Tiotropium Respimat Soft Mist Inhaler versus HandiHaler to improve sleeping oxygen saturation and sleep quality in COPD.

PURPOSE: Patients with chronic obstructive pulmonary disease (COPD) have poor sleep quality as a result of various alterations in oxygenation parameters and sleep macro- and micro-architecture. There is a shortage of data to support the efficacy of long-acting inhaled anticholinergic agents in improving these adverse effects, which are known to have a negative impact on clinical outcomes. We aimed to compare the tiotropium Respimat Soft Mist Inhaler and the HandiHaler in terms of their effects on sleeping oxygen saturation (SaO2) and sleep quality in patients with COPD. METHODS: In a randomized, open-label, parallel-group trial involving 200 patients with mild to moderate COPD (resting arterial oxygen tension >60 mmHg while awake), we compared the effects of 6 months' treatment with the two devices on sleeping SaO2 and sleep quality. Overnight polysomnography and pulmonary function testing were performed at baseline and after 6 months' treatment. RESULTS: A total of 188 patients completed the trial. Both groups showed significant improvement in minimum sleep SaO2 and time of sleep spent with SaO2 below 90 (TST90) compared to baseline. The patients using the Respimat had significantly better TST90 than did those using the HandiHaler. Sleep disturbance was highly variable in these patients, but the sleep stage durations were significantly better in the Respimat group. CONCLUSIONS: Sleeping SaO2 can be improved by tiotropium delivered using either the HandiHaler device or the Respimat Soft Mist Inhaler. However, the patients who used the Respimat device had significantly better TST90 and sleep architecture parameters.

Intensive versus standard follow-up to improve continuous positive airway pressure compliance.

We aimed to compare the effect of intensive versus standard interventions on continuous positive airway pressure (CPAP) adherence 2 years after CPAP initiation, as well as on sleepiness, quality of life, depression, hospitalisation and death rate due to cardiovascular disease (CVD). 3100 patients with newly diagnosed sleep apnoea were randomised into the standard group, with usual follow-up care, or the intensive group, with additional visits, telephone calls and education. Subjective daytime sleepiness (Epworth Sleepiness Scale; ESS), quality of life (36-item Short Form Health Survey; SF-36) and the patient's level of depression (Beck Depression Inventory; BDI) were recorded before and 2 years after CPAP initiation, together with CVD hospitalisations and death rate. 2 years after CPAP initiation, the intensive group used CPAP significantly more than the standard group (6.9 versus 5.2 h per night; p<0.001). ESS, SF-36 and BDI scores were also significantly better in the intensive group. Furthermore, the standard group had significantly more deaths and hospitalisations due to CVD. CPAP usage can be improved by both intensive and standard patient support. However, the patients who received intensive CPAP support had significantly better ESS, BDI and SF-36 scores, and lower cardiovascular morbidity and mortality, suggesting that an intensive programme could be worthwhile.

Patients with idiopathic pulmonary fibrosis with and without obstructive sleep apnea: differences in clinical characteristics, clinical outcomes, and the effect of PAP treatment.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) in patients with idiopathic pulmonary fibrosis (IPF) is associated with worse mortality and clinical outcome. We aimed to assess differences between patients with IPF with and without OSA and the effect of positive airway pressure treatment on sleep and overall life quality, morbidity, and mortality in these patients. METHODS: Forty-five patients with newly diagnosed IPF underwent polysomnography. Using an apnea-hypopnea index ≥ 15 events/h for OSA diagnosis resulted in 16 patients with IPF and 29 with IPF-OSA. The patients completed the Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcomes in Sleep Questionnaire, Fatigue Severity Scale, Short Form-36 life questionnaire, and Beck Depression Inventory before and at the end of the follow-up period. RESULTS: Patients with IPF-OSA showed the most severe functional impairments in questionnaires, especially for General Health component of the Short Form-36 life questionnaire (37 vs 58, P = .03). At the 7-year follow-up, 16 (36%) patients had died, 6 (38%) in the IPF group and 10 (35%) in IPF-OSA group. Patients with ≥6-hour positive airway pressure use had better survival compared with patients with <6-hour use (P = .04). Significant improvement was also observed in Epworth Sleepiness Scale (3 vs 6, P = .03), Pittsburgh Sleep Quality Index (5 vs 8, P = .01), and Fatigue Severity Scale (37 vs 48, P = .008) score in patients with ≥4-hour positive airway pressure use. CONCLUSIONS: OSA plays a significant role on clinical features and quality of life in patients with IPF. Effective positive airway pressure treatment results in a significant improvement in sleepiness, fatigue, sleep quality, and mortality. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: CPAP Therapy in Patients With Idiopathic Pulmonary Fibrosis and Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/record/NCT01637831; Identifier: NCT01637831.

Cardiovascular Effect and Symptom Profile of Obstructive Sleep Apnea: Does Sex Matter?

STUDY OBJECTIVES: To evaluate the influence of sex on obstructive sleep apnea (OSA)-related symptoms and prevalent cardiovascular disease (CVD) in a large clinical population of patients. METHODS: A total of 6,716 patients (mean age 52 years, 24% women) had undergone diagnostic polysomnography and completed the Epworth Sleepiness Scale (ESS), Athens Insomnia Scale, and Beck Depression Inventory. We investigated the predictive value of sex on associated symptoms and prevalent cardiovascular disease, after adjustment for relevant confounding factors including age, obesity, and comorbidities. RESULTS: Most of the patients (90%) had OSA (apnea-hypopnea index [AHI] ≥ 5 events/h), and 66% were obese. Women were older than men and had a higher body mass index; however, men had a thicker neck circumference, a higher waist-to-hip ratio, and increased OSA severity (AHI 36 versus 27 events/h, P < .001). Female sex independently predicted prevalent CVD after adjustment for confounders (odds ratio [95% CI] 1.476 [1.154-1.887], P = .002). Men independently were more likely to report driving problems (3.359 [2.470-4.569], P < .001) and excessive daytime sleepiness (ESS ≥ 16) (1.355 [1.036-1.773], P = .027). Furthermore, female sex was an independent predictive factor for depressive symptoms (2.473 [1.831-3.340], P < .001), frequent awakenings (1.703 [1.323-2.192], P < .001), nocturia (1.727 [1.340-2.226], P < .001) and morning headaches (1.855 [1.488-2.326], P < .001). CONCLUSIONS: Females referred for sleep studies were more likely to exhibit CVD and less likely to complain of typical OSA symptoms than males in this large clinical patient cohort.

The Association Between Adherence to Positive Airway Pressure Therapy and Long-Term Outcomes in Patients With Obesity Hypoventilation Syndrome: A Prospective Observational Study.

STUDY 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/NCT03449641.