Efficacy of vibrotactile positional therapy devices on patients with positional obstructive sleep apnoea: a systematic review and meta-analysis.

INTRODUCTION: Vibrotactile positional therapy (PT) devices are a new treatment modality for positional obstructive sleep apnoea (POSA). This review aimed to determine the effect of vibrotactile PT on the Apnoea Hypopnoea Index (AHI) and the percentage of time spent in the supine position (%Tsupine) in patients with POSA, compared with baseline. Secondary aims were to investigate the effect on daytime sleepiness, quality of life and sleep quality. METHODS: A systematic review and meta-analysis was performed of randomised controlled trials (RCTs) and cohort studies that investigated the effect of vibrotactile PT in POSA patients. Searches were performed via MEDLINE, CENTRAL and Embase up to 29 October 2022. RESULTS: 1119 studies were identified, 18 studies met the inclusion criteria (10 RCTs, 8 cohort studies). The use of vibrotactile PT significantly reduced the AHI at follow-up compared with baseline (mean difference (95% CI) -9.19 events/hour (-11.68 to -6.70); p<0.00001). The mean %Tsupine was also significantly reduced (mean difference (95% CI) -32.79% (-38.75% to -26.83%); p<0.00001). The percentage changes in the AHI and %Tsupine were 43% and 70%, respectively. Secondary outcomes were daytime sleepiness, quality of life and sleep indices. These showed minimal change, although follow-up was short. CONCLUSION: Vibrotactile PT devices are effective in treating POSA; reducing both AHI and %Tsupine. The effect on sleep quality, daytime sleepiness and disease-specific quality of life was minimal. However, there were limited data and follow-up was often brief, meaning that further research is needed to determine the effect of vibrotactile PT on patient-centred outcomes. PROSPERO REGISTRATION NUMBER: CRD42020188617.

The validity of Engagement and Feedback Assessments (EFAs): identifying students at risk of failing.

BACKGROUND: Imperial College School of Medicine, London UK, introduced a new curriculum in 2019, with a focus on the GMC outcomes for graduates, and pedagogy best practice. The new curriculum included formative assessments, named engagement and feedback assessments (EFAs), to support learning, and attainment in the summative examinations. The aims of this study were to assess the validity of EFAs and to determine whether they have utility as a modified form of programmatic assessment to inform decision-making regarding possible interventions by measuring and analysing attendance at and performance in these formative events. METHODS: Seven hundred and sixty-one students were included in the study and assessment results were included for academic years 2019/20 to 2020/21. Forty-one data points per student, (27 in Year 1 and 14 in Year 2) were used, to compare EFA scores with the summative performance. Attendance was monitored through engagement with the EFAs. RESULTS: Cohort 1 (enrolled 2019): In year 1, EFAs were associated with summative exam scores (overall r = 0.63, p < 0.001). Year 2, EFA scores were also associated with summative scores (overall r = 0.57, p < 0.001), including the clinical practical assessment (r = 0.45, p < 0.001). Missing two or more EFAs was associated with a significant increase in the likelihood of failing one or more summative examinations in the first year (OR: 7.97, 95% CI 2.65-34.39) and second year (OR: 3.20, 95% CI 1.74-5.95). Missing more than two EFAs in their first year was also associated with a higher risk of failing a summative examination in the second year (OR: 2.47, 95% CI 1.33-4.71). Students who increased their attendance between year 1 and 2 fared better in summative assessment than those who maintained poor attendance, whereas those that reduced their attendance fared worse than those that maintained high attendance. Cohort 2 (enrolled 2020): Analysis of cohort 2 supported these findings and in this cohort missing two or more EFAs was again associated with an increased likelihood of failing a summative examination (OR = 4.00, 95% CI = 2.02-7.90). CONCLUSION: Our EFA model has validity in predicting performance in summative assessments and can inform prospective interventions to support students' learning. Enhancing attendance and engagement can improve outcomes.

"More than just a medical student": a mixed methods exploration of a structured volunteering programme for undergraduate medical students.

BACKGROUND: As a result of the COVID-19 pandemic Imperial College School of Medicine developed a structured volunteering programme involving 398 medical students, across eight teaching hospitals. This case study aims to explore the relationship between the processes, context, participant experiences and impacts of the programme so that lessons can be learned for future emergencies and service-learning programmes. METHODS: Using an illuminative approach to evaluation we invited all volunteers and supervisors to complete a mixed-methods survey. This explored differences in experience across demographics and contextual factors, correlations between aspects of induction, supervision and overall experience, and reviewed the impacts of the programme. Quantitative responses were statistically analysed and qualitative reflections were thematically coded to triangulate and explain quantitative findings. Follow up interviews were carried out to check back findings and co-create conclusions. RESULTS: We received responses from 61 students and 17 supervisors. Student participants described predominantly altruistic motivations and transformational changes to their professional identity driven by feeling included, having responsibility, and engaging in authentic workplace-based learning afforded by freedom from the assessed curriculum. They reported new perspectives on their future professional role within the multidisciplinary team and the value of workplace-based learning. They reported increases in wellbeing and self-esteem related to feeling included and valued, and positively contributing to service provision at a time of need. Significantly higher overall satisfaction was associated with a personalised induction, active supervision, earlier stage of training, and male gender. Gender-related differences were not explained through our data but have been reported elsewhere and warrant further study. The duration, intensity and type of role that volunteers performed was similar across demographics and did not appear to modulate their overall experience. CONCLUSIONS: Whilst acknowledging the uniqueness of emergency volunteering and the survey response rate of 15% of volunteers, we suggest the features of a successful service-learning programme include: a learner-centred induction, regular contact with engaged and appreciative supervisors, and roles where students feel valued. Programmes in similar settings may find that service learning is most impactful earlier in medical students' training and that students with altruistic motivations and meaningful work may flourish without formal outcomes and assessments.

Reviewing the relationship between OSA and cognition: Where do we go from here?

Obstructive sleep apnoea (OSA) is a disorder of breathing during sleep resulting in temporary reduction in cerebral oxygenation and sleep disruption. A growing body of research reveals a relatively consistent pattern of deficits in cognition, particularly in attention, episodic memory, and executive function, which are partially remediated by treatment. This is where the consensus ends. Despite a number of competing explanations regarding how OSA affects cognition, reliable evidence is hard to find, which may relate to the many, common conditions co-morbid with OSA or to the methodological challenges in this field. This paper reviews the evidence for cognitive impairment in OSA, the proposed models of cognitive harm, the impact of co-morbidities and the many methodological and theoretical challenges of exploring the effect of OSA on cognition. To overcome some of these challenges, we end by proposing a number of future directions for the field, including suggesting some core design elements for future studies.

Randomized crossover trial of a pressure sensing visual feedback system to improve mask fitting in noninvasive ventilation.

BACKGROUND AND OBJECTIVE: A good mask fit, avoiding air leaks and pressure effects on the skin are key elements for a successful noninvasive ventilation (NIV). However, delivering practical training for NIV is challenging, and it takes time to build experience and competency. This study investigated whether a pressure sensing system with real-time visual feedback improved mask fitting. METHODS: During an NIV training session, 30 healthcare professionals (14 trained in mask fitting and 16 untrained) performed two mask fittings on the same healthy volunteer in a randomized order: one using standard mask-fitting procedures and one with additional visual feedback on mask pressure on the nasal bridge. Participants were required to achieve a mask fit with low mask pressure and minimal air leak (<10 L/min). Pressure exerted on the nasal bridge, perceived comfort of mask fit and staff- confidence were measured. RESULTS: Compared with standard mask fitting, a lower pressure was exerted on the nasal bridge using the feedback system (71.1 ± 17.6 mm Hg vs 63.2 ± 14.6 mm Hg, P < 0.001). Both untrained and trained healthcare professionals were able to reduce the pressure on the nasal bridge (74.5 ± 21.2 mm Hg vs 66.1 ± 17.4 mm Hg, P = 0.023 and 67 ± 12.1 mm Hg vs 60 ± 10.6 mm Hg, P = 0.002, respectively) using the feedback system and self-rated confidence increased in the untrained group. CONCLUSION: Real-time visual feedback using pressure sensing technology supported healthcare professionals during mask-fitting training, resulted in a lower pressure on the skin and better mask fit for the volunteer, with increased staff confidence.

Patent foramen ovale is not associated with hypoxemia in severe chronic obstructive pulmonary disease and does not impair exercise performance.

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 (Pao2 ≤ 7.3 kPa) and 63 less hypoxemic (Pao2 > 8.0 kPa) patients with COPD (39% vs. 52%; P = 0.27). Patients with intrapulmonary shunting had lower Pao2 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% Vo2max 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.

A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO).

RATIONALE: Mandibular advancement devices (MADs) are used to treat obstructive sleep apnoea-hypopnoea syndrome (OSAHS) but evidence is lacking regarding their clinical and cost-effectiveness in less severe disease. OBJECTIVES: To compare clinical- and cost-effectiveness of a range of MADs against no treatment in mild to moderate OSAHS. MEASUREMENTS AND METHODS: This open-label, randomised, controlled, crossover trial was undertaken at a UK sleep centre. Adults with Apnoea-Hypopnoea Index (AHI) 5-<30/h and Epworth Sleepiness Scale (ESS) score ≥9 underwent 6 weeks of treatment with three non-adjustable MADs: self-moulded (SleepPro 1; SP1); semi-bespoke (SleepPro 2; SP2); fully-bespoke MAD (bMAD); and 4 weeks no treatment. Primary outcome was AHI scored by a polysomnographer blinded to treatment. Secondary outcomes included ESS, quality of life, resource use and cost. MAIN RESULTS: 90 patients were randomised and 83 were analysed. All devices reduced AHI compared with no treatment by 26% (95% CI 11% to 38%, p=0.001) for SP1, 33% (95% CI 24% to 41%) for SP2 and 36% (95% CI 24% to 45%, p<0.001) for bMAD. ESS was 1.51 (95% CI 0.73 to 2.29, p<0.001, SP1) to 2.37 (95% CI 1.53 to 3.22, p<0.001, bMAD) lower than no treatment (p<0.001 for all). Compliance was lower for SP1, which was the least preferred treatment at trial exit. All devices were cost-effective compared with no treatment at a £20,000/quality-adjusted life year (QALY) threshold. SP2 was the most cost-effective up to £39,800/QALY. CONCLUSIONS: Non-adjustable MADs achieve clinically important improvements in mild to moderate OSAHS and are cost-effective. Of those trialled, the semi-bespoke MAD is an appropriate first choice. TRIAL REGISTRATION NUMBER: ISRCTN02309506.

Upper airway factors that protect against obstructive sleep apnoea in healthy older males.

The prevalence of obstructive sleep apnoea (OSA) increases with age, yet the risk factors for OSA in older people remain poorly understood. This study aimed to define the age-related changes in upper airway morphology in carefully matched groups of healthy older (>60 years, n=11) and younger (<40 years, n=14) males, using direct (magnetic resonance imaging (MRI)) and indirect (acoustic reflection) imaging. The median (interquartile range) combined retropalatal and retroglossal pharyngeal length was greater in older than in younger males (older 8.8 (7.8-9.0) cm, younger 7.8 (7.0-8.3) cm; p=0.03), as was the soft palate cross-sectional area (older 43.1 (36.0-48.8) cm(2), younger 35.3 (30.5-40.5) cm(2); p=0.03), parapharyngeal fat pad diameter (older 1.7 (1.4-2.2) cm, younger 1.2 (1.0-1.8) cm; p=0.03) and cross-sectional area of the fat pads (older 13.8 (9.1-17.1) cm(2); younger 7.4 (5.9-13.0) cm(2); p=0.02) as measured by MRI. Using acoustic reflection, pharyngeal calibre (older 4.8 (3.8-6.6) cm(2), younger 3.4 (2.8-4.6) cm(2); p=0.03), pharyngeal volume (older 35.1 (30.9-55.4) cm(3), younger 27.2 (22.7-44.2) cm(3); p=0.04) and glottis area (older 2.7 (2.1-3.9) cm(2), younger 1.3 (1.1-1.9) cm(2); p=0.003) were also larger in older participants compared with younger participants. There was no difference in craniofacial measures between groups, including volumetric data and hyoid bone position. The larger pharyngeal calibre observed in older males may be compensating for an age-related enlargement in pharyngeal soft tissue that predisposes to OSA.

The impact of sleep and hypoxia on the brain: potential mechanisms for the effects of obstructive sleep apnea.

PURPOSE OF REVIEW: Obstructive sleep apnea (OSA) is a chronic, highly prevalent, multisystem disease, which is still largely underdiagnosed. Its most prominent risk factors, obesity and older age, are on the rise, and its prevalence is expected to grow further. The last few years have seen an exponential increase in studies to determine the impact of OSA on the central nervous system. OSA-induced brain injury is now a recognized clinical entity, although its possible dual relationship with several other neuropsychiatric and neurodegenerative disorders is debated. The putative neuromechanisms behind some of the effects of OSA on the central nervous system are discussed in this review, focusing on the nocturnal intermittent hypoxia and sleep fragmentation. RECENT FINDINGS: Recent preclinical and clinical findings suggest that neurogenic ischemic preconditioning occurs in some OSA patients, and that it may partly explain variability in clinical findings to date. However, the distinct parameters of the interplay between ischemic preconditioning, neuroinflammation, sleep fragmentation and cerebrovascular changes in OSA-induced brain injury are still largely unclear, and more research is required. SUMMARY: Early diagnosis and intervention in patients with OSA is of paramount importance. Future clinical studies should utilize multimodal investigative approaches to enable more reliable referencing for the acuity of the pathological process, as well as its reversibility following the treatment.

Randomized trial of 'intelligent' autotitrating ventilation versus standard pressure support non-invasive ventilation: impact on adherence and physiological outcomes.

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) cmH2 O; 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.

Mandibular movement monitor provides faster, yet accurate diagnosis, for obstructive sleep apnoea: a randomised controlled study.

Many patients with obstructive sleep apnoea (OSA) remain undiagnosed and thus untreated, and in part this relates to delay in diagnosis. Novel diagnostic strategies may improve access to diagnosis. In a multicentre, randomised study, we evaluated time to treatment decision in patients referred for suspected OSA, comparing a mandibular movement (MM) monitor to respiratory polygraphy, the most commonly used OSA detection method in the UK. Adults with high pre-test probability OSA were recruited from both Northern Scotland and London. 40 participants (70% male, mean±SD age 46.8±12.9 years, BMI 36.9± 7.5 kg/m2, ESS 14.9±4.1) wore a MM monitor and respiratory polygraphy simultaneously overnight and were randomised (1:1) to receive their treatment decision based on results from either device. Compared to respiratory polygraphy, MM monitor reduced time to treatment decision by six days, (median(IQR): 13.5(7.0-21.5) vs. 19.5(13.7-35.5), P=0.017) and saved an estimated 29 minutes of staff time per patient.

Mild obstructive sleep apnoea in females: post hoc analysis of the MERGE randomised controlled trial.

Background: A post hoc analysis 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. This post hoc analysis 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±sd 39.1±10.1 versus 44.8±10.3) and higher Epworth Sleepiness Scale (ESS) scores (mean±sd 11.0±4.2 versus 9.5±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) versus 6.0 (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.

Strategies to Assess the Effect of Continuous Positive Airway Pressure on Long-Term Clinically Important Outcomes among Patients with Symptomatic Obstructive Sleep Apnea: An Official American Thoracic Society Workshop Report.

Continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea (OSA). Although CPAP improves symptoms (e.g., daytime sleepiness), there is a lack of high-quality evidence that CPAP prevents many long-term outcomes, including cognitive impairment, myocardial infarction, and stroke. Observational studies suggest that patients with symptoms may be particularly likely to experience these preventive benefits with CPAP, but ethical and practical concerns limited the participation of such patients in prior long-term randomized trials. As a result, there is uncertainty about the full benefits of CPAP, and resolving this uncertainty is a key priority for the field. This workshop assembled clinicians, researchers, ethicists, and patients to identify strategies to understand the causal effects of CPAP on long-term clinically important outcomes among patients with symptomatic OSA. Quasi-experimental designs can provide valuable information and are less time and resource intensive than trials. Under specific conditions and assumptions, quasi-experimental studies may be able to provide causal estimates of CPAP's effectiveness from generalizable observational cohorts. However, randomized trials represent the most reliable approach to understanding the causal effects of CPAP among patients with symptoms. Randomized trials of CPAP can ethically include patients with symptomatic OSA, as long as there is outcome-specific equipoise, adequate informed consent, and a plan to maximize safety while minimizing harm (e.g., monitoring for pathologic sleepiness). Furthermore, multiple strategies exist to ensure the generalizability and practicality of future randomized trials of CPAP. These strategies include reducing the burden of trial procedures, improving patient-centeredness, and engaging historically excluded and underserved populations.

Utility of overnight pulse oximetry and heart rate variability analysis to screen for sleep-disordered breathing in chronic heart failure.

BACKGROUND: Sleep-disordered breathing (SDB) is under diagnosed in chronic heart failure (CHF). Screening with simple monitors may increase detection of SDB in a cardiology setting. This study aimed to evaluate the accuracy of heart rate variability analysis and overnight pulse oximetry for diagnosis of SDB in patients with CHF. METHODS: 180 patients with CHF underwent simultaneous polysomnography, ambulatory electrocardiography and wrist-worn overnight pulse oximetry. SDB was defined as an apnoea-hypopnoea index ≥15/h. To identify SDB from the screening tests, the per cent very low frequency increment (%VLFI) component of heart rate variability was measured with a pre-specified cutoff ≥2.23%, and the 3% oxygen desaturation index was measured with a pre-specified cutoff >7.5 desaturations/h. RESULTS: 173 patients with CHF had adequate sleep study data; SDB occurred in 77 (45%) patients. Heart rate variability was measurable in 78 (45%) patients with area under the %VLFI receiver operating characteristic curve of 0.50. At the ≥2.23% cutoff, %VLFI sensitivity was 58% and specificity was 48%. The 3% oxygen desaturation index was measurable in 171 (99%) patients with area under the curve of 0.92. At the pre-specified cutoff of >7.5 desaturations/h, the 3% oxygen desaturation index had a sensitivity of 97%, specificity of 32%, negative likelihood ratio of 0.08 and positive likelihood ratio of 1.42. Diagnostic accuracy was increased using a cutoff of 12.5 desaturations/h, with sensitivity of 93% and specificity of 73%. CONCLUSIONS: The high sensitivity and low negative likelihood ratio of the 3% oxygen desaturation index indicates that pulse oximetry would be of use as a simple screening test to rule out SDB in patients with CHF in a cardiology setting. The %VLFI component of heart rate variability is not suitable for detection of SDB in CHF.