bluuebunny/crossref_metadata_2025 huggingface dataset:
0566 Utilizing a Triage Tool Questionnaire to Identify PAP-Related Issues in Patients Newly-Initiated on Therapy for OSA
Authors: Saconi Bruno , Watach Alexa , Klimper Matthew , Arguelles Jessica , Hwang Dennis , Keenan Brendan , Plourde Andrew , Tran Jennifer , Sawyer Amy
Published: April 2024

Introduction

Developing strategies to enhance Positive Airway Pressure (PAP) adherence is crucial for improving outcomes in patients with obstructive sleep apnea (OSA). We introduce a novel Triage Tool (TT) questionnaire designed to identify specific usage challenges to facilitate targeted interventions.

Methods

Moderate-severe OSA (AHI≥15) patients newly-initiated on PAP therapy (AutoCPAP, ResMed) were enrolled (Kaiser Permanente, Fontana, CA). A digital platform (Somnoware, Inc.) emailed patients a link to the electronic TT questionnaire at 5, 10, and 30 days post-treatment initiation. The 31-item TT is comprised of 6 domains: Adverse Effects, Pressure, Mask/Device, Disturbed Sleep, Psycho-social, and Unintentional. A Likert scale (1 – 4) was used where ‘1 = not at all’ and ‘4 = a lot’ in response to “how much does this issue bother you?” We characterized the frequency of issues in the overall group and between adherent (Adh) and non-adherent (NA) subgroups (adherent: ≥70% usage, ≥4 hours over 30 days), using descriptive statistics.

Results

Of 150 enrolled patients (age 48±14; male 58%; AHI 41.1±21.1), 73 were Adh and 77 were NA. Overall TT response rate was 57% (63, 60, 50%, respectively, at day 5, 10, 30) and higher for Adh than NA (70.3% ± 5.0 vs 45.9% ± 6.7) Average number of patient endorsed issues (i.e., responses scored 3 or 4) was higher for NA than Adh and decreased over time – day 5: 4.1 ± 4.2 vs 3.4 ± 4.1; day 10: 3.9 ± 5.4 vs 2.8 ± 3.6; day 30: 2.5 ± 5.4 vs 2.2 ± 3.6. Commonly endorsed issues were: dry throat/mouth (21%), waking too early (20%), mask discomfort (19%), nasal congestion (18%), and difficulty initiating sleep (16%). NA patients additionally endorsed difficulty falling (23%) and staying (19%) asleep, waking with mask off (19%) and embarrassment (23%) or concern about appearance (23%). Adh patients more frequently concerned about traveling with PAP (20%).

Conclusion

The TT questionnaire identified “mask/device” discomfort and “adverse effects” as commonly endorsed problems among newly-treated OSA patients. NA patients also reported “disturbed sleep” and “psychosocial” barriers. Identifying specific treatment-related problems experienced by individuals may guide targeted interventions. Further psychometric evaluation is underway to refine the TT questionnaire.

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0567 Utilizing Machine Learning Based on Multi-Modal Data to Predict PAP Adherence in Patients with OSA
Authors: Hwang Dennis , Rusk Sam , Fernandez Chris , Nygate Yoav , Vanasse Tom , Wodnicki Jan , Sekhon Anupamjeet , Shi jiaxiao , Yan Rui
Published: April 2024

Introduction

Predicting future Positive Airway Pressure (PAP) adherence may support treatment decisions and timing of interventions in patients with obstructive sleep apnea (OSA). We developed machine learning (ML) prediction algorithms based on daily PAP metrics and diagnostic sleep study data to predict adherence at 3-months and 1-year.

Methods

ML models (eXtreme Gradient Boost) were trained on a dataset of 37,076 patients (Kaiser Permanente, Southern California) that comprised of daily PAP data (“usage” [minutes/night] and “leak”) and diagnostic sleep study data (Polysomnography and Home Sleep Apnea Tests). Models were trained to predict PAP adherence (≥70% days, ≥4 hours) at 3-months (i.e., 61-90 days) and 1-year (i.e., 330-360 days) after PAP initiation. Developed algorithms were based on: (a) Usage; (b) Leak; (c) Diagnostic sleep study data (i.e., AHI, oximetry metrics, sleep-wake metrics); (d) combination of those data types. For the models utilizing daily PAP data, different input days were applied (i.e., 7, 30, 90, etc.) to the training.

Results

Models based on daily usage alone demonstrated excellent predictive performance with relatively short input days (ROC-AUC 0.86 and 0.96 in predicting 3-month adherence utilizing 7 and 30 input days; 0.74, 0.82, 0.88 in predicting 1-year adherence utilizing 7, 30, and 90 input days). Models based on daily leak demonstrated more modest performance (0.69 and 0.83 predicting 3-month adherence with 7 and 30 input days; 0.60, 0.70, 0.80 predicting 1-year adherence with 7, 30, 90 input days.) Models based only on diagnostic sleep study data (without PAP data) demonstrated only small but similar 3-month and 1-year predictive accuracy (0.57 and 0.56, respectively). The addition of leak and sleep study data to usage did not significantly improve performance.

Conclusion

ML algorithms based on daily usage data early after therapy initiation can accurately predict future adherence to at least 1 year after therapy, enabling decision support after starting PAP. Algorithms using sleep study data could enable treatment decisions prior to prescribing PAP, but performance was modest. Whether the addition of electronic health record or direct ML processing of raw sleep study data could improve predictive accuracy requires further exploration.

Support (if any)

AASM Foundation 205-SR-19
0568 Promoting Shared Decision Making with a Novel Self-Monitoring Program for Veterans with Obstructive Sleep Apnea
Authors: Mak Selene , Ghadimi Sara , Der-Mcleod Erin , Moore Virginia , Naeem Saadia , Chohan Moeed , Zeidler Michelle , Ash Garrett , Fung Constance H
Published: April 2024

Introduction

Optimal shared decision making (SDM) occurs when patients are well-informed about their treatment options and, with clinician collaboration, can determine the best care for their well-being. Data pertaining to treatment success guide future decisions on care management, such as the decision to continue with current therapy versus transitioning to alternate therapies. Unfortunately, patients with obstructive sleep apnea (OSA) on non-positive airway pressure (non-PAP) treatments (e.g., dental devices) often lack night-to-night data supporting therapy effectiveness. We designed a self-monitoring program that provides night-to-night data for Veterans on non-PAP OSA treatment, with the goal of promoting SDM.

Methods

Patients with OSA prescribed non-PAP treatment from a VA sleep center were invited to participate in a quality improvement project for 1, 2, or 4 weeks, depending on project phase. A consumer-grade smartwatch was provided to each patient to collect pulse oximetry (SpO2) data while sleeping. Patients completed a weekly survey on their daytime sleepiness, mood, daily functioning, and use of non-PAP treatment. A report with their survey responses and SpO2 data was sent to patients weekly. A sleep clinician met with patients to discuss the report and OSA treatment. We assessed SDM with CollaboRATE-5 (3-items, score range 0-12, 0=no effort was made, 12=every effort was made). We conducted post-program semi-structured interviews with patients and analyzed interview data using content analysis to infer themes and/or meanings of SDM.

Results

Out of 11 veterans enrolled in the program (1 [9.1%] female, mean age 54, 7 [63.6%] non-white or multiracial), 9 (81.8%) have completed the program. Qualitative analysis revealed 3 themes related to SDM: 1) Information provision; 2) Patient preference elicitation; and 3) Patient preference integration. Four of 9 participants mentioned that they would reconsider PAP therapy at the conclusion of the program. A mean CollaboraRATE score of 7.1 (SD=3.0) indicates that respondents felt the program made some effort to address their concerns and integrated their preferences in OSA treatment.

Conclusion

Implementing a self-monitoring program as part of OSA treatment has promoted SDM with nearly half of patients expressing an interest to retry or consider PAP treatment.

Support (if any)

VA Office of Connected Care
0569 Breathing Easy Together: How Positive Airway Pressure Adherence Benefits Both Patients and Partners
Authors: Troxel Wendy , Baucom Brian , Shock Stevie , Baron Kelly
Published: April 2024

Introduction

Emerging research highlights the interdependence of sleep within couples and the impact of sleep and sleep disorders on couples’ relationship quality. The current study examines how adherence to positive airway pressure (PAP) as well as sleep duration and efficiency associates with both patient and partners’ relationship quality, among patients with obstructive sleep apnea (OSA) and their partners.

Methods

The sample included OSA patients initiating PAP treatment and their partners (N= 36 couples; mean age = 63.06, SD = 9.15). Mixed model analyses examined actor and partner effects of PAP adherence and actigraphy-assessed sleep duration and efficiency, on patient and partners’ self-reported relationship satisfaction and conflict.

Results

Greater patient PAP adherence (defined as > 4 hours use per night on average over 3 months of recording) was associated with higher levels of relationship satisfaction (B = 4.26; SE = 1.40; p = 0.01) and lower levels of relationship conflict (B = -5.24; SE = 2.51; p = 0.04) for patients and partners. Higher patient sleep efficiency was associated with higher levels of patient and partner reported relationship satisfaction (B = 0.12; SE = .06; p = 0.04). Associations involving sleep duration were significantly different for patients and partners. For patients, greater own total sleep time was significantly associated with higher levels of patients’ relationship satisfaction (B = 0.92; SE = 0.35; p = 0.01) whereas greater partner total sleep time was significantly associated with lower levels of patients’ relationship satisfaction (B = -1.35; SE = 0.67; p = 0.045). After adjusting for patient adherence, the magnitude and direction of these associations were similar but the p-values increased slightly (p = 0.085 for sleep efficiency; p = 0.054, 0.14, 0.12, respectively for sleep duration).

Conclusion

Results highlight how sleep and sleep disorders are implicated in couples’ relationship quality. Among couples in which one member has sleep apnea, adherence to PAP treatment and better sleep efficiency is associated with higher relationship satisfaction. Recognizing the dyadic implications of sleep and sleep disorders, including the potential impact on relationship quality, may be a powerful motivator to encourage adherence in sleep disorders populations.

Support (if any)

R21AG067183 (Baron and Troxel)
0570 Impact of a Sleep Apnea Management Group Clinic on PAP Adherence and PROs: A Randomized Controlled Trial
Authors: Bhambra Raman , Khazaie Sepideh , Bena James , Morrison Shannon , Moul Douglas , Foldvary-Schaefer Nancy , Vanek Robon , Mehra Reena , Walia Harneet
Published: April 2024

Introduction

Positive airway pressure (PAP) is the mainstay treatment for obstructive sleep apnea (OSA), yet suboptimal adherence limits treatment effectiveness. We examined the impact of a sleep apnea management (SAM) clinic, an innovative, interactive group clinic which provides interpersonal support to patients and allows access to resources and education, on PAP adherence and patient reported outcomes (PROs) compared to usual care.

Methods

Participants with OSA and newly prescribed PAP therapy and sub-optimally adherent (CMS criteria) during the first two weeks, were randomized to SAM clinic(n=26) versus usual care(n=30) from April 2019 to November 2022 (NCT-03835702). The primary outcome was change in average daily PAP usage, whereas secondary outcomes were changes in Epworth Sleepiness Scale (ESS), Patient Health Questionnaire-9 (PHQ-9), and PROMIS scales from baseline to 1 and 3 months. Baseline adjusted mixed effect linear and logistic models estimated between and within groups differences.

Results

A total of 56 participants were enrolled with a mean age of 55 years, 57% female, 63% Caucasian, median AHI of 22.8 (9.3,39.6), and median baseline PAP usage of 172 minutes. After 3 months, the mean (95% CI) SAM clinic daily PAP use was 193(139, 247) minutes vs usual care at 148(110, 185) minutes with mean difference of 46(-8, 99) minutes per day (p=0.093). Within each group, a mean daily difference of 11(-36,57) minutes (p=0.65) in SAM clinic and -32(-75,12) (p=0.15) in the usual care was observed. No significant differences were observed in PROs between SAM and usual care. Within each group, ESS change was -0.7(-2.5,1.2) (p=0.48) in SAM clinic and -2.5(-4.2, -0.83) (p=.004) in usual care. Significant decrease was noted in PHQ-9 within both SAM clinic at-2.2(-3.9, -0.4) (p=0.019) and in usual care at -2.3(-4.0, -0.7) (p=0.006). Improvement in PROMIS sleep related impairment was noted within both groups: SAM clinic at -3.0(-6.2,0.1) (p=0.059) and usual care group at -3.5(-6.4, -0.60) (p=0.019). Similar changes in PAP adherence and PROS were seen at the 1-month follow-up.

Conclusion

SAM clinic may improve PAP adherence and some PROs better than usual care; however future studies are needed to confirm findings as this trial was underpowered due to premature termination resulting from the pandemic.

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0572 Impact of CPAP Therapy on HbA1c in Patients with Obstructive Sleep Apnea and Pre-Diabetes: A Preliminary Analysis
Authors: Maheshwari Narinder , Lenka Jyoti , Yang Zehan , Salmon Adrian , Wu Helen
Published: April 2024

Introduction

Patients with Obstructive Sleep Apnea (OSA) have higher levels of inflammatory cytokines, like tumor necrosis factor α (TNF-α) and interleukin-6 (IL-6). Similar higher systemic inflammatory cytokines have been linked to insulin resistance, thus emphasizing possible metabolic complications of OSA. Yet, the effect of positive airway pressure (PAP) therapy on glycemic control in those with concomitant OSA and pre-diabetes i unknown.

Methods

We performed a retrospective cohort study analyzing data from our tertiary care sleep center in adults with OSA and concomitant prediabetes who were initiated on CPAP therapy between April 2018 to April 2021. OSA was identified using ICD-9-CM (327.23) and ICD-10code (G47.39). Prediabetes was defined as hemoglobin A1c (HbA1c) between 5.7–6.4%. Demographic data were collected including age, gender, BMI, and number of comorbidities. The data was stratified among those on medications for pre-diabetes versus those that were not on any medications for it. Our outcome of interest was the change of mean A1c after CPAP initiation. Descriptive statistics were performed, while t-test was used to assess the changes of mean A1c values before and after CPAP treatment with a statistically significant level p< 0.05

Results

A total of 71 patients were included in the current analysis. The average age was 61.53 years, and 65% were female, while 44% non-Hispanic whites, 28% non-Hispanic blacks, 21% Hispanics and 6% Asians. Among those with concomitant OSA-prediabetes on medications, the mean HbA1c before CPAP initiation was 6.03% which changed to 6.63% after CPAP initiation over a mean follow up duration of 485 days (p=0.04 from one-tail t-test). Among those with concomitant OSA-prediabetes not on medications, the mean A1c before CPAP initiation was 6% which marginally had changed to 6.42% after CPAP therapy over mean follow up duration of 447 days (p=0.05 from one-tail t-test), again remaining within pre-diabetes range.

Conclusion

Our results show that HbA1c remain stable within pre-diabetes range in patients with concomitant OSA and pre-diabetes using CPAP therapy. Some limitations could be retrospective nature of the study, small sample size, lack of CPAP compliance data. Larger prospective studies are suggested to further investigate the effect of CPAP on progression to diabetes among these patients.

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0574 An Intervention to Promote Positive Airway Pressure (PAP) Use: Qualitative Analysis of Barriers and Facilitators
Authors: Gomez Giselle , Carlson Gwendolyn , Alessi Cathy , Zeidler Michelle , Kelly Monica
Published: April 2024

Introduction

Health literacy of sleep apnea (SA) and access to behavioral strategies to promote positive airway pression (PAP) adherence remain challenges in clinical settings. Understanding what factors hinder or support PAP use is critical to increasing adherence and optimizing patient outcomes. We developed and implemented a brief PAP education and behavioral intervention program (1-hour 1:1 telehealth session prior to initiating PAP and 1-week follow-up call) in a VA sleep medicine clinic to increase SA knowledge and PAP use. To evaluate the program, we collected qualitative feedback from participants.

Methods

The PAP program was offered to Veterans newly diagnosed with SA. Among 43 veterans who participated in the program, 10 completed the Self-Efficacy Measure for Sleep Apnea (SEMSA) prior to program initiation and provided retrospective qualitative feedback within 6 months of initiating PAP. Three raters independently coded qualitative responses and reached consensus on domains and subcategories that emerged.

Results

Veterans (M=56 years) were categorized as “low” (n=5) or “high (n=5)” based on mean SEMSA perceived risk subscale score. Qualitative analysis revealed 3 domains (pre-program SA knowledge, pre-program PAP knowledge, and post-program SA/PAP knowledge) and categories of barriers or facilitators emerged. Four out of the 5 participants in both groups reported a perceived lack of knowledge of SA before the PAP program (unaware of SA-associated health risks). Despite this perception, the high group reported more pre-program basic knowledge about PAP vs. the low group, and knowing a family/friend with a neutral/positive PAP experience. Two participants in the low group expressed negative PAP-related expectations/cognitions vs. no participants in the high group. Participants in both groups reported having increased knowledge about SA/PAP post-PAP program; however, only participants in the low group recalled specific skills/strategies to facilitate PAP use.

Conclusion

Qualitative feedback revealed a general lack of knowledge about SA pre-PAP education program. A PAP education program may help those newly diagnosed with SA increase their health literacy and learn skills/strategies to facilitate PAP use, particularly for those who have a lower risk perception of SA. Future research should explore the impact of negative SA/PAP-related perceptions on PAP adherence.

Support (if any)

AASM Foundation#211-FP-19, VAGLAHS GRECC/CSHIIP, VA-HSR&D-CDA-20-227
0575 Parallel Comparison of Apnea Hypopnea Index with WatchPAT and CPAP Compliance Download
Authors: Akpa Bimaje , Liendo Alicia , Wang QI , iber Conrad , Pusalavidyasagar Snigdha
Published: April 2024

Introduction

Some OSA patients have sleep associated hypoxemia, defined as time spent with oxygen (O2) saturation ◻88% for > 5 minutes (T88). Positive airway pressure (PAP) is the gold standard treatment for OSA. Apnea-Hypopnea index (AHI) estimation from PAP download (DL) is used by clinicians to determine the treatment efficacy. Overnight oximetry with PAP therapy is usually used to check for resolution of hypoxemia. During the COVID-19 pandemic, we used WPAT to check for resolution of hypoxemia in OSA patients who were prescribed PAP therapy. However, this practice change allowed us to compare the AHI measured simultaneously by WPAT and PAP DL

Methods

A retrospective study of 42 patients from August - November 2021 seen at University of Minnesota Sleep Clinic. All patients had a previous diagnosis of OSA and sleep associated hypoxemia confirmed by either Noxturnal [Nox MEDICAL] HSAT or PSG. All patients were being treated with either CPAP or bilevel PAP. Single night of HSAT was obtained with WPAT 100 (Itamar Medical) while simultaneously using PAP at their usual prescribed settings. PAP data included usage time, adherence, 30-day and same night AHI. WPAT data included total AHI, rapid eye movement related AHI, and T88

Results

Of the 42 patients, 60% were males with mean age 58.8 ± 14.6 years, body mass index (BMI) 38.9 ± 9.6 kg/m2 and Epworth sleepiness scale 10.7 ± 5.1. We identified an elevated AHI (≥ 5) with WPAT in more than half of the patients though hypoxemia resolved, ESS improved and OSA was optimally controlled with AHI< 5 per PAP DL. There was a significant difference between the AHI on WPAT and same day PAP DL (AHI; 7.9 ± 12.2; p =0.0006). There was moderate correlation with BMI (r=0.51; p= 0.0017) and poor correlation with central AHI on WPAT (r = 0.29; p= 0.10)

Conclusion

There was discrepancy between AHIs with results from WPAT and PAP DL measured during the same night. Higher residual WPAT AHI could have significant implications with regards to validity of the algorithm used in these devices. This can potentially lower the threshold for performing titration PSGs to ensure optimal treatment of OSA

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0576 Patient Perception of Sleep Medicine During Hospitalization and Treatment of Diagnosed Sleep Apnea
Authors: Rojas Edward , Srinivasan Priyanka , Olgers Kassandra , Knollinger Scott , Stansbury Robert , Sharma Sunil
Published: April 2024

Introduction

Screening for sleep apnea among hospitalized patients has been shown to help practitioners identify sleep apnea and improve patients’ outcome. Patient perception of this intervention from the sleep medicine team has never been examined in a hospital setting. In this study, we examined the attitudes patients held about their diagnosis of sleep apnea and the team working with them.

Methods

Between June 2023 and November 2023, 152 consecutive patients, screened for sleep apnea, went through a sleep study. A carefully designed questionnaire was adapted from the validated Obstructive Sleep Apnea Knowledge and Attitudes (OSAKA) questionnaire. The survey was intended to understand patients’ beliefs on the importance of sleep apnea and their perception of the sleep medicine service. One question was designed to determine the patients’ confidence with using the CPAP therapy. The responses were then analyzed.

Results

Of the 152 patients interviewed, the mean age was 60 years (15) and 59% were female. The average BMI for these patients was 39.2 (20.5). 76% (n=115) mentioned they were aware of sleep apnea before the sleep medicine team’s assessment. On a 5-point scale, 87% of patients ranked at least “3” (important) for the importance of knowing whether they had sleep apnea. Of the subset of patients (n=26) who were prescribed CPAP therapy in the hospital, 63% indicated they at least “agreed” (3 on 5-point scale) with confidence on their ability to use a CPAP device at home.

Conclusion

Our analyses signify most hospitalized patients who underwent sleep apnea screening and evaluation perceived sleep apnea is an important condition and exhibit a constructive attitude towards the sleep medicine team and CPAP therapy. Moreover, a significant number were aware of the condition among their immediate family and community. With patient education and guidance provided by the sleep medicine team, the patients developed a constructive understanding of their diagnosis and how to manage OSA using CPAP therapy. Thus, this study suggests that hospitalized patient’s knowledge of OSA is high, and patients are receptive to pro-active work up.

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0578 Feasibility and Preliminary Efficacy of WePAP, a Dyadic Transdiagnostic Intervention
Authors: Baron Kelly , Baucom Brian , Duff Kevin , Gorovoy Suzanne , Harvey Allison , Sundar Krishna , Troxel Wendy
Published: April 2024

Introduction

The goal of this study was to examine feasibility, acceptability, and preliminary efficacy of WePAP, a novel, couples-based treatment to promote positive airway pressure (PAP) adherence in patients with obstructive sleep apnea (OSA) and sleep quality in patients and partners.

Methods

Patients who were recently diagnosed with OSA and starting PAP and their partners completed pre- and post-treatment self-report measures of study constructs and actigraphy. Couples were randomly assigned to WePAP or information control (IC) groups. Post-PAP assessments and adherence downloads were completed at 1 and 3 months. The main outcomes were feasibility and acceptability ratings. Preliminary efficacy outcomes included: patient PAP adherence and subjective and actigraphy-assessed sleep in patients and partners. Secondary outcomes included depression, quality of life, relationship, and cognitive functioning.

Results

The study enrolled 37 couples (age m= 62.97; SD=9.04). All WePAP couples attended each of the three sessions. Compared to the IC group, patients and partners in WePAP rated the intervention more favorably and were more satisfied. Among the primary efficacy outcomes, PAP adherence was high in both groups (PAP use >4 h= 85% in WePAP and 77% in IC). There were significant within-group differences for subjective sleep, such that patients in both groups showed significant reductions in sleep disturbance at 3-months. In addition, patients in both groups and partners in WePAP showed significant reductions in sleep related impairment at 3-months. Among secondary outcomes, patients in both WePAP and IC showed significant improvements in depression and QOL. WePAP patients also showed small but significant improvements in a measure of processing speed and attention. There were no within- or between-group changes in relationship quality.

Conclusion

Results demonstrate that WePAP is feasible and well-liked by patients and partners, but did not demonstrate greater adherence or improved sleep quality in this sample of highly adherent patients. Future studies should examine longer-term outcomes and enroll patients at greater risk for non-adherence to PAP.

Support (if any)

The research reported in this publication was supported (in part or in full) by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Numbers R21AG067183 (PIs: Baron and Troxel), 3R21AG067183-01A1S1 (Baron/DeVettori), UL1TR002538 and UM1TR004409.
0579 Electrode Configuration Effect on Usage and Self-Titration
Authors: Patel Ruchir , Lundeen Max , Byrd Israel , Lee Kent , Coleman Michael
Published: April 2024

Introduction

Hypoglossal nerve stimulation (HGNS) for obstructive sleep apnea uses an implanted pulse generator with a stimulation lead cuff wrapped around the hypoglossal nerve. The cuff includes three stimulation electrodes configured to +-+ by default but can be customized by a physician, for example to -+-, or a unipolar configuration using the generator as an electrode. Patients activate their therapy nightly with a button press on a short-range telemetry remote. With this remote, patients can titrate the therapy amplitude by increasing or decreasing 0.1V steps. Patients have reported that unipolar stimulation “feels” stronger per step than bipolar. To test this hypothesis, we analyzed the impact of default vs custom electrode configuration on nightly device usage and amplitude increase trajectory.

Methods

Device settings and usage pulled from the manufacturer’s cloud data system, SleepSync (Inspire Medical Systems Inc., Golden Valley MN), since 2018. 24322 patients with a full 90 days of usage data and without adjustments to their stimulation settings (pulse width 90μsec, pulse rate 33Hz) during the 90 days were selected and divided into cohorts based on initial programming to default vs custom electrode configuration (958 patients unipolar, 37 -+-). Usage was calculated as hours of daily therapy. Amplitude increase was calculated as the number of titrated steps up. Usage and amplitude increase were averaged per patient and reported as mean ± standard deviation, and T-tests were used for comparisons.

Results

In all patients, mean pre-implant AHI and ESS were 34.5±15.5 and 10.1±6.4, respectively. Mean BMI and Age were 28.9±3.5 and 62.4±12.2, respectively. Therapy usage with default polarity was higher than custom (6.21±1.67 hrs vs 5.63±1.92, 95% CI=[0.47,0.68]). Patients were able to increase amplitude with default polarity by more steps vs. custom (9.33±10.35 steps vs 6.65±10.61, 95% CI=[2.02,3.34]).

Conclusion

Both device usage and amplitude increase were higher in patients who retained the default electrode configuration vs patients who switched to a custom configuration, confirming hypothesis that the sensation of higher stimulation intensity is larger per step in unipolar configurations. Solutions to provide finer granularity of amplitude increases may improve usage in unipolar configurations.

Support (if any)

Employees of Inspire Medical Systems contributed to the data analysis.
0581 Evaluating the Usability and Performance of a PAP Mask System in the Home Environment
Authors: Pablo Manolito , Banodkar Neha , Camacho Leilani , Deas Ross , Ghamedi Summer , Kuniyoshi Fatima Sert , Middleton Alisha , Zhu Xueling , Uhles Matthew
Published: April 2024

Introduction

Positive airway pressure (PAP) therapy is the first-line therapy treatment for obstructive sleep apnea (OSA); however adherence remains challenging. A comfortable and well-fitted mask can improve adaptation and adherence to PAP therapy. This study evaluated the usability and performance of a prototype tube-up nasal cradle mask (WSN) made of a textile material designed for enhanced comfort compared with users’ own mask in a home-environment.

Methods

Adults who were on PAP therapy for OSA (≥ 6 months) (n = 120, female = 49) evaluated the WSN. Participant’s subjective perceptions on several mask attributes was assessed using an 11-point Likert Scale at days 7, 30 and 90. Objective PAP therapy data were analysed and compared between the users’ own and the prototype mask.

Results

The WSN mask received significant higher median ratings even after 90 days when compared with users’ own mask in terms of ease of use (10 vs. 9), seal (9 vs. 8), comfort (9.5 vs. 8.5), feeling of material (10 vs. 9) and overall performance (10 vs. 9) (p< 0.05 for all comparisons). Participant’s feedback on the textile is mostly positive, noting its softness and more pleasant texture. After 90 days of usage, the majority of patients (92.6%, 100/108) preferred the WSN for long term use. After 30 and 90 days, therapy data comparing WSN vs. own mask and WSN 30 vs.90 days performance indicated that PAP therapy remained effective based on device usage hours and the residual AHI. Objective leak data from the PAP machine is acceptable.

Conclusion

The results of this study showed that patients favored the WSN over their own mask. However, there is no difference in PAP usage with the WSN mask possibly because these patients had a very high compliance at the start of the study. Additional research with PAP users who have low compliance may be useful to determine if the WSN mask has an effect on adherence rate in this population.

Support (if any)

ResMed Pty Ltd, ResMed Inc
0583 Improvement in Sleep Depth on CPAP Is Related to Odds-Ratio-Product (ORP) Type and Apnea-Hypopnea-Index at Baseline
Authors: Guadagni Veronica , Lambing Kari , Gottschalk Genevieve , Gerardy Bethany , Bender Amy , Baddeley Jane , Younes Magdy , Gottschalk Raymond
Published: April 2024

Introduction

In split studies in academic sleep centers, CPAP improved NREM sleep depth, measured by the Odds-Ratio-Product (ORP, range 0 (deep sleep) to 2.5 (full-wakefulness), in only three (of 9) ORP types characterized by having < 10.2% of recording time with ORP< 0.5 (types 1,1, 1,2, and 1,3, with 1,3 additionally having excessive time (>12.5%) in full-wakefulness). Furthermore, ORPNREM did not improve on CPAP when AHI was < 30 hr-1 in any type except 1,3, where it improved marginally. In type 1,3, excessive time (>12.5%) in full wakefulness was only partially corrected with CPAP even at very high AHI, thereby suggesting an associated hyperarousal state. Here, we determined if the same applies during a full-night CPAP titration in a private practice setting.

Methods

We analyzed a cohort of 100 patients (Mage= 54.02±14.62) who underwent full-night diagnostic and full-night CPAP titration at a private sleep laboratory in Ontario, Canada. 77 patients had severe OSA (AHI 66.9hr-1, range 30-148 hr-1) and 23 had mild/moderate OSA (AHI 18.5, range 7.4-27.5 hr-1). In severe patients, there were 32 (41%) with little deep sleep and low/average full wakefulness (types 1,1 and 1,2), 39 (51%) with type 1,3, and 6 (8%) with other types. In the mild/moderate group 12 patients (52%) had type 1,3, and 11 (48%) shared the remaining 8 type.

Results

In severe patients ORPNREM decreased by 0.20±0.23, p< 0.0001 in types 1,1 and 1,2. In type 1,3, ORPNREM decreased by 0.26±0.29, p< 0.0001 (NS from 1,1 and 1,2) and time in full wakefulness and % awake also decreased by 6.82% and 9.80%, respectively (p’s< 0.01). In patients with AHI < 30 there was no significant change in ORPNREM or % wake with any type, including type 1,3, where %awake remained at 37.2% on CPAP.

Conclusion

Similar to earlier findings from split studies, in this cohort about half of the patients had type 1,3, consistent with associated hyperarousal, regardless of OSA severity. Those with the same three types had improved sleep depth on CPAP. While those with 1,3 showed a reduction of full wakefulness with CPAP (from 26.1% to 19.3%), it remained elevated suggesting persisting hyperarousal.

Support (if any)
0586 Positive Airway Pressure Changes in Patients with Obstructive Sleep Apnea After Weight Reduction Surgery
Authors: Kuniyoshi Fatima Sert , Woodford Caleb , Malik Anita , Alpert Naomi , McConnell Will , Sterling Kimberly
Published: April 2024

Introduction

Obesity is a modifiable risk factor for obstructive sleep apnea (OSA). Weight management interventions have been shown to reduce OSA symptoms and severity for some patients. This retrospective analysis aimed to evaluate the impact of weight reduction surgery or procedure (WRS/P) on pressure changes in positive airway pressure (PAP) treated patients as a proxy for changes in OSA severity following surgery.

Methods

We analyzed administrative claims data from 2015 to 2021 of adult (≥18 years) OSA patients linked to PAP device data. The date on which the first ICD-10/9 or CPT code appeared for a WRS/P was the index date. Inclusion criteria were a categorical body mass index (BMI) ≥30 kg/m2 at baseline, at least 1 year of insurance coverage pre-index, and a minimum of 1 year of PAP therapy data post-index. Changes in PAP pressure were assessed as the difference between median PAP pressure 1 month pre-index and the most recent pressure post-index date. Only categorical BMI is coded in claims, so changes in BMI category following WRS/P were assessed using the difference between categorical midpoints.

Results

A total of 17,284 OSA patients underwent WRS/P (mean age 45.6 years; 74.7% female). Patients were categorized based on their pre WRS/P BMI (≥30 - < 35, ≥35 - < 40, ≥40 - < 45, ≥45 - < 50, ≥50 - < 60, and ≥60 kg/m2). The average baseline apnea-hypopnea index (AHI) was 16.9, 18.2, 19.9, 23.4, 25.1, and 27.0 events/h respectively. After WRS/P the average decrease in BMI was 3.3, 5.7, 6.8, 8.1, 10.3, and 13.0 kg/m2; and the average decrease in the median PAP pressure was 0.8, 0.9, 1.0, 1.3, 1.3, and 1.3 cm H2O respectively.

Conclusion

Patients with the highest baseline BMIs experienced the most weight loss after WRS/P. These individuals also had the greatest reductions in PAP pressures following surgery. Using PAP pressure as a proxy for OSA severity, in absence of post-surgery sleep testing, our findings suggest that patients with higher baseline BMIs are likely to achieve the most substantial, albeit not complete, reductions in OSA severity, compared to those with lower baseline BMI, after undergoing WRS/P.

Support (if any)

ResMed
0590 Hypoglossal Nerve Stimulation for OSA – a Systematic Review of Adverse Events in Clinical Trials & Real-world-data
Authors: Wollny Mathias , Heiser Clemens , Ulrich Sommer , Christoph Schoebel , Braun Marcel
Published: April 2024

Introduction

Hypoglossal Nerve Stimulation (HNS) has been recognized as a novel therapeutic approach for individuals suffering from Obstructive Sleep Apnea (OSA). Extensive clinical trials and accumulated real-world data have consistently demonstrated that HNS offers significant, enduring enhancements in managing OSA symptoms and improving overall quality of life for patients. Given the nature of HNS treatment, with the requirement of using an implantable neurostimulation system, patient safety is a critical domain in the assessment of this technology. The objective of this review was to evaluate adverse events (AE) and complications with HNS therapy in a systematic review of published evidence.

Methods

MEDLINE, Cochrane, and Web of Science were systematically searched to identify randomized controlled and real-world observational studies reporting relevant outcomes with HNS therapy for treatment of OSA, which included procedure-, device- and treatment-related AE. Risk of bias assessment was conducted using the ROBINS-I tool.

Results

Out of 499 articles screened, 27 were reviewed for eligibility, and seventeen studies, the majority found having low to moderate risk of bias, and totaling data of 2,095 patients were included for further analysis. Across included studies, reporting of AE was heterogenous with regards to used classifications as well as extent of reporting. Over an average follow-up duration of 17.5 ± 16.9 months, the pooled mortality rate was 0.01% (95% CI = 0.0 to 0.2%), with all reported deaths being unrelated to HNS treatment. The pooled HNS device explant rate was 0.03% (95% CI = 1.0 to 2.1%), with infections and request for removal by patient being the most common indications. The pooled surgical revision rate was 0.08% (95% CI 0.0 to 0.2%). Most reported treatment-related side-effects were transient stimulation-related discomfort (0.08%, 95% CI = 0.0 to 0.2%) and tongue-abrasions (0.07%, 95% CI = 0.0 to 0.2%).

Conclusion

In this systematic review, HNS therapy for treatment of OSA is associated with a positive patient safety profile. AE occur mainly at device implantation and during the treatment acclimatization period. Significant heterogeneity was found for adverse event reporting. Implementation of a harmonized framework for reporting HNS outcomes that includes AE and side-effects is warranted to ensure comparability of results.

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0593 INSPIRE Device Therapy: A Treatment Option for Obstructive Sleep Apnea Post Orthotopic Heart Transplant
Authors: Kale Parag , Harrison Eneida , Vatanapradith Athica , Venkatesan Naren , Carey Sandra , Bindra Amarinder
Published: April 2024

Introduction

Continuous Positive Airway pressure (CPAP) therapy is currently the standard of care for patients with obstructive sleep apnea (OSA). Commonly seen in patients with heart failure, this condition can persist post Orthotopic Heart Transplant (OHT). PAP therapy is frequently not tolerated, yet untreated OSA can potentiate graft failure. The FDA approved INSPIRE device provides hypoglossal nerve stimulation as optional therapy for OSA. However, there is a paucity of data for its utility and efficacy in the post cardiac transplant patients. The heart transplant graft is denervated and it is thus uncertain if treatment would be similarly effective as in patients without OHT. We therefore report our experience in the use of the INSPIRE device following OHT.

Methods

Chart review was performed for this case report using Epic electronic health record

Results

TB is a 72 yr old man status post OHT in 2015. He has known OSA since 2016 for which he was placed on CPAP. He was intolerant to CPAP after OHT. He was therefore referred to ENT for consideration of Inspire device. He underwent uneventful surgical implantation of device in December 2022. He was subsequently followed in the sleep clinic and INSPIRE device settings optimized. He reported improved sleep quality, increased daytime energy and is clinically doing well 10 months after implant. The central apnea index was zero and there were no Cheyne stoke respirations pre and post-implant.

Conclusion

The INSPIRE device is effective and safe following Orthotopic Heart Transplant (OHT). The benefit is seen early and appears to be well tolerated following implant with low procedural complication.

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0595 Tolerability and Activation Parameters Between Early vs Routine Activation of Hypoglossal Nerve Stimulation Therapy
Authors: Patel Ruchir , Rihawi Anas , Weiner Jordan
Published: April 2024

Introduction

The current management protocol for HGNS is derived from the efficacy trials, but there is a lack of published data evaluating the tolerance and safety of earlier activation protocols. Thus, our goal is to compare the early and conventional activation parameters to identify differences. This will help us determine the potential benefits and risks associated with earlier activation and inform future protocols for HGNS management.

Methods

A retrospective cross-sectional study was conducted using data from a sleep specialty clinic of patients who received HGNS implantation for OSA. The patients were divided into two groups: early activation and standard activation. Data collected included age, time from implantation to activation, sensory threshold, and functional threshold. Statistical analysis involved the use of a non-parametric Wilcoxon rank-sum test for continuous variables and Fisher's exact test for categorical variables to identify any significant differences between the two groups.

Results

A study was conducted on 58 patients, with 31 in the early activation group and 27 in the standard activation group. Among the early activation group,35% were female and 65% were male, while the standard activation group had 48% female and 52% male patients. Gender distribution was not significantly different between the two groups (P 0.425). The mean age was66 in the early activation group and 63 in the standard activation group, with no significant difference (P 0.67). The mean days until activation was significantly shorter in the early activation group (22.5 days, 95% CI 23.5-32.4) than in the standard activation group (45.1 days, 95% CI 32.3-47.9) (P0.00). The sensory threshold was significantly lower in the early activation group (mean 0.4, 95% CI 0.35-0.55) compared to the standard activation group (mean 0.7, 95% CI 0.59-0.88) (P 0.002). However, no significant difference in the functional threshold was observed, with mean values of 0.8(95% CI, 0.65-0.94) and 1.0 (95% CI, 0.85-1.27) for the early and standard activation groups, respectively (P 0.07).

Conclusion

Although patients who were activated early seem to have a lower sensory threshold, early activation did not appear to affect their functional threshold or activation standards.

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0597 Hypoglossal Nerve Stimulation Adherence Increasing Yearly
Authors: Jain Vikas , Lundeen Max , Byrd Israel , Lee Kent , Um Michelle , Allred Taye
Published: April 2024

Introduction

Hypoglossal nerve stimulation (HGNS) for obstructive sleep apnea is a surgically implanted device that the patient starts with a button press on a short-range telemetry remote. The therapy ends after a programmable time period (default 8 hours) or the patient manually stops the therapy with another button press. Patients newly implanted with Inspire devices have been observed to use their therapy more than patients implanted in the past. To test the effect of time on adherence, we analyzed newly activated HGNS patients’ usage data year by year.

Methods

De-identified data was collected via the manufacturer’s patient management system (SleepSync, Inspire medical systems). 8532 patients activated from 2018 through 2022 were selected. HGNS adherence was measured as total hours of therapy used per night via remote device uploads. Adherence during the patients’ first year was compared by year of device activation, using one-way analysis of variance (ANOVA) and Tukey’s test for multiple comparisons. Usage by activation year is reported as mean ± standard.

Results

In all patients, the mean pre-implant AHI and ESS were 34.3±15.2 and 9.4±4.9 respectively. Mean BMI and Age were 28.9±3.5 and 61.8±11.3 respectively. 2018 usage: 5.3±1.7 hrs, n=396. 2019 usage: 5.4±1.6 hrs, n=851. 2020 usage: 5.5±1.7 hrs, n=1426. 2021 usage: 5.5±1.6 hrs, n=2876. 2022 usage: 5.6±1.7 hrs, n=2983. ANOVA showed usage differed between at least two years (F=5.7, p< 0.001). Tukey analysis showed the mean patient adherence was significantly different between years 2018 and 2022 (95% CI=[-0.58, -0.08]), between 2019 and 2022 (95% CI=[-0.42, -0.06]), and between 2021 and 2022 (95% CI=[-0.27, -0.02]).

Conclusion

First-year HGNS adherence has increased over time, from 5.3 mean hours in 2018 to 5.6 mean hours in 2022. Iterative improvements in the Inspire Care Pathway over this time frame may have contributed to increased usage. Increasing device utilization is important especially in HGNS patients given their pre-baseline severities are in the moderate to severe range and increased utilization of therapy can lead to significant reductions in mean disease burden.

Support (if any)

Employees of Inspire Medical Systems contributed to the data analysis.
0598 Hypoglossal Nerve Stimulation: Does the Ratio of Apneas to Hypopneas Matter When It Comes to Successful Outcomes?
Authors: Baran Caroline , Hodge Evan , Santiago Louis , Lee Ryan , Kaur Parampreet , Ramzy Joseph , Guglielmello Giuseppe , Narla Gowtham , Zheng Matthew , Cohen David
Published: April 2024

Introduction

While hypoglossal nerve stimulation (HNS) is a safe and effective treatment for moderate to severe obstructive sleep apnea (OSA) HNS is not effective in some patients despite optimal titration. This study investigates whether apnea-predominant OSA versus hypopnea-predominant OSA during pre-operative sleep study can be used to predict successful outcomes after HNS implantation.

Methods

This is a single-center retrospective study of consecutive patients with moderate to severe OSA who underwent implantation of HNS at an academic medical center. Apnea-predominant and hypopnea-predominant were determined by comparing the proportion of obstructive apnea and hypopnea events in pre-operative polysomnography or home sleep apnea testing if polysomnography was not conducted. Post-implantation apnea/hypopnea index (AHI) was derived from polysomnography performed 3 months or later after device activation in all subjects. The Mann-Whitney nonparametric test was used to compare the distribution of AHI reduction between apnea-predominant and hypopnea-predominant cohorts.

Results

Eighty-two patients treated with HNS implanted between December 2021 and July 2023 were evaluated. Sixty-two (75.6%) patients were male, with a median age of 65.5 (55.3-71) years and a median pre-implantation Body Mass Index (BMI) of 29.4 (27.5-31.5) kg/m2. Median pre-implantation AHI was 28.8 (18.5-45.9) events/hour. Before HNS implantation, 45 patients had hypopnea-predominant AHI with a median apnea-to hypopnea ratio of 0.33 (0.14-0.60) and 37 patients had apnea predominant AHI with median apnea-to-hypopnea ratio of 2.23 (1.35-4.37). There was no significant difference between the two cohorts in age or BMI. The pre-implantation AHI was higher in the apnea-predominant cohort (36 (21.2-49.6) events/hour) compared to the hypopnea-predominant cohort (23.7 (18-37) events/hour). Median AHI reduction in the hypopnea-predominant cohort was 78.3% (51.2-90.2%). Median AHI reduction in the apnea-predominant cohort was 72.3% (35.5-85.4%). There was no significant difference in the distribution of AHI reduction between the two groups after HNS (p=0.40).

Conclusion

There was no statistically significant difference between pre-implantation OSA which was apnea-predominant versus hypopnea-predominant in the degree of AHI reduction with HNS therapy. However, this study may be limited on the basis of comparing pre-implantation AHI as obtained on a home sleep study, as compared to post implantation AHI obtained on a diagnostic polysomnogram.

Support (if any)

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