bluuebunny/crossref_metadata_2025 huggingface dataset:
0738 Clinical and Physiological Relevance of Computational Studies of Obstructive Sleep Apnea: A Systematic Literature Review
Authors: Hartfield Phillip , Sparapani Rodney , Woodson B , Rhee John , Garcia Guilherme
Published: May 2022

Introduction

Structural interventions for obstructive sleep apnea (OSA) have unpredictable success rates. Anatomically accurate computer simulations of airflow and soft tissue dynamics may be used in future virtual intervention planning tools to identify the optimal patient interventions. The objective of this study is to review the existing literature on the correlation between computer-derived biomechanical variables and clinical measures of OSA severity.

Methods

Scientific papers written in English that correlated the apnea-hypopnea index (AHI) with computer-derived biomechanical variables were identified by searching on the PubMed and SCOPUS databases the search phrase “sleep apnea” AND “computational fluid dynamics” OR "finite element” OR “fluid structure interaction”.

Results

A total of 19 articles were identified that reported correlations between computer-derived biomechanical variables and AHI, which was the metric of OSA severity reported in most studies. These studies demonstrated that several anatomic and physiologic variables correlate with OSA severity, including airspace cross-sectional areas, airspace volumes, and airflow resistance. No studies were found that correlated computer-derived dynamic measures of upper airway mechanical stability, such as tissue compliance, to OSA severity.

Conclusion

Computer-derived anatomic and physiologic variables may serve as useful predictors of surgical outcome or mandibular device treatment response in OSA patients. Further research is needed to test the hypothesis that virtual surgery planning based on computer-derived measures of upper airway stability can improve outcomes of OSA interventions.

Support (If Any)

This project was funded in part by the Advancing a Healthier Wisconsin Endowment.
0747 Polysomnogram characteristics associated with artificial Intelligence enabled electrocardiogram algorithm predicted probability of atrial fibrillation in patients with obstructive sleep apnea
Authors: Mudrakola Harsha , Morgenthaler Timothy
Published: May 2022

Introduction

Obstructive sleep apnea (OSA) is associated with atrial fibrillation (AF). Several features of OSA are thought to play role in the development of AF. A recently developed artificial intelligence (AI) enabled electrocardiogram (ECG) algorithm predicts the probability of future development of AF from a single ECG. We sought to examine the relationship between polysomnogram (PSG) and clinical features of patients with OSA and the probability of future AF (P-AF).

Methods

Consecutive adults (age ≥ 18) with OSA and with an ECG obtained within 2 years of their attended polysomnograms (PSG) were examined. We excluded patients with AF, left ventricular ejection fraction < 50%, implanted pacemaker or cardioverter defibrillator. We recorded demographics, apnea-hypopnea index (AHI), respiratory arousal threshold (RAT), percent sleep time with SpO2 < 89%, arousal index, and a comorbidity score composed of presence of coronary artery disease (CAD), hypertension (HTN), diabetes mellitus (DM), stroke, and chronic lung disease. One and two-way ANOVA was used to examine the relationship of OSA severity (mild, moderate, or severe) with P-AF. Multiple linear regression further characterized associations with P-AF.

Results

Mean AI determined P- AF was 0.052±0.012 (mean±SE) in mild, 0.064±0.014 in moderate, and 0.105 + 0.014 in severe OSA, demonstrating a significant association of OSA severity with P-AF (p = 0.01). Post-hoc pairwise tests showed a significant difference in P-AF between mild and severe (p = 0.008) but not between moderate and severe OSA (p = 0.083). Multiple linear regression with all the variables listed above showed the association between OSA severity and P-AF remains significant (P = 0.044). Age (p<0.001) and comorbidity score (p<0.001) were the only other variables significantly associated with P-AF.

Conclusion

OSA severity determined by AHI was significantly associated with P-AF as determined by a novel ECG-based AI algorithm independent of other variables. Given the strength of association with age and the comorbidity score, OSA severity may have been associated as it is known to increase with age and comorbid conditions. Future directions include incorporating AI enabled algorithms to identify individuals with the highest risk of AF in whom the role of OSA treatment in reducing risk of AF may be examined.

Support (If Any)
0750 Performance Testing of a Novel Oral Appliance Material; A New Standard for OAT
Authors: Murphy Mark , Carollo John
Published: May 2022

Introduction

Traditionally, oral appliances for treating obstructive sleep apnea have borrowed from the disciplines of removable prosthetics and orthodontics. The materials, design and manufacturing have evolved little. Today, precision milled devices using innovative materials and designs have leapt past artisanal legacy devices. The use of artificial intelligent design to accurately replicate tooth surface anatomy and robotic manufacturing to insure precision are requiring higher table stakes to ‘get in the game’. Mill-able polymethylmethacrylate, MG6™ Technology materials and printed nylons have replaced cold cured acrylics, Thermacryl, soft liners and suck down platforms. The testing and material standards should also evolve as well.

Methods

Typically, no specific ISO testing is performed on legacy device compositions. This new medical grade class VI (the highest category) material promised to be more robust, safer and to have the highest biocompatibility. ISO testing was performed in the following arenas: ISO tests 10993-4 Hemolysis, 10993-4 in vitro hemocompatibility, 10993-5 cytotoxicity, 10993-6 short-term intramuscular implantation, 10993-10 intracutaneous injection, 10993-11 system toxicity and USP 38 physiochemical testing.Similarly, no specific durability testing is done beyond the safety requirement designs set by the FDA. This material was exposed to all the tradition stress, bend and compression testing as well as the MIL-STD-810H Military Free Fall Drop Test. Finally, stain, biogunk and the ease of keeping a device clean are always a concern with legacy device materials. Milled PMMA has been shown previously to be nearly impervious to stain and bioburden uptake. This material was tested along with predicates and PAP mask materials for comparison.

Results

ISO TestingThe Material passed all the tests as indicated in reports nos. BIO-ATX 1856,1857,1858, and BIO-GNT 8321. 832, 833. Military Drop TestThis material passed the military drop test (40 cases, each dropped 6 times). Method Test 810H section 4.6.5 Procedure IV Table 516.8-X Unpackaged handling. Stain TestingMilled Iterative PMMA DE = 3.06Milled Iterative EVO material DE = 3.20CPAP Mask plastic DE = 7.54Milled PMMA w/ soft Liner/Fulcrum Strap DE = 8.27CPAP Mask silicone DE = 11.60PMMA + Liner Anterior Hook DE = 19.05PMMA with Liner Herbst DE = 32.05Nylon with Airway DE = 90.70Nylon with Straps DE = 96.99

Conclusion

Medical grade class VI material sets new standard for oral appliance material performance

Support (If Any)

Data provided by ProSomnus, ISO.org and the DOD.
0753 Predictors of Residual sleep apnea in OSA patients on PAP
Authors: Ni Yuenan , Thomas Robert
Published: May 2022

Introduction

Positive airway pressure (PAP) is the first line therapy for patients with obstructive sleep apnea (OSA). However, clinical OSA may have multiple disease drivers beyond upper airway collapse, such as high loop gain and a low arousal threshold. The burden of residual sleep apnea in patients treated with PAP and it’s predictors remained to be fully defined.

Methods

Adult patients who were diagnosed with OSA through a split-night polysomnography (PSG) in the AASM accredited sleep center at the Beth Israel Deaconess Medical Center, Harvard Medical School and followed using the EncoreAnywhereTM system were prospectively included. Monthly visual/manual scoring of residual events was done. The ratio of patients with residual sleep apnea (defined as a manually-scored respiratory event index (REI) ≥ 15 times/hour in the 3rd month and 12th month were calculated. A linear regression model was used to explore the predictors of residual sleep apnea on PAP.

Results

One hundred and ninety five patients were included. In the 3rd month, there were 166 patients still on PAP. There were 74 (44.58%) with a residual AHI ≥ 15 times/h. In the 12th month, there were 93 patients still on PAP and 41 (44.09%) had residual AHI ≥ 15. In the short term, treatment CAHI (β= 0.511, SE=0.123, p=0.001), age (β= 0.123, SE=0.054, p=0.025), and hypertension (β= 3.627, SE=1.536, p=0.019) were the predictors for residual sleep apnea. In the long term, treatment CAHI (β= 0.598, SE=0.163, p=0.001), male gender (β= -5.117, SE=2.005, p=0.013) and baseline mean arousal duration (β= -0.601, SE=0.184, p=0.002) were predictors for residual sleep apnea.

Conclusion

There was a high percentage of patients with OSA on PAP who have residual sleep apnea. Treatment CAHI is a strong predictor, and may reflect high loop gain effects.

Support (If Any)

Category-I Strategic Research Award from the AASM Foundation to R. J. Thomas
0754 Effects of Atomoxetine plus a Hypnotic on Obstructive Sleep Apnea (OSA) Severity in Patients with a Moderately Collapsible Pharyngeal Airway
Authors: Corser Bruce , Rucosky Gregg , Eves Erica
Published: May 2022

Introduction

The combination of atomoxetine and oxybutynin has demonstrated efficacy in the treatment of OSA. Oxybutynin may play a role as an upper airway dilator muscle activator and/or a hypnotic to improve sleep quality. We assessed the effectiveness of atomoxetine when combined with one of two hypnotics. Trazodone is a known hypnotic with possible effects on pharyngeal muscle activity. The other is lemborexant, an orexin antagonist. The effects of both combinations were assessed in patients with OSA and a moderately collapsible pharyngeal airway.

Methods

Recruited patients were 18 – 65 years of age, with an AHI 4 (4% desaturation criteria) of 10 – 55 and a BMI < 40 kg/m2. Each had to have a moderately collapsible pharyngeal airway using previously defined criteria based on the average percent desaturation during obstructive events (< 8%) and the ratio of hypopneas to total events (> 50%). After a qualifying PSG, each patient spent three nights in the sleep laboratory with approximately one week between studies. Nights were randomized to placebo, atomoxetine 80 mg plus trazodone 100 mg, and atomoxetine 80 mg plus lemborexant 10 mg. Primary outcomes were AHI 4 and the sleep apnea specific hypoxic burden (HB), the area under the SpO2 curve associated with disordered breathing events.

Results

Fifteen patients completed the trial (median [interquartile range] age was 52 [48-55] and BMI was 33.6 [30 – 35.1] kg/m2. Atomoxetine plus trazodone showed a strong trend for AHI 4 reduction from placebo (from 18.2 [11.8 – 31.3] to 7.4 [5.4 – 16.1] events/h, p=0.064), a significant reduction in HB from placebo (from 48.2 [31.2 – 79.6] to 18.7 [14.9 – 43.5] % min/h) and a trend for a reduction in HB with atomoxetine plus lemborexant (from 34.1 [12.1 – 128.8] to 18.7 [14.9 – 43.5] % min/h, p=0.055). There was no change in total sleep time or arousal index between treatment arms. Mild adverse events were reported on atomoxetine plus trazodone (2/15 sinusitis, 1/15 heartburn).

Conclusion

In OSA patients with a moderately collapsible upper airway, the combination of atomoxetine plus trazodone yielded clinically meaningful improvements in measures of sleep disordered breathing and oxygenation while atomoxetine plus lemborexant produced smaller effects.

Support (If Any)

This study was supported by Apnimed.
0758 Behavioral Determinants of PAP Use in Veterans with COMISA: Results of a Randomized Trial
Authors: Barretto Bronson , Martin Jennifer , Fung Constance , Dzierzewski Joseph , Stepnowsky Carl , Song Yeonsu , Zeidler Michelle , Kelly Monica , Enamorado Daniel , Schnurrenberger Jody , Josephson Karen , Mitchell Michael , Alessi Cathy
Published: May 2022

Introduction

Nonadherence to positive airway pressure (PAP) therapy is common in comorbid insomnia and obstructive sleep apnea (COMISA). We previously reported a novel behavioral treatment for COMISA which improves both PAP adherence and sleep. Our current goal was to assess whether improvements in PAP self-efficacy, knowledge, and decisional balance (targets of treatment) are associated with improvements in PAP use and sleep quality. We also collected participants’ perceptions of benefits and challenges of PAP during intervention.

Methods

125 veterans (96% men, 39% non-Hispanic white, 24% Black, 17% Hispanic/Latino) with COMISA were randomized to a 5-week intervention integrating behavioral insomnia therapy with a PAP adherence program versus general sleep education (control). Objective PAP use data and Pittsburgh Sleep Quality Index (PSQI) were collected over 6 months. Three behavior change subscales (PAP Self-Efficacy [PAP-SE], Decisional Balance Index [DBI], Knowledge [KNOW]) were administered at 6-months. Weekly self-report of participant-perceived benefits and challenges of PAP use were collected among intervention participants. Subscale scores, PAP use and PSQI were compared between intervention and control, and associations were tested. Change in mean number of benefits and challenges of PAP use were also tested (all analyses intent-to-treat).

Results

At 6-months, compared to controls, intervention participants had higher scores on all three subscales: PAP-SE (4.1 intervention versus 3.5 control, respectively), DBI (8.3, 0.9) and KNOW (10.5, 9.6, all p<.05). Intervention participants had more PAP use and lower (better) PSQI scores at 6-months (all p<.05). In the total sample, PAP use and PSQI correlated with PAP-SE (r=.52 PAP use, r=-.27 PSQI, respectively), DBI (r=.49, -.35) and KNOW (r=.43, -.21; all p<.05). Among intervention participants, perceived benefits of PAP increased over time (4.3 at week 2, 5.8 at week 4, respectively), and challenges decreased (3.7, 2.3; all p<.05).

Conclusion

Behavioral treatment for COMISA improves behavioral determinants of PAP use, which is associated with improvements in PAP use and sleep quality. In addition, with treatment, perceived benefits of PAP increase and challenges decrease. These findings suggest improvements in self-efficacy, knowledge and perceived benefits of PAP are important mechanisms through which behavioral interventions improve PAP use in older adults with COMISA.

Support (If Any)

VAHSRD (IIR12–353-Alessi, RCSA20-191-Martin) and NIH (NHLBI K24HL143055-Martin, NIA K23AG049955-Dzierzewski)
0759 A real world study assessing patient satisfaction in the primary care setting in relation to excessive daytime sleepiness in participants with obstructive sleep apnea
Authors: Parthasarathy Sairam , Hyman Danielle , Doherty James , Saad Ragy , Zhang Jerry , Morris Susan , Eldemir Lev , Fox Benjamin , Vang Mai Ka Ying , Schroeder Jessica , Marshall Nell , Parks Gregory
Published: May 2022

Introduction

Excessive daytime sleepiness (EDS) is common in obstructive sleep apnea (OSA), despite positive airway pressure (PAP) therapy. These analyses evaluated EDS prevalence and its relationship with satisfaction with care in participants with OSA receiving OSA care in a primary care setting.

Methods

US residents (aged ≥18 years, self-reported physician OSA diagnosis [1/1/2015–3/31/2020]) completed a survey in Evidation Health’s Achievement app assessing Epworth Sleepiness Scale (ESS), specialties of healthcare providers (HCPs) treating OSA, PAP usage, and satisfaction with HCPs and overall OSA care. Self-reported PAP use was categorized: nonuse, nonadherent (<4 h/night, <5 d/wk), intermediate (4–6 h/night, ≥5 d/wk), or highly-adherent (≥6 h/night, ≥5 d/wk) (PAP-adherent=intermediate+highly-adherent groups). Linear modeling assessed the relationship between PAP use and ESS score; logistic regression assessed impacts of PAP adherence and EDS on satisfaction with care. P-values are uncontrolled for multiplicity.

Results

Participants (N=2289) were 50.3% female; 82.5% White; 44.8±11.1 years old (mean±SD); with BMI 35.4±8.7 kg/m2; 42.5% had EDS (ESS>10). OSA was primarily managed by sleep specialists (43.5%), general practitioners (GPs) (42.5% [28.9% saw a GP only; 13.6% saw a GP and a specialist/pulmonologist]), and/or pulmonologists (18.0%). Among participants with OSA managed by a GP only (n=662), proportions (95% CI) with EDS were: PAP nonuse (49% [42.8–54.9]), nonadherent (47% [31.5–63.2]), intermediate (47% [33.4–60.8]), and highly-adherent (35% [29.3–39.9]). Linear modeling (PAP users; n=398) showed an additional h/night of PAP use was associated with lower ESS scores (estimate [SE], –0.26 [0.13]; P<0.05); logistic regression showed association between PAP adherence and higher satisfaction with HCPs (adjOR=2.26; 95% CI=1.09–4.70; P<0.05) and OSA care (adjOR=1.58; 95% CI=0.75–3.36; P>0.05). There was an association between presence of EDS and lower satisfaction with their HCPs (adjOR=0.62; 95% CI=0.39–0.99; P<0.05) and OSA care (adjOR=0.49; 95% CI=0.31–0.79; P<0.05).

Conclusion

In a real-world population of participants with OSA receiving OSA care from GPs, EDS was common, even among highly-adherent PAP users. ESS scores were generally lower with increasing PAP adherence. PAP adherence was associated with increased satisfaction with their HCPs; EDS was associated with lower satisfaction with HCPs and overall OSA care.

Support (If Any)

Jazz Pharmaceuticals
0763 Couples-based treatment for OSA: Qualitative analysis of patient, bedpartner and provider perspectives
Authors: Troxel Wendy , DeVettori Giulia , Kharidia Shilpi , Gallaway Saydra , Watt Melissa , Sundar Krishna , Gilles Allyson , Baron Kelly
Published: May 2022

Introduction

Obstructive sleep apnea (OSA) and its treatment (positive airway pressure; PAP) impacts both patient and bedpartner health and their respective quality of life. Despite the effectiveness of PAP at treating OSA and evidence that PAP adherence benefits both patient and partner, over half of OSA patients are not adherent. Thus, non-adherence to OSA treatment is a couple-level problem, with significant health impacts for both parties. However, bedpartners are rarely integrated into OSA treatments. The current study presents a qualitative analysis of patients, bedpartners, and provider perspectives to inform a novel, couples-based intervention to promote adherence to PAP and sleep health for the couple.

Methods

We conducted 3 focus group discussions with patients and their partners, and 3 focus group discussions with sleep medicine providers. Focus groups utilized a standardized interview guide to examine: 1) impact of OSA and PAP treatment on the couple, 2) interdependence of sleep and 3) feasibility of a couples-based sleep health and PAP adherence intervention. Transcripts were transcribed and analyzed using thematic analysis using Dedoose. A thematic analysis process coded for emerging themes across a deductive framework.

Results

Participants included 7 heterosexual couples, 2 patients who participated without their partners and 9 sleep medicine providers (1 nurse practitioner, 3 PSG techs and 5 sleep medicine physicians). Results demonstrated awareness of how sleep impacts patient and partner mood, next day functioning, and relationship quality. Patients and partners reported working together using a variety of strategies to overcome challenges to OSA treatment. Couple-level barriers to treatment were discussed, including sleep disruptions from PAP and the impacts of treatment on intimacy. Providers reported the utility of involving partners in the sleep evaluation and during equipment set up. Couples-based treatment was viewed as helpful for facilitating adjustment and adherence to PAP, particularly to help patients trouble-shoot common challenges, such as adjusting to the mask. However, providers expressed some concerns about couples-based treatment among couples with poor relationship quality.

Conclusion

Results demonstrate the impact of OSA on the couple and awareness of the importance of including partners in the adjustment to PAP treatment. Findings will be discussed in the context of developing novel behavioral interventions for older adults who face a variety of sleep health issues, in addition to sleep apnea, and in recognition of the dyadic nature of sleep for most adults.

Support (If Any)

1 R21 AG067183-01A1
0765 Enhanced Response to Targeted Hypoglossal Nerve Stimulation in Patients with Normal Sleep Efficiency: A THN3 Post-Hoc Analysis
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 , Shen John , Maurer Joachim
Published: May 2022

Introduction

THN3 was the first reported parallel-arm, randomized controlled trial of hypoglossal nerve stimulation (HGNS), wherein targeted HGNS (THN) was shown to be safe and efficacious at ameliorating sleep disordered breathing in selected patients with moderate to severe OSA and BMI≤35kg/m2 without screening with drug-induced sleep endoscopy. A secondary THN3 objective was to identify baseline characteristics which enhance therapeutic response.

Methods

Predictors of long-term (Month 12/15) apnea-hypopnea index (AHI) response (reduction ≥50% to ≤20/hr) were identified in stages. Baseline characteristics, including polysomnography parameters, were screened one at a time using univariate logistic regression. Variables significant at α=0.25 were further selected using stepwise multivariate logistic regression. Candidate predictors were then optimized by manual, incremental threshold adjustment to maximize AHI response rate (RR). Optimized predictors were ranked according to the AHI RR and size of the corresponding subpopulation, with a goal of capturing at least 40% of the overall THN3 cohort.

Results

Baseline sleep efficiency (SE) in the normal range (>85%) achieved the highest AHI RR while retaining 42% (58/138) of the THN3 cohort. Similar to the overall study population, subgroup subjects were predominantly middle-aged (age 54±7 years), male (83%), Caucasian (86%) and overweight/obese (BMI 30±3 kg/m2). Short-term (Month 4) AHI RRs in the Treatment and Control groups were 59.5% and 20.0%, respectively, with long-term AHI RR at 50.9%. Median AHI was reduced from 35.1 to 16.0, as compared to 29.3 to 9.0 in the STAR trial of distal HGNS. ODI RRs (reduction ≥25%) for Treatment and Control were respectively 73.0% and 30.0% at Month 4 and 64.9% at Month12/15. Enhanced response carried through to larger point estimates for improvement in secondary variables, including the Epworth Sleepiness Scale and the Functional Outcomes of Sleep Questionnaire, exceeding minimum clinically important differences thresholds of 2-3 and 1.7-2.0, respectively.

Conclusion

Normal SE at Baseline was associated with enhanced AHI and ODI RR as well as patient-reported outcome measures for patients receiving THN therapy, providing results similar to those obtained with distal HGNS. Future studies, including the ongoing OSPREY trial, will be needed to prospectively validate these findings.

Support (If Any)

LivaNova
0767 Clinical implementation of a program to improve PAP acceptance and adherence for sleep disordered breathing among Veterans: Preliminary results
Authors: Kelly Monica , Moghtaderi Isabel , Zhu Ruoyan , Yuan Nathaniel , Sarrami Kayvon , Patel Jay , Moshtagh-Sisan Mahtab , Alessi Cathy , Zeidler Michelle
Published: May 2022

Introduction

Positive airway pressure (PAP) is the gold standard in treating sleep disordered breathing (SDB); however, consistent use of this therapy has challenges such as comfort and equipment optimization. Despite various educational, technological, psychosocial and pharmacological strategies, the average adherence rate of 34% have changed very little over the past 20 years. A recent study of 3013 US veterans determined a baseline average PAP adherence rate of 50%. We developed and implemented a novel PAP readiness education program (PREP) for veterans newly diagnosed with SDB in a Veterans Administration sleep clinic to promote greater PAP acceptance and adherence.

Methods

Patients (N=63, Mean age 62.2±12.4 years) with newly diagnosed SDB were offered a 1-hour telehealth session prior to initiating PAP therapy that included psychoeducation about SDB and PAP treatment expectations, with troubleshooting techniques (i.e. scheduled practice, mindfulness). A 1-week follow-up call was conducted to communicate PAP data and address treatment barriers. PAP use reports were downloaded and analyzed at 1-7 days (first week), 1-30 days (first month), and 31-60 days (60-days) post-PAP initiation. PAP acceptance was defined as ≥1 day of use and adherence as ≥4 hours of use at each timepoint.

Results

Among 63 Veterans offered PREP, 66.6% (n=42) participated in PREP. Among participants, acceptance of PAP was as follows: 57.1% used ≥1 day in the first week, 64.3% used ≥1 day in the first month, and 45.2% used ≥1 day at 60-days post-PAP initiation. Percent of days with use ≥4 hours was 28.9% ±30.4 in the first week and 24.9% ±30.0 in the first month. PAP adherence at 60-days post-PAP initiation was 34.3% ±38.5 at 60-days.

Conclusion

Implementation of a 1-session plus 1-week follow-up call PAP readiness education program within a sleep medicine clinic was well received by patients and resulted in PAP acceptance by 2/3 of veterans in the first month post-PAP initiation. PAP adherence results may have reflected the impact of a nationwide PAP device recall that occurred during the study period. Further work is needed to test this intervention in a clinical population and to identify predictors of PAP acceptance and adherence in real-world clinical settings.

Support (If Any)

AASM Foundation #211-FP-19, VAGLAHS GRECC and CSHIIP
0768 A Million Dreams: Improving Compliance and Treatment of Obstructive Sleep Apnea via Upper Airway Stimulation Therapy. Real-World Outcomes
Authors: Goss Deborah , Ashtyani Fariborz , Ashtyani Laura , Martinez Maria , Leadley Lauri , Patterson Patricia , Moore David , Stevens Damien , Faber Kevin , Lee Kent , Araujo Matheus
Published: May 2022

Introduction

Patient compliance to continuous positive airway pressure (CPAP) has been about 50% at 4-years despite numerous improvements in mask design, flow algorithms, education, and monitoring software. Compliance, however, is not equivalent to efficacy. Upper Airway Stimulation (UAS) is an alternative for select CPAP intolerant patients. We used a patient management platform to track UAS compliance and efficacy.

Methods

Anonymized, aggregated device usage and outcomes data was analyzed from a HIPAA compliant patient management platform (Inspire Cloud, Inspire Medical Systems, Golden Valley MN) through October 2021. Demographic data is not collected. We used this database to understand therapy outcomes. Data are presented as mean and standard deviation, unless otherwise noted.

Results

There were 1.74 million usage nights for 5,709 patients across 550 clinics. Patients increased median stimulation amplitude from 1.4 to 2.2 volts between activation to 90 days after activation. Typical therapy was activated at 11:44pm, and turned off at 5:51am, with one 13-minute pause per night, and therapy was on 89% of nights.Usage was 5.5 ± 1.8 hours per nights overall, and 6.0 ± 1.9 hours per night used. At 90 days, 90% of patients had usage > 4 hours per nights overall, and 96% had usage > 4 hours per night used.Average pre-implant AHI was reduced from 35 ± 15 events/hour (n=2760), to 9 ± 12 (n=1609) after therapy. ESS was reduced from 11 ± 5 (n=1254) to 7 ± 5 (n=1164).

Conclusion

This data represents the first big-data reporting of UAS therapy usage in general clinical practice including nightly data. It demonstrates high nightly usage with minimal pauses and marked improvement in symptoms. It demonstrates the potential that CPAP intolerant patients with can be fully adherent with alternative therapy.

Support (If Any)

Statistical support provided by Inspire Medical systems.
0769 Comparison of Expiratory Pressures Generated by ULTepap, Provent, Bongo Rx, and Theravent EPAP Devices: A Laboratory Bench Testing
Authors: Sleeper Geoffrey , Rashidi Majid , Strohl Kingman , Najimi Neda , Ghoul Rawad El , Chiang Ambrose
Published: May 2022

Introduction

Expiratory positive airway pressure (EPAP) has been a treatment option for patients with obstructive sleep apnea (OSA). Among devices like Provent, Theravent, and Bongo, ULTepap is a new FDA-cleared EPAP device that seals around the nares with a nasal pillow interface. Comparisons among the expiratory pressures that these devices might generate are not available. Research Question: Are expiratory threshold therapy devices equivalent in generating backpressure in an expiratory direction?

Methods

A test rig was designed and fabricated to test the pressures generated by ULTepap, Provent, Theravent, and Bongo Rx. Airflow was generated by a linear actuator-driven piston in a syringe, and a range of flow rates was provided by varying the voltage input to the actuator. The resulting pressures were measured in an expiratory and inspiratory direction.

Results

The backpressures produced by ULTepap and Provent were comparable at flow rates of 99/142/212 ml/sec (average 3.5/7.5/13.8 cmH2O for ULTepap vs 4.5/8.5/14.5 cmH2O for Provent, p=0.7918). Bongo Rx and Theravent devices produced substantially lower backpressures than ULTepap devices (average 0.8/1.8/3.5 cmH2O for Bongo Rx and 0.9/2.2/5.3 cmH2O for Theravent at flow rates of 99/142/212 ml/sec, p=0.0138 and 0.0404, respectively). In comparison, all four devices presented very low inspiratory flow resistance, with all generating 0.5 cmH2O or less at all flow rates.

Conclusion

Not all FDA-cleared EPAP devices produce similar expiratory pressure profiles. ULTepap generated backpressures closest to that of Provent. Clinical trials comparing the efficacy, tolerance, and role of these EPAP devices in patients with OSA are warranted.

Support (If Any)
0773 When CPAPs are in Short Supply: A Review of Other FDA Approved OSA Interventions
Authors: Zamora Tania , Deering Sean , Stepnowsky Carl
Published: May 2022

Introduction

The CPAP recall of 2021 has highlighted an inherent problem that occurs when a field of medicine is overly dependent on a single class of medical devices to treat a condition. The global shortage of CPAP devices has led to numerous individuals with OSA being unable to obtain a CPAP machine to treat their condition, including those with severe OSA. CPAP is well known to be efficacious in treating OSA, but has limited effectiveness, particularly for mild-to-moderate cases. It has been reported that there are nearly 200 different medical devices approved by the FDA to treat OSA. The goal of this project was to search the FDA databases to investigate the number of devices currently on file with the FDA. A secondary goal was to examine the range of FDA product categories for the treatment of OSA.

Methods

An FDA database (AccessGUDID; https://accessgudid.nlm.nih.gov) with a release date of December 1, 2021 was searched for devices that are approved for the treatment of sleep apnea. The text string “sleep apnea” was used for the search. Diagnostic devices, duplicate versions of the same treatment devices, and device accessories were excluded from the total counts. The FDA classifies medical devices into three categories (I, II, III), with a higher classification level indicating greater risk to patients.

Results

The FDA AccessGUDID database search returned 166 results, which resulted in 72 unique devices across 10 product code categories. 9 of the 10 product codes in the FDA database were class II (medium risk) and 1/10 was classified as III (high risk). 65 of the devices were reported to be in commercial distribution at the time of the search and 7 were not.

Conclusion

This analysis found that a relatively large number of FDA-approved devices exist for the treatment of OSA across a range of product categories. The field is encouraged to develop a better understanding of which subgroups of OSA patients could benefit from alternative forms of treatment in an effort to diversify treatment options and reduce the field’s reliance on a single type of device, particularly for patients with mild-to-moderate OSA.

Support (If Any)

VA IIR 16-277
0776 The 2021 CPAP Recall. A Report from a Single Practitioner’s Experience
Authors: Rosenthal Leon
Published: May 2022

Introduction

CPAP is the gold standard in the treatment of OSA. While CPAP has been characterized as cumbersome, patients derive benefit from this therapy and many report inability to sleep without the use of CPAP. In this context, the 2021 CPAP recall has represented a major challenge for all stakeholders in the delivery and management of OSA. Patients have been the most affected by the uncertainties triggered by the recall. The purpose of this report is to evaluate continued therapy among patients who have been able to replace their PAP equipment.

Methods

Consecutive patients seen in follow-up visit following replacement of the recalled unit are included. At the time of writing, the cohort includes 49 patients (age 64+/- 10; BMI: 34 +/- 9; AHI: 35+/-26; male: 27). Prior to the unit replacement (T1), 20 were on Auto-PAP, 2 on Auto-BiPAP, and 23 on CPAP. Only 6 units have been replaced by the manufacturer with the remaining patients opting to have their units replaced with the other main brand available in the US. At follow-up (T2), only 4 continued CPAP, 2 on Auto-VPAP and the remaining on Auto-PAP. Replacement units were prescribed based on the previous settings with modifications based on the clinical assessment. For those on Auto-PAP (or bilevel settings), their pressures were not significantly different from baseline to follow-up (T1: minimum pressure 7.2+/-3; maximum pressure 10.8+/-4. T2: minimum pressure: 7.1+/-3; maximum pressure 11.5+/-3). For those on CPAP who have continued therapy with Auto-PAP, the T1 pressure was 8.8+/-3 and their 90-95% pressure at T2 was 9+/-3 cwp (p<0.01).

Results

The cohort showed adherence of 442+/-79 min at T1, which was increased at T2 (455+/-69, p<.05). 4-hr adherence was comparable at 94+/-9 and 96+/-9, respectively. The Epworth Sleepiness Scale (ESS) was comparable at T1 (4.3+/-3) and T2 (4.6+/-3). Of interest, the unit’s estimated AHI was improved at T2 1.9+/-2 when compared to T1 at 3.7+/-4 (p<0.01), which was not explained by type or brand of therapy. An unexpected finding was the differential improvement in the level of adherence between males and females where the change in adherence from T1 to T2 for males was 24+/-39 min, and for females 0.5+/-42.

Conclusion

Patients on CPAP therapy have faced significant challenges due to the 2021 recall from one of the main producing brands. The results of the study illustrate the slow response in the replacement of the recalled units. Only 12% of the units in the present cohort were replaced within the recall program. The results document the resilience of this cohort in maintaining a high therapeutic adherence despite the uncertainties created by the recent recall.

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0780 Continuous Positive Airway Pressure Adherence and the Risk of 30-day Hospital Readmission in Older Adults with Obstructive Sleep Apnea and Cardiovascular Disease
Authors: Bailey M Doyinsola , Wickwire Emerson , Albrecht Jennifer
Published: May 2022

Introduction

Obstructive sleep apnea (OSA) negatively impacts outcomes among patients with pre-existing cardiovascular disease (CVD). Evidence suggests treating OSA can prevent additional cardiovascular events and health care utilization, but the benefits of continuous positive airway pressure (CPAP) are strongly related to adherence. We evaluated the effect of adherence to CPAP on 30-day hospital readmissions among Medicare beneficiaries with OSA and pre-existing CVD.

Methods

We conducted a retrospective study of a 5% sample of Medicare beneficiaries aged ≥ 65 years with pre-existing CVD who were newly diagnosed with OSA, initiated CPAP 2009-2013, maintained continuous Medicare coverage for 24 months post-CPAP initiation, and had at least one hospitalization. Monthly indicators of CPAP adherence (charges for machines, masks, or supplies) were summed over 25 months to create a CPAP adherence variable and then beneficiaries categorized as low, partial, or high adherers (i.e., <4, 4-12 and >12 CPAP charges, respectively).The primary outcome was the risk of 30-day readmission. Bivariate associations were assessed between CPAP adherence status, covariates, and potential confounders. Odds ratios (OR) with 95% confidence intervals (CI) were estimated using logistic regression models, controlling for demographic factors, and pre-existing comorbidities. Statistical significance was assessed at p < 0.05.

Results

We identified 1,301 beneficiaries meeting study criteria. The mean age was 73±6 years, 87% were White (n=1,137), and 53% were male (n=684). In the 2-year period following CPAP initiation, the overall 30-day readmission rate was 10.2%. Beneficiaries who were readmitted were more likely to be male and with a higher comorbidity burden. In adjusted models and compared to patients with low CPAP use (<4 charges), those with partial use (4-12 charges) and high use (>12 charges) had a lower odds of 30-day readmission (OR = 0.82, 95% CI 0.53-1.23 and OR = 0.41, 95% CI 0.24-0.70).

Conclusion

In this nationally representative sample of older adults with CVD and comorbid OSA, higher CPAP use was associated with decreased odds of 30-day readmission, highlighting the importance of adherence in mitigating negative outcomes.

Support (If Any)

This work is supported by an investigator-initiated grant and a diversity supplement from the American Association of Sleep Medicine Foundation (Albrecht, PI).
0786 Assessing the Adequacy of Auto Titrating Positive Airway Pressure Treatment in Patients with Severe Obstructive Sleep Apnea Diagnosed on Home Sleep Testing
Authors: Burcovschii Serghei , Beshay Sarah , Majid Ruckshanda , Mathew Reeba
Published: May 2022

Introduction

Auto titrating positive airway pressure (Auto-PAP) therapy has been increasingly prescribed to treat obstructive sleep apnea (OSA) without reliance on in-laboratory PAP titration studies. Given the current pandemic and the limited use of in laboratory titrations, Auto-PAPs have been prescribed increasingly. The ability to achieve optimal control of obstructive events with Auto-PAP for patients with severe OSA (respiratory disturbance index (RDI) >30/hour of recording) on home sleep apnea testing (HSAT) has not been systematically investigated. Our study looks at the success of treatment on Auto-PAP in patients diagnosed with severe OSA on HSAT.

Methods

We retrospectively reviewed charts of patients who were diagnosed with severe OSA on HSAT and were prescribed an Auto-PAP at the Memorial Hermann – Texas Medical Center Sleep Disorders Center between September 2019 and May 2020. The usage data, residual AHI and adherence was assessed. Successful treatment was determined as a residual AHI (rAHI) <15. We excluded patients those who were non-adherent to PAP therapy. This study was conducted as a quality improvement initiative at our institution.

Results

We identified 24 patients diagnosed with severe OSA on HSAT and prescribed Auto-PAP. Nine patients were excluded due to non-adherence to Auto-PAP (37%). Of the remaining 15 patients, 80% were male, the average age was 53.7 years (range 36-69) and the average RDI on HSAT was 51.4 events/hour (SD 17.1). The average usage >4 hours was 76% in the adherent patients. The median pressure on Auto-PAP was 9 cm H2O (range 5.3-16.3). The average rAHI of 1.8 events/hour (range 0.3- 6.1). Usage data revealed only 1 patient with rAHI>5 and central apnea index of 3.9, who was then referred for an in-lab PAP titration study.

Conclusion

Sensors in the airway circuit of PAP devices measure airflow, vibration, and flattening of the airflow profile. Auto-adjusting PAP devices use this feedback to make online adjustments in pressure to maintain upper airway patency. Our study suggests that Auto-PAP is an effective initial therapy even for severe OSA, permitting both timely and adequate control of OSA especially when in laboratory titrations are limited. Close monitoring is however recommended to ensure adherence, and also to assess the potential emergence of central events.

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0787 Healthcare Utilization in Initiation of Oral Appliance vs Positive Airway Pressure Therapy for Sleep Apnea
Authors: Stothard Ellen , Hickey Mark , Wertz Adam
Published: May 2022

Introduction

The COVID-19 pandemic and related supply chain issues have created shortages in integral components of Positive Airway Pressure (PAP) devices, the gold standard treatment for sleep apnea. Concurrently, patients have delayed care and are returning in increasing numbers. With these overlapping pressures, alternative treatments are needed. Custom-fabricated Oral Appliances (OA) are uniquely poised as a solution. However, it is unknown if initiation and treatment cost and healthcare utilization are similar to PAP or will create further disruptions at scale.

Methods

Patients who initiated PAP or OA therapy 2018-2020 were included. Matched visits 2017-2021 were referenced. Patients with multiple treatment initiations were excluded. Healthcare utilization quantified number visits, stratified by provider type (Physician, Physician Assistant (PA), American Board of Dental Sleep Medicine (ABDSM) Accredited Dentist, or Registered Polysomnographic Technologist (RPSGT)). Contractual amounts for CPT codes were averaged to estimate cost.

Results

5172 patients, 374 received OA (7.2%). Prior to initiation, OA therapy utilized more visits on average than PAP (4.5±1.7(±SD) vs 3.5±1.9, p<0.0001). Following initiation, OA therapy utilized fewer visits than PAP (4.1±3.9 vs 5.5±4.6, p<0.0001). Specialized provider visits, i.e. dentist for OA, were lower compared to RPSGT for PAP therapy, both before and after initiation (1.4±0.8 vs 2.0±1.4 before, 1.9±1.2 vs 2.6±1.8 after, both p<0.0001). Further, prior to initiation, Physician and PA utilization was similar between OA and PAP therapies (1.4±0.8 vs 1.5±1.0 Physician, 1.1±0.8 vs 1.2±0.8 PA, both p>0.057). However, following initiation, OA therapy utilized fewer Physician visits than PAP (1.7±1.1 vs 2.1±1.7, p<0.0001) but similar PA visits (1.9±1.5 vs 2.1±1.4, p>0.5). Together, with OA dental visits estimated to be the least expensive associated visit, this analysis estimates that the provider cost of initiation of OA therapy is lower than that of PAP.

Conclusion

Overall, OA therapy requires less healthcare utilization, especially of providers with highest reimbursement rates. While OA requires more initial appointments, PAP therapy requires more follow up visits with specialized providers and physicians, thereby increasing cost for patients. Additional cost burden of these visits could impact patient willingness to initiate treatment. This analysis provides supportive evidence for OA as an alternative to PAP with lower treatment cost and healthcare utilization, which may provide an advantage for the already over-burdened healthcare system.

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0789 Mask Magnets May Interact with Pacemakers and Implantable Cardioverter-Defibrillators
Authors: Ruoff Chad , Tashman Yasemin , Miller Bernie , Houser Ryan , Cheema Kamal , Haley Caitlin , Petersen Ann , Lizak Matthew , Goswami Umesh , Lizak Trevor , Krahn Lois , Srivathsan Komandoor
Published: May 2022

Introduction

Placing a magnet over a Permanent Pacemaker (PPM) or Implanted Cardioverter-Defibrillator (ICD) may cause the device to pace asynchronously or inhibit tachyarrhythmia detection, respectively, potentially preventing delivery of electrical shocks. Manufacturers for masks used with positive airway pressure devices have started using magnets in place of more traditional headgear clips to connect the headgear to mask. Mask manufactures do not list presence of a PPM/ICD as a contraindication to use of a mask with magnet but do recommend keeping the mask some distance away from PPM/ICD. A published case series describes two patients with magnet response events captured during PPM/ICD interrogation that correlated with nightly use of CPAP. The authors were able to replicate the response by placing the mask with magnet directly over the patient’s pulse generate site. Although we advise all patients with implanted device to avoid use of masks with magnets, select patients refuse to stop using mask with magnets regardless of our policy. We, therefore, started offering these patients referral for PPM/ICD interrogation to evaluate for an interaction between mask with magnet and PPM/ICD as next best alternative.

Methods

We retrospectively reviewed all patients (n=10) referred for routine PPM/ICD interrogation to test whether the mask with magnet interacted with PPM/ICD when mask on face as during normal use (i.e., simulated normal use) or magnetic area of mask placed directly over the PPM/ICD (i.e., direct contact).

Results

Although no interaction was detected in any patient (n=10) with simulated normal use (0 %), one interaction was documented with direct contact (10 %).

Conclusion

Although simulated normal use of masks with magnets did not demonstrate any interactions, it is concerning that one patient (10 % of patients) demonstrated an interaction with direct contact of magnetic area of mask over the PPM/ICD. It is not uncommon for patients to remove a mask during the night while sleeping. This preliminary data along with the published case series calls for further research and increased awareness of this potential interaction for both sleep and cardiac health care providers.

Support (If Any)

None