bluuebunny/crossref_metadata_2025 huggingface dataset:
419 STOP-Bang Score and History of Radiation Predicts Risk of Obstructive Sleep Apnea in Cancer Patients: A Machine Learning Study
Authors: Paul Ankita , Wong Karen , Das Anup , Lim Diane , Tan Miranda
Published: May 2021

Introduction

Cancer patients are at an increased risk of moderate-to-severe obstructive sleep apnea (OSA). The STOP-Bang score is a commonly used screening questionnaire to assess risk of OSA in the general population. We hypothesize that cancer-relevant features, like radiation therapy (RT), may be used to determine the risk of OSA in cancer patients. Machine learning (ML) with non-parametric regression is applied to increase the prediction accuracy of OSA risk.

Methods

Ten features namely STOP-Bang score, history of RT to the head/neck/thorax, cancer type, cancer stage, metastasis, hypertension, diabetes, asthma, COPD, and chronic kidney disease were extracted from a database of cancer patients with a sleep study. The ML technique, K-Nearest-Neighbor (KNN), with a range of k values (5 to 20), was chosen because, unlike Logistic Regression (LR), KNN is not presumptive of data distribution and mapping function, and supports non-linear relationships among features. A correlation heatmap was computed to identify features having high correlation with OSA. Principal Component Analysis (PCA) was performed on the correlated features and then KNN was applied on the components to predict the risk of OSA. Receiver Operating Characteristic (ROC) - Area Under Curve (AUC) and Precision-Recall curves were computed to compare and validate performance for different test sets and majority class scenarios.

Results

In our cohort of 174 cancer patients, the accuracy in determining OSA among cancer patients using STOP-Bang score was 82.3% (LR) and 90.69% (KNN) but reduced to 89.9% in KNN using all 10 features mentioned above. PCA + KNN application using STOP-Bang score and RT as features, increased prediction accuracy to 94.1%. We validated our ML approach using a separate cohort of 20 cancer patients; the accuracies in OSA prediction were 85.57% (LR), 91.1% (KNN), and 92.8% (PCA + KNN).

Conclusion

STOP-Bang score and history of RT can be useful to predict risk of OSA in cancer patients with the PCA + KNN approach. This ML technique can refine screening tools to improve prediction accuracy of OSA in cancer patients. Larger studies investigating additional features using ML may improve OSA screening accuracy in various populations

Support (if any):
430 Outcome of Sleep-Wake Pattern in Obstructive Sleep Apnea Patients after Positive Airway Pressure Therapy using Actigraphy
Authors: Luekitinun Narumol , Panjapornpon Kanlaya , Plurksathaporn Pattharaphong , Tangsrikertikul Rungaroon , Tongkien Wanlana , Pungtaway Sunsanee , na Mahasarakam Siwaporn Pawaphutanon , Singpeam Rungridee , Pinthong Pairaya
Published: May 2021

Introduction

The initial phase of continuous positive airway pressure (CPAP) therapy in patients with obstructive sleep apnea (OSA) may affect sleep parameters and PAP compliance. Actigraphy is a validated method using accelerometer to objectively measure sleep parameters in patients with a range of sleep disorders, including OSA, particularly to follow-up after treatment. We compare sleep parameters from actigraphy, sleep log, sleep diary, Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), heart rate and blood pressure in OSA patients before and after CPAP therapy for 1 week.

Methods

This pilot study have been prospectively performed at Central Chest Institute of Thailand (CCIT) since June to November 2020. Adult OSA patients, diagnosed by ICSD-3 criteria and achieved optimal or good CPAP pressure titration from split-night polysomnography (PSG), were informed and consent to wear actigraphy before and after CPAP therapy each for 1 week. Clinical and sleep parameters were recorded and analyzed using Wilcoxon matched-pair signed-rank and Mann Whitney U test. P-value < 0.05 was considered to have statistical significance.

Results

All 11 OSA patients participated in this study. Most patients were male (63.6%), hypertension (54.5%) and dyslipidemia (45.4%). Means of age, body mass index (BMI), ESS, PSQI, apnea hypopnea index (AHI), nadir SpO2, and CPAP usage were 45.5 ± 15.9 years, 29.1 ± 5.2 kg/m2, 10.8 ± 3.9, 7.7 ± 2.9, 65.2 ± 37.7 events/h, 82.3 ± 10.8 % and 9.5 ± 3.1 cmH2O, respectively. Comparing before and after 1-week CPAP therapy, an average number of wake bouts ((NWB), 48.4 vs 38 events, p=0.010), ESS (11 vs 9, p=0.035) and PSQI (8 vs 4, p=0.005) were significantly decrease. Additionally, when comparing between poor and good CPAP compliance group, NWB (55.1 vs 36.3 events, p=0.036) and the difference of wake after sleep onset (WASO, 10.5 vs -0.11 min, p=0.035) were significantly decrease.

Conclusion

OSA patients treated with CPAP for 1-week experienced marked improvement in sleepiness, sleep quality and nighttime awakening.

Support (if any):
432 Brain Structure and Baroreflex Sensitivity Associations in Obstructive Sleep Apnea with and without CPAP
Authors: Pal Amrita , Martinez Fernando , Aysola Ravi , Harper Ronald , Henderson Luke , Macey Paul
Published: May 2021

Introduction

Obstructive sleep apnea (OSA) disrupts multiple aspects of autonomic regulation; it is unclear whether intervention with continuous positive airway pressure (CPAP) can correct such disruptions. One key index of autonomic regulation is baroreflex sensitivity (BRS), an index that indicates heart rate (HR) changes to blood pressure (BP) alterations, and which is a significant measure for evaluating long-term cardiovascular changes induced by OSA. BRS can be assessed from BP and HR changes during an autonomic challenge task such as handgrip (HG). In a cross-sectional study, we assessed BRS during HG in untreated OSA (OSA_un) and CPAP treated OSA (CPAP), together with healthy control (CON) participants to determine if CPAP can recover BRS.

Methods

We collected ECG and continuous beat-by-beat BP from 95 people: 32 newly-diagnosed OSA_un (51.5±13.9years; AHI 21.0±15.3events/hour; 20male); 31 CPAP (49.4±14.0years; 22.4±14.1events/hour in initial diagnosis; 23male); and 32 CON (44.1±13.8years; 10male). We acquired data over 7 mins, during which people performed three 30s HGs (60 s baseline, 90 s recovery, 80% maximum strength). We calculated BRS over the 7 min period using sequence analysis in AcqKnowledge 5.0 BRS, followed by group comparisons using ANOVA. We also analyzed BP, HR, and their variabilities: BPV and HRV (sympathetic-vagal).

Results

Mean arterial BP increases during HG were similar in all groups, although baseline mean arterial BP was higher in OSA_unc and CPAP, relative to CON (p < 0.05; OSA_un:mean±std, 90±11mmHg; CPAP: 88±10mmHg; CON 82±13mmHg). BRS was lower in OSA_un and CPAP, relative to CON (p < 0.05; OSA_un: 13.1±7.6 ms/mmHg; CPAP: 13.7±9.0 ms/mmHg; control 18.3±11.9 ms/mmHg). Other cardiovascular measures of BPV, HR, and HRV in addition to BP showed significant increases in response to HG, but these changes were similar in all 3 groups.

Conclusion

BRS during HG was reduced in both OSA_un and CPAP compared to CON, while HG evoked similar overall changes in BP and HR in all three groups. Although CPAP reduces sympathetic tone measured as Muscle Sympathetic Nerve Activity (MSNA), BRS appears to be unaffected by the intervention. Irreversible changes in the baroreflex network may occur with OSA that are not altered with CPAP usage.

Support (if any)

NR-017435, HL135562
434 Precision Oral Appliance Therapy: The Prime-Time Treatment for OSA
Authors: Sall Edward
Published: May 2021

Introduction

CPAP was previously considered the “gold standard” due to its high efficacy in eliminating obstructive events. Despite improvements in technology, the “effectiveness” of CPAP has been compromised by poor real-world compliance. Technological improvements have improved the “effectiveness” of Oral Appliances. This study reports the efficacy of a novel, precision engineered Oral Appliance for the primary treatment of all severities of OSA.

Methods

Digital scans and digital bite registrations were recorded with a George Gauge utilizing a a 3mm bite fork. Initial protrusion was set at 40–60% and varied according to the degree of overbite and overjet, the severity of OSA, and the presence or absence of TMJ symptoms. All patients were fitted with a ProSomnus (IA) MAD and titrated according to their subjective symptoms. An efficacy study was obtained with a HST after titration and compared to the initial PSG or HST.

Results

Outcome data on 85 patients (37 female, 48 males, aged 56.7 +/1 10.2 years) was retrospectively reviewed. The patients were consecutively ordered for follow up data, many patients did not return for follow ups. The pre-treatment AHI was 24.5 +/- 19.1 with 36 patients Mild, 26 Moderate and 23 Severe patients. O2 Nadir was 84.1% +/- 5.5%. Post treatment AHI was 5.5 +/- 4.9 with an AHI reduction of 71.6% +/- 20.3%. 59% of the patients scored <5, 31% 10 on the outcome AHI data. O2 Nadir improved to 88.2% overall. 31 patients had RERA’s (RDI-AHI) >10 with an average of 16.7 +/- 7.5, of these patients 27 saw a reduction of RERA’s of 54.4% from 16.9 to 7.1.

Conclusion

The data shows that a precision oral appliance is capable of successfully treating patients with all levels of severity, with the majority of patients treated to an AHI<5. 23 severe patients with an average AHI of 49.7 were treated to a final average of 8.6, 4 of the patients scored above 10. Additionally, patients successfully saw a reduction in upper airway resistance airflow as evidenced by a reduction of RERA’s of 54.5%, showing that a precision oral appliance can have a significant impact on the upper airway.

Support (if any)

None
436 Obstructive Sleep Apnea Treatment (e.g., CPAP) Differential Effects on Cognitive Performance
Authors: Hlaing Ei , Dollinger Stephanie Clancy , Brown Terry
Published: May 2021

Introduction

The efficacy of CPAP treatment for cognitive improvement among patients with OSA is inconsistent. Naegele et al. (1995) found that short term memory impairment persisted even after 4 to 6 months of CPAP; O’Donoghue et al. (2012) have reported they did not find improvement in vigilance or memory; Felver-Grant (2007) found that working memory improved but not other cognitive tests. Kanbay et al. (2015) found patients improved on the MMSE scores after 3 months of CPAP treatment. Kim et al. (2018) claimed just 3 weeks of CPAP treatment improved attention, sleep quality, and excessive daytime sleepiness (EDS). CPAP therapy has little effect on the improvement of cognitive deficits associated with OSA if the patients did not complain of daytime sleepiness (Zhou et al,, 2016).

Methods

Both untreated OSA patients (N=19) and ApneaLinkTM- screened controls (N=16) were administered a battery of cognitive tests before the patients started using CPAP and these two conditions were tested again after 3 months of CPAP treatment. A Fisher’s Exact Chi-Square test was used to determine if there was an association between conditions (OSA patients vs. Controls) and level of performance on cognitive tests (low vs. high scores) at the baseline and after 3 months of treatment.

Results

Depression scores, subjective sleep quality scores (global PSQI), EDS scores (Epworth Sleepiness Scale), and mood disturbance (Profile of Mood States) decreased after 3 months of CPAP treatment just for patients. Controls (individuals without moderate or severe OSA) performed better at the second time on phonemic fluency, immediate recall memory test, and 30 minute delayed memory recall test.

Conclusion

The fact that patients did not do better at time 2 on any of the cognitive tests may indicate a long term effect of hypoxia on the brain. The cognitive deficits may not reverse within the first 3 months of CPAP although self-reported depressive symptoms and perception of sleep quality and positive mood have improved when patients reported they are compliant with the treatment.

Support (if any)

A grant from the Center for Integrative Research on Cognitive Neural Science, Southern Illinois University Carbondale was received.
439 Continuous Positive Airway Pressure and Cardiovascular Risk in a Large Clinical Sample of Obstructive Sleep Apnea Patients
Authors: Mazzotti Diego , Chen Aiyu , An Jaejin , Arguelles Jessica , Keenan Brendan , Maislin Greg , Sawyer Amy , Glick Henry , Pack Allan , Hwang Dennis , Shi Jiaxiao
Published: May 2021

Introduction

While studies support the beneficial short-term role of continuous positive airway pressure (CPAP) therapy on cardiometabolic risk in adults with obstructive sleep apnea (OSA), its sustained effect on cardiovascular disease (CVD) risk is unknown. CPAP use data linked to electronic health records (EHR) offer opportunities to understand the role of OSA treatment for preventing CVD. We evaluated the association between CPAP use and CVD incidence in patients referred to a sleep study at a large health system.

Methods

We included adult patients with available apnea-hypopnea index (AHI) between 01/2018-02/2020 in Kaiser Permanente Southern California. At baseline, eligible participants had >1 year of continuous insurance coverage allowing gaps <90 days and were free of CVD 1 year prior to OSA diagnosis. Participants were distributed into three groups: no OSA (AHI<5), OSA (AHI≥5) with any CPAP use (median[IQR] 2.5[0.7–5.0] h/day) and OSA without evidence of CPAP use. CVD incidence was defined as first occurrence of myocardial infarction, stroke, unstable angina, heart failure or CVD death, based on validated EHR algorithms. We used Cox proportional hazards models to assess the association between OSA with or without CPAP use and CVD incidence, adjusted for baseline age, sex, body mass index, race/ethnicity, Charlson comorbidity index, and use of anti-hypertensives and lipid-lowering medications. Stratified analyses were conducted based on OSA severity.

Results

We included 11,145 patients without OSA, 13,898 with OSA and CPAP use, and 20,884 patients without CPAP use. Median follow-up was 262 days (IQR=129–409). CVD incidence rates were, respectively, 0.26%, 0.45% and 0.56%. In adjusted models, moderate-severe OSA (AHI≥15) without CPAP use was associated with increased CVD incidence when compared to no OSA (HR=1.71; 95%CI=1.11–2.64; p=0.016). OSA with any CPAP use was associated with lower CVD incidence (HR=0.68; 95%CI=0.50–0.93; p=0.016) when compared to OSA patients with no CPAP use. Stronger effects were observed when restricting the sample to moderate-severe OSA (HR=0.56; 95%CI=0.39–0.81; p=0.002).

Conclusion

Our analysis in a large observational clinical sample suggests that moderate-severe OSA with no CPAP use is associated with increased CVD incidence. Moreover, OSA with CPAP use was associated with decreased CVD incidence relative to no CPAP use.

Support (if any)

AASM Foundation (194-SR-18;205-SR-19); AHA (20CDA35310360).
445 Predictors of the accuracy of positive pressure therapy machine-detected apnea-hypopnea events
Authors: Ni Yuenan , Thomas Robert
Published: May 2021

Introduction

During positive airway pressure (PAP) therapy for sleep apnea syndromes, the machine detected apnea hypopnea index (AHI) is an important method for clinicians to evaluate the beneficial effects of PAP. There are concerns about the accuracy of this detection, which also confounds a related question-how common and severe are residual events on PAP. Our study aimed for estimating the long term accuracy of machine detected AHI and the predictors.

Methods

Subjects with OSA who underwent a split night polysomnography were recruited prospectively. Those treated with PAP and tracked by the EncoreAnywhereTM system were analyzed. The ones who stopped PAP within one month were excluded for this analysis. Compliance, therapy data and waveform data were analyzed. Machine detected versus manually scored events were compared at the 1st, 3rd, 6th and 12th month from PAP initiation, and logistic regression was done to explore the factors associated with a high AHI difference.

Results

One hundred and seventy-two patients with mean age of 58.79 ± 13.80 and 63.4% male were included. The differences between the machine detected AHI and manual scored AHI was 10.72 ±8.43 in the first month and were stable for up to 12 months. Male sex, large leak ≥ 1.5% of the whole night, titration arousal index ≥ 15 times/hour, and higher ratio of unstable breathing were associated with AHI difference ≥ 5 times/hour.

Conclusion

The limited agreement between machine detected AHI in the tracking system and manually scored AHI persists for up to 12 months. Gender, large leak, the amount of unstable breathing on PAP, and arousal index during the titration were factors associated with this inaccuracy.

Support (if any)

positive airway pressure, apnea hypopnea index; detection accuracy
448 Association between Positive Airway Pressure Adherence and Healthcare Costs
Authors: An Jaejin , Glick Henry , Shi Jiaxiao , Chen Aiyu , Arguelles Jessica , Keenan Brendan , Maislin Greg , Mazzotti Diego , Sawyer Amy , Pack Allan , Hwang Dennis
Published: May 2021

Introduction

The impact of positive airway pressure (PAP) therapy for obstructive sleep apnea (OSA) on healthcare costs is uncertain. We explored the relationship between 3-year PAP adherence and direct healthcare cost utilizing the Tele-OSA study cohort.

Methods

The Tele-OSA randomized clinical trial demonstrated improved PAP adherence in patients receiving automated feedback messaging regarding their PAP use versus usual care. The study enrolled patients at Kaiser Permanente Southern California, a large integrated healthcare system, from 2014–2015. Patients with moderate-severe OSA (Apnea Hypopnea Index [AHI] ≥15) from all study arms were consolidated, then stratified into PAP adherence groups based on mean PAP hours and PAP use patterns over 3-year follow-up period: (a) high adherence (consistent ≥4 hours/night); (b) moderate adherence (2–3.9 hours/night or inconsistent ≥4 hours/night); (c) low adherence (<2 hours/night). Healthcare costs (2020 US dollars) were derived by assigning costs from Federal fee schedules to healthcare utilization extracted from electronic health records. The 6-month mean healthcare costs during follow-up were estimated using generalized linear models adjusting for patient demographics, comorbidities, Medicaid coverage, prior healthcare cost, and AHI.

Results

Of 374 patients (mean age 50 years, 63% male), 22% were categorized into high adherence, 18% moderate adherence, and 60% low adherence to PAP therapy. Mean (SD) hours of PAP use were 6.5 (1.1) hours, 3.7 (1.3) hours, and 0.3 (0.5) hours for high, moderate, and low adherence groups, respectively. The high adherence group had the lowest average (SE) adjusted 6-month healthcare costs compared with other groups (High: $2,991 [$234]; Moderate: $3,604 [$412]; Low: $3,854 [$300]). Cost savings of high vs low adherence were $862 (95% CI $1540, $185). Cost savings of moderate vs low adherence were $250 (95% CI -$694, $1,193).

Conclusion

Better PAP adherence was associated with significantly lower healthcare costs over 3 years in patients with moderate-severe OSA. Findings support the importance of care strategies to enhance long-term PAP adherence for OSA therapy.

Support (if any)

The Tele-OSA Study was supported by AASM Foundation SRA Grant #: 104-SR-13
449 The Effects of Positional and Sleep Stage Dependency on Mandibular Advancement Device Treatment Outcome in Obstructive Sleep Apnea
Authors: Lee Chien-Feng , Chen Yunn-Jy , Chen Yu-Ching , Lin Ming-Tzer , Lee Pei-Lin , Yu Chong-Jen
Published: May 2021

Introduction

Mandibular advancement device (MAD) responder phenotype are not well understood in patients with obstructive sleep apnea (OSA). Recent studies have reported the association between MAD treatment response and polysomnographic phenotypes using positional and sleep stage dependency, but with inconsistent findings. Thus, the study aims to investigate the relationship between the two phenotypes and MAD response.

Methods

This retrospective study recruited patients with OSA (apnea-hypopnea index [AHI] >10/h), who were 20 to 80 years old, treatment naïve, and received MAD treatment for more than three months from 2009 to 2017. AHIsupine/AHInon-supine ≥2 and <2 meant supine predominant (supine-p) and non-positional OSA, respectively. REM-AHI/NREM-AHI ≥2, ≤0.5, and between 0.5 to 2 indicated REM-predominant (REM-p), NREM-predominant (NREM-p), and stage-independent (SI) OSA, respectively. Three criteria defined successful MAD treatment (i.e., criterion 1: residual AHI <5/h with >50% reduction; criterion 2: residual AHI 50% reduction; criterion 3: reduction >50%). The association between the two phenotypes and the three treatment criteria was identified using multivariable logistic regression.

Results

A total of 218 patients with a median age of 52.5 years, body mass index (BMI) of 25.4 kg/m2, and AHI of 28.2/h were recruited. Supine-p OSA had lower waist circumferences than non-positional OSA. The REM-p group had lower AHI and more female than the NREM-p and SI group. Supine-p OSA had better response than non-positional OSA (criterion 1: 43.2% vs 34.1%; criterion 2: 63.6% vs 34.1%; criterion 3: 77.3% vs 51.2%). NREM-p OSA had lower response across all three criteria (REM-p vs NREM-p vs SI: criterion 1: 57.6% vs 0% vs 42.0%; criterion 2: 75.8% vs 16.7% vs 56.5%; criterion 3: 75.8% vs 33.3% vs 77.1%). The odds of MAD response for supine-p OSA was 3.78 (95% CI = 1.44–9.93) to 3.98 (95% CI = 1.58–9.99)-fold than non-positional OSA while the odds for NREM-p OSA were 0.06 (95% CI = 0.01–0.58) to 0.15 (95% CI = 0.03–0.67)-fold than SI OSA after adjusting demographics and clinical features affecting MAD response.

Conclusion

Positional and sleep stage dependency were associated with MAD response and could be indicators for personal-tailored OSA treatment.

Support (if any)

The Ministry of Science and Technology, Taiwan (MOST 109-2314-B-002-252)
460 Alianza Barbed Pharyngoplasty in Moderate to Severe OSAS Patients
Authors: Sabatino Lorenzo , Moffa Antonio , Rinaldi Vittorio , Casale Manuele
Published: May 2021

Introduction

Alianza barbed pharyngoplasty is a recent non-resective surgical tecnique, indicated for patients with obstructive sleep apnea syndrome (OSAS) with circular retropalatal obstruction pattern. It has the aim of stabilizing and reducing the collapsibility of the palato-pharyingeal area during sleep. It uses barbed absorbable sutures that allow to suspend palato-pharyngeal structures to anatomical non-collapsable landmarks (posterior nasal spine, pterigoideal hamulus, pterigomandibular raphe). The aim of this study is to evaluate efficacy and safety of Alianza barbed pharyngoplasty in moderate to severe OSAS.

Methods

Thirty-six consecutive patients with moderate to severe OSAS underwent Alianza barbed pharyngoplasty. Preoperatively all patients presented with palatal hypertrophy, concentric collapse and retropalatal flatter during drug induced sleep endoscopy (DISE) and did not tolerate CPAP and/or MAD therapies. All patients underwent clinical examination, polysomnography, and subjective evaluation of snoring with visual analogue scale (VAS) and Epworth Sleepiness Scale (ESS) both pre-operatively (T0) and at 6 months postoperatively (T1).

Results

There was a significant reduction of AHI at T1, from 32.49 ± 14.55 to 12.1 ± 12.16 (p< 0.05) of AHI. Mean AHI gain was of 20.39 ± 11.58, in particular 13.34 ± 5.48 in moderate OSAS patients and 30.18 ± 9.34 in severe OSAS patients. There was also a significant ODI reduction, from 27.57 ± 15.68 to 12.97 ± 13.25 (p< 0.05). There was a significant reduction of ESS, from 8.75 ± 4.51 to 4.05 ± 2.39 (p< 0.05) and a significant reduction of snoring VAS from 7.85 ± 1.23 to 3.2 ± 1.7 (p< 0.05).

Conclusion

Alianza barbed pharyngoplasty led to significant improvement both in objective parameters measured with polysomnography (AHI and ODI), and in subjective parameters (ESS and snoring VAS) in moderate to severe OSAS patients.

Support (if any):
461 Hypoglossal Nerve Stimulation: Effectiveness of Therapy for Treatment of Positional Obstructive Sleep Apnea
Authors: White Michelle , Stuewe Elena , Zacharias Rajesh , Grover Aarti , Wein Richard
Published: May 2021

Introduction

Hypoglossal nerve stimulation (HGNS) therapy is highly effective treatment for patients with moderate-severe obstructive sleep apnea (OSA). Positional OSA is considered when the apnea-hypopnea index (AHI) is at least twice as high in supine position compared with non-supine position. There are few studies in the literature investigating response to HGNS in patients with positional OSA.

Methods

Pre- and post-implant polysomnography (PSG) data was retrospectively reviewed in 46 patients who underwent HGNS at a large tertiary care center from November 2017 to March 2020. Supine and non-supine AHI were used to diagnose positional OSA on pre- and post-implant PSG. Pre-implant AHI was recorded from both in-lab PSG as well as home sleep tests, while post-implant AHI was based on in-lab hypoglossal nerve stimulator titration performed three months after device activation. Overall AHI pre- and post-implantation and absolute AHI reduction (pre-implant AHI – post-implant AHI) were evaluated. Basic demographic information including age, sex and BMI were also recorded.

Results

25/46 patients (54%) were diagnosed with positional OSA on pre-implant PSG. Patients with positional OSA had lower pre-implant overall AHI than patients without positional OSA (AHI 29.6 and 38.9, respectively, p<0.05) and lower absolute AHI reduction than patients without positional OSA (18.2 and 26.7, respectively, p<0.05). There were no statistically significant differences in BMI and post-implant overall AHI between these groups. 19/25 patients (76%) with pre-implant positional OSA had persistent positional OSA on post-implant PSG.

Conclusion

Patients with positional OSA prior to HGNS had lower pre-implant overall AHI and absolute AHI reduction than patients without positional OSA. However, post-implant overall AHI was comparable, suggesting similar benefit in HGNS therapy regardless of positional OSA diagnosis. HGNS does not appear to resolve positional OSA, given that 76% of patients with positional OSA pre-implantation had persistent positional OSA post-implantation. Positional OSA after HGNS should be recognized in patients with persistent symptoms or inability to tolerate higher device amplitudes, and treatment with combination therapy with positional device can be considered.

Support (if any):
465 Evaluating the Impact of Sleep Disordered Breathing on Adverse Cardiovascular Outcomes After Bariatric Surgery
Authors: Heinzinger Catherine , Chindamporn Pornprapa , Bena James , Wang Lu , Milinovich Alex , Kaw Roop , Kashyap Sangeeta , Cetin Derrick , Aminian Ali , Kempke Nancy , Foldvary-Schaefer Nancy , Aboussouan Loutfi , Mehra Reena
Published: May 2021

Introduction

Sleep disordered breathing (SDB), including obstructive sleep apnea (OSA) and obesity-associated sleep hypoventilation (OASH), has well-characterized adverse effects on the cardiovascular system and increases morbidity and mortality. Long-term impact on cardiovascular outcomes post-bariatric surgery, however, remains unclear. We hypothesize that patients with SDB have increased frequency of major adverse cardiovascular events (MACE) post-bariatric surgery than those without.

Methods

Patients undergoing polysomnography (PSG) prior to bariatric surgery at The Cleveland Clinic from 2011–2018 were retrospectively examined and followed up from date of last surgery to 2019, including the perioperative period. Primary predictors include moderate-severe OSA, i.e. apnea hypopnea index(AHI)>15, and OASH, i.e. body mass index (BMI)≥30kg/m2 and either end-tidal CO2≥45mmHg or serum bicarbonate≥27mEq/L. MACE (coronary artery events, cerebrovascular events, heart failure or atrial fibrillation)-free probability was compared using hazard ratios estimated from Cox proportional hazards models on four groups: OASH with moderate-severe OSA (N=492), OASH-only (N=442), moderate-severe OSA-only (N=203), and a reference group without OASH or moderate-severe OSA (N=243). Multivariable Cox proportional hazards models adjusting for age, sex, BMI were fit on MACE survival. Analysis was performed based on an overall significance level of 0.05, using SAS software (version 9.4, Cary, NC).

Results

The sample comprised 1380 patients: age: 43.5±12 years, BMI: 49±9 kg/m2, 17.7% male, 63.7% White. Risk of MACE across the groups bordered significance (p=0.051). Compared to the reference group, the OASH with moderate-severe OSA group had higher risk of MACE (HR2.53, 95%CI:1.07–6.00,p=0.035). Patients with moderate-severe OSA had higher risk of MACE than those with AHI<15 (HR1.94, 95%CI:1.20–3.13,p=0.007). Patients with severe OSA had higher risk of MACE than those AHI<30 (HR2.01, 95%CI:1.28–3.14,p=0.002). For every 5-unit AHI increase, risk of MACE increased by 6% (HR1.056, 95%CI:1.029–1.084,p<0.001) with slight reduction in point estimates in adjusted models.

Conclusion

Preliminary data from this largest-to-date sample of systematically phenotyped patients with SDB undergoing bariatric surgery show significant differences in risk of MACE and MACE-free survival mitigated after consideration of obesity. Further investigation to elucidate effect modification by obesity and metabolic factors is needed.

Support (if any)

Cleveland Clinic Transformative Resource Neuroscience Award
466 Transvenous Phrenic Nerve Stimulation for Central Sleep Apnea: A Systematic Review
Authors: Sagalow Emily , Ananth Ashwin , Fares Elie , Fast Zhanna
Published: May 2021

Introduction

RespiCardia™ remedē® System, a transvenous phrenic nerve stimulator, is indicated to treat central sleep apnea (CSA) in certain patients. CSA involves disruption of the normal breathing pattern during sleep; CSA is associated with decreased patient quality of life and worsens cardiovascular outcomes. Existing therapies for CSA are often complicated by poor patient adherence to therapy and occasional adverse effects. The remedē® System uses electrical stimulation of the phrenic nerve to cause diaphragmatic contraction and attempts to restore normal breathing during sleep.

Methods

Systematic review was conducted according to the Preferred Reporting of Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Databases were queried by two independent reviewers for English-language studies published between 2000 and 2020. The initial search screened for all occurrences of “remede” then was further refined to include studies evaluating use of the RespiCardia™ remedē® System as a treatment for CSA in multiple patients.

Results

Two hundred twenty-seven articles were identified from initial search results. Fourteen articles were identified through screening of title and abstracts from initial results. Seven additional articles were identified through reference review. Full-text review of all the articles was then completed. All articles were published after 2010. Of the 21 articles, a total of 1621 patients underwent device implantation. We sought to summarize the available evidence regarding patient selection for implantation, immediate and delayed complications, adherence to therapy, and polysomnographic evidence of efficacy.

Conclusion

The remedē® System has been demonstrated to improve sleep and respiratory parameters including AHI, CAI, arousal index, REM sleep, and ODI with few complications. This device proves to be a safe and effective treatment for moderate to severe CSA in adult patients, especially those with HF. Future studies examining long-term outcomes and delayed complications are needed.

Support (if any):
467 Positive Airway Pressure Tracking Systems: Outcomes of Polysomnographic Testing Prompted by the Residual Apnea Hyponea Index
Authors: Imtiaz Komal , Mathew Reeba , Nuzhny Valentin , Sargsyan Lilit , Majid Ruckshanda
Published: May 2021

Introduction

To assess positive airway pressure (PAP) adherence and efficacy, tracking systems have been developed to monitor hours of CPAP use, mask leak, and residual apnea-hypopnea index (AHI) while patients are on treatment. No formal guidelines however have been developed on how to interpret and utilize this information. We looked at treatment outcomes after an in-laboratory sleep study reevaluation was made based on clinical symptoms and the residual AHI.

Methods

We performed a retrospective chart review of adult patients evaluated with an in-laboratory polysomnogram (PSG) based on a clinical concern for inadequately treated obstructive sleep apnea (OSA) and the residual AHI obtained from the PAP tracking system. We documented the outcomes of the repeat study and follow-up AHI after the new intervention (if recommended). We excluded patients non-adherent to PAP.

Results

Nine patients were identified between January 2015 and 2020 at the McGovern Medical School Outpatient Sleep Clinic. All nine patients were male with an average age of 69.2 years (range 44–84). The average AHI on the diagnostic study (CMS criteria) was 37.1 events/hour (range 17.4–67.1). The average residual AHI prompting reevaluation was 9 events/hour (median 15.9). All patients had a change in treatment based on recommendations made after their sleep study. The clinical suspicion for central events on the tracking system was confirmed on PSG on three patients who were subsequently switched to adaptive servo-ventilation. Two patients were found to have central events without a previous suspicion for central events. Four were prescribed a higher pressure or BPAP for suspected untreated OSA confirmed on the repeat PSG. All of the patients had a decreased residual AHI (average 6.3 events/hour) after treatment changes were made.

Conclusion

Reevaluation with a PSG after concerns of the residual AHI led to a change in diagnosis (complex sleep apnea) or the need for higher treatment pressures in our cohort. This lead to the optimization of therapy and a decrease in AHI on the tracking system post-intervention, hence justifying the repeat PSG. Exact guidelines however need to be set to standardize the recommendations with a potential cut-off residual AHI after which a repeat PSG is the standard.

Support (if any):
469 Utilization of the STOP-Bang questionnaire for referral of obstructive sleep apnea in various geographical regions
Authors: Pivetta Bianca , Chen Lina , Nagappa Mahesh , Saripella Aparna , Waseem Rida , Englesakis Marina , Chung Frances
Published: May 2021

Introduction

Obstructive sleep apnea (OSA) is a highly prevalent global health concern and is associated with many adverse outcomes for patients. Our objective is to determine the utility of the STOP-Bang questionnaire in the sleep clinic setting to screen for and stratify the risk of OSA among populations from different geographical regions.

Methods

The following electronic databases were systematically searched from 2008 to March 2020: MEDLINE, Medline-in-process, Embase, EmCare Nursing, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, Journals @ Ovid, Web of Science, Scopus, and CINAHL. Inclusion criteria were: 1) assessment of the STOP-Bang questionnaire to screen for OSA in adult subjects (age ≥18 years); 2) patients referred to sleep clinic; 3) lab-polysomnography or home sleep apnea testing results confirmed the OSA diagnosis; and 4) apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) was used to diagnose and grade the severity of OSA. Clinical and demographic data were extracted from each article independently by two reviewers (B.P., L.C.). Pooled predictive parameters were calculated using 2x2 contingency tables. Random effects meta-analyses and meta-regression with sensitivity analyses were performed. The Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) guidelines were followed.

Results

Forty-seven studies (n=26,547) studies met the criteria for systematic review (mean age: 49±14 years, mean body mass index: 32±8 kg/m2, 65% male). Studies were organized into different geographic regional groups – North America, South America, Europe, Middle East, East Asia, and South/Southeast Asia. The prevalence of all OSA, moderate-to-severe OSA, and severe OSA was 80%, 58%, and 39%, respectively. The area under the receiver operating curve of a STOP-Bang score ≥3 to detect moderate-to-severe OSA is high (>0.80) in all regions, except in East Asia (0.52). A STOP-Bang score ≥ 3 has excellent sensitivity (>90%) and high discriminative power to exclude moderate-to-severe, and severe OSA with negative predictive values of 77% and 91%, respectively.

Conclusion

The meta-regression analysis demonstrates that the STOP-Bang questionnaire can be utilized as an effective OSA screening tool among different geographical populations to assist in prioritizing patients with suspected OSA for assessment in sleep clinic.

Support (if any):
471 Identifying gaps in evaluation, treatment, and treatment adherence in women Veterans with sleep disordered breathing risk factors
Authors: Moghtaderi Isabel , Kelly Monica , Carlson Gwendolyn , Swistun Dominika , Fung Constance , Zeidler Michelle , Mitchell Michael , Josephson Karen , Lee Diane , Partch Lisa , Badr Safwan , Washington Donna , Yano Elizabeth , Alessi Cathy , Martin Jennifer
Published: May 2021

Introduction

In our recent national survey study, 13% of women Veterans reported a diagnosis of Sleep Disordered Breathing (SDB), of whom 65% used positive airway pressure (PAP) treatment. We also found many women Veterans at high risk for SDB were undiagnosed (43%). The current study builds upon this survey research to identify rates of evaluation, diagnosis, treatment, and treatment adherence among women Veterans with risk factors for SDB.

Methods

We analyzed telephone screening data from an ongoing SDB treatment adherence intervention study for women Veterans in Los Angeles county. A total of 173 women Veterans, identified by retrospective chart review as having at least one risk factor for SDB (i.e. high blood pressure, diabetes, obesity, depression, or > 50 years old), completed the screener. Screening questions included 1) previous diagnostic testing for SDB, 2) SDB diagnosis 3) SDB treatment type, and 4) past week SDB treatment use. Descriptive statistics regarding evaluation and treatment of SDB are reported.

Results

In total, 31% of respondents endorsed having previously completed diagnostic testing, of whom, 54% reported an SDB diagnosis. Of those with diagnosed SDB, 82.8% were prescribed treatment (PAP [72.4%], oral appliance [6.9%], surgery [3.5%]), and 17.2% did not report being prescribed any SDB treatment. Of the 21 (72.4%) women Veterans diagnosed with SDB that were prescribed PAP, only 33% reported using treatment in the past week. Of the 2 women Veterans (6.9%) prescribed an oral appliance, 0% reported past week use.

Conclusion

Less than 1/3 of women Veterans with at least one risk factor for SDB had previously been evaluated for SDB; however, over 1/2 of women Veterans who were evaluated tested positive for SDB. Additionally, most women Veterans had not used PAP or oral appliance therapy in the past week. Greater clinical attention is needed to identify, evaluate, and diagnose SDB in women Veterans. Moreover, further research is needed to evaluate and inform interventions to address SDB treatment adherence barriers in women Veterans.

Support (if any)

VA HSR&D IIR 16–244 and RCS 20–191; NIH/NHLBI K24 HL143055, VAGLAHS GRECC and VA Office of Academic Affiliations.
472 Sleep Quality in Pregnancy: An Analysis of Cardiopulmonary Coupling in the nuMoM2b Cohort
Authors: Christian Francis , Hilmisson Hugi , magnusdottir Solveig , Thomas Robert
Published: May 2021

Introduction

The impact of pregnancy on sleep quality and sleep-breathing is of interest due to concerns of an impact on maternal, intra-uterine and neonatal health. The Sleep Disordered Breathing (SDB) sub-study of the Nulliparous Pregnancy Outcomes Study (NuMoM2b) provided a large cohort of single gestational women who underwent home sleep apnea testing (HSAT) to evaluate for SDB. To evaluate changes in sleep during pregnancy, we utilized publicly available data from http://www.sleepdata.org for cardiopulmonary coupling (CPC) analysis to evaluate SDB, as well as sleep duration and quality. No outcomes data is currently available.

Methods

Standardized Level 3 HSAT was performed after visit 1 (V1), (6–15 weeks’ gestation) and visit 3 (V3), (22 -31 weeks’ gestation) on 3702 women from the NuMoM2b cohort. CPC-analysis was performed using clinically validated algorithms based on CPC-method using ECG and oxygen saturation data (SpO2) as the input signals. SleepImage Apnea Hypopnea Index (sAHI) was calculated to evaluate for SDB (FDA; 182618). Additional calculations to determine sleep latency, sleep duration, wake after sleep onset, and sleep quality (SQI) were performed. The SQI-metric incorporates measures of sleep stability and instability and is then presented on a scale of 0 – 100 where a higher number is desirable.

Results

3,261 & 2,511 participants had data at visits 1 & 3, respectively. A total of 3,012 and 2,332 individuals had ECG data of sufficient quality. The mean age of the analyzed cohort was 27 years old. SDB events were overall low, but significantly increased across visits, sAHI [(1.6 ± 2.5)/hour (V1) vs (2.9 ± 4.1) (V3)], p< 0.001. There was a statistically significant increase in sleep latency [7.4 ± 12.7 (V1) vs 18.7 ± 27.8 (V3)], p< 0.001 and reduction in total sleep time [401.2 ± 85.6 (V1) vs 348.5 ± 79.3 (V3)], p< 0.001. Most notably, there was a >10% reduction in the SQI, indicative of increased unstable, fragmented sleep as pregnancy progressed [72.1 ± 13.8 (V1), 60.5 ± 16.2 (V3)], p < 0.001.

Conclusion

Using objective measures based on CPC analysis from HSAT derived signals, sleep disordered breathing, sleep duration and sleep quality are all adversely impacted as gestation progresses.

Support (if any):
480 Cardiovascular and metabolic risk in patients with suspected comorbid insomnia and obstructive sleep apnea (COMISA)
Authors: e Cruz Miguel Meira , Seixas Luana , Santos Augusto , Garrido João , Lopes Yuri , Palombini Luciana , Gozal David , Galtieri Ranuzia , Salles Cristina
Published: May 2021

Introduction

Only few studies looked for a possible association of cardiovascular disorders (CVD), in comorbid insomnia with obstructive sleep apnea (COMISA) even though this is a relevant topic in order to prevent one of the major causes of morbimortality. The present study aimed to investigate the association of insomnia symptoms in patients at risk for obstructive sleep apnea in terms of prevalence and clinical interactions and to evaluate the risk of CVD in patients with a risk for COMISA.

Methods

This is a cross-sectional study. All medical records with data such as age, sex, height, weight and BMI, time to sleep, time to wake up, total sleep time, the Epworth Sleepiness Scale (ESS), STOP-BANG Questionnaires were studied. Insomnia and comorbidities were also investigated, and the patientsanswered yes or no to systemic arterial hypertension, diabetes, CVD.

Results

685 patients were enrolled on the present study. We observed that the mild, moderate, and high risk for COMISA presented progressively increasing levels for the frequency of hypertension, diabetes, and CVD. A binary logistic regression was performed to assess whether risk for COMISA could be a predictor for CVD, and it was found that the model containing risk for COMISA was statistically significant: [x2(1)=5.273;p<0.021, R2 Negelkerke=0.014]. Risk for COMISA presented itself as a significant predictor for CVD (OR=1.672; 95% CI=1.079–2.592).

Conclusion

There was an increased frequency of associated comorbidities such as CVD, systemic arterial hypertension, and diabetes, according to the mild, moderate, or high risk. These findings highlight the need for a cardiometabolic evaluation in patients with this comorbid condition which may impact prognosis and therapeutic success.

Support (if any):
490 Efficacy of FT218 on Polysomnographic Measures of Sleep Continuity in Patients With Narcolepsy: Results From the REST-ON Trial
Authors: Dauvilliers Yves , Thorpy Michael , Roth Thomas , Rosenberg Russell , Corser Bruce , Shapiro Colin , Ajayi Akinyemi , Dubow Jordan , Seiden David , Kushida Clete
Published: May 2021

Introduction

Disturbed nocturnal sleep (DNS) is a common symptom in patients with narcolepsy, characterized by fragmented sleep, including frequent brief nightly awakenings. Sodium oxybate (SO) is an effective treatment for narcolepsy; however, currently available formulations must be taken twice nightly. FT218 is an investigational once-nightly controlled-release formulation of SO. Here, we evaluated the efficacy of FT218 on polysomnographic (PSG) measures of DNS and number of arousals (NAs) in patients with narcolepsy types 1 and 2.

Methods

This was a randomized, double-blind, placebo-controlled, multicenter study. Patients with narcolepsy aged ≥16 years were randomized 1:1 to receive FT218 or matching placebo: 4.5 g/night for 1 week, 6.0 g/night for 2 weeks, 7.5 g/night for 5 weeks, and 9.0 g/night for 5 weeks. Secondary endpoints included PSG measurements of DNS (defined as shifts to wake/N1 from N1, N2, N3, and REM) and NAs (defined per AASM Scoring Manual guidelines [v2.6]).

Results

Patients receiving FT218 had significant improvements vs placebo in DNS; the LS mean difference between FT218 and placebo was −22.63 for 9.0 g (week 13), −17.70 for 7.5 g (week 8), and −11.00 for 6.0 g (week 3) (all P<0.001). Patients receiving FT218 also had significant reduction in number of NAs vs placebo; the LS mean difference between FT218 and placebo for NAs was −23.68 (P<0.001) for 9.0 g, −19.41 (P<0.001) for 7.5 g, and −11.29 (P=0.021) for 6.0 g. The most common adverse reactions were nausea, dizziness, enuresis, headache, decreased appetite, and vomiting.

Conclusion

FT218 at all evaluated doses showed significant reduction in DNS and number of NAs vs placebo for all doses of FT218 evaluated. FT218 was generally well tolerated; the most common adverse events were consistent with known SO side effects. FT218 could offer a new once-nightly treatment option for DNS in patients with narcolepsy as demonstrated by PSG measures.

Support (if any)

Avadel Pharmaceuticals.