The relationships between improvements in daytime sleepiness, fatigue and depression and psychomotor vigilance task testing with CPAP use in patients with obstructive sleep apnea.

OBJECTIVE: The purpose of this study was to determine if the subjective improvements in daytime sleepiness, fatigue and depression experienced by patients with obstructive sleep apnea (OSA) with continuous positive airway pressure (CPAP) therapy predict an objective improvement in vigilance, and whether patients with mild-to-moderate OSA differ from patients with severe OSA in this regard. METHODS: A total of 182 patients underwent psychomotor vigilance task (PVT) testing and measurements of subjective daytime sleepiness, fatigue and depression at baseline and after a minimum of one month of adherent CPAP use at an adequate pressure. RESULTS: Patients with both mild-to-moderate (n = 92) and severe (n = 90) OSA experienced improvements in subjective daytime sleepiness, fatigue and depression, but objective improvement in vigilance was only seen in patients with severe OSA. In patients with severe OSA, while a correlation was found between improvements in daytime sleepiness and some PVT parameters, changes in subjective daytime sleepiness, fatigue and depression scores were not predictive of objective improvement in vigilance while controlling for all these subjective symptoms and for age, gender, body mass index, apnea-hypopnea index/respiratory event index and total sleep time/total recording time with pulse oximetry below 90%. CONCLUSIONS: We found no predictive relationship between subjective improvements in daytime sleepiness, fatigue and depression and objective vigilance with CPAP use in patients with OSA. These results suggest that subjective complaints of daytime impairment and objective measures of vigilance in patients with OSA should be assessed separately while evaluating the efficacy of CPAP therapy on daytime functioning.

"To sleep, perchance to tweet": in-bed electronic social media use and its associations with insomnia, daytime sleepiness, mood, and sleep duration in adults.

OBJECTIVES: The use of mobile device-based electronic social media (ESM) in bed is rapidly becoming commonplace, with potentially adverse impacts on sleep and daytime functioning. The purpose of this study was to determine the extent to which in-bed ESM use is associated with insomnia, daytime sleepiness, mood, and sleep duration in adults. METHODS: This was a cross-sectional observational study conducted among 855 hospital employees and university students (mean age, 43.6years; 85% female) via an online questionnaire. RESULTS: Nearly 70% of participants indulged in in-bed ESM use, with nearly 15% spending an hour or more a night doing so. The degree of in-bed ESM use did not vary by gender, but higher levels of in-bed ESM use were seen in younger and middle-aged than elderly participants. Compared with participants with no in-bed ESM use and controlling for age, gender, and ethnicity, participants with high in-bed ESM use were more likely to have insomnia, anxiety, and short sleep duration on weeknights, but not depression or daytime sleepiness; low in-bed ESM use only increased the likelihood of short sleep duration on weeknights. In-bed ESM use by a bed partner did not have an adverse association with sleep or mood. CONCLUSIONS: In-bed ESM use is associated with sleep and mood dysfunction in adults. These findings are of relevance to clinicians, therapists, and the public at large, as they suggest that limitation of in-bed ESM use is a potential interventional strategy in the overall management of sleep hygiene and mental health.

The utility of patient-completed and partner-completed Epworth Sleepiness Scale scores in the evaluation of obstructive sleep apnea.

PURPOSE: Excessive daytime sleepiness in obstructive sleep apnea (OSA) is often rated differently by patients and their partners. This cross-sectional study compared the utility of patient-completed and partner-completed Epworth Sleepiness Scale (ESS) scores in the evaluation of suspected OSA. METHODS: Eighty-five patient-partner pairs were enrolled, and 75 patients completed diagnostic sleep studies. The individual and combined utilities of patient-completed and partner-completed ESS scores in identifying OSA and predicting various sleep study-derived indicators of disease severity were determined. RESULTS: Mean partner-completed ESS scores were higher than patient-completed ESS scores (12.3 ± 4.2 vs. 9.4 ± 4.8, p < 0.0001); Bland-Altman plot showed significant bias (partner-completed ESS scores 33.5 % higher, SD ±55.2 %). Partner-completed and combined (but not patient-completed) ESS scores correlated weakly with the apnea-hypopnea index (AHI; partner-completed ESS score r s  = 0.25, p = 0.029; combined ESS score r s  = 0.29, p = 0.013) and oxygen desaturation index (partner-completed ESS score r s  = 0.26, p = 0.025; combined ESS score r s  = 0.23, p = 0.047). None of the ESS scores correlated with body mass index, arousal index, or other parameters of nocturnal oxygen desaturation. In OSA (AHI > 15/h) detection, partner-completed ESS scores had greater sensitivity than patient-completed ESS scores (76.9 vs. 46.2 %) but poorer specificity (39.1 vs. 65.2 %); sensitivity was greatest (82.7 %) when either patient-completed or partner-completed ESS score was 10 or higher, and specificity was greatest (80.8 %) when both scores were 10 or higher. CONCLUSIONS: Neither patient-completed nor partner-completed ESS scores by themselves have great utility in identifying OSA or predicting its severity. However, taking both scores into consideration together improves the sensitivity and specificity of the screening process.

The impact of Sleep Time-Related Information and Communication Technology (STRICT) on sleep patterns and daytime functioning in American adolescents.

This cross-sectional study explored the extent and impact of mobile device-based Sleep Time-Related Information and Communication Technology (STRICT) use among American adolescents (N = 3139, 49.3% female, mean age = 13.3 years). Nearly 62% used STRICT after bedtime, 56.7% texted/tweeted/messaged in bed, and 20.8% awoke to texts. STRICT use was associated with insomnia, daytime sleepiness, eveningness, academic underperformance, later bedtimes and shorter sleep duration. Moderation analysis demonstrated that the association between STRICT use and insomnia increased with age, the association between STRICT use and daytime sleepiness decreased with age, and the association between STRICT use and shorter sleep duration decreased with age and was stronger in girls. Insomnia and daytime sleepiness partially mediated the relationship between STRICT use and academic underperformance. Our results illustrate the adverse interactions between adolescent STRICT use and sleep, with deleterious effects on daytime functioning. These worrisome findings suggest that placing reasonable limitations on adolescent STRICT use may be appropriate.

Is There a Clinical Role For Smartphone Sleep Apps? Comparison of Sleep Cycle Detection by a Smartphone Application to Polysomnography.

STUDY OBJECTIVES: Several inexpensive, readily available smartphone apps that claim to monitor sleep are popular among patients. However, their accuracy is unknown, which limits their widespread clinical use. We therefore conducted this study to evaluate the validity of parameters reported by one such app, the Sleep Time app (Azumio, Inc., Palo Alto, CA, USA) for iPhones. METHODS: Twenty volunteers with no previously diagnosed sleep disorders underwent in-laboratory polysomnography (PSG) while simultaneously using the app. Parameters reported by the app were then compared to those obtained by PSG. In addition, an epoch-by-epoch analysis was performed by dividing the PSG and app graph into 15-min epochs. RESULTS: There was no correlation between PSG and app sleep efficiency (r = -0.127, p = 0.592), light sleep percentage (r = 0.024, p = 0.921), deep sleep percentage (r = 0.181, p = 0.444) or sleep latency (rs = 0.384, p = 0.094). The app slightly and nonsignificantly overestimated sleep efficiency by 0.12% (95% confidence interval [CI] -4.9 to 5.1%, p = 0.962), significantly underestimated light sleep by 27.9% (95% CI 19.4-36.4%, p < 0.0001), significantly overestimated deep sleep by 11.1% (CI 4.7-17.4%, p = 0.008) and significantly overestimated sleep latency by 15.6 min (CI 9.7-21.6, p < 0.0001). Epochwise comparison showed low overall accuracy (45.9%) due to poor interstage discrimination, but high accuracy in sleep-wake detection (85.9%). The app had high sensitivity but poor specificity in detecting sleep (89.9% and 50%, respectively). CONCLUSIONS: Our study shows that the absolute parameters and sleep staging reported by the Sleep Time app (Azumio, Inc.) for iPhones correlate poorly with PSG. Further studies comparing app sleep-wake detection to actigraphy may help elucidate its potential clinical utility. COMMENTARY: A commentary on this article appears in this issue on page 695.

The efficacy of a chinstrap in treating sleep disordered breathing and snoring.

STUDY OBJECTIVES: A previously published case report suggested that a chinstrap alone might improve obstructive sleep apnea (OSA). We conducted this study to determine whether a chinstrap was a feasible alternative to continuous positive airway pressure (CPAP) in patients with OSA. METHODS: 26 adult patients with OSA (apnea-hypopnea index [AHI] > 5/h on diagnostic polysomnogram [PSG]) underwent a modified split-night PSG, using only a chinstrap for the first 2 hours of sleep, followed by CPAP titration for the remainder of the night. Improvements in AHI, arterial oxygen saturation (SpO2), and snoring with chinstrap use were compared to results with optimal CPAP pressures. RESULTS: There was no significant difference between the diagnostic PSG and the chinstrap portion of the split-night PSG in the following parameters: general AHI (median [IQR] 16.0/h [9.7-26.0] vs. 25.9/h [10.7-42.7]), SpO2 nadir (84.0% [80.5-87.5] vs. 87.0 [84.0-88.5]), AHI in REM sleep (26.7/h [16.8-43.7] vs. 42.4/h [21.3-57.7]), AHI in supine sleep (24.9/h [11.9-51.5] vs. 29.8/h [11.7-55.5]), snoring index (253.2/h [147.5-353.1] vs. 180.0/h [9.8-393.3]) or subjective snoring scale (3.0 [0.8-3.0] vs. 2.5 [0.4-3.0]). The AHI and SpO2 nadir in the 13 patients with mild OSA also did not improve with chinstrap use (9.6/h [8.1-12.2] vs. 10.6/h [6.8-35.4] and 87.0% [83.0-90.0] vs. 88.0% [87.0-89.0]). All these parameters showed significant improvement with optimal CPAP titration (p < 0.05). CONCLUSIONS: A chinstrap alone is not an effective treatment for OSA. It does not improve sleep disordered breathing, even in mild OSA, nor does it improve the AHI in REM sleep or supine sleep. It is also ineffective in improving snoring.

Asthma outcomes and costs of therapy with extrafine beclomethasone and fluticasone.

BACKGROUND: Characteristics of inhaled corticosteroids (ICSs) differ, but data comparing the real-life effectiveness of various ICSs for asthma are lacking. OBJECTIVE: We sought to compare real-life asthma outcomes and costs of extrafine hydrofluoroalkane (HFA)-beclomethasone and fluticasone administered through a pressurized metered-dose inhaler. METHODS: This retrospective matched cohort study examined database markers of asthma control from a large US longitudinal health care claims database over 1 baseline and 1 outcome year for 10,312 patients with asthma aged 12 to 80 years receiving their first ICS as HFA-beclomethasone or fluticasone and matched on baseline demographic characteristics and asthma severity. RESULTS: Patients started on HFA-beclomethasone had significantly higher odds (adjusted odds ratio, 1.19; 95% CI; 1.08-1.31) of achieving overall control (risk and impairment), which was defined as no hospital attendance for asthma, oral corticosteroids, or antibiotics for lower respiratory tract infection and less than 2 puffs per day of short-acting ß-agonist; they also experienced a lower rate of respiratory-related hospitalizations or referrals (adjusted rate ratio, 0.82; 95% CI, 0.73-0.93) than patients started on fluticasone. Other database outcome measures were similar in the 2 cohorts. Prescribed HFA-beclomethasone doses were lower (P < .001) than fluticasone doses (median, 320 µg/d [interquartile range, 160-320 µg/d] vs 440 µg/d [interquartile range, 176-440 µg/d]). Adjusted respiratory-related health care costs were significantly lower for HFA-beclomethasone than fluticasone (mean, $1869 [95% CI, $1727-$2032] vs $2259 [95% CI, $2111-$2404]), representing a mean annual savings of $390 (95% CI, $165-$620) per patient prescribed HFA-beclomethasone rather than fluticasone. CONCLUSIONS: Asthma treatment outcomes were similar or better with HFA-beclomethasone prescribed at significantly lower doses and with lower costs than fluticasone.

Effect of montelukast for treatment of asthma in cigarette smokers.

OBJECTIVE: Many asthmatic patients are unable to quit cigarettes; therefore information is needed on treatment options for smokers. This study evaluates 10 mg/d montelukast and 250 µg of fluticasone propionate twice daily, each compared with placebo, in patients with self-reported active smoking (unable to quit) and asthma. METHODS: Patients (ages 18-55 years, with asthma [≥1 year], FEV1 of 60% to 90% of predicted value, airway reversibility [≥12%], and self-reported active smoking [≥0.5 to ≤2 packs per day]) were randomized (after a 3-week, single-blind, placebo, run-in period) to 1 of 3 parallel, 6-month, double-blind treatment arms. The primary efficacy end point was the percentage of days with asthma control during treatment. Adverse experiences (AEs) were also evaluated. RESULTS: There were 347, 336, and 336 patients randomized to montelukast, fluticasone, and placebo, respectively. The mean percentage of days with asthma control over 6 months of treatment was 45% (montelukast, P < .05 vs placebo), 49% (fluticasone, P < .001 vs placebo), and 39% (placebo); the difference between montelukast and fluticasone was not significant (P = .14). Patients with a smoking history of ≤11 pack years (the median value) tended to show more benefit with fluticasone, whereas those with a smoking history of >11 pack years tended to show more benefit with montelukast. AEs occurred in similar proportions among treatment groups. CONCLUSIONS: In a population of asthmatic patients actively smoking cigarettes, both 10 mg/d montelukast and 250 µg of fluticasone propionate twice daily significantly increased the mean percentage of days with asthma control compared with placebo.

Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children.

OBJECTIVES: To evaluate the effect of montelukast, 5 mg, or inhaled salmeterol, 50 microg, added to inhaled fluticasone in reducing the maximum percentage decrease in forced expiratory volume in 1 second (FEV1) after a standardized exercise challenge and response to rescue bronchodilation with albuterol in children aged 6 to 14 years with persistent asthma and exercise-induced bronchoconstriction (EIB). METHODS: Randomized, double-blind, double-dummy, multicenter, 2-period, 4-week, crossover study conducted between December 22, 2005 and November 14, 2008 at 30 centers in Europe, Asia, Mexico, and South America. Patients with asthma receiving inhaled corticosteroids demonstrated an FEV1 of 70% or higher of the predicted value and EIB (defined as a decrease in FEV1 > or = 15% compared with preexercise baseline FEV1 on 2 occasions before randomization). Standardized exercise challenges were performed at baseline (prerandomization) and at the end of each active treatment period. RESULTS: Of 154 patients randomized, 145 completed the study. Montelukast, compared with salmeterol, significantly reduced the mean maximum percentage decrease in FEV1 (10.6% vs 13.8%; P = .009), mean area under the curve for the first 20 minutes after exercise (116.0% x min vs 168.8% x min; P = .006), and median time to recovery (6.0 vs 11.1 minutes; P = .04). Response to albuterol rescue after exercise challenge was significantly greater (P < .001) with montelukast. Montelukast and salmeterol were generally well tolerated. CONCLUSIONS: Attenuation and response of EIB to albuterol rescue after exercise challenge were significantly better with montelukast than with salmeterol after 4 weeks of treatment.

The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity.

OBJECTIVE: To determine the effect of montelukast on asthma during the allergy season in children with persistent asthma and seasonal aeroallergen sensitivity. DESIGN: This 3-week double-blind, placebo-controlled, parallel-group multicenter study compared daily montelukast 5 mg chewable tablets and placebo in patients 6-14 years of age with forced expiratory volume in 1 second (FEV(1)) > or = 60 and < or = 85% predicted, persistent asthma that is also active during allergy season, and documented sensitivity to seasonal allergens. Concomitant inhaled corticosteroid use was permitted in up to 40% of enrolled patients. The primary endpoint was the percentage change from baseline in FEV(1) over 3 weeks of treatment. Additional endpoints included the percentage change from baseline in beta-agonist use, average changes in daytime and nighttime symptom score, AM and PM peak expiratory flow rate (PEFR), investigator's global asthma evaluation, and parent/guardian global asthma evaluation at the end of the treatment period. Adverse experiences (AEs) were collected to assess safety and tolerability. RESULTS: A total of 421 patients were randomized to montelukast (N = 203) or placebo (N = 218). For the primary endpoint, the percentage change from baseline FEV(1), montelukast was not significantly different from placebo (least squares mean 9.53% vs. 9.15%, respectively; p = 0.810). Compared with placebo, montelukast was associated with significantly lower (better) investigator's global asthma evaluation (LS mean 2.71 vs. 2.98; p < 0.05) and parent/guardian global asthma evaluation (LS mean: 2.63 vs. 2.90; p < 0.05) scores. There were no significant differences between treatment groups for the other efficacy evaluations. Both treatments were well tolerated, with no significant differences observed in AE rates. CONCLUSION: Montelukast did not significantly improve FEV(1) compared with placebo over three weeks of treatment during the allergy season in pediatric patients with seasonal allergen sensitivity. (ClinicalTrials.gov identifier: NCT00289874).

Montelukast, compared with fluticasone, for control of asthma among 6- to 14-year-old patients with mild asthma: the MOSAIC study.

BACKGROUND: Guidelines recommend daily controller therapy for mild persistent asthma. Montelukast has demonstrated consistent benefit in controlling symptoms of asthma and may be an alternative, orally administered, nonsteroidal agent for treating mild asthma. METHODS: The Montelukast Study of Asthma in Children (MOSAIC study) was a 12-month, multicenter, randomized, double-blind, noninferiority trial to determine the effect of once-daily, orally administered montelukast (5 mg) (n = 495), compared with twice-daily, inhaled fluticasone (100 microg) (n = 499), on the percentage of asthma rescue-free days (RFDs) (any day without asthma rescue medication and with no asthma-related resource use). Patients 6 to 14 years of age had mild persistent asthma (average percentage of predicted forced expiratory volume in 1 second: 87.2%; RFDs at baseline: 64%). Montelukast would be considered not inferior to fluticasone if the upper limit of the 95% confidence interval for the difference in mean percentages of RFDs (fluticasone minus montelukast) was above -7% (a difference of approximately 2 days/month). RESULTS: The mean percentage of RFDs was 84.0% in the montelukast group and 86.7% in the fluticasone group. The least-squares mean difference was -2.8% (95% confidence interval: -4.7% to -0.9%), within the noninferiority limit of -7%. The proportion of patients requiring systemic corticosteroids and the number of patients with an asthma attack were greater in the montelukast group. Both montelukast and fluticasone were well tolerated. CONCLUSIONS: Montelukast was demonstrated to be not inferior to fluticasone in increasing the percentage of RFDs among 6- to 14-year-old patients with mild asthma. Secondary end points, including percentage of predicted forced expiratory volume in 1 second value, days with beta-receptor agonist use, and quality of life, improved in both groups but were significantly better in the fluticasone treatment group.

Montelukast reduces asthma exacerbations in 2- to 5-year-old children with intermittent asthma.

The PREVIA study was designed to investigate the role of montelukast, a leukotriene receptor antagonist, in the prevention of viral-induced asthma exacerbations in children aged 2 to 5 years with a history of intermittent asthma symptoms. The study was a 12-month multicenter, double-blind, parallel-group study of patients with asthma exacerbations associated with respiratory infections and minimal symptoms between episodes. Patients were randomized to receive oral montelukast 4 or 5 mg (depending on age) (n = 278) or placebo (n = 271) once per day for 12 months. Caregivers recorded children's symptoms, beta-agonist use, and health care resource use in a diary card. Over 12 months of therapy, montelukast significantly reduced the rate of asthma exacerbations by 31.9% compared with placebo. The average rate of exacerbation episodes per patient was 1.60 episodes per year on montelukast compared with 2.34 episodes on placebo. Montelukast also delayed the median time to first exacerbation by approximately 2 months (p = 0.024), and the rate of inhaled corticosteroid courses (p = 0.027) compared with placebo. Montelukast effectively reduced asthma exacerbations in 2- to 5-year-old patients with intermittent asthma over 12 months of treatment and was generally well tolerated.

Montelukast and fluticasone compared with salmeterol and fluticasone in protecting against asthma exacerbation in adults: one year, double blind, randomised, comparative trial.

OBJECTIVES: To assess the effect of montelukast versus salmeterol added to inhaled fluticasone propionate on asthma exacerbation in patients whose symptoms are inadequately controlled with fluticasone alone. Design and setting A 52 week, two period, double blind, multicentre trial during which patients whose symptoms remained uncontrolled by inhaled corticosteroids were randomised to add montelukast or salmeterol. PARTICIPANTS: Patients (15-72 years; n = 1490) had a clinical history of chronic asthma for > or = 1 year, a baseline forced expiratory volume in one second (FEV1) value 50-90% predicted, and a beta agonist improvement of > or = 12% in FEV1. MAIN OUTCOME MEASURES: The primary end point was the percentage of patients with at least one asthma exacerbation. RESULTS: 20.1% of the patients in the group receiving montelukast and fluticasone had an asthma exacerbation compared with 19.1% in the group receiving salmeterol and fluticasone; the difference was 1% (95% confidence interval -3.1% to 5.0%). With a risk ratio (montelukast-fluticasone/salmeterol-fluticasone) of 1.05 (0.86 to 1.29), treatment with montelukast and fluticasone was shown to be non-inferior to treatment with salmeterol and fluticasone. Salmeterol and fluticasone significantly increased FEV1 before a beta agonist was used and morning peak expiratory flow compared with montelukast and fluticasone (P < or = 0.001), whereas FEV1 after a beta agonist was used and improvements in asthma specific quality of life and nocturnal awakenings were similar between the groups. Montelukast and fluticasone significantly (P = 0.011) reduced peripheral blood eosinophil counts compared with salmeterol and fluticasone. Both treatments were generally well tolerated. CONCLUSION: The addition of montelukast in patients whose symptoms remain uncontrolled by inhaled fluticasone could provide equivalent clinical control to salmeterol.