% of subjects used bilevel PAP; the percentage was 75% in the moderate OHS group and 76% in the severe OHS group, which was slightly but not significantly increased compared to moderate OHS, but was significantly increased compared to mild OHS.The mean daily use of PAP therapy at the most recent visit was 6.0 ± 1.7 h/night. Most patients (95.9%) had objective usage of ≥ 4 h/night and 56.9% had objective usage of ≥ 6 h/ night. Patients who used bilevel PAP therapy also had greater PAP usage (6.3 ± 1.7 h/night versus 5.6 ± 1.6 h/night, P = .027). PAP usage was also significantly different among OHS severity groups (mild: 5.8 ± 1.4 h/night; moderate: 6.9 ± 1.9 h/night; severe: 5.9 ± 2.0 h/night; P = .03). The moderate group had higher usage compared to the mild group (P = .025).No significant weight loss or improvement in spirometry tests were observed at the end of the follow-up period (data not shown). Two patients (1 mild, 1 severe) underwent weight reduction surgery, and both lost a significant amount of weight and no longer required PAP therapy. Although initially 45% of the patients required daytime and/or nocturnal supplemental oxygen, oxygen was discontinued in a significant proportion of patients (based on awake ABG levels, effective PAP therapy and nocturnal oximetry results) and only 8.9% were still on oxygen therapy at the end of the follow-up period.Arterial Blood GasesTable 3 describes the observed PaCO2, HCO3−, and PaO2 values as well as the ESS, BDI, and SF-36 scores at baseline, after the end of the follow-up period, and the mean change from baseline. At the end of the follow-up period, PaO2 had increased from baseline (P < .001) and both PaCO2 and HCO3− had decreased (P < .001) (Figure 2). Similar results were found in the subgroup of patients who never smoked (Table S2 in the supplemental material). In all three OHS groups separately, the comparison of pretreatment with the last posttreatment measurements demonstrated significant improvements in median PaCO2 values (P < .001), mean PaO2 values (P < .05), and mean HCO3− values (P < .005) (see supplemental material).Table 3 Comparison of ABG and questionnaire scores at baseline and at the end of the follow-up period for all patients.Table 3 Comparison of ABG and questionnaire scores at baseline and at the end of the follow-up period for all patients.Figure 2: Changes in ABG at baseline and at the end of the follow-up period.Values presented as mean ± standard deviation below graph. ABG = arterial blood gas.Download FigureIn stepwise multiple linear regression models, the magnitude of change in PaCO2 was associated only with PAP use (β = −1.5 mmHg per average hour of nightly PAP use [95% confidence interval (CI), −2.5, −0.5]; P = .007) and baseline PaCO2 (β = −0.87 [95% CI, −1.2, −0.5]; P < .001) after controlling for the potential confounders (Table S3 in the supplemental material). The change in PaO2 was related only to baseline PaO2 (β = −0.89 [95% CI −1.2, −0.57]; P < .001) and HCO3− change only with baseline HCO3− (β = −0.77 [95% CI −1.1, −0.5]; P < .001).At the end of the study, 38 patients (18%) had daytime PaCO2 > 45 mmHg (median PaCO2 46.9 mmHg [46.03–48.78]). These patients had higher baseline daytime PaCO2 (54 versus 49 mmHg, P = .03), were categorized mostly as moderate to severe OHS at baseline (82%, P = .02) and were similar in age, sex, BMI, type of PAP therapy, spirometry tests, or presence of comorbidities (P > .05). Mean adherence to PAP therapy was 6.7 ± 1.5 h/night for patients who achieved normocapnia versus 5.7 ± 1.3 h/night for those who remained hypercapnic (P = .038). When we separately analyzed the clinical characteristics of the patients with persistent daytime PaCO2 > 45 mmHg, most of them had a follow-up PaCO2 of 45–49 mmHg, and 5 (2.3%) had a PaCO2 above 50 mmHg. These patients had optimal nighttime SpO2 correction and were clinically asymptomatic and consequently, PAP treatment was maintained.Questionnaires ScoresPAP therapy also significantly improved ESS (P < .001), BDI (P < .001), and SF-36 (P < .001) scores in all patients in the three OHS groups and in the subgroup of patients who never smoked (Table 3, Figure 3, and Table S2).Figure 3: Changes in questionnaires scores at baseline and at the end of the follow-up period.Values presented as mean ± standard deviation below graph. BDI = Beck Depression Inventory, ESS = Epworth Sleepiness Scale, SF-36 = Short Form 36 Health Survey.Download FigureChange in ESS was correlated only with baseline ESS (β = −0.78 [95% CI −0.89, −0.67]; P < .001). Change in BDI was associated with baseline BDI (β = −0.68 [95% CI −0.8, −0.6]; P < .001), baseline SF-36 (β = −0.16 [95% CI −0.25, −0.01]; P = .004), and awake PtcCO2 (β = −0.097 [95% CI −0.26, −0.03]; P = .041). Change in SF-36 was correlated with PAP use (β = 0.8 [95% CI 0.12, 1.45]; P = .007) and baseline SF-36 (β = −0.27 [95% CI −0.45, −0.16]; P < .001) (Table S4 in the supplemental material).Subgroup Analysis by Hours of PAP UseBecause PAP use was among the strongest correlated factors in most of the aforementioned parameters, subgroup analysis was performed to compare changes in these parameters between patients with PAP use ≥ 6 and < 6 h/night. Baseline demographics, spirometric measurements, ABG analysis, and PSG parameters (Table S5 and Table S6 in the supplemental material) did not differ between these subgroups (P > .05). Patients who used PAP therapy ≥ 6 h/night had a considerably greater improvement in ABG and SF-36 score than patients who were less adherent (Table 4, Figure 4). Similar results were obtained in the subgroup of patients who never smoked (Table S7 in the supplemental material). Furthermore, the benefit of PAP adherence on PaCO2 and SF-36 seems to continue after 6 hours of PAP use (Table S8 in the supplemental material). The final PaCO2 normalized (< 45 mmHg) in 71% of patients with adherence below 6 h/night compared to 76% of patients with adherence equal or above 6 h/night (P = .18). In more adherent patients, the need for daytime home oxygen therapy decreased from 56% to 5% (P < .001), and in less adherent patients it decreased from 30% to 12% (P = .003). At least one serious cardiovascular event was diagnosed in 15.1% of the patients who used PAP therapy for < 6 h/ night compared to none of the more adherent patients during follow-up (P = .001).Table 4 Comparisons of changes in ABG and questionnaire scores over the follow-up according to PAP use per night.Table 4 Comparisons of changes in ABG and questionnaire scores over the follow-up according to PAP use per night.Figure 4: Changes in ABG and in questionnaires scores according to PAP compliance.Values presented as mean ± standard deviation below graph. ABG = arterial blood gas, BDI = Beck Depression Inventory, ESS = Epworth Sleepiness Scale, PAP = positive airway pressure, SF-36 = Short Form 36 Health Survey.Download FigureMortalityThe median follow-up was 30 months (24–52 months). During the entire observation period, a total of 11 deaths (5% of all patients) were recorded. The main cause of death (in 90%) was cardiovascular diseases (heart failure in two patients, sudden death in three patients, ischemic heart disease in three patients, and stroke in two patients). Other causes of death were cancer (10%).With regard to diagnostic OHS subgroups, 2 patients (1.6%) in the mild OHS group died, whereas in the moderate-severe group, there were 9 deaths (9%). Baseline PaCO2 (r = −.2, P = .03), total sleep time spent with SaO2 < 90% (r = .23, P = .02), and hours of PAP use (r = −.26, P = .003) were found to predict mortality. The use of" @default.
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- W2890106031 title "The Association Between Adherence to Positive Airway Pressure Therapy and Long-Term Outcomes in Patients With Obesity Hypoventilation Syndrome: A Prospective Observational Study" @default.
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