Julia L. Kelly

Background New generation positional therapy devices provide vibrotactile feedback to patients with positional obstructive sleep apnoea (POSA), reducing supine sleep time and sleep apnoea severity. Longer-term effects on POSA severity, sleepiness and quality of life (QoL) are unclear. Methods A randomised, parallel, double-blinded trial compared neck-worn positional therapy with sham-positional therapy over 3 months (ClinicalTrials.gov: NCT04153240). Adult patients with POSA (apnoea/hypopnoea index (AHI) >5 events/hour, 2:1 when supine vs non-supine) were randomised (1:1). The primary endpoint was AHI at 3 months, positional versus sham. Secondary analyses: interaction between the treatment effect and age; QoL, including Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI). Results Between October 2019 and August 2022, 120 patients with median baseline AHI of 12.8 events/hour (IQR 9.2–18.5) were randomised; 59 to positional therapy and 61 to sham; 92 (77%) completed the trial. Positional therapy significantly reduced the AHI by −4.41 events/hour (95% CI −7.77 to –1.06; p=0.011) compared with sham, a 34% improvement. There was a significant improvement in PSQI: −1.0 (95% CI −2.1 to 0.0; p=0.04), but not ESS: −0.6 (95% CI −1.8 to 0.6; p=0.3), with positional therapy compared with sham (baseline ESS 8.8). Similar results were seen in younger (18–64) and older (≥65) age groups. Patients’ bed partners reported improvements in snoring and sleep quality for the patient and themselves. Over half of participants using the active device opted to continue. Conclusion Neck-worn positional therapy reduced the severity of OSA and improved sleep quality but not sleepiness, over 3 months. Bed partner’s reported improvements in snoring and sleep quality. Trial registration number NCT04153240.

Background: Newer positional therapy (PT) devices provide vibrotactile feedback to patients with positional obstructive sleep apnoea (POSA). There is scarce data on their effect on longer-term effects on sleep apnoea severity and symptoms. Methods: A randomised, parallel, double-blinded trial compared PT with sham over 3 months. Adults with POSA were randomised to either neck-worn vibrotactile PT (Night Shift™; Advanced Brain Monitoring, USA) or identical sham device. The primary endpoint was the apnoea hypopnoea index (AHI) at 3 months. Secondary analyses included the Epworth Sleepiness Scale score (ESS) and the Pittsburgh Sleep Quality Index (PSQI). Results: 120 patients were randomised. Patients had a mean±SD age of 52.7±12.3 years, mean BMI of 28.4±4.2 kg/m2, median AHI of 12.8 /hr (IQR 9.2, 18.5), mean ESS of 8.8±4.7, 94 (78%) were male, and 92 (77%) completed the trial. There was a significant improvement in the AHI of 4.4 /hr (95% CI 1.1, 7.8; p= 0.01, Figure ) with PT compared with sham. There was a significant improvement in the PSQI of 1.0 (95%CI 0.0, 2.1; p=0.04), but not the ESS (0.6, 95%CI -0.6, 1.8; p=0.3) with PT compared to sham. Figure: AHI at baseline and after 3-months of PT and Sham PT erj;64/suppl_68/PA863/F1 F1 F1 Conclusion: PT reduced the severity of OSA and improved sleep quality but not sleepiness. Patients were minimally symptomatic and further research is needed in those with excessive sleepiness.

Background: Apost hocanalysis of the MERGE trial was conducted, to investigate whether sex differences are evident at the mildest end of the disease spectrum, for symptoms associated with obstructive sleep apnoea (OSA) and the response to continuous positive airway pressure (CPAP) treatment.Methods: MERGE participants with mild OSA (apnoea–hypopnoea index 5–15 events·h⁻¹; American Academy of Sleep Medicine 2012 criteria) were randomised to either CPAP plus standard care (sleep hygiene counselling) or standard care alone for 3 months. Quality of life (QoL) was measured by questionnaires completed before and after the 3 months. Thispost hocanalysis of participants of the MERGE trial compared the symptom presentation, and response to CPAP, between the sexes.Results: 233 patients were included; 71 (30%) were female. Females were more symptomatic at baseline in all QoL questionnaires. Specifically, females had lower 36-item Short-Form Health Survey (SF-36) Vitality scores (mean±sd39.1±10.1versus44.8±10.3) and higher Epworth Sleepiness Scale (ESS) scores (mean±sd11.0±4.2versus9.5±4.4). Both sexes experienced snoring, but more females reported fatigue and more males reported witnessed apnoeas. All symptoms improved with CPAP for both sexes; however, females had larger improvements in SF-36 Vitality scores, which was the primary outcome of the MERGE trial (mean change 9.4 (95% CI 6.8–12.0)versus6.0 (95% CI 4.3–7.7); p=0.034), and ESS (mean change −4.1 (95% CI −5.1– −3.0)versus−2.5 (95% CI −3.1– −1.8); p=0.015), after adjustment for baseline scores and CPAP usage.Conclusions: Sex differences are apparent in patients with mild OSA. Females experience worse QoL symptoms than males at presentation to the sleep clinic; however, these improve significantly with CPAP treatment.

Background: The coronavirus disease 2019 pandemic has accelerated the adoption of virtual care strategies for the management of patients with obstructive sleep apnoea/hypopnoea syndrome (OSAHS).Research question: What is the effectiveness of virtual consultations compared to in-person consultations for the management of continuous positive airway pressure (CPAP) therapy in adult patients with OSAHS?Methods: A systematic review and meta-analysis (PROSPERO; CRD42022297532) based on six electronic databases plus manually selected journals was conducted in January 2022. Two researchers independently selected, quality appraised and extracted data. The co-primary outcomes were patient-reported sleepiness, assessed by the Epworth Sleepiness Scale (ESS), and reported cost-effectiveness.Results: 12 studies (n=1823 adults) were included in the review. Seven studies (n=1089) were included in the meta-analysis which showed no difference in the magnitude of improvement in patient-reported sleepiness scores between virtual and in-person consultations (mean difference −0.39, 95% CI −1.38–0.60; p=0.4), although ESS scores improved in both groups. Virtual care strategies modestly increased CPAP therapy adherence and were found to be less costly than in-person care strategies in the three Spanish trials that reported cost-effectiveness.Conclusion: The findings of this review suggest that virtual care delivered by telephone or video consultations is as effective as in-person consultations for improving subjective sleepiness in patients with OSAHS treated with CPAP. This clinical management strategy may also improve CPAP adherence without increasing the costs, supporting its potential as a follow-up management strategy, where patients prefer this approach.

Background: The efficacy of CPAP at the mildest end of the OSA spectrum is unclear. The MERGE trial investigated the effect of CPAP on quality of life in patients with mild OSA (Wimms et al. 2019). This subset analysis aimed to determine the effectiveness of CPAP in a subset of patients with ‘very9 mild OSA, defined as having mild OSA according to the sensitive AASM 2012 criteria, but no OSA using the earlier AASM 2007 criteria (i.e. AHI >5 to 5 to ≤15 events/hr, AASM 2007 or 2012) in parallel to receive either CPAP plus Standard Care or Standard Care alone for 3 months. A subset of 95 of 301 patients were identified as having ‘very9 mild OSA. Results: The subset of 95 ‘very9 mild OSA patients had a median (IQR) AHI 6.80(5.7, 8.8) events/hr, and were symptomatic (Vitality 41.9(10.9); ESS 10.3(4.7)). 50 of 95 were allocated to CPAP, and 45 to Standard Care. ‘Very9 mild OSA patients had significantly improved Vitality after 3 months of CPAP, compared to Standard Care (+9.2 points, 95% CI +5.6 to +12.7; p<0.0001). Sleepiness also improved (ESS: -3.9, 95% CI -5.3 to -2.5; p<0.0001) as well as fatigue, functionality, anxiety, depression and insomnia. The ‘very9 mild OSA patients used their CPAP for a median (IQR) 4:04(2:00, 5:42) hrs:min/night. Conclusions: This subset analysis has shown the clinical effectiveness of CPAP treatment in patients at the mildest end of the disease spectrum, with 9very9 mild but symptomatic OSA. The results were similar to those observed in the primary analysis of the MERGE trial.

Background and objective: Effective non‐invasive ventilation (NIV) therapy is dependent on optimal ventilator settings to maximize clinical benefit and patient tolerance. Intelligent volume‐assured pressure support (iVAPS) is a hybrid mode of servoventilation, providing constant automatic adjustment of pressure support (PS) to achieve a target ventilation determined by the patient's requirements. In a randomized crossover trial, we tested the hypothesis that iVAPS, with automated selection of ventilator settings, was non‐inferior to standard PS ventilation, with settings determined by an experienced health‐care professional, for controlling nocturnal hypoventilation in patients naive to NIV.Methods: Eighteen patients referred to a ventilator clinic with chronic obstructive or restrictive lung disease and newly diagnosed nocturnal hypoventilation (10 male, median (interquartile range): age 54(41–61) years, mean daytime PaO₂ 9.25(8.59–10.31) kPa, ‐PaCO₂ 6.38(5.93–6.65) kPa were randomized to iVAPS and standard PS. Polysomnography with transcutaneous CO₂ monitoring was performed at baseline and 1 month after each treatment period. Nightly hours of therapy were recorded by the ventilator.Results: iVAPS delivered a lower median PS compared with standard PS (8.3(5.6–10.4) vs 10.0(9.0–11.4) cmH₂O; P = 0.001) for the same ventilatory outcome (mean overnight: SpO₂ 96(95–98) vs 96(93–97)%; P = 0.13 and PtcCO₂ 6.5(5.8–6.8) vs 6.2(5.8–6.9); P = 0.54). There was no difference in outcome between ventilator modes for spirometry, respiratory muscle strength, sleep quality, arousals or O₂ desaturation index. Adherence was greater with iVAPS (5:40(4:42–6:49) vs 4:20(2:27–6:17) hh:mm/night; P = 0.004).Conclusions: iVAPS servoventilation with automation of ventilation settings is as effective as PS ventilation initiated by a skilled health‐care professional in controlling nocturnal hypoventilation and produced better overnight adherence in patients naive to NIV.

Rationale: Patent foramen ovale (PFO) may be disadvantageous in chronic obstructive pulmonary disease (COPD). It is unknown whether right-to-left shunting through PFO increases during exercise impairing exercise performance. Objectives: To determine whether (1) PFO prevalence is greater in hypoxemic versus less hypoxemic patients with COPD, (2) PFO is associated with clinically relevant impairment, and (3) right-to-left shunting increases during exercise and impairs exercise performance. Methods: Patients with COPD and age-matched control subjects underwent contrast transthoracic echocardiography and transcranial Doppler to identify PFO. Patients with COPD with no shunt and patients with large PFO underwent cardiopulmonary exercise tests with contrast transcranial Doppler, esophageal, and gastric balloon catheters. Measurements and Main Results: PFO prevalence was similar in 50 patients with COPD and 50 healthy control subjects (46% vs. 30%; P = 0.15). Large shunts were more common in patients with COPD (26% vs. 6%; P = 0.01). In an expanded COPD cohort, PFO prevalence was similar in 31 hypoxemic (Pa o₂ ≤ 7.3 kPa) and 63 less hypoxemic (Pa o₂ > 8.0 kPa) patients with COPD (39% vs. 52%; P = 0.27). Patients with intrapulmonary shunting had lower Pa o₂ than both patients with PFO and those with no right-to-left shunt (7.7 vs. 8.6 vs. 9.3 kPa, respectively; P = 0.002). Shunting significantly increased during exercise in patients with COPD with PFO. Endurance time at 60% Vo_2max was 574 (178) seconds for patients with PFO and 534 (279) seconds for those without (P = ns). Conclusions: Hypoxemic patients with COPD do not have a higher prevalence of PFO. Patients with COPD with PFO do not perform less well either on a 6-minute walk or submaximal exercise testing despite increased right-to-left shunting during exercise.