bluuebunny/crossref_metadata_2025_split huggingface dataset:
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

Abstract

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 &gt;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

Abstract

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

Abstract

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&lt; 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

Abstract

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 &lt; 10.2% of recording time with ORP&lt; 0.5 (types 1,1, 1,2, and 1,3, with 1,3 additionally having excessive time (&gt;12.5%) in full-wakefulness). Furthermore, ORPNREM did not improve on CPAP when AHI was &lt; 30 hr-1 in any type except 1,3, where it improved marginally. In type 1,3, excessive time (&gt;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&lt; 0.0001 in types 1,1 and 1,2. In type 1,3, ORPNREM decreased by 0.26±0.29, p&lt; 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&lt; 0.01). In patients with AHI &lt; 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

Abstract

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 - &lt; 35, ≥35 - &lt; 40, ≥40 - &lt; 45, ≥45 - &lt; 50, ≥50 - &lt; 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

Abstract

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.

Support (if any)
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

Abstract

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.

Support (if any)
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

Abstract

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

Abstract

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&lt; 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.