An exploration of clinical, behavioral, and community factors associated with sleep duration and efficiency among middle-aged Black/African American smokers.

STUDY OBJECTIVES: We examined the most important correlates to sleep duration and efficiency from a comprehensive array of multilevel factors. METHODS: Baseline data from a cohort of 216 Black/African American smokers aged 40-65 years were examined. The binary outcomes of healthy sleep duration (6-8 h/night) and efficiency (≥85%) were ascertained from 14 consecutive days of actigraphy. Seventy-three independent variables from socio-demographic, individual behavioral, individual physiological, interpersonal, and community domains were assessed. Random survival forest decision trees were generated for each outcome, and variable importance metrics used to rank the predictive abilities of exposure variables. The 5 most predictive exposure variables for each outcome were entered into a regression model of the respective outcome (with age and sex). RESULTS: Study participants (N = 216) had a mean age of 54.57 years (SD = 6.17) and 57% were male. Healthy sleep duration was achieved by 56.5% and healthy sleep efficiency by 13.6% of the sample. Regression models showed every additional minute of light physical activity was associated with 1% increased odds, while every unit decrease in the inflammation marker of interleukin-8 was associated with 12% increased odds, of achieving a healthy sleep duration. Every unit increase in total social support was associated with a 34% increased odds, while every unit increase in the hazardous drinking score corresponded with 30% decreased odds, of achieving healthy sleep efficiency. CONCLUSIONS: Light physical activity, social support, and alcohol consumption may be key modifiable intervention targets to improving sleep duration and sleep efficiency in this population.

Sleep Duration and Efficiency Associated With Better Functional Exercise Capacity in Black Smokers at Risk for COPD.

BACKGROUND: Black smokers have earlier development of lung disease as well as poorer sleep health than whites. RESEARCH QUESTION: In a sample of black smokers, to what extent does sleep health modify the association between smoking level and functional exercise capacity? DESIGN AND METHODS: Cross-sectional data from 209 black smokers (≥ 1 cigarette in last month), aged 40 to 65 years with no evidence of sleep-disordered breathing (apnea-hypopnea index < 15) or severe COPD (FEV1 > 50%), were used for the current study. Self-reported smoking rate, objectively measured sleep efficiency (SE), total sleep time (TST), and the 6-min walk test (6MWT) for functional exercise capacity were the key assessments. RESULTS: The mean age was 54.8 years (SD, 5.96), and mean cigarettes smoked per day (cpd) was 8.71 (SD, 6.78). Mean SE was 69.9% (SD, 12.3%), and mean TST was 307.99 min (SD 92.2). In adjusted linear regression models of the 6MWT (meters), TST (slope estimate, -0.14; P = .14) and SE (slope estimate, -1.0; P = .19) were negatively associated with 6MWT. The smoking rate × SE interaction was highly significant (slope estimate, 0.18; P = .007) such that in individuals who smoked ≥ 10 cpd, every additional percentage of SE garnered an additional distance of 0.83 to 6.62 m. Similarly, the smoking rate × TST interaction was significant (slope estimate, 0.019; P = .03) such that in smokers who smoked ≥ 10 cpd, every additional minute of TST garnered an additional distance of 0.04 to 0.60 m. INTERPRETATION: Higher SE and, to a lesser extent, longer TST, in black adults who smoke ≥ 10 cpd is associated with better 6MWT performance. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT03534076; URL: www.clinicaltrials.gov.

Transitioning from adequate to inadequate sleep duration associated with higher smoking rate and greater nicotine dependence in a population sample.

INTRODUCTION: Inadequate sleep (≤6 and ≥9h) is more prevalent in smokers than non-smokers but the extent to which sleep duration in smokers relates to smoking behaviors and cessation outcomes, is not yet clear. To begin to address this knowledge gap, we investigated the extent to which sleep duration predicted smoking behaviors and quitting intention in a population sample. METHODS: Data from current smokers who completed the baseline (N=635) and 5-year follow-up (N=477) assessment in the United Kingdom Biobank cohort study were analyzed. Multivariable regression models using smoking behavior outcomes (cigarettes per day, time to first cigarette, difficulty not smoking for a day, quitting intention) and sleep duration (adequate (7-8h) versus inadequate (≤6 and ≥9h) as the predictor were generated. All models adjusted for age, sex, race, and education. RESULTS: Worsening sleep duration (adequate to inadequate) predicted a more than three-fold higher odds in increased cigarettes per day (OR=3.18; 95% CI=1.25-8.06), a more than three-fold increased odds of not smoking for the day remaining difficult (OR=3.90; 95% CI=1.27-12.01), and a >8-fold increased odds of higher nicotine dependence (OR=8.98; 95% CI=2.81-28.66). Improving sleep duration (i.e., inadequate to adequate sleep) did not predict reduced cigarette consumption or nicotine dependence in this population sample. CONCLUSION: Transitioning from adequate to inadequate sleep duration may be a risk factor for developing a more "hard-core" smoking profile. The extent to which achieving healthy sleep may promote, or optimize smoking cessation treatment response, warrants investigation.

Smoking Cessation in Pulmonary Care Subjects: A Mixed Methods Analysis of Treatment-Seeking Participation and Preferences.

BACKGROUND: African-American smokers experience disproportionate COPD morbidity. As a front-line COPD behavioral management strategy, smoking cessation is less prevalent among African-American smokers. Identifying barriers and predictors to smoking cessation in this population is important to bridging this disparity. METHODS: In this study, the predictors of enrollment and attendance to a 3-session urban hospital smoking cessation program were examined. A retrospective chart review was conducted for all pulmonary clinic patients who smoked and were referred to the cessation program between June 2013 and May 2014. Demographic, smoking behavior, cardiopulmonary, and health status variables were extracted (N = 253). Second, a qualitative assessment of the beliefs and barriers for smoking cessation and physical activity were examined in a sub-sample of the population (n = 41). RESULTS: One-hundred forty-seven of the pulmonary subjects (58%) enrolled in the cessation program, and 40 attended all sessions (16% of the total sample). Participants with COPD (odds ratio = 4.65, P = .030), or had a mother who had cancer (odds ratio = 4.49, P = .027), were more likely to attend the program. Qualitatively, pulmonary care patients who wanted to quit smoking and be more physically active cited: strong beliefs about the inability to engage in these behaviors, belief that quitting and increased activity might exacerbate poor health, and an inability to obtain pharmacotherapy as barriers to adopting these behaviors. CONCLUSIONS: Smoking cessation program attendance in this sample of mostly African-American smokers was poor. Increased knowledge about cessation benefits and access to full-course pharmacotherapy, particularly in those without a COPD diagnosis and who do not have a maternal history of cancer, may be high-priority targets to promote cessation program uptake in this population. Increased knowledge and access to safe forms of physical activity may also be beneficial.

Long-term safety of glycopyrrolate: A randomized study in patients with moderate-to-severe COPD (GEM3).

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is one of the leading causes of death in the United States. Long-acting muscarinic antagonists (LAMAs) are a class of medications used as maintenance therapy for COPD. The GEM3 (Glycopyrrolate Effect on syMptoms and lung function) study assessed the long-term safety and efficacy of a LAMA, glycopyrrolate (GLY) 15.6 µg twice daily (b.i.d.), compared with an approved long-acting ß2-agonist (LABA), indacaterol (IND) 75 µg once daily (q.d.) in patients with stable, symptomatic COPD with moderate-to-severe airflow limitation. METHODS: This 52-week, multicenter, double-blind, parallel-group study randomized patients (1:1) of the United States to receive GLY 15.6 µg b.i.d. or IND 75 µg q.d. both delivered via the Neohaler(®) device. The primary objective was to assess the safety and tolerability in terms of adverse event (AE) reporting rates over 52 weeks. Safety was also determined by evaluating multiple secondary endpoints, including vital signs, electrocardiograms (ECGs), and time to first moderate or severe exacerbation. Efficacy-related secondary endpoints included pre-dose forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). RESULTS: Of the 511 randomized patients (GLY, n = 254; IND, n = 257), 81.6% completed the study. The overall incidences of AEs (GLY, 77.3%; IND, 77.0%) and serious AEs (GLY, 13.1%; IND, 13.3%) were comparable between the groups. The incidence of major adverse cardiovascular events was low and comparable between the groups. No clinically relevant differences for vital signs or ECG parameters were observed between the treatment groups. The three sudden deaths reported within 30 days of the treatment (GLY, n = 2; IND, n = 1) were adjudicated as unrelated to the study medication. In terms of efficacy, GLY 15.6 µg b.i.d. showed improvements in pre-dose FEV1 and FVC from baseline, which was comparable to those with IND 75 µg q.d., with no statistically significant differences. No significant differences were observed between the treatment groups in the time to first moderate or severe COPD exacerbation. CONCLUSION: GLY 15.6 µg b.i.d. showed a long-term safety profile comparable to that of IND 75 µg q.d. and provided rapid and sustained bronchodilation over 52 weeks in patients with COPD with moderate-to-severe airflow limitation. CLINICAL TRIAL REGISTRATION NUMBER: NCT01697696.

Demographic, physiologic and radiographic characteristics of COPD patients taking chronic systemic corticosteroids.

Long-term therapy with systemic corticosteroids is not recommended in the treatment of chronic obstructive pulmonary disease (COPD). However, experience demonstrates that some patients receive low dose therapy. Our objective was to describe the demographic, physiologic and radiologic characteristics of COPD patients treated with chronic systemic corticosteroids. We analyzed COPD subjects with GOLD I-IV disease in the COPDGene® study. Subjects were divided into 2 groups based on whether they reported using chronic oral steroids or not; 1264 subjects were included. Fifty-eight (4.5%) reported chronic systemic corticosteroid use. There were no differences in age, race, co-morbid conditions (other than asthma), or body mass index between the groups. There was a greater proportion of GOLD III (41% vs. 26%) and IV (41% vs. 13%) subjects in the group using chronic systemic corticosteroids. This group used more respiratory medications, required more oxygen (2.31 ± 0.21 vs. 0.59 ± 0.05 L/min; p < 0.0001), and walked less distance (245.4 ± 17.4 vs. 367.2 ± 3.9 meters; p < 0.0001). They reported more total (1.7 ± 0.16 vs. 0.62 ± 0.03; p < 0.0001) and severe exacerbations per year (0.41 ± 0.05 vs. 0.18 ± 0.01; p < 0.0001). BODE (5.0 ± 0.3 vs. 2.6 ± 0.1; p < 0.0001), MMRC (3.31 ± 0.19 vs. 1.90 ± 0.04; p < 0.0001) and SGRQ scores (54.9 ± 2.9 vs 53.3 ± 0.6; p < 0.0001) were higher. They also had a higher percentage of emphysema (22.4 ± 1.9 vs. 14.0 ± 0.4;%, p = <0.0001) on CT scan. COPD patients that report using chronic systemic corticosteroids have more severe clinical, physiologic, and radiographic disease.