NIV@Home: a pilot randomized controlled trial of in-home noninvasive ventilation initiation compared to a single-day admission model.

Objective: Noninvasive ventilation (NIV) is the primary treatment for respiratory insufficiency in neuromuscular disease. NIV implementation is usually conducted within hospitals; however, in-home implementation with intensive follow-up is an effective alternative. This pilot study aimed to assess model feasibility, acceptability, and NIV usage at 12-weeks after a single visit in-home implementation of NIV with remote monitoring follow-up (NIV@Home) compared to an in-hospital day admission NIV initiation plus planned polysomnography (Usual care). Methods: A single-blinded randomized controlled trial (www.anzctr.org.au ACTRN12620000682943) of adults with neuromuscular disease referred for NIV implementation. Participants were stratified by disease (MND or Other diagnoses) and bulbar symptoms before randomization to NIV@Home or Usual care, with follow-up at 12-weeks. The primary outcome was NIV usage. Secondary outcomes included feasibility, health-related quality of life, symptoms, carer burden, and NIV experience (semi-structured qualitative interviews). Results: Twenty-three participants (MND bulbar = 9, MND non-bulbar = 11, Other = 3) were randomized (NIV@Home = 9). No statistical differences were observed in the percentage of MND participants using NIV for >4 hours/day (NIV@Home = 33% vs. Usual care = 60%, p = 0.370), average use (NIV@Home = 2.4 [1.5-9.3] vs. 5.3 [1.8-7.0] hours/day, p = 0.568), or secondary outcomes. In-home NIV implementation was feasible and safe but took more therapist time (NIV@Home = 278 [270-305] vs. 172 [130-200] minutes, p < 0.001). Participants in the NIV@Home group reported substantial advantages to receiving care in home. Conclusion: In-home NIV implementation is feasible and acceptable to people with MND but requires more therapist time. Larger studies are required to determine whether there are clinically important differences between this model of NIV initiation and a traditional hospital-based model.

Meeting the Needs of People With Severe Quadriplegia in the 21st Century: The Case for Implanted Brain-Computer Interfaces.

BACKGROUND: In recent decades, there has been a widespread adoption of digital devices among the non-disabled population. The pervasive integration of digital devices has revolutionized how the majority of the population manages daily activities. Most of us now depend on digital platforms and services to conduct activities across the domains of communication, finance, healthcare, and work. However, a clear disparity exists for people who live with severe quadriplegia, who largely lack access to tools that would enable them to perform daily tasks digitally and communicate effectively with their environment. OBJECTIVES: The purpose of this piece is to (i) highlight the unmet needs of people with severe quadriplegia (including cases for medical necessity and perspectives from the community), (ii) present the current landscape of assistive technology for people with severe quadriplegia, (iii) make the case for implantable BCIs (how they address needs and why they are a good solution relative to other assistive technologies), and (iv) present future directions. RESULTS: There are technologies that are currently available to this population, but these technologies are certainly not usable with the same level of ease, efficiency, or autonomy as what has been designed for the non-disabled community. This hinders the ability of people with severe quadriplegia to achieve digital autonomy, perpetuating social isolation and limiting the expression of needs, opinions, and preferences. CONCLUSION: Most importantly, the gap in digital equality fundamentally undermines the basic human rights of people with severe quadriplegia.

Management of Sleep-Disordered Breathing in a Spinal Cord Injury Rehabilitation Center: Model of Care Adaptation and Implementation.

Background: Obstructive sleep apnea (OSA) is highly prevalent and poorly managed in spinal cord injury (SCI). Alternative management models are urgently needed to improve access to care. We previously described the unique models of three SCI rehabilitation centers that independently manage uncomplicated OSA. Objectives: The primary objective was to adapt and implement a similar rehabilitation-led model of managing OSA in an SCI rehabilitation center in Australia. Secondary objectives were to identify the local barriers to implementation and develop and deliver tailored interventions to address them. Methods: A clinical advisory group comprised of rehabilitation clinicians, external respiratory clinicians, and researchers adapted and developed the care model. A theory-informed needs analysis was performed to identify local barriers to implementation. Tailored behavior change interventions were developed to address the barriers and prepare the center for implementation. Results: Pathways for ambulatory assessments and treatments were developed, which included referral for specialist respiratory management of complicated cases. Roles were allocated to the team of rehabilitation doctors, physiotherapists, and nurses. The team initially lacked sufficient knowledge, skills, and confidence to deliver the OSA care model. To address this, comprehensive education and training were provided. Diagnostic and treatment equipment were acquired. The OSA care model was implemented in July 2022. Conclusion: This is the first time a rehabilitation-led model of managing OSA has been implemented in an SCI rehabilitation center in Australia. We describe a theory-informed method of adapting the model of care, assessing the barriers, and delivering interventions to overcome them. Results of the mixed-methods evaluation will be reported separately.

Understanding the Relationships Between Sleep Quality and Depression and Anxiety in Neurotrauma: A Scoping Review.

Sleep problems, depression, and anxiety are highly prevalent after a spinal cord injury (SCI) and traumatic brain injury (TBI) and may worsen functional outcomes and quality of life. This scoping review examined the existing literature to understand the relationships between sleep quality, depression, and anxiety in persons with SCI and TBI, and to identify gaps in the literature. A systematic search of seven databases was conducted. The findings of 30 eligible studies reporting associations between sleep quality and depression and/or anxiety after SCI or TBI were synthesized. The included studies were mostly cross-sectional and employed a range of subjective and objective measures of sleep quality. Poor subjective sleep quality and insomnia tended to be significantly associated with increased levels of depression and/or anxiety, but no such associations were reported when sleep quality was measured objectively. Two longitudinal studies observed worsening depressive symptoms over time were related to insomnia and persistent sleep complaints. Two interventional studies found that treating sleep problems improved symptoms of depression and anxiety. The findings of this review suggest that sleep and psychopathology are related in persons with neurotraumatic injuries. This has important therapeutic implications, because individuals may benefit from therapy targeting both sleep and psychological issues. More longitudinal and interventional studies are warranted to further understand the direction and strength of the relationships and how they impact patient outcomes.

Prevalence of central sleep apnea in people with tetraplegic spinal cord injury: a retrospective analysis of research and clinical data.

STUDY OBJECTIVES: Over 80% of people with tetraplegia have sleep-disordered breathing (SDB), but whether this is predominantly obstructive or central is unclear. This study aimed to estimate the prevalence of central sleep apnea (CSA) in tetraplegia and the contributions of central, obstructive, and hypopnea respiratory events to SDB summary indices in tetraplegia. METHODS: Research and clinical data from 606 individuals with tetraplegia and full overnight polysomnography were collated. The proportions of different respiratory event types were calculated; overall and for mild, moderate, and severe disease. The prevalence of Predominant CSA (Central Apnea Index [CAI] ≥ 5 and more central than obstructive apneas) and Any CSA (CAI ≥ 5) was estimated. Prevalence of sleep-related hypoventilation (SRH) was estimated in a clinical sub-cohort. RESULTS: Respiratory events were primarily hypopneas (71%), followed by obstructive (23%), central (4%), and mixed apneas (2%). As severity increased, the relative contribution of hypopneas and central apneas decreased, while that of obstructive apneas increased. The prevalence of Predominant CSA and Any CSA were 4.3% (26/606) and 8.4% (51/606) respectively. Being male, on opiates and having a high tetraplegic spinal cord injury were associated with CSA. SRH was identified in 26% (26/113) of the clinical sub-cohort. CONCLUSIONS: This is the largest study to characterize SDB in tetraplegia. It provides strong evidence that obstructive sleep apnea is the predominant SDB type; 9-18 times more prevalent than CSA. The prevalence of CSA was estimated to be 4%-8%, significantly lower than previously reported.

Rapidly and slowly progressive neuromuscular disease: differences in pulmonary function, respiratory tract infections and response to lung volume recruitment therapy (LVR).

INTRODUCTION: Reduced lung volumes are a hallmark of respiratory muscle weakness in neuromuscular disease (NMD). Low respiratory system compliance (Crs) may contribute to restriction and be amenable to lung volume recruitment (LVR) therapy. This study evaluated respiratory function and the immediate impact of LVR in rapidly progressive compared to slowly progressive NMD. METHODS: We compared vital capacity (VC), static lung volumes, maximal inspiratory and expiratory pressures (MIP, MEP), Crs and peak cough flow (PCF) in 80 adult participants with motor neuron disease ('MND'=27) and more slowly progressive NMDs ('other NMD'=53), pre and post a single session of LVR. Relationships between respiratory markers and a history of respiratory tract infections (RTI) were examined. RESULTS: Participants with other NMD had lower lung volumes and Crs but similar reduction in respiratory muscle strength compared with participants with MND (VC=1.30±0.77 vs 2.12±0.75 L, p<0.001; Crs=0.0331±0.0245 vs 0.0473±0.0241 L/cmH2O, p=0.024; MIP=39.8±21.3 vs 37.8±19.5 cmH2O). More participants with other NMD reported an RTI in the previous year (53% vs 22%, p=0.01). The likelihood of having a prior RTI was associated with baseline VC (%predicted) (OR=1.03 (95% CI 1.00 to 1.06), p=0.029). Published thresholds (VC<1.1 L or PCF<270 L/min) were, however, not associated with prior RTI.A single session of LVR improved Crs (mean (95% CI) increase = 0.0038 (0.0001 to 0.0075) L/cmH2O, p=0.047) but not VC. CONCLUSION: These findings corroborate the hypothesis that ventilatory restriction in NMD is related to weakness initially with respiratory system stiffness potentiating lung volume loss in slowly progressive disease. A single session of LVR can improve Crs. A randomised controlled trial of regular LVR is needed to assess longer-term effects.

Typical within and between person variability in non-invasive ventilator derived variables among clinically stable, long-term users.

BACKGROUND: Despite increasing capacity to remotely monitor non-invasive ventilation (NIV), how remote data varies from day to day and person to person is poorly described. METHODS: Single-centre, 2-month, prospective study of clinically stable adults on long-term NIV which aimed to document NIV-device variability. Participants were switched to a ventilator with tele-monitoring capabilities. Ventilation settings and masking were not altered. Raw, extensible markup language data files were provided directly from Philips Respironics (EncoreAnywhere). A nested analysis of variance was conducted on each ventilator variable to apportion the relative variation between and within participants. RESULTS: Twenty-nine people were recruited (four withdrew, one had insufficient data for analyses; 1364 days of data). Mean age was 54.0 years (SD 18.4), 58.3% male with body mass index of 37.0 kg/m2 (13.7). Mean adherence was 8.53 (2.23) hours/day and all participants had adherence >4 hours/day. Variance in ventilator-derived indices was predominantly driven by differences between participants; usage (61% between vs 39% within), Apnoea-Hypopnoea Index (71% vs 29%), unintentional (64% vs 36%) and total leak (83% vs 17%), tidal volume (93% vs 7%), minute ventilation (92% vs 8%), respiratory rate (92% vs 8%) and percentage of triggered breaths (93% vs 7%). INTERPRETATION: In this clinically stable cohort, all device-derived indices were more varied between users than the day-to-day variation within individuals. We speculate that normative ranges and thresholds for clinical intervention need to be individualised, and further research is necessary to determine the clinically important relationships between clinician targets for therapy and patient-reported outcomes.