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CPAP Adherence Predictors in a Randomized Trial of Moderate-to-Severe OSA Enriched With Women and Minorities.

ABSTRACT: BACKGROUND:Suboptimal CPAP adherence in OSA clinical trials involving predominantly white men limits interpretability and generalizability. We examined predictors of CPAP adherence in a clinical trial enriched with minorities. METHODS:The Sleep Apnea Stress Study-a randomized, double-blind, sham-controlled trial of patients with moderate-to-severe OSA-included participants with complete 8-week adherence data (n = 138). Overnight 14-channel polysomnography, anthropometry, socioeconomic status, mood questionnaires, and week 1 CPAP adherence were analyzed via adjusted linear models relative to CPAP adherence (average minutes per night usage). RESULTS:Overall, age was 51 ± 12 years, 55% of the patients were male, 55% were white, BMI was 36.7 ± 7.7 kg/m2, and median apnea-hypopnea index was 20 (interquartile range, 13-37). In univariate analyses adherence increased with randomization to active CPAP (81 min; 95% CI, 30-132), increasing age (35 min/decade; 95% CI, 13-57), white race (78 min, 95% CI, 26-129), and per hour of week 1 adherence (41 min, 95% CI, 32-51). Active CPAP (48 min, 95% CI, 6-91), increasing age (27 min/decade, 95% CI, 10-44), and higher 1-week adherence (36 min/h, 95% CI, 27-46) were significantly associated with improved adherence in multivariable analyses. Subgroup analyses showed stronger associations of adherence with treatment arm in whites and increasing age in minorities. Increasing age and white race were more strongly associated with adherence in women. CONCLUSIONS:In this trial with near-even sex distribution and high ethnic minority representation, we identified CPAP assignment, increasing age, and early adherence to be associated with improved adherence in addition to sex-specific and race-specific adherence differences. These results can inform targeted clinical trial adherence optimization strategies. TRIAL REGISTRY:ClinicalTrials.gov; No.: NCT00607893; URL: www.clinicaltrials.gov.

SUBMITTER: May AM

PROVIDER: S-EPMC6130325 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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CPAP Adherence Predictors in a Randomized Trial of Moderate-to-Severe OSA Enriched With Women and Minorities.

May Anna M AM Gharibeh Tarek T Wang Lu L Hurley Amanda A Walia Harneet H Strohl Kingman P KP Mehra Reena R

Chest 20180421 3

<h4>Background</h4>Suboptimal CPAP adherence in OSA clinical trials involving predominantly white men limits interpretability and generalizability. We examined predictors of CPAP adherence in a clinical trial enriched with minorities.<h4>Methods</h4>The Sleep Apnea Stress Study-a randomized, double-blind, sham-controlled trial of patients with moderate-to-severe OSA-included participants with complete 8-week adherence data (n = 138). Overnight 14-channel polysomnography, anthropometry, socioecon ...[more]

PMID: 29684316

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Project description:BackgroundThe titration pressure of continuous positive airway pressure (CPAP) is important in patients with obstructive sleep apnea (OSA). This study aimed to understand the difference between drug-induced sleep endoscopy (DISE)-guided CPAP titration and conventional sleep center (CSC) CPAP titration in patients with OSA.MethodsIn this randomized, controlled, and single-blind crossover trial, we compared the effects of 1-month CPAP treatment in patients with OSA with either DISE-guided CPAP titration or CSC CPAP titration. Twenty-four patients with OSA were recruited for the study. All patients underwent polysomnography, DISE-guided CPAP titration, and accommodation. Initially, patients were randomly assigned to receive either DISE-guided CPAP titration or CSC CPAP treatment for the first month. They were then switched to other treatments in the second month. The Epworth sleepiness scale (ESS) score was recorded at baseline, 1 and 2 months.ResultsThe upper limit of the pressure of DISE-guided titration and CSC CPAP titration was not significantly different (13.9 ± 0.7 vs. 13.5 ± 0.5 cm H2O; P = 0.92). The residual apnea-hypopnea index and compliance were also not significantly different between the groups. ESS score significantly improved from baseline to 1 month after CPAP treatment in both groups. Both epiglottis (anterior-posterior collapse) and tongue base collapse were significantly associated with 95% CPAP pressure (P = 0.031 and 0.038, respectively). After multivariate regression analyses, the epiglottis (anterior-posterior collapse) was an independent factor for 95% CPAP pressure. The incidence rate of bradycardia was 58.3%, which is a safety concern for DISE. Despite the high incidence of bradycardia, all patients with bradycardia recovered with proper management.ConclusionBoth modalities were comparable in terms of establishing the pressure settings required to treat patients. Further large-scale studies are required to confirm these results.Trial registrationhttps://clinicaltrials.gov/, NCT03523013.

Project description:Background and Objectives: Obstructive sleep apnea (OSA) is associated with daytime somnolence, cognitive impairment and high cardiovascular morbidity and mortality. Obesity, associated cardiovascular comorbidities, accelerated erythropoiesis and muscular mitochondrial energetic dysfunctions negatively influence exercise tolerance in moderate-severe OSA patients. The cardiopulmonary exercise testing (CPET) offers an integrated assessment of the individual's aerobic capacity and helps distinguish the main causes of exercise limitation. The purpose of this study is to evaluate the aerobic capacity of OSA patients, before and after short-term continuous positive airway pressure (CPAP). Materials and Methods: Our prospective study included 64 patients with newly diagnosed moderate-severe OSA (apnea hypopnea index (AHI) 39.96 ± 19.04 events/h) who underwent CPET before and after CPAP. Thirteen patients were unable to tolerate CPAP or were lost during follow-up. Results: 49.29% of our patients exhibited a moderate or severe decrease in functional capacity (Weber C or D). CPET performance was influenced by gender but not by apnea severity. Eight weeks of CPAP induced significant improvements in maximal exercise load (? = 14.23 W, p = 0.0004), maximum oxygen uptake (? = 203.87 mL/min, p = 0.004), anaerobic threshold (? = 316.4 mL/min, p = 0.001), minute ventilation (? = 5.1 L/min, p = 0.01) and peak oxygen pulse (? = 2.46, p = 0.007) as well as a decrease in basal metabolic rate (BMR) (? = -8.3 kCal/24 h, p = 0.04) and average Epworth score (? = -4.58 points, p < 0.000001). Conclusions: Patients with moderate-severe OSA have mediocre functional capacity. Apnea severity (AHI) was correlated with basal metabolic rate, resting heart rate and percent predicted maximum effort but not with anaerobic threshold or maximum oxygen uptake. Although CPET performance was similar in the two apnea severity subgroups, short-term CPAP therapy significantly improved most CPET parameters, suggesting that OSA per se has a negative influence on effort capacity.

Project description:BackgroundMost patients with comorbid sleep apnea (OSA), cardiovascular (CV) disease, and/or cerebrovascular (CeV) disease simultaneously take medications. Whether OSA and continuous positive airway pressure (CPAP) interact with CV/CeV medications remains unknown. This study aimed to determine the interaction among OSA, CPAP, and CV/CeV medications; the effects of medications on major adverse cardiac and cerebrovascular events, and survival in patients with comorbid OSA and CV/CeV.MethodsThis was a post hoc analysis of the data from one center of the Sleep Apnea Cardiovascular Endpoints Study. Participants (aged 45-75 years) with comorbid OSA and CV/CeV were randomized to receive usual care with or without CPAP from December 2008 to November 2013. The primary endpoint was death and the secondary endpoint was a composite of death, myocardial infarction, stroke, hospitalization for unstable angina, heart failure, and transient ischemic attack.ResultsIn total, 131 patients were analyzed. Sixty-three were in the CPAP group and 68 were in the usual care group, 41 had good adherence to CPAP (65.1%), and the median follow-up time was 43.0 (35.0, 54.0) months. In Cox regression analysis, ACE inhibitors and nitrates were independent factors for decreased survival in patients with comorbid OSA and CV/CeV (chi-square = 22.932, P = 0.003; ACE inhibitors: OR 7.241, P = 0.048, 95% CI 1.016-51.628; nitrates: OR 18.012, P = 0.011, 95% CI 1.923-168.750). ACE inhibitors increased mortality and secondary endpoints in the CPAP group (chi-square = 4.134, P = 0.042) but not in patients with good CPAP adherence. Clopidogrel and nitrates decreased survival in usual care group (clopidogrel: chi-square = 5.312, P = 0.021; nitrates: chi-square = 6.417, P = 0.011), but not in CPAP group.ConclusionsOSA may predispose patients with CV/CeV and CV/CeV medications to a negative effect. CPAP treatment may neutralize the negative effects of OSA by relieving chronic intermittent hypoxia. Trial registration ClinicalTrials.gov (NCT00738179, first registration date: 20/08/2008).

Project description:To determine if the type of continuous positive airway pressure (CPAP) mask interface influences CPAP treatment efficacy, adherence, side effects, comfort and sleep quality in patients with moderate-severe obstructive sleep apnea (OSA).This took place in a hospital-based tertiary sleep disorders unit. It is a prospective, randomized, crossover trial comparing three CPAP interfaces: nasal mask (NM), nasal mask plus chinstrap (NM-CS) and oronasal mask (ONM) each tried in random order, for 4 weeks. After each 4-week period, patient outcomes were assessed. Participants had a new diagnosis of obstructive sleep apneas. Forty-eight patients with moderate-severe OSA (32 males, mean ± standard deviation apnea-hypopnea index (AHI) 55.6 ± 21.1 events/h, age 54.9 ± 13.1 years, body mass index 35.8 ± 7.2 kg/m2) were randomized. Thirty-five participants completed the full study, with complete data available for 34 patients.There was no statistically significant difference in CPAP adherence; however, residual AHI was higher with ONM than NM and NM-CS (residual AHI 7.1 ± 7.7, 4.0 ± 3.1, 4.2 ± 3.7 events/h respectively, main effect P = .001). Patient satisfaction and quality of sleep were higher with the NM and NM-CS than the ONM. Fewer leak and mask fit problems were reported with NM (all chi-square P < .05), which patients preferred over the NM-CS and ONM options (n = 22, 9 and 4 respectively, P = .001).The CPAP adherence did not differ between the three different mask interfaces but the residual AHI was lower with NM than ONM and patients reported greater mask comfort, better sleep, and overall preference for a NM. A nasal mask with or without chinstrap should be the first choice for patients with OSA referred for CPAP treatment.Registry: Australian and New Zealand Clinical Trials Registry, URL: https://www.anzctr.org.au, title: A comparison of continuous positive airway pressure (CPAP) interface in the control of leak, patient compliance and patient preference: nasal CPAP mask and chinstrap versus full face mask in patients with obstructive sleep apnoea (OSA), identifier: ACTRN12609000029291.

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CPAP Adherence Predictors in a Randomized Trial of Moderate-to-Severe OSA Enriched With Women and Minorities.

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CPAP Adherence Predictors in a Randomized Trial of Moderate-to-Severe OSA Enriched With Women and Minorities.

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