Martha E. Billings

Is the relationship between race and continuous positive airway pressure adherence mediated by sleep duration

STUDY OBJECTIVES Black race has been associated with decreased continuous positive airway pressure (CPAP) adherence. Short sleep duration, long sleep latency, and insomnia complaints may affect CPAP adherence as they affect sleep and opportunity to use CPAP. We assessed whether self-reported sleep measures were associated with CPAP adherence and if racial variations in these sleep characteristics may explain racial differences in CPAP adherence. DESIGN Analysis of data from a randomized controlled trial (HomePAP), which investigated home versus laboratory-based diagnosis and treatment of obstructive sleep apnea. SETTING Seven American Academy of Sleep Medicine-accredited sleep centers in five cities in the United States. PATIENTS OR PARTICIPANTS Enrolled subjects (n = 191) with apnea-hypopnea index ≥ 15 and sleepiness (Epworth Sleepiness Scale > 12). INTERVENTIONS N/A. MEASUREMENTS AND RESULTS Multivariable regression was used to assess if subjective sleep measures and symptoms predicted 3-mo CPAP use. Mediation analysis was used to assess if sleep measures mediated the association of race with CPAP adherence. Black participants reported shorter sleep duration and longer sleep latency at baseline than white and Hispanic participants. Shorter sleep duration and longer sleep latency predicted worse CPAP adherence. Sleep duration mediated the association of black race with lower CPAP adherence. However, insomnia symptoms were not associated with race or CPAP adherence. CONCLUSIONS Among subjects with similar severity of obstructive sleep apnea and sleepiness, baseline self-reported sleep duration and latency, but not perceived insomnia, predicted CPAP adherence over 3 mo. Sleep duration explains some of the observed differences in CPAP use by race. Sleep duration and latency should be considered when evaluating poor CPAP adherence. CLINICAL TRIAL INFORMATION PORTABLE MONITORING FOR DIAGNOSIS AND MANAGEMENT OF SLEEP APNEA (HOMEPAP) URL: http://clinicaltrials.gov/show/NCT00642486. NIH clinical trials registry number: NCT00642486.

Psychometric Performance and Responsiveness of the Functional Outcomes of Sleep Questionnaire and Sleep Apnea Quality of Life Index in a Randomized Trial: The HomePAP Study

STUDY OBJECTIVES Measures of health-related quality of life (HRQL) specific for sleep disorders have had limited psychometric evaluation in the context of randomized controlled trials (RCTs). We investigated the psychometric properties of the Functional Outcomes of Sleep Questionnaire (FOSQ) and Sleep Apnea Quality of Life Instrument (SAQLI). We evaluated the FOSQ and SAQLI construct and criterion validity, determined a minimally important difference, and assessed for associations of responsiveness to baseline subject characteristics and continuous positive airway pressure (CPAP) adherence in a RCT population. DESIGN Secondary analysis of data collected in a multisite RCT of home versus laboratory-based diagnosis and treatment of obstructive sleep apnea (HomePAP trial). PARTICIPANTS Individuals enrolled in the HomePAP trial (n = 335). INTERVENTIONS N/A. MEASUREMENT AND RESULTS The FOSQ and SAQLI subscores demonstrated high reliability and criterion validity, correlating with Medical Outcomes Study 36-Item Short Form Survey domains. Correlations were weaker with the Epworth Sleepiness Scale (ESS). Both the FOSQ and SAQLI scores improved after 3 mo with CPAP therapy. Averaging 4 h or more of CPAP use was associated with an increase in the FOSQ beyond the minimally important difference. Baseline depressive symptoms and sleepiness predicted FOSQ and SAQLI responsiveness; demographic, objective obstructive sleep apnea (OSA) severity and sleep habits were not predictive in linear regression. CONCLUSIONS The FOSQ and SAQLI are responsive to CPAP intervention, with the FOSQ being more sensitive to differences in CPAP adherence than the SAQLI. These instruments provide unique information about health outcomes beyond that provided by changes in physiological measures of OSA severity (apnea-hypopnea index). CLINICAL TRIAL INFORMATION Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP) URL: http://clinicaltrials.gov/show/NCT00642486. NIH clinical trials registry number: NCT00642486.

Medicare long-term CPAP coverage policy: a cost-utility analysis.

STUDY OBJECTIVES CPAP is an effective treatment for OSA that may reduce health care utilization and costs. Medicare currently reimburses the costs of long-term CPAP therapy only if the patient is adherent during a 90-day trial. If not, Medicare requires a repeat polysomnogram (PSG) and another trial which seems empirically not cost-effective. We modeled the cost-effectiveness of current Medicare policy compared to an alternative policy (clinic-only) without the adherence criterion and repeat PSG. DESIGN Cost-utility and cost-effectiveness analysis. SETTING U.S. Medicare Population. PATIENTS OR PARTICIPANTS N/A. INTERVENTIONS N/A. MEASUREMENTS AND RESULTS We created a decision tree modeling (1) clinic only follow-up vs. (2) current Medicare policy. Costs were assigned based on Medicare reimbursement rates in 2012. Sensitivity analyses were conducted to test our assumptions. We estimated cumulative costs, overall adherence, and QALY gained for a 5-year time horizon from the perspective of Medicare as the payer. Current Medicare policy is more costly than the clinic-only policy but has higher net adherence and improved utility. Current Medicare policy compared to clinic-only policy costs

Acute Constrictive Pericarditis After Lung Transplantation for Lymphangioleiomyomatosis

30,544 more per QALY. CONCLUSIONS Current CMS policy promotes early identification of those more likely to adhere to CPAP therapy by requiring strict adherence standards. The policy effect is to deny coverage to those unlikely to use CPAP long-term and prevent wasted resources. Future studies are needed to measure long-term adherence in an elderly population with and without current adherence requirements to verify the cost-effectiveness of a policy change.

Effect of Continuous Positive Airway Pressure on Stroke Rehabilitation: A Pilot Randomized Sham-Controlled Trial

Lymphangioleiomyomatosis (LAM) is a rare, cystic, progressive lung disease with many extrapulmonary manifestations, which may complicate allograft function after transplantation. We present a LAM patient with new dyspnea and declining spirometry without rejection, infection or recurrence one year after bilateral lung transplantation. Investigation revealed acute constrictive pericarditis, which has not been reported previously in a lung transplant patient with LAM. This represents a novel complication likely due to progression of extrapulmonary LAM and should be considered in LAM transplant patients with dyspnea.

Circadian Dysrhythmias in the Intensive Care Unit

STUDY OBJECTIVES Obstructive sleep apnea (OSA) predicts poor functional outcome after stroke and increases the risk for recurrent stroke. Less is known about continuous positive airway pressure (CPAP) treatment on stroke recovery. METHODS In a pilot randomized, double-blind, sham-controlled trial, adult stroke rehabilitation patients were assigned to auto-titrating or sham CPAP without diagnostic testing for OSA. Change in Functional Independence Measure (FIM), a measure of disability, was assessed between rehabilitation admission and discharge. RESULTS Over 18 months, 40 patients were enrolled and 10 withdrew from the study: 7 from active and 3 from sham CPAP (p > 0.10). For the remaining 30 patients, median duration of CPAP use was 14 days. Average CPAP use was 3.7 h/night, with at least 4 h nightly use among 15 patients. Adherence was not influenced by treatment assignment or stroke severity. In intention-to-treat analyses (n = 40), the median change in FIM favored active CPAP over sham but did not reach statistical significance (34 versus 26, p = 0.25), except for the cognitive component (6 versus 2.5, p = 0.04). The on-treatment analyses (n = 30) yielded similar results (total FIM: 32 versus 26, p = 0.11; cognitive FIM: 6 versus 2, p = 0.06). CONCLUSIONS A sham-controlled CPAP trial among stroke rehabilitation patients was feasible in terms of recruitment, treatment without diagnostic testing and adequate blinding-though was limited by study retention and CPAP adherence. Despite these limitations, a trend towards a benefit of CPAP on recovery was evident. Tolerance and adherence must be improved before the full benefits of CPAP on recovery can be assessed in larger trials.

The Effect of Sleeping Environment and Sleeping Location Change on Positive Airway Pressure Adherence

Circadian rhythms underlie nearly all physiologic functions and organ systems. Circadian abnormalities have attendant implications for critical illness survival. The intensive care unit (ICU) environment, with its lack of diurnal variation in sound, light, and social cues, may precipitate circadian dysrhythmias. Additional features of critical care, including mechanical ventilation and sedation, likely perpetuate circadian misalignment. Critical illness itself, from sepsis to severe brain injury, can compromise circadian health. Use of daylight, time-restricted feedings, and administration of melatonin can possibly restore circadian rhythm. However, further study is necessary to assess the effectiveness of these interventions and their impact on ICU outcomes.

Environmental Determinants of Insufficient Sleep and Sleep Disorders: Implications for Population Health

STUDY OBJECTIVES Poor adherence undermines the effectiveness of positive airway pressure (PAP) therapy for sleep apnea. Disparities exist in PAP adherence by race/ethnicity and neighborhood socioeconomic status (SES), but the etiology of these differences is poorly understood. We investigated whether home environmental factors contribute to PAP adherence and whether identified factors explain disparities in adherence by SES. METHODS Adult patients with sleep apnea were surveyed at clinic visits about their sleep environment. Medical records were abstracted for demographic data, sleep apnea severity, comorbidities, and objective PAP adherence. We evaluated the association between aspects of home sleep environment with PAP adherence using multivariate linear and logistic regression, and assessed effect modification by SES factors. RESULTS Participants (n = 119) were diverse, with 44% nonwhite and 35% uninsured/Medicaid. After adjusting for age, sex, race/ethnicity, insurance, neighborhood SES, education, and marital status, participants who endorsed changing sleeping location once per month or more (18%, n = 21) had 77% lower odds of meeting PAP adherence criteria (> 4 h/night for 70% of nights) and less PAP use (median -11 d/mo, 95% confidence intervals -15.3, -6.5). Frequency of sleeping location change was the only environmental factor surveyed associated with PAP adherence. CONCLUSIONS Frequent change in sleeping location is associated with reduced PAP adherence, independent of sociodemographic factors. This novel finding has implications for physician-patient dialogue. PAP portability considerations in device selection and design may modify adherence and potentially improve treatment outcomes. Prospective investigation is needed to confirm this finding and inform design of possible interventions.

Continuous Positive Airway Pressure Use and Socioeconomic Status. Differences Are Not All about Equipment Cost

Purpose of ReviewSleep is important for overall health and well-being. Insufficient sleep and sleep disorders are highly prevalent among adults and children and therefore a public health burden, particularly because poor sleep is associated with adverse health outcomes. Emerging evidence has demonstrated that environmental factors at the household- and neighborhood-level can alter healthy sleep. This paper will (1) review recent literature on the environmental determinants of sleep among adults as well as children and adolescents and (2) discuss the opportunities and challenges for advancing research on the environment and sleep.Recent FindingsEpidemiologic research has shown that social features of environments, family, social cohesion, safety, noise, and neighborhood disorder can shape and/or impact sleep patterns and physical features such as light, noise, traffic, pollution, and walkability can also influence sleep and is related to sleep disorders among adults and children. Prior research has mainly measured one aspect of the environment, relied on self-reported sleep, which does not correlate well with objective measures, and investigated cross-sectional associations. Although most studies are conducted among non-Hispanic white populations, there is growing evidence that indicates that minority populations are particularly vulnerable to the effects of the environment on insufficient sleep and sleep disorders.SummaryThere is clear evidence that environmental factors are associated with insufficient sleep and sleep disorders. However, more research is warranted to evaluate how and which environmental factors contribute to sleep health. Interventions that target changes in the environment to promote healthy sleep should be developed, tested, and evaluated as a possible pathway for ameliorating sleep health disparities and subsequently health disparities.

Early diagnosis and treatment of obstructive sleep apnea after stroke: Are we neglecting a modifiable stroke risk factor?Authors Respond:

Continuous positive airway pressure (CPAP) is an efficacious treatment for obstructive sleep apnea (OSA) that improves daytime functioning and reduces the risk for cardiovascular events. Yet consistent use of this potentially life-saving therapy remains a major barrier to achieving intended outcomes. At least 30% of patients with OSA reject CPAP treatment initially, and fewer than half who initially accept therapy are adherent over time (at more than 4 hours a night) (1). Lowsocioeconomic-status (SES) groups have higher cardiovascular mortality (2, 3) and poorer sleep quality (4), and thus perhaps have even more to gain with CPAP therapy. Thus, it is of concern that the evidence to date suggests that CPAP acceptance and adherence rates are lower among low-SES subjects. In this month’s issue of AnnalsATS, Kendzerska and colleagues (pp. 93–100) examine the association of patient neighborhood income level with acceptance of CPAP therapy (5). The primary outcome for this study was rate of CPAP acceptance, which was modeled as time to CPAP purchase. At a median of 6 months after a diagnostic study, fewer patients living in the lowest-income neighborhoods had acquired CPAP equipment than those in other neighborhoods (43% vs. 52% acceptance), although this association did attenuate after adjusting for confounders. Performed at a single center in Canada, the study by Kendzerska and colleagues reflected the benefits of a universal healthcare system, with a single payer covering the majority of CPAP device and supply costs. In this system, individuals pay no diagnostic charges and 0–25% of the cost of CPAP therapy. This benefit potentially reduces health disparities resulting from differences in the ability to pay for treatment The study has several important limitations that restrict inferences that can be made from the findings. The analyses do not account for individual differences in copayment. It is probable that copayment amount differed by neighborhood SES. Using just average neighborhood income to categorize SES may lead to misclassification, as other SES features such as education level, unemployment rates, and household value may better reflect the multifaceted nature of neighborhood SES. The role of race and ethnicity is also not explored. Minorities are often more predominant in low-SES neighborhoods. The effect of race and ethnicity on CPAP acceptance may partially explain the observed association of race and ethnicity with adherence (6, 7). The study confirms prior findings of differences in acceptance rates of CPAP by SES. In Israel, a larger association between income level or residential SES and CPAP acceptance was observed, perhaps because of the higher copay (25–50%) requirement (8). Implementing financial incentives in Israel did enhance acceptance among low-SES patients (9), indicating that cost of the device does factor into patient acceptance of treatment. However, when the cost of equipment is eliminated, differences in acceptance, albeit smaller, are still seen by SES. In a randomized trial, with no out-of-pocket costs for equipment, acceptance was significantly lower in subjects from the lowest-SES neighborhoods compared with others (83% vs. 94%) (6). This suggests that factors beyond the direct cost of CPAP likely contribute to differences in CPAP acceptance by SES. Initial acceptance of CPAP is certainly necessary to achieve long-term adherence to CPAP therapy. However, there are likely also distinct personal, social, cognitive, and economic factors that contribute to ongoing adherence, which may differ from factors determining acceptance. Prior work has found differences in CPAP adherence by SES in settings where equipment cost was minimal. Two studies have found an association of neighborhood SES on CPAP adherence: one among U.S. veterans in Philadelphia, Pennsylvania (10), and another in a multisite randomized control trial (6). In both instances, there were no direct out-of-pocket costs for CPAP therapy, yet differences in use remained significant. A study in New Zealand found that individual SES (income, deprivation level, and education) also predicted adherence. Most patients in that study received government funding for CPAP; thus, the cost of devices did not contribute to differences (7). In Brazil, acceptance was similar for patients receiving care in public (receiving government assistance with minimal out-of-pocket costs) versus private clinics; however, the public clinic patients abandoned therapy more often (11). Thus, again, factors beyond the direct cost of therapy associated with low SES are likely contributing to differences in CPAP use. The relationship of SES to CPAP use may be driven less by cost and more by