Citations

Abstract Introduction A previously published case report suggested that alcohol might cause false-negative results in home sleep apnea testing (HSAT) utilizing Peripheral Arterial Tonometry (PAT). Alcohol is consumed by nearly a third of people globally. Based on this, along with rapid growth in PAT HSAT utilization, we aimed to prospectively study the interaction between alcohol consumption and PAT HSAT technology. We hypothesized that alcohol use would significantly attenuate sleep disordered breathing metrics in contrast to existing literature suggesting alcohol may exacerbate sleep apnea. Methods We planned to recruit subjects (N=100) from Mayo Clinic Arizona sleep clinic who were being evaluated for sleep-disordered breathing and elected to undergo home sleep apnea testing (WatchPAT ONE). Participants were required to report social alcohol use (no more than 1-3 drinks per day). The first and second home sleep apnea test were conducted on separate nights (night 1: without alcohol; night 2: with alcohol). Patients also completed a questionnaire, detailing their normal alcohol intake as well as intake during the respective sleep tests. Statistical analysis included paired sample t-test as well as a descriptive analysis. Results A total of 75 subjects were recruited (mean age [± SD] 56.8 ± 11.9; 90.7% male; mean BMI 29.8 ± 5.8) and 56 patients completed both sleep tests. The mean apnea hypopnea index (AHI) was not statistically different (p=0.784) between night 1 and night 2 (without alcohol: 19.6/hour ± 21.0; with alcohol: 19.3 ± 21.5, respectively). Similarly, no statistically significant difference was found in the AHI during REM and NREM sleep. Conclusion Preliminary data does not suggest a statistically significant difference in AHI without or with alcohol. While no significant change in AHI was observed, this study highlights the need for further investigation into the impact alcohol may have on PAT technology. Further analyses and data enrichment are underway. Support (if any) Mayo Foundation

Abstract Introduction Obstructive sleep apnea (OSA) is effectively treated with continuous positive airway pressure (CPAP), but access remains a challenge. The COVID-19 pandemic accelerated telehealth, offering a convenient alternative to in-person visits for OSA evaluation and treatment initiation. This study compares patients managed entirely via video telehealth to those managed entirely in person. We hypothesize that virtual are as effective as in-person evaluations in managing most OSA patients. Methods The study is approved by the Mayo Clinic IRB. We retrospectively studied adult patients diagnosed with OSA requiring CPAP initiation between June 2020–2023. Data collected included baseline demographics, home sleep apnea testing (HSAT) results, polysomnography (PSG) results, Epworth Sleepiness Scale (ESS) scores, OSA severity, compliance results, other relevant comorbidities (i.e. cardiovascular diseases). Visit type categorized as “in-person” for patients who had both initial and follow-up appointments in-person, while “telehealth” group included patients who had both appointments virtually. Results Of 59 patients, 33 had telehealth (56%). The groups had similar medians in age (66 vs 62), sex (73% vs 67% male), and BMI (30 vs 32). There was no significant difference in median ESS scores (8 vs 7, p=0.7). However, the severity of OSA (moderate to severe) was higher in the in-person group (73% vs 45%, p=0.03). When baseline sleep study data was investigated, there were no differences in AHI and average SpO2 values measured by HSAT or PSG between the two groups (p>0.05 for all). CPAP compliance was significantly higher in the telehealth group compared to in-person (78% vs 40%, OR: 5.5, 95% CI: 1.7-17.1, p=0.003). Virtual visit type was the only independent predictor of compliance (p=0.006), after adjusting for age, BMI, comorbidities and OSA severity in multivariate analysis. However, there was no difference in average daily CPAP usage (6:39 vs 7:18, p=0.5) and percentage of days with usage >4 hours (91% vs 95, p=0.5). Median AHI after treatment improved in both groups, with no significant difference between groups (1.7 vs 2.4, p=0.8). Conclusion Telehealth offers a successful alternative to in-person visits for OSA evaluation, with similar outcomes and significantly better compliance, enhancing OSA management. Support (if any)

Abstract Introduction Adherence with mask-based therapies remains a significant challenge for optimal treatment of patients with sleep disordered breathing. Transvenous phrenic nerve stimulation (TPNS) to treat central sleep apnea offers a novel, automated approach to enhance nightly adherence by initiating therapy based on patient-specific programmed conditions such as sleep schedule, activity, and body position. Therapy automatically pauses when the patient sits up or changes position, facilitating re-initiation of sleep. This research aimed to determine the degree of adherence achieved with TPNS’s automated activation approach. Methods Device data from 128 remedē® System Pivotal Trial participants were analyzed to calculate hours of therapy activation. Daily use from device data within the 14 days prior to scheduled visits were used to calculate median daily hours of therapy per patient, and subsequently the overall median daily use for all patients. Therapy duration was defined as the sum of time of delivered therapy when all conditions to activate therapy were met between the first time therapy came on to the last time off during the night, excluding time when activity or body position did not meet the programmed criteria for therapy activation. Results The median [Q1-Q3] nightly therapy duration at 6, 12, 18, and 24 months was 5.9 [4.9-6.6], 5.7 [5.0-6.8], 6.0 [5.3-6.8], and 5.9 [4.9-6.5] hours, respectively. Using a definition for adequate therapy as the percentage of patients with usage ≥4 hours/night for at least 70% of nights, 86%, 82%, 83%, and 90% of patients met the criteria at these visits. Only two patients (< 2%) who had therapy activated discontinued treatment prior to 6 months due to stimulation intolerance. Patients with median delivered therapy ≥4 hours/night reported more quality of life improvement than patients with < 4 hours of therapy. Conclusion The automatic activation of TPNS therapy resulted in a higher duration of nightly usage and higher rate of adequate delivered therapy than generally are reported for mask-based therapies. This high usage may yield a greater overall reduction in central sleep apnea burden over the whole night compared to therapies that require the patient to initiate the therapy. Support (if any) ZOLL Respicardia, Inc.

Abstract Introduction Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) is a phase 4, prospective, multicenter, single-arm, multiple-cohort, open-label study (NCT05875974) evaluating the effectiveness of low-sodium oxybate (LXB, Xywav®) treatment on outcomes including sleep quality (using polysomnography [PSG] and self-reported questionnaires) in participants with narcolepsy or idiopathic hypersomnia. Data reported here are from the narcolepsy cohort. Methods DUET included a screening period (with 2-week washout for current oxybate users), an 8-day baseline (BL) period, a 2- to 8-week LXB titration period, a 2-week stable-dose period (SDP), an 8-day end-of-treatment (EOT) period, and a 2-week safety follow-up. Participants underwent nocturnal PSG (ad libitum protocol) at BL and EOT. The Karolinska Sleepiness Scale (KSS) was administered 90 minutes post-awakening from PSG to measure situational sleepiness (9-point scale; 1=“extremely alert” to 9=“extremely sleepy, can’t keep awake”). Participants completed an electronic sleep diary (eDiary) daily during the BL and EOT periods, including questions regarding nightly sleep patterns, total sleep time (TST), sleep quality (5-point scale; “very good” to “very poor”), and how rested/refreshed the participant felt upon awakening (5-point scale; “very well” to “not at all”). Completion of ≥5 eDiary days during the 8-day assessment before PSG visits was required for analysis. eDiary and KSS data were analyzed in the completer set (enrolled participants who were dosed with LXB and completed SDP and PSG at EOT). Results Fifty-five participants with narcolepsy (type 1, n=26; type 2, n=29) enrolled (completer set, n=34). Most were female (40/55; 73%) and White (44/55; 80%); mean (SD) age was 33.4 (12.9) years. Mean (SD) self-reported nocturnal TST at BL (n=32) and EOT (n=20) was 8.1 (1.6) and 8.3 (0.9) hours, respectively. The percent of participants rating their sleep quality as “very good”/“good” increased from 15.6% (BL) to 70.0% (EOT). The percent of participants with rested sleep (“very well”/“well”/“somewhat” rested) increased from 46.9% (BL) to 90.0% (EOT). Likewise, mean (SD) rating of self-reported sleepiness decreased from 5.1 (2.0) at BL to 3.8 (1.9) at EOT. Conclusion Following open-label LXB treatment, participants with narcolepsy reported improvements in sleep quality and feeling more rested and less sleepy upon awakening. Support (if any) Jazz Pharmaceuticals

Abstract Introduction Residual excessive daytime sleepiness (RES) despite effective positive airway pressure (PAP) therapy for obstructive sleep apnea (OSA) is a clinical problem impacting quality of life and daily function. Wake-promoting agents (WPAs) such as modafinil, armodafinil, and solriamfetol have demonstrated efficacy in reducing RES in randomized controlled trials (RCTs); however, their effectiveness in typical sleep clinic populations remains underexplored. This study aimed to evaluate the efficacy, safety, and tolerability of these WPAs in real-world clinical settings. Methods This retrospective study analyzed electronic health records of 69 randomly selected, consenting patients with OSA who are on PAP therapy and a WPA at Mayo Clinic from 9/19/2019 to 9/19/2024. Researchers reviewed charts for treatment indication, duration, adverse effects, and response (categorized as “complete,” “partial,” or “poor”). Therapy longevity was assessed using initiation, refill, and discontinuation data. Outcomes were analyzed with paired t-tests, chi-square tests, and regression models. Results Of 69 patients, 45 were excluded because: WPA use before observation period (24), off-label WPA use (13), WPA use before CPAP (3), or other (5). Off-label reasons included neurologic-condition-related fatigue (6), depression augmentation (5), and autoimmune-condition-related fatigue (2). 24 patients were on WPAs for RES with PAP-treated OSA, including 3 with mixed indications, and were included in analyses. The median age was 65 (IQR 11). BMI at OSA diagnosis was 33.6 (IQR 6.4). Most subjects were male (75%). Initial Epworth Sleepiness Scale scores (ESS) were 12.3±1.1. ESS at the first WPA prescription were 15.4±0.9 (p=0.04). Most patients (83.3%) started on modafinil. Of the 4 patients who started on armodafinil or solriamfetol, chart review showed a previous trial of modafinil without benefit. After optimizing the initial WPA dosage, ESS improved by 3.3±1.4 points (p=0.04) to 12.1 ±1.2. Side effects limited WPA use in 20.8% of patients. Median first WPA duration was 141 days (IQR 53-280) with no significant difference between these WPAs (p=0.81). Conclusion Although WPAs have narrowly defined approved indications, they are often prescribed off-label for comorbidities. Unlike straightforward use in RCTs, real-life use is more complicated. Patients prescribed WPAs for the targeted approved indication show statistically significant benefits, although adverse effects limited their use for some. Support (if any)

Abstract Introduction Jazz DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) is a phase 4, prospective, multicenter, single-arm, multiple-cohort, open-label study (NCT05875974) evaluating effectiveness of low-sodium oxybate (LXB, Xywav®) treatment on outcomes including polysomnography (PSG)-based sleep architecture in participants with idiopathic hypersomnia or narcolepsy (type 1 [NT1] or 2 [NT2]). Methods DUET included a screening period (2-week washout for current oxybate users), 8-day baseline (BL) period, 2- to 8-week LXB titration period, 2-week stable-dose period (SDP), 8-day end-of-treatment period (EOT), and 2-week safety follow-up. Participants underwent nocturnal PSG (ad libitum protocol) at BL and EOT. PSGs were scheduled to allow a minimum of 10 hours in bed, unless the participant naturally awakened earlier; bedtime was determined by habitual bedtime. PSG recordings were centrally scored. Data were analyzed for participants in the narcolepsy cohort completer set. Total shifts from deeper to lighter sleep stages was defined as N1/N2/N3/REM to wake and N2/N3/REM to N1. Key secondary endpoints (total stage shifts, N3 duration) were controlled for multiplicity with sequential testing; other P-values are considered nominal. Results Fifty-five participants with narcolepsy enrolled (NT1, n=26; NT2, n=29); 34 completed the study (NT1, n=16; NT2, n=18). Most were female (73%) and White (80%) (mean±SD age, 33.4±12.9 years). Mean±SD total sleep time (TST) at BL/EOT was 453.2±80.1/452.4±70.0 minutes (LSM change [95% CI]: –0.78 [–23.7, 22.1]; P=.9451). Mean±SD number of total shifts from deeper to lighter sleep stages at BL/EOT was 54.6±28.0/41.6±25.6 (LSM [95% CI]: –13.1 [–19.0, –7.1]; P<.0001 [controlled for multiplicity]). Mean±SD time spent in N1 at BL/EOT was 45.3±28.4/37.2±25.2 minutes (LSM [95% CI]: –8.1 [–14.9, –1.4]; P=.0196), % of stage was 10.4%/8.2% (P=.0037); in N2 was 241.8±61.2/243.3±76.1 minutes (LSM [95% CI]: 1.5 [–23.6, 26.6]; P=.9040), 53.1%/53.2% (P=.9869); in N3 was 61.1±34.8/106.1±69.5 minutes (LSM [95% CI]: 45.0 [27.0, 63.0]; P<.0001 [controlled for multiplicity]), 13.7%/24.0% (P<.0001); and in REM was 105.0±42.7/65.8±33.1 minutes (LSM [95% CI]: –39.2 [–50.8, –27.5]; P<.0001), 22.8%/14.7% (P<.0001). Conclusion Participants with narcolepsy taking open-label LXB showed negligible change in TST and N2, increased N3, decreased N1 and REM, and fewer shifts from deeper to lighter stages of sleep. Support (if any) Jazz Pharmaceuticals

Abstract Introduction Identifying central sleep apnea (CSA) during home sleep apnea testing is important to guide appropriate treatment for sleep-disordered breathing (SDB) and underlying cardiovascular conditions, including heart failure and atrial fibrillation. SANSA (Huxley Medical, Inc.) is a multi-diagnostic chest-worn monitor capable of detecting SDB, cardiac arrhythmias, and heart function. Using polysomnography (PSG) as a reference, we developed a machine learning (ML) method to classify respiratory events from this monitor as central or obstructive. Methods Data was analyzed from ninety-five subjects with suspected SDB who wore the chest monitor simultaneously with PSG overnight. To address known scoring heterogeneity of CSA, PSG records were scored for central apneas by two core laboratories (Core 1 and Core 2). Core 1 annotations from twenty-eight records were first used to train a random forest classifier to differentiate obstructive (N=680) and central events (N=388). The model used oximetry, respiratory effort, and snoring to classify events based on effort, duration, and other features. A five-fold cross validation was used to evaluate event-level performance. The model was then used to estimate subject-level CAI for all subjects and compared with Core 2 scores. Results Algorithm event-level sensitivity and specificity to detect central events was 72.7% and 81.0%. Subject-level CAI for all records between the chest monitor and Core 2 had a correlation coefficient of 0.90 and root mean squared error (RMSE) of 4.6 events/hour, versus 0.82 and 4.7 events/hour comparing Core 1 and Core 2. Sensitivity and specificity to detect CAI≥10 events/hour was 80.0% (4/5) and 98.9% (89/90), compared to 100% (3/3) and 98.9% (91/92) for CAI≥15. Conclusion An ML algorithm to differentiate obstructive and central events collected from the chest-worn monitor demonstrated favorable event-level performance and comparable CAI agreement to that between two PSG core laboratories. Home-based CSA detection alongside cardiac monitoring could identify high risk patients for expedited therapy, cardiology referral, or follow-up PSG. These results motivate further validation in a larger cohort as well as investigation of outcomes related to time to evaluation and management. Support (if any) National Science Foundation; Georgia Research Alliance; Huxley Medical, Inc.

AbstractStandard of care first‐line systemic treatment for advanced biliary tract cancer includes chemo‐immunotherapy with gemcitabine, cisplatin, and durvalumab, followed by maintenance durvalumab monotherapy. The present work aims to investigate the differences in baseline clinical and molecular characteristics between patients with early progression during chemo‐immunotherapy and those who reach durvalumab maintenance therapy. The study population included patients with unresectable, locally advanced, or metastatic BTC who received treatment at 38 clinical Institutions in 12 countries from July 2021 to December 2023. The primary objective of the study was to investigate whether baseline clinical and molecular characteristics differed between patients with early progression during chemo‐immunotherapy versus those reaching durvalumab maintenance therapy. Four hundred forty‐eight patients were included in this study. Two hundred twenty‐seven patients (50.7%) received maintenance with durvalumab monotherapy, whereas 221 (49.3%) did not receive maintenance therapy due to PD during first‐line chemo‐immunotherapy before completing 8 cycles. Results show that patients who received maintenance were more likely to be older (≥70 years), have an ECOG = 0, locally advanced disease, and a neutrophil‐to‐lymphocyte ratio (NLR) <3. A higher proportion of patients with BAP1 mutations received maintenance, while TP53 mutations were more common in those who progressed early. According to the present analysis, a substantial proportion of patients (50.7%) with advanced BTC who were treated with chemotherapy plus durvalumab proceeded to receive maintenance therapy with durvalumab monotherapy, with a median treatment duration of 4.4 cycles. Patients ≥70 years, with ECOG PS 0, with locally advanced disease, and with NLR <3 had a higher likelihood of receiving maintenance therapy.

Background: Patients with severe and life-limiting illnesses transitioning out of the hospital often rely on family caregivers (FCGs) to manage communication with health care teams during hospitalizations and outpatient care. However, FCGs infrequently receive adequate training or support to prepare for these responsibilities. Effective communication between FCGs and health care teams is critical for preparing FCGs and reducing risks for poor outcomes. This study tested an eight-week intervention to improve FCG preparedness and communication practices during transitions out of the hospital. Methods: Conducted from 2018 to 2022, this randomized controlled trial included adult FCGs in rural areas in the United States (Minnesota, Wisconsin, and Iowa). FCGs caring for adults who received inpatient palliative care and were transitioning out of the hospital were eligible. The intervention group received teaching, guidance, and counseling from a palliative care nurse interventionist via video visits before and for eight weeks after discharge. The control group received monthly phone calls but no intervention. Outcomes included changes in FCG-reported preparedness for caregiving and communication with health care teams. Results: Of the 429 consented, 367 (183 intervention and 184 control participants) initiated the intervention; 164 had complete preparedness data, and 161 had complete communication data at baseline and eight weeks. In unadjusted analyses, the intervention group showed statistically significant improvements in preparedness but not communication practices. After adjusting for factors associated with care transitions, the findings persisted. Conclusion: Partnering rural FCGs with palliative care nurses via video can improve caregiver preparedness during care transitions. Improving communication practices may need more targeted strategies.

Abstract The establishment of guidelines and curriculum standards for medical physics residency training is a critical component of setting expectations and competencies for the profession. Since the last publication of these standards, residency training has become integrated into the eligibility criteria for most medical physics certification bodies. The rapid growth of medical physics requires periodic review of the curriculum to remove outdated approaches, update established knowledge, and add emerging technologies. The goal of this document is to provide a reference standard for residency training program directors, training mentors, and residents to guide creation and/or optimization of their program's curriculum. The document is intentionally forward‐looking to capture emerging technological advances including hybrid diagnostic and therapeutic delivery systems and applications of image processing. This document is an update of the current residency training curriculum. Version history of residency training guidelines Publication Title Date 2013 Essentials and Guidelines for Clinical Medical Physics Residency Training Programs—AAPM Report No. 249 2006 Essentials and Guidelines for Hospital‐Based Medical Physics Residency Training Programs—Report No. 90 1992 Essentials and Guidelines for Hospital‐Based Medical Physics Residency Training Programs—Report No. 36 The Work Group on Periodic Review of Medical Physics Residency Training (WGMPRT) would like to acknowledge the authors of past versions of this document as they form the basis for this update. It is the sincere hope of the WGMPRT that this report will continue to be used by the medical physics community to guide training in the profession.