bluuebunny/crossref_metadata_2025 huggingface dataset:
0537 Enhancing PAP Adherence in Black and Hispanic Patients Utilizing an Automated Telemonitoring Intervention
Authors: Hwang Dennis , Yan Rui , Arguelles Jessica , Jemmott John , Klimper Matthew , Rosen Ilene , Keenan Brendan , Kuna Samuel T , Maislin Greg , Mazzotti Diego , Pack Allan , Saconi Bruno , Watach Alexa , Shi jiaxiao , Becker Kendra , Kim Joseph , Sawyer Amy
Published: April 2024

Introduction

The Tele-OSA randomized trial demonstrated improved PAP adherence in obstructive sleep apnea (OSA) patients receiving a telemonitoring intervention (automated messages triggered by low usage [U-Sleep, ResMed]). We conducted a sub-group analysis to explore the effect of the intervention in Black and Hispanic adults (B/H) compared to adults of all other races/ethnicities.

Methods

Tele-OSA (Kaiser Permanente; Fontana, CA) enrolled 556 patients with OSA [AHI≥5] newly initiated on PAP (AirSense 10, AutoCPAP) and randomized to Telemonitoring (TM) or Usual Care (UC). TM showed improved adherence compared to UC at 3 months (primary endpoint). TM was further split into two groups: those in which the intervention was discontinued per-protocol at 3 months (TM3) and those inadvertently continued indefinitely (TMC). Post-hoc analysis revealed that the TMC group maintained higher PAP adherence than the UC group over two years, while the TM3 group showed no difference from UC. In the current study, we conducted a sub-group analysis comparing adherence (mean “minutes/night” and “% days used”) between B/H and all other races/ethnicities in the TMC and UC groups across four time intervals: 3-6; 6-12; 12-18; 18-24 months. Kruskal-Wallis tests were used to compare the groups at each time interval.

Results

Of the 556 trial participants (50.5±12.1 years; 58.6% male, AHI 31.9±25.8), 269 were B/H (221 Hispanic; 48 Black) and 287 were non-B/H (233 White; 39 Asian). At baseline (i.e., Usual Care) B/H adults consistently showed lower adherence compared to non-B/H over two years (min/night for each time interval: 170.9±164.7 vs 195.5±172.5; 144.2±168.4 vs 167.1±172.7; 128.0±169.3 vs 158.9±181.2; 119.5±170.2 vs 148.1±184.3). B/H TMC participants had equivalent or higher PAP use compared to non-B/H TMC participants at each interval (251.8±142.1 vs 235.2±175.77; 211.2±152.1 vs 204.9±175.3; 190.4±168.3 vs 180.3±182.5; 163.3±180.2 vs 158.9±184.9). Similar findings were seen when analyzing “% nights used”.

Conclusion

Our study findings show that B/H adults had lower PAP adherence compared to non-B/H adults over a two-year period. Notably, a TM intervention effectively closed the disparity gap, resulting in similar PAP adherence levels for B/H and non-B/H adults. These findings underscore the importance of rigorously testing distance-accessible strategies to enhance PAP adherence and promote health equity.

Support (if any)

AASM Foundation104-SR-13
0540 Comparing Periodic Limb Movements of Sleep Before and After Hypoglossal Nerve Stimulation Therapy
Authors: Cho Unjung , Lee Chang-Hoon , Moon Hye-Jin , Im KyoungBin
Published: April 2024

Introduction

Patients with obstructive sleep apnea (OSA) exhibit high prevalence of periodic limb movements of sleep (PLMS). While many studies have explored the impact of positive air pressure (PAP) therapy on PLMS, there was no study of the impact of hypoglossal nerve stimulation (HNS) therapy on PLMS. We reported high prevalence of PLMS in patients receiving HNS therapy (separate abstract). We hypothesized the following: 1) OSA patients with PLMS become candidates for HNS therapy at a higher rate given PAP failure associated with PLMS; 2) HNS therapy itself increases PLMS. This study aims to test the above hypotheses by assessing pre- and post-HNS sleep study data and comparing PLMS in temporal fashion.

Methods

Among subjects receiving HNS therapy from December 2020 to August 2023, 38 subjects with periodic limb movement index (PLMI) data before and after HNS therapy were selected for the subgroup analysis. PLMS diagnosis was based on PLMI ≥ 15. We compared PLMI and PLMS diagnosis between before and after HNS therapy using Wilcoxon's signed rank test and McNemar test.

Results

In our study of 38 subjects, the average of PLMI before and after HNS therapy were median 7.1/hr (interquartile range, 0, 34.6) and 17.2/hr (interquartile range, 3.1, 37.5) respectively, resulting in no statistical significance (P=0.064 by Wilcoxon's signed rank test). Prevalence of PLMS before and after HNS therapy were 36.8% and 60.5% respectively showing significant increase with HNS therapy (P=0.039 by McNemar test).

Conclusion

Our study results indicate comparable baseline prevalence of PLMS as shown in other studies among OSA and significant increase in PLMS while using HNS therapy in this paired pre- and post-HNS analysis, suggesting HNS therapy being a possible cause of PLMS in OSA patients. Further work is warranted to re-confirm the above finding and potentially investigate long-term effect of HNS therapy on PLMS, and PLMS on the outcome of HNS therapy.

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0542 The Association Between the Effective Apnea Hypopnea Index and Blood Pressure Reduction Efficacy After Treatment
Authors: Ni Yuenan , Thomas Robert
Published: April 2024

Introduction

The effect of sleep apnea treatment on reducing cardiovascular disease risk remains inconclusive. This study aims to assess if the effective apnea hypopnea index (eAHI), a measure of residual sleep apnea burden post-treatment, is a factor in determining blood pressure (BP) response to continuous positive airway pressure therapy. The eAHI integrates time on therapy, residual apnea, and % of sleep time untreated.

Methods

A secondary analysis of the Heart Biomarker Evaluation in Apnea Treatment (HeartBEAT) study, a randomized, controlled, parallel group assessment of continuous positive airway pressure (CPAP), oxygen and sleep hygiene. The Delta-AHI (▲AHI) was defined as the difference between baseline AHI and effective AHI at 12 weeks. Logistic and linear regression models estimated the predictors for nocturnal systolic BP change following sleep apnea therapy.

Results

One hundred and sixty-nine subjects with a mean age of 62.82 ± 6.99 years were included in the final analysis. Fifty subjects had ▲AHI ≤ 8 / hour of sleep and 119 subjects were higher. After adjustment, baseline mean nighttime systolic blood pressure (OR 1.036, 95% CI 1.015-1.058, p: 0.001) and ▲AHI ≥ 8 / hour (OR 2.406, 95% CI 1.116-5.185, p:0.025) were independent predictors for mean nighttime systolic blood pressure change > 3 mm Hg. The effective AHI was negatively related with BNP (β: -2.564, SE: 0.167, p: 0.029) and positively related with troponin change (β: 0.703, SE: 0.256, p: 0.007).

Conclusion

The ▲AHI was an independent predictor of the blood pressure response to sleep apnea treatment.

Support (if any)
0551 Telemedicine Motivational Enhancement in Heart Failure and Sleep Apnea Randomized Clinical Trial
Authors: Orbea Cinthya Pena , Bena James , Hsich Elieen , Drerup Michelle , Khayat Rami , Mehra Reena
Published: April 2024

Introduction

Despite evidence suggesting that Positive Airway Pressure (PAP) in patients with Acute Decompensated Heart Failure (ADHF) with Obstructive Sleep Apnea (OSA) confers improvement of cardiovascular outcomes, PAP adherence remains exceedingly low. We hypothesized that motivational enhancement (ME) via a telemedicine intensive approach improves PAP adherence post-discharge in hospitalized patients with ADHF and OSA

Methods

Telemedicine Intensive Motivational Enhancement (TIME) (NCT04752462) is an ongoing randomized clinical trial designed to investigate telemedicine ME effect on post-discharge PAP adherence, rehospitalizations, and patient-reported outcomes compared to standard of care at 3 and 6 months in patients admitted with ADHF and in-hospital OSA diagnosis (respiratory event index, REI>5). We describe baseline characteristics of 56 patients currently enrolled. Unadjusted and adjusted linear models were used to describe associations of OSA measures (Respiratory Event Index, REI and percentage of recording time< 90%SaO2,T90) with Kansas City Cardiomyopathy Score(KCCQ). Adjusted models included age, sex, race, and body mass index(BMI).

Results

Since April 2021, 5,742 patients were screened and of these, 3,822 had an admission diagnosis of ADHF, of which 343 underwent in-hospital portable sleep testing. Of these, patients were excluded for the following reasons: central predominant apneas (CA >50% of total REI) 31.5%(n=108), sleep-related hypoxemia 18.7%(n=64), negative for OSA 20.1%(n=69), declined PAP therapy 10.5%(n=36) or declined to participate in the clinical trial 2.9(n=10). Characteristics of the 56 participants currently enrolled are:age:60±14 years, 38% women, 45%black race, BMI of 35±8, left ventricular ejection fraction:40±16%, REI:26±14 and T90:19±17% and Epworth Sleepiness Scale:6[IQR, 3-10]. Comorbidities were hypertension 77%, atrial fibrillation 34%, valvular disease 21%, myocardial infarction 20%, and diabetes 39%. Self-reported health status at baseline was poor with a KCCQ score of 38±26. In adjusted analyses, for each unit increase of REI and T90, the overall KCCQ scores were associated with non-significant reduction by -0.29 (95% CI:-0.89,0.31, p=0.34) and -0.19(95%CI: -0.73,0.35,p=0.49) points respectively.

Conclusion

The TIME trial is designed to elucidate the effect of ME through telemedicine on PAP adherence and patient outcomes post-discharge in patients with ADHF and OSA. Directionally increased OSA severity was related to lower KCCQ scores, as expected, in OSA and ADHF, however, these relationships were not significant.

Support (if any)

AASM Foundation
0554 Cardiac Impact of Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea
Authors: Gupta Suhani , Kanagarajan Karthik , Brandt Alexander , Stokes Jonathan , Hellman Joseph , Hensler Matthew , Chung Eugene
Published: April 2024

Introduction

Sleep disordered breathing is a common contributor to cardiovascular morbidities. Inspire™ hypoglossal nerve stimulation is an effective way to treat moderate to severe obstructive sleep apnea (OSA). Although the cardiovascular effect of this relatively new treatment is not established, resolution of OSA is associated with reduced cardiac afterload and sympathetic tone and should be of benefit to the heart. Accordingly, we report on a small case series (n=6) of OSA patients treated with this device, with available echocardiograms before and after device therapy.

Methods

In a single center retrospective analysis, we compared echocardiograms from mean of 479 days before and mean of 464 days after device implantation.

Results

Mean apnea hypopnea index decreased from baseline of 41 events/hour to 9.7 events/hour. Echocardiographic data suggest that with treatment, cardiac chambers decrease in size (left ventricle 5.5 to 5.1 cm, right ventricle 4.3 to 4.0 cm, left atrial volume index 42 to 33 ml / m2). Left ventricular ejection fraction increases (43 to 51 %). Central venous pressure decreases (4.4 to 3 mmHg) and mitral and tricuspid valve regurgitation appear to be somewhat less.

Conclusion

In this first report of hypoglossal nerve stimulation therapy for OSA, treatment appears to have a salutary impact on cardiac structure and function. While the small number of patients makes it impossible to draw definitive conclusions, the consistent direction of trends for all the relevant parameters is notable. Larger, prospective studies are warranted to confirm these preliminary observations.

Support (if any)
0557 The Impact of Gender on the Obstructive Sleep Apnea—Depression Relationship
Authors: Patel Sanjay , Dexter R , Woodford Caleb , Cameron Ann , Alpert Naomi , McConnell Will , Sterling Kimberly , Cistulli Peter , Malhotra Atul , Pépin Jean-Louis , Cole Kate
Published: April 2024

Introduction

Obstructive sleep apnea (OSA) and depression commonly co-exist and have complex relationships. Depressive symptoms may be a particularly common manifestation of OSA among women, with women going undiagnosed with OSA for many years. Conversely, effective OSA treatment may improve depression control. We sought to evaluate the relationship between OSA and depression including the impact of treatment, and how this varies by gender.

Methods

We linked administrative claims data with objective positive airway pressure (PAP) therapy device usage data to identify a cohort of adult patients diagnosed with OSA, newly initiated on a PAP device, with medical and pharmaceutical claims data available from 1 year prior to 2 years post PAP initiation date (index). Depression was defined by at least 2 healthcare encounters with a depression diagnosis code in the year prior to index, with no depression pre-index defined by no depression diagnosis codes. PAP adherence was categorized as consistently adherent, intermediately adherent, or non-adherent based on objective usage over 2 years.

Results

A total of 345,707 patients with OSA initiating PAP were included in this analysis, of whom 57,397 (16.6%) had depression, including 25.5% of women and 10.6% of men (p< 0.001). In both women and men, individuals with depression had a greater burden of most comorbidities, including severe obesity, hypertension, type 2 diabetes, coronary artery disease, cerebrovascular disease, and heart failure. Over 2 years, PAP adherence was lower among patients with depression. Women with depression had the lowest proportion of adherent patients (23.3% vs 28.8% men with depression, 31.3% women without depression, 37.8% men without depression, p< 0.001). Hours per day and days per week of PAP use followed this same pattern. Lower PAP adherence was associated with lower rates of antidepressant medication use at 1- and 2-years post-PAP initiation in both women and men.

Conclusion

We found in a real-world cohort that depression commonly co-exists with OSA, particularly in women. PAP adherence is lower in those with depression, especially among women. This study highlights the need to further understand the impact of depression in women with OSA.

Support (if any)

ResMed
0559 Predictive Parameters of Veterans with False Negative Home Sleep Apnea Test in Diagnosis of Obstructive Sleep Apnea
Authors: Duggal Aarti , Bond Sarah , Thammasitboon Supat
Published: April 2024

Introduction

Obstructive sleep apnea (OSA) is prevalent among United States Veterans. The STOP-BANG questionnaire and Home Sleep Apnea Testing (HSAT) provide a cost-effective alternative to polysomnography (PSG). However, HSAT's diagnostic accuracy is not always precise. Our hypothesis posits a higher false negative (FN) rate in veterans with specific demographics or comorbidities, even with a STOP-BANG score of 3 or more. Our study explores variations in HSAT diagnostic accuracy across demographics and predictive parameters for FN HSAT in identifying OSA patients.

Methods

This retrospective chart review includes Veterans referred to SLVHCS Sleep Center for OSA evaluation (01/01/2023 to 12/01/2023) with a STOP-BANG score of 3 or more. HSAT with WatchPAT® was performed, followed by confirmatory PSG post-negative WatchPAT® analysis. FN rates and predictive parameters were compared between FN and true negative (TN) using paired t-testing and chi-square testing.

Results

A total of 107 negative HSAT patients (68.22% male, 31.78% female) with an average age of 43.36 ± 11.9 were included in the study. Among patients with negative HSATs, males had a higher FN rate than females (73% vs. 44%, p=0.0028). Further analyses showed no significant differences in age, BMI, PSG sleep time, STOP-BANG score, or psychiatric comorbidity between false and true negatives. Interestingly, a trend was noticed in African Americans, who had more FN tests than Caucasians (69.8% vs. 59.2%, p=0.090).

Conclusion

Our findings suggest a higher likelihood of FN results in negative HSATs among male compared to female Veterans. Additionally, there may be an association of higher FN tests in the African American race. Further analyses with a larger sample size and inclusion of true positive tests are needed for a conclusive assessment of HSAT's diagnostic capability in the specified categories.

Support (if any)
0577 Women's Perspectives of Received Support When Initiating Continuous Positive Airway Pressure (CPAP) Treatment
Authors: Morris Jonna , Speakman Campell , Patel Sanjay , Luyster Faith
Published: April 2024

Introduction

Women are less adherent to CPAP than men, but the reasons are unclear. Our goal was to qualitatively explore women’s perceptions of support from their healthcare provider, durable medical equipment (DME) company, and family or friends during the initiation and continuation of CPAP treatment.

Methods

We conducted 28 semi-structured interviews with women diagnosed with OSA who via self-report were using CPAP every night (n=11), using CPAP intermittently (n=8), or had discontinued use (n=9). The women had mean age ± SD = 51 ± 15, were 29% Black, 71% White, and OSA severity was 40% mild, 21% moderate, 25% severe, 14% unknown. Interview questions were structured to elicit the women’s detailed experiences and perceptions of support while beginning CPAP treatment. Two independent reviewers analyzed responses using a thematic approach that identified the major conceptual categories.

Results

All the women described overcoming challenges when initiating CPAP treatment, in particular those related to mask fit and discomfort, machine set up, and receiving adequate support when problems arose. In their descriptions of how they solved their challenges, three themes emerged: 1) Self-advocacy was essential, yet many women hesitated to ask for continued support, 2) Tenacity and ‘trial and error’ were crucial to overcoming challenges, 3) Desire for live support including video calls for demonstration of CPAP set up and also general coaching or reinforcement. Women who consistently used CPAP every night, were more likely to discuss overcoming challenges during treatment initiation compared to those who had discontinued its use or were using it intermittently. The consistent CPAP users also discussed receiving support from various sources, particularly their DME company, but also healthcare providers, friends, family, and even Facebook groups; in contrast the women who discontinued its use were less likely to discuss receiving support outside an initial call to their DME.

Conclusion

Women had to actively pursue support and information that wasn't readily available during initiation and continuation of CPAP treatment, potentially creating a deterrent to its use. Tailored support may be necessary to assist women in overcoming challenges during the initial stages of treatment.

Support (if any)

University of Pittsburgh, School of Nursing, Center for Research and Evaluation
0582 Exploring a Supplemental Measure of CPAP Adherence
Authors: Velazquez Yzabel , Zamora Tania , Sarmiento Kathleen , Stepnowsky Carl
Published: April 2024

Introduction

Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population. The prevailing treatment for OSA is positive airway pressure (CPAP), but benefits depend on regular use. CPAP adherence is operationally defined as the number of hours of CPAP use per 24-hour period at the prescribed pressure. There are a variety of alternate metrics help to describe CPAP use, with most focused on duration and some type of categorization. Given the limited utility of these kinds of CPAP metrics, we wondered if a different type of CPAP adherence metric might be warranted. Putting on the CPAP mask is a behavioral action, so we explored the value of a metric focused on putting the mask on at least once per day.

Methods

Participants in an CPAP trial were provided standard education about their diagnosis and treatment at baseline. Follow-up visits were held two and four months from start of treatment. Treatment adherence metrics were derived from CPAP usage data. The “anyuse” metric was defined as the percentage of nights the mask was put on at least once in a 24-hour period.

Results

Twenty participants had a mean age of 50.2±13.9, mean AHI of 23.3±16.0, and mean BMI of 31.3.8±4.9 (kg/m2). Nightly CPAP adherence measured over the two-month period was 2.6±1.6 hours per night (mean±SD). The average anyuse at two-month was 78% ± 0.24 (12%-100%). Anyuse was moderately correlated with CPAP adherence (r=0.682, r-squared=0.465, p< 0.001), which means that while 46% of the variance in adherence was accounted for by anyuse, 54% of the variance was not.

Conclusion

The anyuse metric is a relatively simple metric that might have value as a supplemental metric to CPAP adherence. Importantly, it does not overlap substantially with CPAP adherence and provides a measure of initial behavioral action. A possible related metric is a count of the number of mask on events per day. Further exploration of these metrics appears to be warranted.

Support (if any)

This project was supported in part by the VA HSR&D IIR 16-277 and the VA San Diego Healthcare System Pulmonary Sleep Medicine Section and Research Service.
0585 PAP Therapy Impact on Bariatric Surgery Complications: A 30-Day Pre-Operative Evaluation
Authors: Bugazia Seif , Badhwar Ankita , Shakaroun Dania , Carlin Arthur , Roehrs Timothy , Skiba Virginia
Published: April 2024

Introduction

The coexistence of obstructive sleep apnea (OSA) and obesity creates an intricate clinical scenario, particularly for individuals pursuing bariatric surgery. OSA increases perioperative risks, including prolonged stay, re-intubation, and cardiovascular events. It is generally recommended that patients with OSA start using Positive Airway Pressure (PAP) therapy before surgery, however studies are mixed on whether use of PAP reduces postoperative or long-term complications, and many include only subjective compliance data. We examined objective pre-operative PAP use among OSA patients undergoing bariatric surgery and its impact in reducing post-operative complications.

Methods

Our study included data from 140 individuals who underwent bariatric surgery gathered over a 6-month period, with 79 having verified PAP use in the 30-days before surgery. A correlation analysis was conducted comparing 30-day pre-operative PAP use to total operative time, time in the Post-Anesthesia Care Unit (PACU), length of inpatient stay, collective PACU and inpatient time, ED visits within the 30 days post-op. There were no deaths, ICU transfers, respiratory or surgical complications in this sample. Furthermore, PAP use was categorized into tertiles, and an analysis of variances was completed for the following secondary variables: Apnea-Hypopnea Index (AHI), time with oxygen saturation < 88% and < 90%, age, and weight. Mean PAP use in minutes was 376±59 for the highest-use group, 183±61 for intermediate-use group, and 10±16 for lowest-use group.

Results

Our correlation analysis revealed no significant associations between 30-day pre-operative PAP use and above-mentioned outcomes. Upon PAP use stratification into tertiles, a statistically significant effect became apparent in relation to PACU time (p = 0.008), with oxygen saturation < 88% as a significant covariate. The PACU time in minutes varied across tertiles, with the highest-use group having a PACU time of 169±106, the intermediate-use group with 217± 156s, and the lowest-use group with 202±129.

Conclusion

Overall, complications rates after bariatric surgery were low. Increased PAP use was significantly associated with shorter stays in the PACU, perhaps related to faster time to recovery from anesthesia due to lower number of desaturations, hence mitigating need for continued nursing monitoring which could potentially lower healthcare associated cost.

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0588 Combination Therapy: Hypoglossal Nerve Stimulation and Oral Appliance Therapy
Authors: Glick Aaron , Richardson Sue Ellen , Singh Supriya
Published: April 2024

Introduction

Hypoglossal nerve stimulation (HGNS) is an implantable body that protrudes the tongue anteriorly during sleep. This surgical procedure is effective with minimal side effects, however for some patients 80 complications arise and require additional treatment modalities. One such alternative is oral appliance therapy that uses a different mechanism of action to displace the mandible anteriorly which is worn on the upper and lower teeth.

Methods

Five patient charts were identified out of 80 that had undergone hypoglossal nerve stimulation surgery with subsequent placement of oral appliance. Patient characteristics were identified to understand clinical reasoning leading to combination therapy and success of treatment.

Results

The most common reasons for a referral to the dentist after surgical placement of hypoglossal nerve stimulator is due to abrasion of the tongue (60%) and residual snoring (60%) with some patients having multiple reasons for the referral. Oral appliances were made for 4 of the 5 patients. Of the 4 patients all have evidence of tooth wear with 50% of patients having minor chipping on a front tooth. Average pre-treatment AHI was 33±13 to average post-treatment for combination therapy (HGNS with oral appliance) AHI of 6±2. Combination treatment eliminated both residual snoring and abrasion of the tongue in all patients.

Conclusion

The limitations are that there was a small sample size since a referral after HGNS surgery to oral appliance is rare. While conclusions about the patient characteristics cannot be generalized to the general population due to the small sample size, it was found that all patients had evidence of tooth wear which is common in the obstructive sleep apnea population. Clinically, combination therapy of HGNS and oral appliance therapy can be a viable alternative for some patients.

Support (if any)

None.
0592 Accelerometer Control Performs Comparable to Pressure Sensor Control of Hypoglossal Nerve Stimulation Timing
Authors: Roy Asim , Doghramji Karl , Manchanda Shalini , Byrd Israel , Manne-Nicholas James , Thorp Chris , Dieken Dave , Cornelius Jason
Published: April 2024

Introduction

The hypoglossal nerve stimulation (HNS) system from Inspire Medical Systems, Inc (Golden Valley, MN) monitors respiration with a pressure sensor to deliver stimulation during inspiration. The sensor is embedded in a lead that is typically implanted in the second intercostal space and anterior to the generator. Inspiratory phase overlap fraction (IPOF) is the fraction of the inspiration phase concurrent with the stimulation burst. An accelerometer embedded in the generator to replace the implanted sensor lead could simplify the HNS system and implant procedure. To test whether an accelerometer control system performs comparably to the pressure sensor control system, we compared the IPOF of the commercial HNS system to that derived from an externally mounted accelerometer.

Methods

Fifty-six patients previously implanted with an HNS system (8 Inspire II, 48 Inspire IV) underwent a polysomnogram (PSG) while also wearing two accelerometers on their chest (approximately 5 cm below each the left and right clavicle, a typical implant location). The commercial system stimulation timing was exported and time-aligned with the PSG waveform to calculate the commercial system’s IPOF. The accelerometer waveforms were exported and time-aligned with the PSG respiration sensor, then the sensing algorithm was applied to the accelerometer waveforms to determine stimulation timing and calculate the accelerometer system’s IPOF. IPOF is reported as mean ± standard deviation [95% confidence interval for the mean]. The entire cohort was used in commercial system analysis but was divided into separate groups for accelerometer algorithm tuning and validation.

Results

Commercial system IPOF was 78%±7%, 95%CI [76%-79%] (n=56, 298 sleep hours). Accelerometer system IPOF was 86%±6%, 95%CI [84%-88%] in the tuning group (n=26, 133 sleep hours) and 83%±8%, 95%CI [80%-85%] in the validation group (n=30, 165 sleep hours).

Conclusion

Results from this study demonstrate an externally worn accelerometer based IPOF is comparable to the pressure sensor based IPOF of the implanted HNS system. This suggests an accelerometer control system embedded in the generator could replace the implanted pressure sensor to provide at least equivalent stimulation delivery.

Support (if any)

This study was funded by Inspire Medical Systems. Inspire employees contributed to the study execution and data analysis.
0596 Comparative Analysis of Continuous Positive Airway Pressure and Hypoglossal Nerve Stimulation
Authors: Khan Taimoor , Heinzinger Catherine , Foldvary-Schaefer Nancy , Mehra Reena , Lee Kent , Lundeen Max , Araujo Matheus Lima Diniz
Published: April 2024

Introduction

Continuous positive airway pressure (CPAP) adherence represents a pervasive, multifactorial challenge. Hypoglossal nerve stimulation (HNS) is an alternative treatment for moderate-severe obstructive sleep apnea (OSA) for those who are CPAP-intolerant. We hypothesized differential predictors of therapy adherence and greater adherence with HNS versus CPAP.

Methods

We compared adherence and its predictors in patients from the Cleveland Clinic HNS registry (cloud-based data monitoring) versus those on CPAP from the HomePAP study at the 1st and 3rd month timepoints. Linear models assessed age, sex and body mass index (BMI) as 1- and 3-month HNS and CPAP adherence predictors. Propensity score matching (1:1) without replacement and t–tests were used to compare adherence across the groups. Propensity scores were estimated with support vector machine using age, sex, BMI and Epworth Sleepiness Scale (ESS) at baseline.

Results

We analyzed data from n=63 HNS patients (age:57.9±10.0 years, 60% male, body mass index (BMI):28.8 ±3.3 kg/m2), ESS score:8.83±4.69) and n=126 CPAP patients from the HomePAP study (age:49.8±11.9 years, 63% male, BMI:39.1±9.43 kg/m2, ESS score:14.3±3.8). At 1-month, female sex was associated with increased HNS therapy usage (1.20, SE:0.47, p< 0.01); a finding not observed at 3-months. Propensity score-matched analysis included 28 HNS patients (age: 53.6± 9.9 years, 67% male, BMI:30.7± 2.6 kg/m2, ESS:11.4± 3.7) and 28 CPAP patients (age:58.5± 9.6 years, 85% male, BMI:31.2± 4.0 kg/m2, ESS:12.2± 3.6). At 1-month (HNS n=28, CPAP n=27), usage was 3.90±1.0 hours for CPAP and 6.97±1.09 hours for HNS (p< 0.01). At 3-months (HNS N=27, CPAP N=24), usage was 4.38±1.87 (SD) hours for CPAP and 6.44±1.96 hours for HNS (p< 0.01).

Conclusion

In this comparative analysis, we identify female sex as a factor associated with early adherence to HNS, findings not observed with CPAP. Using a rigorous approach to address baseline differences, we identify a substantial increased level of adherence in HNS versus CPAP therapy of approximately 2-3 hours which persisted until 3 months. Future investigation should focus on assessing HNS versus CPAP adherence-related improvement in clinical outcomes.

Support (if any)

NIH grant R21HL170206.
0599 Effects of Proximal HGN Stimulation in HTN Subjects with Moderate to Severe OSA: A 5-Year Analysis of the THN3 RCT
Authors: Schwartz Alan , Jacobowitz Ofer , Mickelson Samuel , Miller Mitchell , Oliven Arie , Certal Victor , Hopp Martin , Winslow David , Huntley Tod , Nachlas Nathan , Gillespie M Boyd , Weeks Brian , Lovett Eric , Malhotra Atul , Maurer Joachim
Published: April 2024

Introduction

Hypoglossal nerve stimulation (HGNS) improves sleep-disordered breathing (SDB), oxygenation, and quality of life (QOL) in obstructive sleep apnea (OSA), but to date, has not been shown to improve cardiovascular outcomes. The THN3 randomized, controlled trial of proximal HGNS included subjects with office systolic blood pressure (SBP) ≤160mmHg or diastolic pressure ≤100mmHg. In post-hoc analyses, we examined whether antihypertensive effects of HGNS could be identified in a hypertensive THN3 subgroup.

Methods

THN3 participants (AHI 20-65/hr; BMI ≤ 35 kg/m2, no drug-induced sleep endoscopy screening) were followed for 5 years after HGNS system implant. In addition to annual measurements of SDB and QOL, BP was measured at every visit. Normotensive and hypertensive subgroups were fit to a linear mixed model with quadratic terms and 2 latent classes in order to estimate group BP trajectories from the time of HGNS initiation. Differences in baseline characteristics between classes were also evaluated.

Results

Of 137 subjects with evaluable data, 130 (95%) belonged to a normotensive class. SBP remained stable in this group, with estimated SBP mean (95%CI) of 128.9 (127.2,130.6), 129.2 (127.7,130.8), 129.5 (127.7,131.3), 129.7 (127.8,131.6), 129.8 (127.9,131.8), and 129.9 (127.3,132.5) mmHg at Baseline followed by Years 1-5 measurements, respectively. The remaining 7 (5%) subjects belonged to a hypertensive class. SBP decreased over time in these hypertensive patients with HGNS, with the estimated SBP mean trajectory of 156.4 (145.5,167.3), 142.8 (133.8,151.8), 134.8 (125.5,144.2), 132.5 (123.2,141.7), 135.7 (126.5,144.9), and 144.5 (132.2,156.9) mmHg. Aside from SBP, the groups differed at Baseline in average oxygen desaturation index (37.5±10.1 vs. 32.6±3.3/hr, normotensive vs. hypertensive) and percentage of sleep time with oxygen saturation < 90% (11.9±9.8 vs. 4.7±3.8%). No meaningful differences were detected in Baseline age, sex or BMI.

Conclusion

Amelioration of OSA and nocturnal hypoxemia with proximal HGNS may improve SBP in hypertensives with moderate to severe OSA. If so, HGNS may improve long-term cardiovascular outcomes. Future analyses in the ongoing OSPREY and other trials should determine whether HGNS predicts reductions in SBP.

Support (if any)

LivaNova
0602 Application of a Physiology Based OSA Endotype Model to Predict Oral Appliance Outcomes Using Home Sleep Study Data
Authors: Eckert Danny , Dutta Ritaban , Levendowski Daniel
Published: April 2024

Introduction

Prediction of oral appliance therapy (OAT) response to treat obstructive sleep apnea (OSA) remains a major clinical challenge (currently ~50% or less depending on treatment definition). Recent physiology-based studies indicate that different combinations of pathophysiological traits or “OSA endotypes” are associated with OAT outcomes. However, methodologies to identify OSA endotypes to inform patient selection for OAT have largely been limited to in-laboratory and detailed physiology testing which limits clinical translation potential. Accordingly, we recently developed a physiology-based model that uses standard polysomnography and clinical data to predict OAT outcomes with correct OAT treatment classification in ~60 to >90% of cases depending on the treatment outcome definition (Dutta et al, J Clin Sleep Med, 2022). Here we applied this model to a large clinical cohort who had a home-based diagnostic study to determine the proportion of people estimated to respond to OAT.

Methods

Model based OAT predictions were performed using clinical data (i.e., age and BMI) plus standard sleep study outputs from >6,500 consecutive home-based diagnostic studies (Sleep Profiler PSG- Advanced Brain Monitoring). All participants had an apnea/hypopnea index (AHI) >5 events/h. The proportion of participants who were estimated to respond to OAT according to the model was calculated across three commonly used treatment outcome definitions: 1) AHI< 5, 2) AHI< 10 events/h and 3) 50% reduction in AHI.

Results

On average, participants (39% female) were middle-aged (49±15 years ([Mean±SD]), had moderately severe OSA (AHI=28±23 events/h) and were obese (BMI=32±7 kg/m2). ~10% were predicted to fully respond (AHI< 5 events/h) to OAT, ~43% to achieve an AHI< 10 events/h and 42% to have a 50% reduction in AHI. Conversely, ~41% of participants were predicated to not respond to OAT across all 3 treatment definitions.

Conclusion

While further prospective validation is required, these real-world data suggest that application of a novel physiology based OSA endotype algorithm using standard clinical and home sleep study information may be helpful to identify successful candidates for OAT (and vice versa) in a substantial proportion of people diagnosed with OSA with greater accuracy that current clinical practice.

Support (if any)

DJE is funded by a National Health and Medical Research Investigator Grant (1196261).
0617 Efficacy of Nasal Expiratory Positive Airway Pressure in Veterans with Obstructive Sleep Apnea
Authors: Tsai Tiffany , Olteanu Nicoleta , Liu Zi Yu , Wilson Brigid , Strohl Kingman , Gandotra Kamal , Ashraf Fareeha , Chiang Ambrose
Published: April 2024

Introduction

Nasal expiratory positive airway pressure (EPAP) stands as a viable therapeutic solution for individuals with obstructive sleep apnea (OSA). Bongo Rx (AirAvant Medical, Deerfield Beach, Florida) has obtained FDA clearance for treating patients with mild-to-moderate OSA despite limited publication. Amidst the global continuous positive airway pressure (CPAP) shortage, veterans with mild to moderate OSA were presented with the option of Bongo Rx. Individuals who opted to use Bongo Rx for a minimum of one month were subjected to WatchPAT testing (Itamar/ZOLL, Atlanta, Georgia) while on Bongo Rx. This retrospective study aimed to assess the efficacy of Bongo Rx in veterans who underwent follow-up WatchPAT within 12 months from the initial baseline.

Methods

Retrospective chart review. OSA-related measures were compared before and after Bongo Rx using paired t-tests to compare means or Wilcoxon signed-rank tests when values were highly skewed.

Results

Twenty-two veterans with OSA met the eligibility criteria and their data were analyzed. Mean age 60; M:F ratio 16:6; BMI 33.5; 15 White (68%), 6 Black (27%), and 1 Pacific Islander (5%); 10 veterans had mild OSA (45%), 10 moderate OSA (45%), and 2 severe OSA (9%). Overall, Bongo Rx reduced mean WatchPAT Apnea-Hypopnea Index (AHI) by 40% (baseline AHI 16.6 and Bongo-AHI 10.0, p=0.0007), mean respiratory disturbance index (RDI) by 41% (baseline RDI 19.4 and Bongo-RDI 11.5, p=0.0003), and mean oxygen desaturation index (ODI) by 31% (baseline ODI 14.4 and Bongo-ODI 9.9, p=0.0038). Mean SpO2 nadir increased by 2.4% (baseline SpO2 nadir 82% and Bongo SpO2 nadir 84%), median time with SpO2 under 88% (T88) decreased by 58% (baseline T88 1.2 min and Bongo-T88 0.5 min), and these changes were not statistically significant (all p>0.05). Notably, the two severe OSA cases showed 73% and 42% improvement of AHI (baseline AHI 37.0 and Bongo-AHI 7.7 in one, and baseline AHI 38.4 and Bongo-AHI 22.2 in another).

Conclusion

Nasal EPAP with Bongo Rx seems efficacious in reducing AHI, RDI, and ODI in patients with mild to moderate OSA. The efficacy of Bongo Rx in severe OSA should be explored in future research. Further investigation into tolerance and adherence is warranted.

Support (if any)
0619 Depression and Treatment Use in Patients with Obstructive Sleep Apnea on Glucagon-Like Peptide 1 Receptor Agonists
Authors: Cole Kate , Dexter R , Cameron Ann , Woodford Caleb , Alpert Naomi , McConnell Will , Sterling Kimberly , Cistulli Peter , Malhotra Atul , Pépin Jean-Louis
Published: April 2024

Introduction

Depression and obesity are both prevalent among patients with obstructive sleep apnea (OSA). Treating OSA has been shown to improve depressive symptoms. Routine treatment for OSA often includes positive airway pressure (PAP) therapy combined with weight management strategies, including glucagon-like peptide 1 receptor agonists (GLP-1s), which have been approved to treat type 2 diabetes (T2D) and obesity. Little is known about the relationship between GLP-1 use and OSA and depression treatment patterns, or how these may be affected by depression status and gender.

Methods

Administrative insurance claims from 2014-2023 for adult patients with OSA who filled a GLP-1 prescription with ≥1 year of enrollment before and after the first recorded GLP-1 fill (index date) were analyzed. Depression was defined based on ICD-10 diagnosis codes within the year prior to index. Antidepressant use and OSA treatment in the year pre- and post-index were described.

Results

Of 151,529 patients included (mean age 54.3 years; 48.9% female), 26.3% had depression prior to index. Those with depression were more often women (66.2% vs 42.8%). Prevalence of Medicaid insurance (40.9%) and class III obesity (65.7%) was highest among women with depression, compared to men or those without depression. T2D was common (85.7% overall), with higher prevalence among men. Prior to index, approximately 53% of women and 56% of men had evidence of PAP therapy; this decreased slightly to approximately 48% and 51%, respectively, in the year after index, regardless of depression status. Among patients with depression, prevalence of ≥1 antidepressant prescription was consistent pre- and post-index, but higher among women than men in both periods (pre: 86.0% vs 81.0%; post: 86.0% vs. 80.4%). In the year after index, approximately 41% of women and 39% of men discontinued GLP-1s, regardless of depression status.

Conclusion

Among patients with OSA starting GLP-1 therapy, prevalence of PAP-related claims were similar in patients with and without depression and by gender. Antidepressant use remained consistent among men and women with depression. Future research should evaluate the impact of GLP-1 use on treatment patterns by indication (T2D or obesity/overweight).

Support (if any)

ResMed
0628 Consistent Efficacy of Once-Nightly Sodium Oxybate Across Patient Demographic and Baseline Disease Characteristics
Authors: Thorpy Michael , Roth Thomas , Kushida Clete , Morse Anne , Harsh John , Ortiz Luis , Gudeman Jennifer , Dauvilliers Yves
Published: April 2024

Introduction

Once-nightly sodium oxybate (ON-SXB; LUMRYZ™) was investigated in patients with narcolepsy type 1 (NT1) or 2 (NT2) in the phase 3 REST-ON trial; treatment with 6, 7.5, and 9 g demonstrated significant improvements vs placebo (all P< 0.001) for the coprimary endpoints of change from baseline in mean sleep latency on the Maintenance of Wakefulness Test (MWT), Clinical Global Impression-Improvement (CGI-I) rating, and weekly number of cataplexy episodes (NCA), and the secondary endpoint Epworth Sleepiness Scale (ESS) score. This post-hoc analysis assessed ON-SXB efficacy in various subgroups.

Methods

REST-ON (NCT02720744) participants aged ≥16 years with NT1 or NT2 were randomized 1:1 to ON-SXB (4.5 g, 1 week; 6 g, 2 weeks; 7.5 g, 5 weeks; 9 g, 5 weeks) or placebo for 13 weeks. Least squares mean differences (LSMDs) in changes from baseline for ON-SXB vs placebo for mean sleep latency on MWT, NCA (NT1 only), and ESS, and odds ratios for “much”/“very much” improved on CGI-I, were compared among baseline demographic (age, sex, race, body mass index [BMI] category) and narcolepsy disease characteristic (NT1/NT2; concomitant alerting agent use) subgroups.

Results

The modified intent-to-treat population included 190 participants (ON-SXB, n=97; placebo, n=93). LSMDs for ON-SXB 9 g vs placebo in change from baseline on the MWT at week 13 revealed significant improvements (P< 0.05) for subgroups based on age, sex, race, BMI, narcolepsy type, and alerting agent/no alerting agent use. Odds ratios were significant in favor of ON-SXB 9 g vs placebo for “much” or “very much” improved on CGI-I at week 13 (P< 0.05) for both low/high age, female sex, white/non-white, high BMI, NT1, and alerting agent/no alerting agent use. LSMDs were significant in favor of ON-SXB 9 g vs placebo for change from baseline in NCA (P< 0.05) in all subgroups, except non-white and male. For the ESS, all subgroups exhibited significant improvements (P< 0.05) with ON-SXB 9 g vs placebo, except NT2. Comparable differences were found with the 6-g dose at Week 3 and the 7.5-g dose at Week 8.

Conclusion

Post-hoc subgroup analyses demonstrate the robust efficacy of ON-SXB across demographic and clinical subgroups.

Support (if any)

Avadel Pharmaceuticals
0630 Efficacy of Sodium Oxybate in Adults with Idiopathic Hypersomnia : A Randomized Placebo-controlled Trial
Authors: Dauvilliers Yves , Chenini Sofiene , Thobois ophélie , Rassu Anna Laura , Denis claire , Guiraud Lily , Jaussent Isabelle , Barateau Lucie
Published: April 2024

Introduction

Idiopathic hypersomnia (IH) is a rare central hypersomnolence disorder characterized by excessive daytime sleepiness, prolonged nighttime sleep and sleep inertia. The efficacy and safety of low-sodium oxybate was reported in a phase 3 randomized withdrawal study in IH on Epworth Sleepiness scale (ESS) and Idiopathic Hypersomnia Severity Scale (IHSS). We conducted a phase 3, monocentric, double-blind, randomized, parallel group, placebo-controlled trial of sodium oxybate (SXB) in IH with ESS, IHSS and Maintenance of Wakefulness Test (MWT) assessment.

Methods

Eligible participants 18–60 years of age with IH according to criteria (ICSD3) with ESS ≥14 were randomly assigned to treatment with SXB or placebo in a 1:1 ratio. After a 2-week screening without any CNS drugs and never exposed to oxybate, patients started a 6-week individual twice nightly up-titration scheme from 4.5 g to a maximum of 9 g, treatment was administered at stable dose (6g or 9g) for 2 weeks, followed by a 1-week taper period. The primary endpoint was the mean change from baseline to week 8 on ESS. Key secondary endpoints were safety, changes in average sleep latency on the MWT and IHSS.

Results

Between October 2018 and January 2023, we screened 48 patients, 45 were randomized (36 females, mean age 29.0±7.5, ESS 16.5±2.7, 40 having long sleep time; 22 assigned to SXB and 23 placebo), and 40 (19 receiving SXB and 21 placebo) completed the double-blind period. Between-group differences (SXB vs placebo) for the mean [IC95%] change in ESS from baseline to endpoint were -6.54 [-9.35;-3.73] (p=0.004). Between-group differences for the average sleep latency on the MWT from baseline to endpoint were 13.87 [8.35 ;19.39] (p=0.0001), and for IHSS -10.87 [-15.71;-6.03] (p=0.0004). Treatment-emergent adverse events were reported in 17 (77%) of 22 patients with SXB and 7 (30%) of 23 with placebo. The most frequently reported adverse events were nausea, headache, and dizziness.

Conclusion

SXB resulted in a clinically meaningful improvement in adults with IH, reducing excessive sleepiness on the ESS, improving wakefulness on the MWT and decreasing IH severity on IHSS after 8 weeks. The safety profile was similar to that previously reported with SXB. NCT03597555

Support (if any)

Grant from Jazz Pharmaceuticals