bluuebunny/crossref_metadata_2025_split huggingface dataset:
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

Abstract

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&lt;.05). Intervention participants had more PAP use and lower (better) PSQI scores at 6-months (all p&lt;.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&lt;.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&lt;.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

Abstract

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 (&lt;4 h/night, &lt;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&gt;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&lt;0.05); logistic regression showed association between PAP adherence and higher satisfaction with HCPs (adjOR=2.26; 95% CI=1.09–4.70; P&lt;0.05) and OSA care (adjOR=1.58; 95% CI=0.75–3.36; P&gt;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&lt;0.05) and OSA care (adjOR=0.49; 95% CI=0.31–0.79; P&lt;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

Abstract

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

Abstract

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 (&gt;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

Abstract

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

Abstract

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 &gt; 4 hours per nights overall, and 96% had usage &gt; 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

Abstract

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

Abstract

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

Abstract

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&lt;0.01).

Results
The cohort showed adherence of 442+/-79 min at T1, which was increased at T2 (455+/-69, p&lt;.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&lt;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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