Characterisation of Symptom and Polysomnographic Profiles Associated with Cardiovascular Risk in a Sleep Clinic Population with Obstructive Sleep Apnoea.

Aim: Recent data have identified specific symptom and polysomnographic profiles associated with cardiovascular disease (CVD) in patients with obstructive sleep apnoea (OSA). Our aim was to determine whether these profiles were present at diagnosis of OSA in patients with established CVD and in those with high cardiovascular risk. Participants in the Sydney Sleep Biobank (SSB) database, aged 30-74 years, self-reported presence of CVD (coronary artery disease, cerebrovascular disease, or heart failure). In those without established CVD, the Framingham Risk Score (FRS) estimated 10-year absolute CVD risk, categorised as "low" (<6%), "intermediate" (6-20%), or "high" (>20%). Groups were compared on symptom and polysomnographic variables. Results: 629 patients (68% male; mean age 54.3 years, SD 11.6; mean BMI 32.3 kg/m2, SD 8.2) were included. CVD was reported in 12.2%. A further 14.3% had a low risk FRS, 38.8% had an intermediate risk FRS, and 34.7% had a high risk FRS. Groups differed with respect to age, sex and BMI. OSA severity increased with established CVD and increasing FRS. The symptom of waking too early was more prevalent in the higher FRS groups (p=0.004). CVD and FRS groups differed on multiple polysomnographic variables; however, none of these differences remained significant after adjusting for age, sex, and BMI. Conclusion: Higher CVD risk was associated with waking too early in patients with OSA. Polysomnographic variations between groups were explained by demographic differences. Further work is required to explore the influence of OSA phenotypic characteristics on susceptibility to CVD.

Heart Rate Variability Analysis in Obstructive Sleep Apnoea Patients with Daytime Sleepiness.

STUDY OBJECTIVES: Recent studies suggest sleepy patients with OSA are at higher risk for incident cardiovascular disease. This study assessed cardiac autonomic function in sleepy versus non-sleepy patients with obstructive sleep apnoea (OSA) using heart rate variability (HRV) analysis. We hypothesised that HRV profiles of sleepy patients would indicate higher cardiovascular risk. METHODS: Electrocardiograms (ECG) derived from polysomnograms (PSG) collected by the Sydney Sleep Biobank were used to study HRV in groups of sleepy (ESS≥10) and non-sleepy OSA patients (ESS<10). HRV parameters were averaged across available ECG signal during N2 sleep. RESULTS: A total of 421 patients were evaluated, with mean age of 54 (14) years, body mass index (BMI) of 33 (9) kg/m2, apnoea hypopnoea index (AHI) of 21 (28) events/h and, 66% male. The sleepy group consisted of 119 patients, and the non-sleepy group 302 patients. Sleepy patients exhibited lower HRV values for: root mean square successive difference (RMSSD, p= 0.028); total power (TP, p= 0.031); absolute low frequency (LF, p= 0.045); and high frequency (HF, p= 0.010) power compared to Non-Sleepy patients. Sleepy patients with moderate to severe OSA exhibited lower HRV values for: (RMSSD, p= 0.045; TP, p= 0.052) ; absolute LF (p= 0.051); and HF power (p= 0.025). There were no differences in other time and frequency domain HRV markers. CONCLUSIONS: This study shows a trend towards parasympathetic withdrawal in sleepy OSA patients, particularly in moderate to severe cases, lending mechanistic support to the link between the sleepy phenotype and CVD risk in OSA.

Symptom Burden of Patients with Chronic Obstructive Pulmonary Disease Attending the Westmead Breathlessness Service: Prevalence, Associations, and Sex-Related Differences.

Purpose: Chronic obstructive pulmonary disease (COPD) is a progressive disease resulting in a range of symptoms including breathlessness. "Symptom burden" describes the severity and impact of multiple symptoms in an individual and is best quantified using validated symptom instruments but is not routinely measured in clinical practice. Therefore, we wanted to assess overall symptom burden in patients with moderate-to-severe COPD and find associated independent predictors. Patients and methods: A single-centre cross-sectional study of patients with COPD who attended the Westmead Breathlessness Service between March 2017 and May 2022 was conducted. We obtained baseline demographic data, lung function, assessed quality of life (CAT), anxiety/depression (HADS), and measured symptom burden (CMSAS). We compared variables between men and women using unpaired t tests or Mann-Whitney tests for continuous variables, and Fisher's exact tests for categorical variables. We used multiple regression to look for independent predictors of overall symptom burden. Data were analysed using Stata/IC 15.1. Results: Eighty-nine patients with COPD, mean age 72.6 years, 55% male, mean FEV1 32% predicted, reported an average of 8.9 symptoms including 6.9 physical and 1.6 psychological symptoms. The most common physical symptoms were shortness of breath (100%) and lack of energy (80%), and the most common psychological symptoms were worrying (65%) and feeling anxious (61%). Median CMSAS total score was higher in women than men (1.34 versus 1.04, respectively; p=0.03) with more women experiencing nervousness (p=0.011) and anxiety (p=0.005). Female sex (p=0.003), HADS-Anxiety (p=0.0001), and HADS-Depression (p=0.0001) were independently associated with total CMSAS score in a multiple linear regression model and explained 63% of total CMSAS variability. Conclusion: Very high physical and psychological symptom burden exists among patients with severe COPD. Anxiety, depression, and female sex were independently associated with increasing symptom burden. Identifying and understanding sex differences for COPD symptoms, and interventions targeting anxiety and depression may help to reduce overall symptom burden within this population.

Sleep disordered breathing has minimal association with retinal microvascular diameters in a non-diabetic sleep clinic cohort.

INTRODUCTION: Obstructive sleep apnea (OSA) may increase stroke risk; retinal arteriolar (central retinal arteriolar equivalent, CRAE) diameter narrowing and/or retinal venular (central retinal venule equivalent, CRVE) widening may predict stroke. We examined relationships between sleep disordered breathing (SDB) and CRAE and CRVE and in a diabetes-free sleep clinic cohort. METHODS: Patients for SDB assessment were recruited (Main Group, n = 264, age: 58.5 ± 8.9 yrs [mean ± SD]; males: 141) for in-laboratory polysomnography (standard metrics, eg apnea hypopnea index, AHI) and retinal photographs (evening and morning). A more severe SDB sub-group (n = 85) entered a 12-month cardiovascular risk factor minimisation (hypertension/hypercholesterolemia control; RFM) and continuous positive airway pressure (CPAP) intervention (RFM/CPAP Sub-Group); successfully completed by n = 66 (AHI = 32.4 [22.1-45.3] events/hour, median[IQR]). Univariate (Spearman's correlation, t-test) and multiple linear regression models examined non-SDB and SDB associations with CRAE and CRVE measures. RESULTS: Main Group: Evening CRAE predictors were: systolic blood pressure (0.18µm decrease per mmHg, p = 0.001), age (2.47µm decrease per decade, p = 0.012), Caucasian ethnicity (4.45 µm versus non-Caucasian, p = 0.011), height (0.24 µm decrease per cm increase, p = 0.005) and smoking history (3.08 µm increase, p = 0.052). Evening CRVE predictors were: Caucasian ethnicity (11.52 µm decrease versus non-Caucasian, p>0.001), diastolic blood pressure (0.34 µm increase in CRVE per mmHg, p = 0.001), hypertension history (6.5 µm decrease, p = 0.005), and smoking history (4.6 µm increase, p = 0.034). No SDB metric (all p>0.08) predicted CRAE or CRVE measures. RFM/CPAP Sub-Group: A one-unit increase in ln(AHI+1) was associated with a 0.046µm increase in CRAE (n = 85; p = 0.029). Mean evening CRAE and CRVE values did not change across the intervention (n = 66), but evening CRVE decreased ~6.0 µm for individuals with AHI >30 events/hr. CONCLUSION: No major SDB associations with CRAE or CRVE were identified, although the RFM/CPAP intervention reduced evening CRVE for severe OSA patients. Implications for cerebro-vascular disease risk remain uncertain. TRIAL REGISTRATION: The protocol was registered with the Australian New Zealand Clinical Trials Registry (Trial Id: ACTRN12620000694910).

Diabetes and hyperglycaemia among hospitalised patients with COVID-19 in Western Sydney: a retrospective cohort study.

BACKGROUND: Diabetes has been recognised as a major risk factor for COVID-19 mortality and hospital complications in earlier studies. AIMS: To examine the characteristics of hospitalised COVID-19 patients with diabetes and the impact of diabetes and hyperglycaemia on hospital outcomes. METHODS: This was a retrospective cohort study. Admission glucose levels, HbA1c, diabetes status and hospital outcomes were determined for subjects admitted from June to November 2021 by matching a pathology data set, a clinical data set and the hospital administrative database. The outcomes of interest were death, intensive care unit (ICU) admission and length of stay (LOS). RESULTS: There were 1515 individuals admitted with COVID-19 with 49 deaths (3.2%) and 205 (13.5%) ICU admissions. The median length of hospital stay was 3.7 days. Three hundred and ten patients (20%) had diabetes, with 46 (15%) newly diagnosed. Patients with diabetes had a higher mortality than patients who did not have diabetes (8% vs 2%, P < 0.001), were more likely to be admitted to ICU (20% vs 12%, P = 0.001) and have longer median LOS stay (6.6 (interquartile range (IQR) 2.9-12.5) vs 2.9 (IQR 0.5-7.1) days, P < 0.001). In multivariate models, neither diabetes nor admission glucose predicted death. Admission glucose level but not diabetes was an independent predictor of ICU admission and LOS. CONCLUSIONS: There is a high prevalence of diabetes among patients hospitalised with COVID-19, with worse outcomes. In contrast to previous studies, the association of diabetes with mortality was not significant when adjusted for other variables. This is possibly related to the benefits of vaccination and current medical and ICU interventions.

Retinal abnormalities, although relatively common in sleep clinic patients referred for polysomnography, are largely unrelated to sleep-disordered breathing.

STUDY OBJECTIVES: There has been long-standing interest in potential links between obstructive sleep apnea (OSA) and eye disease. This study used retinal photography to identify undiagnosed retinal abnormalities in a cohort of sleep clinic patients referred for polysomnography (PSG) and then determined associations with PSG-quantified sleep-disordered breathing (SDB) severity. METHODS: Retinal photographs (n = 396 patients) were taken of each eye prior to polysomnography and graded according to validated, standardized, grading scales. SDB was quantified via in-laboratory polysomnography (PSG; n = 385) using standard metrics. A questionnaire (n = 259) documented patient-identified pre-existing eye disease. Within-group prevalence rates were calculated on a per patient basis. Data were analyzed using multivariate logistic regression models to determine independent predictors for retinal abnormalities. P < 0.05 was considered significant. RESULTS: Main findings were (1) 76% of patients reported no pre-existing "eye problems"; (2) however, 93% of patients had at least one undiagnosed retinal photograph-identified abnormality; (3) most common abnormalities were drusen (72%) and peripapillary atrophy (PPA; 47%); (4) age was the most common risk factor; (5) diabetes history was an expected risk factor for retinopathy; (6) patients with very severe levels of SDB (apnea hypopnea index ≥ 50 events/h) were nearly three times more likely to have PPA. CONCLUSION: Retinal photography in sleep clinic settings will likely detect a range of undiagnosed retinal abnormalities, most related to patient demographics and comorbidities and, except for PPA, not associated with SDB. PPA may be indicative of glaucoma, and any association with severe SDB should be confirmed in larger prospective studies.

Exercise and Quality-of-Life Outcomes of Two Versus Three Weekly Sessions of Pulmonary Rehabilitation.

PURPOSE: This study aimed to assess whether there are differences in exercise or health-related quality-of-life (HRQoL) outcomes following twice-weekly supervised sessions of pulmonary rehabilitation (PR) compared with three times weekly over an 8-wk program in patients with chronic obstructive pulmonary disease (COPD). METHODS: We conducted a quasi-experimental, single-center observational study using 198 subjects who completed two supervised PR sessions (intervention group) compared with 208 historical controls who completed three weekly sessions. We assessed between-group differences in outcomes after balancing groups using inverse probability of treatment weighting (IPTW) of propensity scores, followed by regression adjustment. RESULTS: Both groups achieved clinically and statistically significant improvements in exercise and HRQoL following the PR program. After IPTW and regression adjustment, the intervention group had a lower post-PR 6-min walk time by 1.2: 95% CI, -12.9 to 10.5 m ( P = .84), compared with the control group. Although post-PR COPD Assessment Test (CAT) scores decreased in both groups, the intervention group had a higher post-PR CAT score by 1.5: 95% CI, 0.37 to 2.66 a.u. ( P = .01), compared with the control group. All other HRQoL measures failed to reach statistical significance. None of the between-group differences reached minimal clinically important differences for COPD. CONCLUSIONS: Our findings support current international guidelines for twice-weekly supervised PR sessions combined with unsupervised home exercise sessions. We conclude there is no disadvantage in running a PR program for patients with COPD using twice-weekly supervised sessions compared with three times weekly supervised sessions.

Hand-held fans: Physical Properties and Perceptions of Patients with COPD.

RATIONALE: Patients with chronic obstructive pulmonary disease (COPD) may remain breathless despite optimal medical treatment. Hand-held fans (HHFs) are recommended to relieve breathlessness, but little is known about physical properties of different fans and the impact HHF properties may have on patient perceptions of fans. OBJECTIVE: To describe the physical properties of HHFs and investigate the relationship of these properties to patient fan preference. METHODS: We recruited 33 participants with COPD who were attending a pulmonary rehabilitation program. Participants trialled 5 HHFs in random order. Participants rated perceived airflow, pleasantness of airflow, noisiness, and ease of use of each fan using a 1-10 numerical rating scale (NRS). After trialling all 5 fans, participants ranked each HHF from best (5 arbitrary units; a.u.) to worst (1 a.u.). Rankings for each fan were tallied to produce total HHF scores (T-HHF; maximum=165 a.u.). Objective measurements were made of sound intensity (dB; sound level meter), airflow between 5cm and 30cm from the middle of the fan (anemometer), blade rotation speed, blade size and total fan weight. We assessed the strength of association of T-HHF scores against mean NRS values using Spearman correlation coefficients and used linear regression to compare measured to perceived airflow, and noisiness to sound intensity. RESULTS: Participants were 68.5 ± 8.9 years (mean ± SD), 63% male, with a median FEV1 of 0.99L(IQR 0.76-1.31L). There was considerable variability between the 5 fans tested in terms of participant perceptions and physical properties with an almost 5-fold difference in air velocity at 30cm and a 3-fold difference in blade rotation speed. The most preferred fan had a T-HHF score of 140 and had the highest airflow (1.9 m/s) measured at 30cm. T-HHF score positively correlated with pleasantness of airflow (r = 0.46; P < 0.001), perceived airflow (r=0.58; P<0.001) and airflow velocity at 30cm from fan blades (r=1.0; P = 0.02). There were positive linear relationships between fan airflow velocity and perceived air amount, and between measured sound intensity and perceived noisiness(both P<0.001). Women reported significantly higher perceived airflow than men (P < 0.001). CONCLUSIONS: The physical properties of the five included HHFs are quite distinct. Patient preference was related to pleasantness of airflow, perceived airflow, and measured airflow at 30cm. Gender differences in perceived airflow were noted. Future research should explore the relationship between HHF characteristics and relief of breathlessness.

Predictors for carotid and femoral artery intima-media thickness in a non-diabetic sleep clinic cohort.

INTRODUCTION: The impact of sleep disordered breathing (SDB) on arterial intima-media thickness (IMT), a surrogate measure for cardiovascular disease, remains uncertain, in part because of the potential for non-SDB vascular risk factor interactions. In the present study, we determined predictors for common carotid (CCA) and femoral (CFA) artery IMT in an adult, sleep clinic cohort where non-SDB vascular risk factors (particularly diabetes) were eliminated or controlled. METHODS: We recruited 296 participants for polysomnography (standard SDB severity metrics) and CCA/CFA ultrasound examinations, followed by a 12 month vascular risk factor minimisation (RFM) and continuous positive pressure (CPAP) intervention for participants with a range of SDB severity (RFM Sub-Group, n = 157; apnea hyponea index [AHI]: 14.7 (7.2-33.2), median [IQR]). Univariable and multivariable linear regression models determined independent predictors for IMT. Linear mixed effects modelling determined independent predictors for IMT change across the intervention study. P<0.05 was considered significant. RESULTS: Age, systolic blood pressure and waist:hip ratio were identified as non-SDB predictive factors for CCA IMT and age, weight and total cholesterol:HDL ratio for CFA IMT. No SDB severity metric emerged as an independent predictor for either CCA or CFA IMT, except in the RFM Sub-Group, where a 2-fold increase in AHI predicted a 2.4% increase in CFA IMT. Across the intervention study, CCA IMT decreased in those who lost weight, but there was no CPAP use interaction. CFA IMT, however, decreased by 12.9% (95%CI 6.8, 18.7%, p = 0.001) in those participants who both lost weight and used CPAP > = 4hours/night. CONCLUSION: We conclude that SDB severity has little impact on CCA IMT values when non-SDB vascular risk factors are minimised or not present. This is the first study, however, to suggest a potential linkage between SDB severity and CFA IMT values. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12611000250932 and ACTRN12620000694910.

Maintenance of non-pharmacological strategies 6 months after patients with chronic obstructive pulmonary disease (COPD) attend a breathlessness service: a qualitative study.

OBJECTIVES: This study aimed to explore the degree to which non-pharmacological strategies for chronic breathlessness are sustained 6 months after completing a breathlessness service in patients with chronic obstructive pulmonary disease (COPD), and patient perceptions regarding the need for ongoing support. DESIGN: A qualitative approach was taken using semistructured telephone interviews. Thematic analysis used an integrative approach. SETTING: The Westmead Breathlessness Service (WBS) trains patients with COPD to self-manage chronic breathlessness over an 8-week programme with multidisciplinary input and home visits. PARTICIPANTS: Patients with moderate to very severe COPD who had completed the WBS programme 6 months earlier. RESULTS: Thirty-two participants were interviewed. One or more breathlessness self-management strategies were sustained by most participants, including breathing techniques (n=22; 69%), the hand-held fan (n=17; 53%), planning/pacing and exercise (n=14 for each; 44%) and strategic use of a four-wheeled walker (n=8; 25%). However, almost a third of participants appeared to be struggling psychologically, including some who had refused psychological intervention. A 'chaos narrative' appeared to be prevalent, and many participants had poor recall of the programme. CONCLUSIONS: Self-management strategies taught by breathlessness services to patients with moderate to very severe COPD have potential to be sustained 6 months later. However, psychological coping may be more challenging to maintain. Research is needed on ways to improve resilience to set-backs and uptake of psychological interventions, as well as to understand and address the implications of poor recall for self-management. TRIAL REGISTRATION NUMBER: ACTRN12617000499381.

Confidence of nurses with inhaler device education and competency of device use in a specialised respiratory inpatient unit.

We performed a cross-sectional study within a specialised respiratory inpatient unit assessing 25 nurses' [85% female, 8.0 ± 7.9 (mean ± SD) years' experience in nursing] confidence in providing inhaler device education using a self-reported questionnaire, and their competency (% correct steps) in using eight different inhaler devices. Sixteen percent of participants were 'not confident' providing inhaler education, while 84% were 'moderately' or 'extremely' confident. The mean (±SD)% correct steps for all devices was 47 ± 17%. There was no correlation between % correct steps and nursing years (r = 0.21, p = 0.31), or 'confidence' with providing inhaler education (r = 0.02, p = 0.91) but % correct steps strongly correlated with number of individual device prescriptions within the hospital in the preceding year (r = 0.78, p = 0.039). Most respiratory nurses felt confident in teaching inhaler technique but their overall demonstrated ability to correctly use inhalers was poor, especially for less frequently prescribed devices within our hospital. Regular assessment and ongoing education on correct inhaler technique for respiratory nurses is necessary to optimise all device usage by nurses, irrespective of experience or confidence.

CPAP treatment in REM-related obstructive sleep apnea: a distinct clinical phenotype of sleep disordered breathing.

PURPOSE: REM-related obstructive sleep apnea (REM-OSA), as defined using revised apnea-hypopnea index (AHI) criteria, might represent a specific OSA phenotype. However, there is a lack of data on outcomes of treatment in this population. This study evaluated the effects of CPAP treatment over 12 months on clinical outcomes for patients with the polysomnography phenotype of REM-OSA. METHODS: We conducted a prospective observational study with the following inclusion criteria: subjective sleepiness and diagnostic polysomnography demonstrating AHIREM≥15 events/h, AHINREM<5 events/h, and ≥ 30 min of REM sleep. Clinical outcomes assessed included Epworth Sleepiness Scale (ESS), psychomotor vigilanc test reaction time (PVT-RT), and CPAP adherence at baseline, 1, 3, 6, and 12 months; Functional Outcomes of Sleep Questionnaire (FOSQ) and Depression Anxiety Stress Scales (DASS-21) at baseline, 1, 3 and 12 months. The reason is the first 3 outcomes (ESS, PVT, adherence) were assessed at baseline, 1, 3, 6, and 12 months, while the next 2 outcomes (FOSQ, DASS) were assessed at baseline, 1, 3, and 12 months. The edited version is not as clear in separating these outcomes into 2 groups; Functional Outcomes of Sleep Questionnaire (FOSQ); and Depression Anxiety Stress Scales (DASS-21) at baseline, 1, 3, and 12 months. Linear mixed effects models were used to investigate the joint effects of time and average CPAP adherence on our outcomes of interest. RESULTS: Twenty participants completed a minimum of 1 month of CPAP treatment and were included for analysis. During the trial, 8 participants discontinued CPAP (4 before 3 months, 1 before 6 months, 3 before 12 months), and 19 participants completed 12 months of treatment. Baseline ESS was elevated at 12.6 units. Average CPAP usage for all 27 participants over 12 months was 2.9 ± 2.4 h. There was a significant decrease in ESS and increase in FOSQ at all time points, and the decrease in ESS was only seen in the CPAP-adherent subgroup. Decreases in DASS-21 and PVT-RT were not sustained. CONCLUSIONS: CPAP treatment in sleepy patients with moderate to severe REM-OSA is associated with reduced sleepiness and improved quality of life. TRIAL REGISTRATION: The trial was registered in the Australian New Zealand Clinical Trials Registry: ACTRN12620000576921, 18/05/2020 (retrospectively registered).

ABCA3 deficiency from birth to adulthood presenting as paediatric interstitial lung disease.

Paediatric disorders of pulmonary surfactant may occur due to mutations involving surfactant proteins B and C, and ATP-binding cassette subfamily A member 3 (ABCA3) genes. Recessive frameshift or nonsense ABCA3 mutations are associated with respiratory failure and neonatal death but milder phenotypes of ABCA3 deficiency due to missense, splice site, and insertion/deletions may result in survival beyond infancy. To date, only one case report describes the clinical course from birth to age 21 years and there are less than 10 adult cases. No guidelines exist for medical therapy due to the rarity of this condition. We describe the clinical course of a patient over 39 years and her younger brother who were both diagnosed at birth with an unspecified paediatric interstitial lung disease (ILD) and were eventually diagnosed with ABCA3 mutation in their adulthood. Our report highlights the minimal progression of the ABCA3-related ILD without long-term medications, but the development of dyspnoea due to progressive pulmonary hypertension and airflow obstruction.

Patient perspectives on how to optimise benefits from a breathlessness service for people with COPD.

This study aimed to inform understanding of how to optimise patient-perceived benefits from a breathlessness service designed for patients with moderate to very severe chronic obstructive pulmonary disease (COPD). The Westmead Breathlessness Service (WBS) trains patients to self-manage over an 8-week programme, with multidisciplinary input and home visits. A qualitative approach was taken, using semi-structured telephone interviews. Each transcript was globally rated as suggesting 'significant', 'some' or 'no' impact from WBS, and thematic analysis used an integrative approach. Forty-one consecutive participants were interviewed to reach 'information power'. Eighteen (44%) participants reported 'significant' impact, 17 (41%) 'some' impact, and two (5%) 'no' impact. Improvements to breathlessness were usually in the affective and impact dimensions but, more uncommonly, also sensory-perceptual. Participants who benefited in self-esteem, confidence and motivation attributed this to one-to-one multidisciplinary coaching and home visits. Further research should test whether including/excluding more intensive programme elements based on individual need might improve cost-effectiveness.

Protocol for a Single-Blind, Randomized, Parallel-Group Study of a Nonpharmacological Integrated Care Intervention to Reduce the Impact of Breathlessness in Patients with Chronic Obstructive Pulmonary Disease.

Background: Patients with chronic obstructive pulmonary disease (COPD) frequently experience breathlessness despite maximal medical therapy. Nonpharmacological management is effective in studies enrolling patients with a variety of respiratory diseases; however, the impact on patients with COPD is unclear. Methods: A protocol for a mixed-methods, single-center, observer-blinded, fast-track randomized-controlled, parallel-group trial comparing an immediate eight-week nonpharmacological Westmead Breathlessness Service (WBS) to a standard care control group is described. Population: At least moderate COPD (FEV1:FVC ≤0.7; FEV1%predicted ≤60%) and persistent disabling breathlessness (modified Medical Research Council ≥2). Intervention: Individualized prescription of nonpharmacological breathlessness interventions, including a handheld fan, breathing techniques, postures to relieve breathlessness, relaxation, nutritional advice, energy conservation, and exercise advice delivered by a team including doctors, nurses, a physiotherapist, an occupational therapist, a dietitian, and speech pathologist. Control: Participants who receive the WBS intervention after an eight-week period while receiving usual care (standard care group). Outcome: Primary outcome-Chronic Respiratory Questionnaire (CRQ) Mastery subscale. Secondary outcomes include numerical rating scale of breathlessness intensity, unpleasantness, and confidence managing breathlessness; quality of life as measured by other CRQ subscales; Hospital Anxiety and Depression Scale score; daily step count; health resource utilization 12 months pre- and postintervention; and cost-effectiveness. Qualitative analysis of participant interviews will provide additional context for interpreting the quantitative results. Discussion: This study aims to establish the efficacy and cost-effectiveness of an eight-week nonpharmacological breathlessness intervention in patients with COPD. Trial Registration: The Australian New Zealand Clinical Trial Registry ACTRN12617000499381 (06/04/17).

Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea.

BACKGROUND AND AIM: Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system. METHODS: This prospective, open-label, non-randomised, single-arm treatment study was conducted at eight centres in three countries (Australia, France and the UK). Primary outcomes were incidence of device-related serious adverse events and change in the apnoea-hypopnoea index (AHI). The secondary outcome was the change in the 4% oxygen desaturation index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring and device use. This trial was registered with ClinicalTrials.gov, number NCT03048604. RESULTS: 22 out of 27 implanted participants (63% male, aged 55.9±12.0 years, body mass index (BMI) 27.4±3.0 kg·m-2) completed the protocol. At 6 months BMI was unchanged (p=0.85); AHI decreased from 23.7±12.2 to 12.9±10.1 events·h-1, a mean change of 10.8 events·h-1 (p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9 events·h-1, a mean change of 9.3 events·h-1 (p<0.001). Daytime sleepiness (Epworth Sleepiness Scale; p=0.01) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10; p=0.02) both improved significantly. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. 91% of participants reported device use >5 days per week, and 77% reported use for >5 h per night. No device-related serious adverse events occurred during the 6-month post-implantation period. CONCLUSIONS: Bilateral HNS using the Genio™ system reduces OSA severity and improves quality of life without device-related complications. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.

Correction to: Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion.

The article "Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion", written by John R. Wheatley, Terence C. Amis, Sharon A. Lee, Renee Ciesla, Gilbert Shanga was originally published electronically on the publisher's internet portal (currently SpringerLink) on May, 22, 2019 without Open Access. The article has now been made Open Access.

The prevalence of poor sleep quality and its associated factors in patients with interstitial lung disease: a cross-sectional analysis.

BACKGROUND: Many patients with interstitial lung disease (ILD) experience poor sleep quality, which may contribute to decreased quality of life. Sleep disordered breathing is commonly associated with ILD but there is less information on other factors that may contribute to poor sleep quality. METHODS: We conducted a cross-sectional analysis of 101 patients with a diagnosis of ILD at a pulmonary rehabilitation assessment clinic. We assessed the prevalence of poor sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and performed multivariable logistic regression analysis to determine factors independently associated with poor sleep quality. RESULTS: Median forced expiratory volume in 1 s was 64% predicted (interquartile range (IQR) 50-77%) and vital capacity was 62% predicted (IQR 48-78%). 67 (66%) out of 101 patients reported poor sleep quality. The median PSQI was 8 units (IQR 4-11 units). There were no significant differences in physical or physiological parameters including age, sex distribution, body mass index or spirometry values between subjects with good sleep quality and those with poor sleep quality (all p>0.1). Multivariable logistic regression showed that depression (p=0.003) and Epworth Sleepiness Scale (p=0.03) were independently associated with poor sleep quality. CONCLUSION: Poor sleep quality is common in patients with ILD and is independently associated with increasing symptoms of depression and sleepiness. Routine assessment of sleep quality should be undertaken and interventions targeting depression and coexisting sleep disorders may be required in symptomatic patients to determine if sleep quality and ultimately, health-related quality of life improves as a result.

Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion.

INTRODUCTION: This exploratory study characterized the performance of a nasal dilator strip with improved spring forces in lowering nasal resistance during sleep and reducing sleep-disordered breathing in subjects with difficulty sleeping due to chronic nocturnal nasal congestion. METHODS: Subjects applied the strip at bedtime for 28 days (active phase; n = 70). Objective assessments included snoring variables, breathing route during sleep, and polysomnography measures compared with baseline. Nasal breathing, congestion, and sleep were measured subjectively using rating scales and questionnaires. During a crossover nasal resistance phase (n = 55), nasal resistance was measured using posterior rhinomanometry with the strip applied on one of two nights. RESULTS: In the active phase, breathing and sleep were perceived to improve, with less daytime sleepiness (P < 0.04) and increased ease of breathing, sleep quality, staying asleep, and feeling refreshed in the morning (all P < 0.0001). However, while objective polysomnography metrics were generally similar with and without the strip, median wake after sleep onset time was numerically reduced by ~ 11 min, and the spontaneous arousal rate fell by ~ 37%. In the nasal resistance phase (n = 55), median resistance (at 0.2-0.25 l/s) while asleep was 39.1% lower with (n = 37) versus without (n = 36) the strip (1.34 vs. 2.20 cmH2O/l/s; P = 0.048). CONCLUSIONS: This exploratory study supports a role for the improved spring force nasal dilator strip in alleviating sleep-related symptoms in subjects with chronic nasal congestion, potentially via lowering nasal resistance and reducing nocturnal awakenings. A larger study is indicated to confirm these preliminary data. CLINICALTRIALS. GOV IDENTIFIER: NCT03105297. FUNDING: GlaxoSmithKline Consumer Healthcare. Plain language summary available for this article.