bluuebunny/crossref_metadata_2025_split huggingface dataset:
0553 Prevalence of Insomnia and Anxiety in a National Sample of Patients with Obstructive Sleep Apnea and Depression
Authors: Cole Kate , Dexter R Benjamin , Pépin Jean-Louis , Sterling Kimberly , Wickwire Emerson 
Published: May 2023

Abstract

Introduction
Insomnia and anxiety are highly comorbid both with depression and with obstructive sleep apnea (OSA). This retrospective study sought to characterize patients with these conditions among a national sample of individuals with depression and comorbid OSA.

Methods
A national sample of administrative claims data of OSA patients was used for this analysis. Included patients either had two healthcare encounters or one hospitalization with a depression ICD-10 diagnosis code the year prior to OSA diagnosis and before initiation on positive airway pressure (PAP) therapy for treatment of OSA. Anxiety, insomnia, and other comorbidities were identified by the presence of at least one ICD-10 code associated with healthcare encounters in the year prior to starting PAP therapy. Age, sex, and insurance coverage were characterized at the time of the first OSA diagnostic sleep test. Healthcare resource utilization was assessed for the year prior to starting PAP therapy.

Results
36,668 patients with depression and comorbid OSA were included. 56% had comorbid anxiety, 28% had comorbid insomnia, and 35% had neither anxiety nor insomnia. Compared to those without anxiety or insomnia, patients with anxiety or insomnia were more commonly female (64% vs 57%) and had a higher prevalence of asthma (25% vs 20%), psychotic (14% vs 7%) and other mood disorders (24% vs. 14%), fibromyalgia (11% vs 7%) and GERD (43% vs 33%). Relative to individuals with insomnia or anxiety, patients without insomnia or anxiety experienced fewer ER visits, all-cause hospitalizations, depression-related hospitalizations, specialist visits, and self-harm events in the year prior to PAP initiation. Relative to patients with comorbid insomnia, those with comorbid anxiety demonstrated slightly higher healthcare resource use in the year prior to PAP initiation.

Conclusion
Anxiety and insomnia are prevalent comorbidities in patients with depression and obstructive sleep apnea, with more than half of patients suffering comorbid anxiety and a quarter of patients having comorbid insomnia. Future research should examine comprehensive patient care strategies that can be used in patients with comorbid anxiety or insomnia to encourage healthy sleep behaviors and successful acclimation to OSA treatment.

Support (if any)
ResMed
0555 Sex and Age Differences in Rapid Eye Movement Related Obstructive Sleep Apnea
Authors: Block Lucy , Suarez-Rivas Hailie , Hong Xinyi , Buckley Ashura 
Published: May 2023

Abstract

Introduction
Rapid Eye Movement (REM) related Obstructive Sleep Apnea (OSA) is a subcategory of OSA in which apneas or hypopneas occur predominantly or exclusively during REM and may be more prevalent in women and children. There is no consensus on the definition. Here, we examine interactions of age and sex on diagnosis per definition.

Methods
Patients who underwent a PSG at the Sleep Service at NIH in a 24- month period were included. Four REM-OSA definitions used most in the literature represented the diagnostic criteria.

Results
139 total participants (ages 1.5-76 y, 58 female) were evaluated. Twenty-eight men (20%) and eighteen women (13%) met criteria for at least 1 definition. Twenty participants (1.5-76 years) met definition one (9 female), 19 met definition two (9 female), 19 met definition three (9 female), and 36 met definition four (15 female). Fifteen of fifty-six (27%) pediatric patients (8 female) met criteria by at least one definition. Two female pediatric participants met definitions one, two and three, and all 15 pediatric participants met definition four. The average total AHI was 5.93 for women and 7.78 for men, while the average REM AHI was 17.96 (5.6-47.1) for women and 17.14 (5.3-51.7) for men. Twenty-six (18 female) REM-OSA patients had a total AHI of less than 5. For pediatric patients the average total AHI was 3.56 for girls and 2.73 for boys, and the average REM AHI was 9.41 for girls and 8.29 for boys.

Conclusion
The prevalence of REM-predominant OSA is difficult to determine as there are multiple definitions in use. REM-predominant OSA has been associated with hypertension, poor glycemic control, and mood disturbance and may be underdiagnosed due to current guidelines. Current definitions of mild, moderate and severe apnea are based on total AHI over the course of the sleep period. In our study, more than half of participants with REM-OSA by any definition had a total AHI of less than 5, despite the high average REM AHI for both sexes. These patients would not have met criteria for a diagnosis of OSA which has clear treatment implications.

Support (if any)
National Institutes of Health Intramural Research Program
0556 Simultaneous comparison of unedited and manually edited HSAT with level 1 PSG in persons with hospitalized TBI
Authors: Le Loan , Schwartz Daniel J , Nakase-Richardson Risa , Almeida Emily J , Anderson William , Patel Kevin , Sudolcan Benjamin , Nallu Sagarika 
Published: May 2023

Abstract

Introduction
Previous studies have shown automatic scoring of portable level 3 sleep study provides similar findings when compared to polysomnography (PSG), establishing home sleep apnea tests (HSAT) as an adequate screening tool for OSA. Accuracy of level 3 studies with Nox T3 portable sleep studies (Noxturna Inc., Atlanta GA) may improve with manual editing to include total sleep time (TST). No other studies have compared unedited versus manually edited HSAT with level 1 in-lab PSG performed simultaneously. This study evaluates if added manual editing optimizes the diagnostic accuracy of HSAT in classifying the severity of OSA, using both AASM and CMS criteria.

Methods
Secondary analysis of six-center (n=206) sleep apnea diagnostic comparative effectiveness trial. Participants underwent simultaneous administration of level 1 PSG (Philips Alice 6 LDx Diagnostic Sleep system) and Nox T3 portable sleep study with centralized scoring using AASM and CMS criteria. All HSAT were autoscored and then edited by the registered polysomnographic technician. Editing entailed establishing start and stop recording times based on accompanying actigraphy data (reduction in movement) in the portable device and elimination of recording artifact.

Results
Using AASM criteria, poor sensitivity OSA (AHI≥5) was observed using unedited vs PSG (p=.01) compared to manually edited HSAT vs. PSG (p=.06). No statistically significant difference was observed using AHI≥15 or via categorization across four levels of OSA (none, mild, moderate, or severe). In contrast, CMS criteria comparisons to PSG showed poor specificity of OSA (AHI≥5) for unedited (p=.003) compared to edited (p=.372) HSAT studies. As expected, total sleep time was overestimated using T3 actigraphy devices compared to the criterion standard across both edited and unedited studies (p=.001, .001 respectively).

Conclusion
Improvements in sensitivity and specificity of OSA were noted using edited versus unedited T3 HSAT when compared to Level 1 PSG using both AASM and CMS criteria. Results support need for manualized editing of HSAT in persons with hospitalized TBI.

Support (if any)
PCORI (CER-1511-33005), GDHS (W91YTZ-13-C-0015)
0560 Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea: Effect Sizes and Numbers Needed to Treat or Harm
Authors: Chepke Craig , Cutler Andrew , Floam Samantha , Parks Gregory , Rosenberg Russell 
Published: May 2023

Abstract

Introduction
Solriamfetol (Sunosi®), a dopamine/norepinephrine reuptake inhibitor that has been shown to activate TAAR1, is approved (US and EU) to treat excessive daytime sleepiness (EDS) in adults with narcolepsy (75-150mg/day) or obstructive sleep apnea (OSA) (37.5-150mg/day). Effect size, number needed to treat (NNT) and number needed to harm (NNH) are statistical representations of efficacy and tolerability that clinicians may find helpful in guiding treatment decisions. This analysis characterized these statistical parameters from two registrational studies.

Methods
We conducted a post-hoc analysis of data from two phase 3 studies in adults with excessive daytime sleepiness associated with narcolepsy (TONES 2) or OSA (TONES 3). Effect size compared to placebo, NNT, and NNH were calculated based on previously published endpoints, post-hoc analyses, and adverse events.

Results
On the Maintenance of Wakefulness Test, effect size compared to placebo (Cohen’s d) was 0.29, 0.82, and 1.13 for 75mg, 150mg, and 300mg doses of solriamfetol in TONES 2 and 0.46, 0.89, 1.08, and 1.28 for 37.5mg, 75mg, 150mg, and 300mg in TONES 3. On the Epworth Sleepiness Scale (ESS), d was 0.47, 0.80, and 1.02 for 75mg, 150mg, and 300mg in TONES 2, and 0.42, 0.37, 0.99, and 1.04 for 37.5mg, 75mg, 150mg, and 300mg doses in TONES 3. NNT for patients achieving an ESS ≤10 was 7, 5, and 3 for 75mg, 150mg, and 300mg doses in TONES 2 and 8, 6, 4, and 3 for 37.5mg, 75mg, 150mg, and 300mg doses in TONES 3. On the Patient Global Impression of Change (PGIc), NNT was 4, 3, and 3 for 75mg,150mg, and 300mg doses in TONES 2 and 16, 5, 3, and 3 for 37.5, 75mg, 150mg, and 300mg in TONES 3. Similar NNT were found for the Clinician Global Impression of Change as for the PGIc. In both TONES 2 and TONES 3, NNH pooled across doses for adverse events occurring in ≥5% of patients and greater than placebo were all &gt;10, with the exception of headache in TONES 2 (NNH=6).

Conclusion
This post-hoc analysis demonstrates favorable effect size, NNT, and NNH values for solriamfetol in the treatment of EDS associated with narcolepsy and OSA.

Support (if any)
Axsome Therapeutics
0561 Solriamfetol Real World Experience Study: Safety, Efficacy, and Follow-Up for Patients with Obstructive Sleep Apnea in Germany
Authors: Winter Yaroslav , Mayer Geert , Kotterba Sylvia , Benes Heike , Burghaus Lothar , Parks Gregory , Abeynayake Iresha , Romero-Cruz Pamela , Floam Samantha , Kwak Hannah , Kallweit Ulf 
Published: May 2023

Abstract

Introduction
Excessive daytime sleepiness (EDS) is a symptom of Obstructive Sleep Apnea (OSA) that can persist despite primary airway therapy and can be managed with wake-promoting agents. Solriamfetol (Sunosi®) is a wake-promoting agent approved to treat EDS associated with OSA (37.5–150 mg/day). This real-world study characterizes dosing/titration strategies among European physicians initiating solriamfetol and patient outcomes following initiation.

Methods
This is an ongoing retrospective chart review conducted by physicians in Germany and France. Data are reported from 52 German patients with OSA. Eligible patients (≥18 years old, diagnosed with EDS due to OSA, reached a stable solriamfetol dose, and completed ≥6 weeks of treatment) were classified into 1 of 3 groups based on solriamfetol initiation strategy: changeover (switched/switching from existing EDS medication[s]), add-on (added/adding to current EDS medication[s]), or new-to-therapy (no current/previous EDS medication).

Results
Patients’ mean±SD age was 50.0±13.1 years; 65% were male. All patients used primary airway therapy. Obesity was the most common comorbidity (56%). New-to-therapy was the most common initiation strategy (n=39), then add-on (n=9), and changeover (n=4). The most common starting doses of solriamfetol were 37.5 (n=34; 65%) and 75 mg/day (n=17; 33%). Solriamfetol was titrated in 30 patients (58%); the majority were titrated within 7 days. Mean±SD Epworth Sleepiness Scale (ESS) score was 15.5±3.2 (n=52) at initiation and 10.7±3.7 at follow-up (n=48), with a mean decrease of 5.0± 3.2 points. Across subgroups, mean ESS scores at initiation and follow-up ranged from 15.2–16.8 and 10.3-11.6, with mean decreases from 4.5–6.5 points. Improvements in EDS after solriamfetol initiation were reported for most patients (patient-reported, 90%; physician-reported, 88%). Most patients reported the effects of Solriamfetol to last ≥6 hours (81%) with no change in their night-time sleep quality (86%). Common adverse effects were headache, insomnia, and irritability.

Conclusion
These real-world data describe the use of solriamfetol in a cohort of German patients with OSA. Solriamfetol was typically initiated at 37.5 mg/day; titration was common. ESS improvements were greater than the minimum clinically important difference (MCID) of 2-3, and most patients and physicians perceived improvement in EDS. Common adverse events were consistent with those previously reported for solriamfetol.

Support (if any)
Axsome Therapeutics and Jazz Pharmaceuticals
0563 The Evaluation of a Revolutionary Custom-Made Oral Appliance Design on Effectiveness, Efficacy, and Compliance
Authors: Ojile Joseph , Uhles Matthew , Postol Kevin , Lillenberg James , Alisic Sabina , Gonzalez Alexis 
Published: May 2023

Abstract

Introduction
Evaluate the clinical effectiveness of the SomnoDent Avant with Bflex technology, a custom-made oral appliance therapy (OAT) device in the treatment of mild/moderate Obstructive Sleep Apnea (OSA) for naïve and PAP non-compliant patients. Hypothesis for the study was that the unique strap mechanism design of the appliance encouraged mouth closure and nasal breathing, would have high levels of effectiveness, particularly for supine sleepers. The evaluation of the initial fit of the device as well as patient’s and bed partner’s acceptance were also investigated

Methods
Prospective 90 day trial, participants age ≥ 18 with AHI of ≥10 to ≤30 events/hr. confirmed by using a WatchPAT, Home Sleep Apnea Testing (HSAT) device at baseline. Initial advancement of the lower jaw was 60%. Treatment effectiveness is derived from two endpoints: efficacy and compliance. The efficacy of the OAT is defined as the change from baseline in AHI, based on one and three-month HSAT. Efficacy was measured in supine, lateral and prone positions. Compliance data was obtained from the Dentitrac (BRAEBON Medical Corporation) chip embedded in the SomnoDent Avant device looking at usage for at least 4 hours per night for at least 5 out of 7 nights a week.

Results
Preliminary data from 50 participants (66% male, 35% female), age: 52.3 ± 11.8 yrs., BMI: 31.1. A statistically significant 3-month trend change from baseline AHI -11.0 ± 7 (37/37), Average usage:7.0hrs/night, ESS: 3 month change from baseline -3.3 ± 4.0 (80.0% improvement), FOSQ 10: 1.7 ± 2.2 (76.7% improvement). Adequate (first-time) fit of the device upon initial insertion 89.3%, bed partner sleep improvement 83.3%, and 88.9% would recommend the use of the Avant OAT device.

Conclusion
• SomnoDent Avant demonstrated high effectiveness in the treatment of OSA, particularly with supine dependent OSA participants. The unique design of the Avant strap likely acts to close the patient’s mouth, encouraging nasal breathing • Statistical improvement in the quality of life • Optimum first-time fit • Improvement in bed partner quality of sleep

Support (if any)
SomnoMed
0565 The Obstructive Sleep Apnea CPAP Therapy Compliance; Progressions, Challenges and Interventions
Authors: Khalili Kianoush 
Published: May 2023

Abstract

Introduction
Obstructive sleep apnea (OSA) is a common sleep disorder affecting 26% of the United States adult population and is associated with adverse health outcomes. Despite the advent of an array of treatment options, PAP remains the primary treatment modality for OSA since the approach was introduced in 1981. The objective of this systematic review is to determine how we can increase compliance to PAP therapy as the gold standard of OSA treatment.

Methods
A systematic review was conducted to study meta-analyses performed to determine the clinical significance of using PAP in several modalities, PAP initiation strategies, educational and behavioral interventions, tele monitoring, humidification, level of AHI, different mask interfaces, and flexible or modified pressure profile PAP to treat OSA in adults.

Results
Data demonstrated a clinically significant improvement in PAP adherence with the use of educational, behavioral, troubleshooting, and telemonitoring interventions. Also systematic reviews show that nasal interfaces compared to oronasal interfaces have improved adherence and slightly greater reductions in OSA severity, heated humidification compared to no humidification reduces some continuous PAP-related side effects. Finally, AHI level of 15 and above but not demographic variables payed a role in compliance.

Conclusion
All medical therapies have challenges with patient adherence. PAP therapy for OSA has unique challenges as available data indicate that optimal benefit is derived from continued use throughout the patient's sleeping period while clinical trials continue to demonstrate suboptimal group adherence ranging from 3–5 h/night. Given this, substantial work remains to be done to determine the optimal combination of strategies to maximize adherence. All researches on increasing adherence has evaluated outcomes at 3 months or less, despite evidence that usage continues to wane over time long-term. Evaluation of strategies to maintain adherence long term is a critical research priority. Other fields to focus are strategies for identification of patient-factors that place them at risk for nonadherence prior to PAP use, and the development and validation of specific algorithms to utilize with telemonitoring to identify nonadherent patients early after initiation of PAP. Comparative effectiveness studies will be needed to develop a comprehensive adherence program that can be deployed into routine clinical care.

Support (if any)
0566 The Usefulness of ApneaLinkTM as a Screening Test for Diagnosis of Obstructive Sleep Apnea
Authors: Kim Sangjun 
Published: May 2023

Abstract

Introduction
To investigate the usefulness of ApneaLinkTM as a screening test for obstructive sleep apnea by analyzing the correlation between ApneaLinkTM and polysomnography (PSG).

Methods
From January 1, 2018 to December 31, 2020, patients who visited the sleep clinic with snoring, sleep apnea, and excessive daytime sleepiness at the otolaryngology department of this hospital were subjected to both standard sleep PSG and ApneaLinkTM. Correlations of Apnea-Hypopnea Index (AHI) and Respiratory Disturbance Index (RDI) in standard PSG with AHI and Risk Indicator (RI) in ApneaLinkTM were investigated. To determine the usefulness of ApneaLinkTM as a screening test for patients with moderate or severe sleep apnea, cut-off values of AHI and RI of ApneaLinkTM were determined using receiver operating characteristic (ROC) curves.

Results
The correlation coefficient between AHI in PSG and AHI or RI in ApneaLinkTM was both 0.647, showing a high positive correlation. The correlation coefficient between RDI in PSG and AHI or RI in ApneaLinkTM was both 0.637, showing a high positive correlation. When the cut-off value of AHI with the ApneaLinkTM test was 19.0, it showed a sensitivity of 76.29% and a specificity of 78.95%, which could be expected to produce more than 15 of RDI in PSG.

Conclusion
Through this study, it was found that ApneaLinkTM could be used as a screening test for obstructive sleep apnea.

Support (if any)
0568 Trends in OSA Disease Severity Over Nearly Two Decades: Update on the VA San Diego Experience
Authors: Nokes Brandon , Zamora Tania , Cervantes-Gameros Cesar , Perrine William , Barker Robert , Stepnowsky Carl 
Published: May 2023

Abstract

Introduction
The Veterans Health Administration (VA) is one of the largest integrated healthcare systems in the United States. Key risk factors for obstructive sleep apnea (OSA) include aging, weight, and male gender, all of which are highly prevalent in the VA population and help to explain the higher rates of OSA in the VA. The Pulmonary Sleep Program at the VA San Diego Healthcare System (VASDHS) started a patient database over twenty years ago for its home sleep apnea testing (HSAT) program. An analysis of ten years of diagnostic HSAT data was reported on over 12,500 patients in 2014. This analysis focuses on an update on the last four years and a comparison to 2014.

Methods
A retrospective review of the local clinical database of HSAT diagnostic testing was conducted. The database contained 8,928 sleep studies from 2018 to 2022. Invalid studies were removed. Only initial diagnostic studies were included.

Results
Of the 8,928 diagnostic studies, 2,564 tested negative for OSA (28.7%). Of the 6,364 positive cases, 43.3% were mild, 28.8% were moderate, and 27.9% were severe. The percentages of each OSA severity level were stable across these years (mild: 42%-45%; moderate: 27%-32%; and severe: 26%-29%). The mean AHI did not significantly change from 2018 (24.1+/-20.6) to 2022 (25.1+/-21.2) (overall mean 24.4+/-20.3; range: 5-140).

Conclusion
Based on this extensive retrospective review of diagnostic testing at a single, high-volume HSAT program, it appears that OSA severity levels have stabilized over these past five years, with the highest percentage of mild OSA cases (~43%) followed by moderate (~29%) and severe (~28%). Our facility saw a significant decrease in severe cases (60% to 30%) and increase in mild OSA (7% to 35%) from 2004 to 2013. Today, over 4 out of every 10 new OSA diagnoses are mild, which has significant treatment implications given that adherence to the two primary medical device options is suboptimal. Identifying patient-centered treatment options for these patients is a priority.

Support (if any)
VA RR&D D2651-R and the Sleep Medicine Section of the VA San Diego Healthcare System supported this project.
0575 Cataplexy Response With FT218 (Once-Nightly Sodium Oxybate): Post Hoc Responder Analysis From the Phase 3 Rest-ON Clinical Trial
Authors: Thorpy Michael , Kushida Clete , Ajayi Akinyemi , Dubow Jordan , Gudeman Jennifer 
Published: May 2023

Abstract

Introduction
In the phase 3 REST-ON trial (NCT02720744), participants with narcolepsy type 1 (NT1) treated with once-nightly sodium oxybate (ON-SXB; FT218), an investigational, extended-release formulation, had significant reductions in cataplexy episodes (ON-SXB vs placebo: 4.5 g, P&lt; 0.05 [post hoc]; 6 , 7.5, and 9 g, all P&lt; 0.001). This post hoc responder analysis further characterized improvements in mean weekly cataplexy episodes in trial participants.

Methods
In REST-ON, participants aged ≥16 years with NT1/NT2 were randomized 1:1 to double-blind ON-SXB or placebo for 13 weeks. Participants took 4.5 g (1 week), 6 g (2 weeks), 7.5 g (5 weeks), and 9 g (5 weeks). Participants with NT1 recorded number of cataplexy episodes per day (0, 1, 2, 3, 4, or ≥5) in a diary. Percentage of participants with ≥25%, ≥50%, ≥75%, and 100% reductions in weekly cataplexy episodes from baseline were compared (ON-SXB vs placebo; Fisher exact test).

Results
In the modified intent-to-treat population, 145 participants had NT1 (ON-SXB, n=73; placebo, n=72). Baseline mean (SD) number of weekly cataplexy episodes was 18.9 (8.7) for the ON-SXB group and 19.8 (8.9) for placebo. At week 1 (4.5 g), significantly more participants taking ON-SXB had ≥25% reduction in cataplexy (43.8% vs 26.4%; P&lt; 0.05). Significantly more participants receiving ON-SXB had ≥25%, ≥50%, or ≥75% reduction in cataplexy vs placebo at weeks 3, 8, and 13 and complete resolution of cataplexy at weeks 8 and 13 (6-g dose: ≥25%, 68.5% vs 40.3% [P&lt; 0.001]; ≥50%, 38.4% vs 20.8% [P&lt; 0.05]; ≥75%, 23.3% vs 4.2% [P=0.001]; 100%, 2.7% vs 0 [P=NS]; 7.5-g dose: ≥25%, 67.1% vs 43.1%; ≥50%, 53.4% vs 25.0%; ≥75%, 32.9% vs 8.3% [all P&lt; 0.001]; 100%, 6.8% vs 0 [P&lt; 0.05]; 9-g dose: ≥25%, 58.9% vs 41.7% [P&lt; 0.001]; ≥50%, 49.3% vs 26.4% [P&lt; 0.001]; ≥75%, 32.9% vs 15.3% [P&lt; 0.01]; 100%, 11.0% vs 2.8% [P&lt; 0.05]).

Conclusion
In this post-hoc analysis, ON-SXB 4.5 g significantly reduced cataplexy by week 1. Additionally, ~10% of participants taking ON-SXB 7.5 and 9 g were free of cataplexy episodes. These data may be useful for clinicians when setting expectations of ON-SXB effectiveness for patients with cataplexy.

Support (if any)
Avadel Pharmaceuticals