bluuebunny/crossref_metadata_2025_split huggingface dataset:
0304 Characterizing age and sex-related changes in sleep EEG K-complex morphology in 3,909 individuals
Authors: Valencia Daphne , Schoenholz Reagan , Bischoff Giles , Mullins Anna , Kam Korey , Fakhoury Ahmad , Varga Andrew , Rapoport David , Ayappa Indu , Mazumdar Madhu , Berkalieva Asem , Parekh Ankit 
Published: May 2022

Abstract

Introduction
K-complexes are hallmarks of sleep stage N2 and are thought to be associated with two distinct roles that serve as either or both, a sleep protective mechanism or a cortical arousal response. K-complexes and their morphological features (number, delta surrounding K complexes, etc.) have been implicated in sustained attention as well as in Alzheimer’s disease wherein a decline in the number of K-complexes appeared to discriminate diseased individuals from healthy controls. Yet, age and sex-related changes in K-complex morphology are not well-known.

Methods
We analyzed data from the Sleep Heart Health Study (SHHS) to understand age- and sex-related changes in K-complex morphology. The SHHS is a cohort study comprised of 5,804 men and women aged 40 and older aimed at investigating the cardiovascular consequences of sleep-disordered breathing. K-complex (on C3/A2) features were quantified using previously published and validated open-source algorithm (DETOKS; Parekh et. al. J. Neurosci Meth. 2015). Three features of K-complexes were studied: number of K-complexes (density), delta (∆SWAK) and alpha (∆alphaK) surrounding K-complexes.

Results
Of the 5,804 studies available, 3,909 that had at least 6h of usable EEG were analyzed (mean = 62±11 yrs., range [40-90 yrs.], 53%female). With aging, K-complex density and (rho=-0.1, p&lt;0.0001), ∆SWAK (rho=-0.2, p&lt;0.0001) were inversely associated with age, while ∆alphaK (rho=0.1, p&lt;0.01) was significantly positively associated with age. The inverse association of K-complex density with age was greater in men compared to women (rhomen=-0.3, p&lt;0.0001, rhowomen=-0.1, p&lt;0.01). Women had greater K-complex density compared to men (1.8[1.3-2.4] vs. 1.3[0.9-1.8], median[IQR]; std. mean diff =0.4). The changes in K-complex morphology with age remained significant after controlling for OSA severity.

Conclusion
Age is associated with decline in K-complex morphology such that K-complex density and delta activity surrounding K-complexes declines whereas alpha activity surrounding K-complexes increases. An age-related decline in delta activity surrounding K-complexes and an increase in alpha activity surrounding K-complexes is consistent with the potential role for these features in either sleep-state maintenance or arousal responsiveness. Whether the decline in K-complex morphology seen here with aging, and its interaction with sex-related differences, is accelerated in neurodegenerative disorders such as AD remains to be tested.

Support (If Any)
Support: NIH K25HL151912, AASMFoundation BS-233-20
0313 The Role of Objective Sleep on Subjective and Objective Cognition in Older Adults with Insomnia: A Pilot Study
Authors: Costa Amy , Musich Madison , Knous Dakota , McCrae Christina , Cowan Nelson , Curtis Ashley 
Published: May 2022

Abstract

Introduction
Cognitive complaints and objective cognitive dysfunction are common in aging populations, but findings regarding associations between them are inconclusive. Given age-related sleep changes [more lighter-staged sleep, reduced sleep efficiency (SE)], and known relationships between insomnia complaints and cognitive dysfunction, this pilot tested whether polysomnographic sleep moderates associations between subjective and objective cognition in older adults with insomnia complaints.

Methods
Older adults with insomnia complaints (N=37, Mage=68.9, SD=6.23, 20 women) completed one night of polysomnography (Sleep Profiler-PSG2TM) and the NIH Toolbox [Pattern Comparison (processing speed), Dimensional Change Card Sort (cognitive flexibility), Stroop (attention and inhibition), and Sternberg (working memory). Additionally, participants completed the Cognitive Failures Questionnaire (subscores CFQ-memory, CFQ-distractibility CFQ-blunders computed). Multiple regressions examined if polysomnographic sleep (SE, %N1, %N3) moderated associations between subjective/objective cognition, controlling for apnea-hypopnea index and depression.

Results
%N1 moderated associations between Sternberg performance and CFQ-memory (R2=.13, p=.03), CFQ-distractibility (R2=.20 p=.01) and CFQ-blunders (R2=.19 p=.02). At highest %N1, worse working memory was associated with less complaints in memory (β=16.4, p=.03), distractibility (β=12.4, p=.009) and blunders (β=15.3, p=.02). Additionally, %N1 (R2=.14, p=.02) and SE (R2=.17, p=.02) moderated the association between dimensional change performance and CFQ-distractibility. At lowest %N1, worse cognitive flexibility was associated with more distractibility complaints (β=-988.8, p=.02), while at highest %N1, worse cognitive flexibility was associated with less distractibility complaints (β=3881.4, p=.02). At lowest SE, worse cognitive flexibility was associated with less distractibility complaints (β=2354.0 p=.02), while at highest SE, worse cognitive flexibility was associated with more distractibility complaints (β=-1414.1 p=.03).

Conclusion
Preliminary findings suggest in older adults with insomnia complaints, greater time spent in lighter-staged sleep and more sleep fragmentation may exacerbate discrepancies in the objective/subjective cognition relationship, while less time spent in lighter-staged sleep and less sleep fragmentation may converge the objective/subjective relationship. Objective sleep should be considered when understanding discrepancies between subjective reports versus neuropsychological/objective cognition profiles. Prospective studies with larger samples examining how sleep impacts the trajectory of subjective/objective cognition in aging are warranted.

Support (If Any)
This research was made possible by an award (PI:Curtis) from the American Academy of Sleep Medicine Foundation, a foundation of the American Academy of Sleep Medicine.
0326 Influence of Sleep and Cardiovascular Health on Cognitive Outcomes in Older Adults
Authors: Maybrier Hannah , Lucey Brendan , Holtzman David , Head Denise 
Published: May 2022

Abstract

Introduction
High and low sleep duration have been associated with reduced executive function (EF) and episodic memory (EM). However, causal pathways have not been identified. Cardiovascular health may contribute to the relationship between sleep and cognitive aging. Sleep disturbance has been associated with increased hypertension and heart disease in older adults, and cerebrovascular insufficiency has been consistently linked with cognitive decline. Therefore, the mediating and moderating effects of cardiovascular disease risk (CVD) on the relationship between sleep duration and longitudinal change in EF and EM were examined.

Methods
Statistical analyses were preregistered (osf.io/6yw7g). Average total sleep time (TST) over 2-6 nights was estimated using single-channel EEG at baseline (N=332). CVD was estimated using the abbreviated Framingham Heart Score approximately one year post-baseline. Outcome variables were linear change in EF and EM composite scores [BL1] per year up to 7 years after baseline. EF subtests measured semantic fluency, working memory, and task switching. EM subtests measured verbal associative memory, narrative episodic memory, and list learning. Covariates included age, gender, Alzheimer disease (AD) biomarkers (ratio of phosphorylated tau181 to amyloid-ß42), global cognition, and apnea-hypopnea index.

Results
Greater TST was linearly associated with reduced CVD (ß=-.157, p=.006). Quadratic effects of TST on EF and EM were observed (EF: ß=-.105, p=.002; EM: ß=-.203, p=.007). Lowest TST was related to greater reduction in EF; highest TST was related to greater reduction in EF and EM. Mediating effects of CVD for EF and EM were observed (ps&lt;.05) but were non-significant when age and AD biomarkers were included (p=.10, p=.08, respectively). A non-significant trend indicated CVD moderated effects of TST on EF (ß=.10, p=.055), controlling for age and AD biomarkers. Less sleep combined with higher CVD tended to be associated with greater decline in EF. CVD did not moderate effects of TST on EM (ß=.07, p=.254).

Conclusion
Consistent with prior literature, CVD and TST were independently associated with cognitive decline. Although findings suggest that CVD may influence effects of TST on cognitive decline, more evidence is needed. Future analyses will examine alternative sleep measures (e.g., sleep efficiency, slow wave spectral density).

Support (If Any)
NIH: T32-AG000030, P01-AG03991, P01-AG026276, P30-AG066444.
0359 Clinical Performance Quality of a Precision Oral Appliance Made from Novel Medical Grade Class VI Material
Authors: Murphy Mark , Liptak Len , Kim Sung , Ojeda Yoann 
Published: May 2022

Abstract

Introduction
Oral appliance therapy device quality is an important factor for successful, efficient treatment of Obstructive Sleep Apnea. Poor device quality, defined in this investigation as the remake rate, is costly. A previous investigation reports that 13% of oral appliance therapy devices required remakes, each costing an estimated $300 in lost productivity, fees for remakes, and three weeks of lost therapy. Other investigations associate poor quality with even higher costs and an increased propensity for the patient to discontinue treatment.

Methods
In this retrospective study design, quality data for 34,261 consecutively manufactured oral appliance therapy devices made from a novel medical grade class VI material was collected. Quality data was analyzed in total, and with 30-day and 60-day lag periods. The purpose of the lag periods was to account for the time between manufacture and delivery.

Results
Total remake rates were 1.2% (416/34,261). Total remake rates with a 30-day lag period were 1.3% (416/30,946). Total remakes with a 60-day lag period were 1.5% (416/26,964).

Conclusion
The clinical performance quality for a new precision oral appliance made from a novel medical grade class VI material is encouraging. Remake rates were between 1.2% and 1.5% depending on the lag period, which is directionally favorable in comparison with previously reported remake data.

Support (If Any)
Data provided by ProSomnus Sleep Technologies.
0360 PAP Adherence, Follow-Up, and Telehealth During the COVID-19 Pandemic
Authors: Kim David , Powell Tyler , Brock Matthew , Foster Shannon , Hansen Shana 
Published: May 2022

Abstract

Introduction
Positive airway pressure (PAP) is the gold standard therapy for OSA. However, patient follow-up and adherence to PAP therapy remains variable. With the onset of the COVID-19 pandemic, many sleep centers shifted towards telemedicine. In order to evaluate the impact of telehealth, we assessed the rates of follow-up and PAP adherence among patients newly diagnosed with OSA prior to and after the onset of the COVID-19 pandemic.

Methods
Patients aged 18-75 years enrolled in our military sleep center who met eligibility criteria were divided into a pre-pandemic group and a pandemic group. For the pre-pandemic group, initial and follow-up clinic appointments occurred via face-to-face encounters. For the pandemic group, these clinic appointments occurred via telephone encounters. PAP follow-up was defined as a clinic appointment occurring within 6 months of the initial OSA diagnosis and the onset of PAP therapy. Adequate PAP adherence was defined as usage of the device ≥ 4 hours per night on ≥ 70% of nights during a consecutive 30-day period. Differences among the two groups regarding PAP follow-up, PAP adherence, and demographic data were analyzed.

Results
Eligible patients (n=234) were divided into a pre-pandemic group (n=117) and a pandemic group (n=117). Demographic data for the pre-pandemic group vs. pandemic group included the following: mean age 42.2 vs. 40.3 years; 78.6% vs. 88.0% male; 60.7% vs. 76.9% active duty military, mean BMI 30.1 vs. 30.1; mean AHI 28.5/hr vs. 27.7/hr; mean Epworth Sleepiness Scale score 11.7 vs. 12.0; mean Insomnia Severity Index 16.9 vs. 16.8. The rates of PAP follow-up were 59.0% (pre-pandemic group) vs. 41.0% (pandemic group). The rates of adequate PAP adherence were 34.8% (pre-pandemic group) vs. 25.0% (pandemic group).

Conclusion
There were higher rates of PAP follow-up and PAP adherence among patients seen via face-to-face encounters occurring prior to the onset of the COVID-19 pandemic. While utilization of telehealth in our center did not result in improved outcomes, there may still be utility in offering telehealth to the sleep patient population. Additional studies are needed to identify effective interventions that can be implemented to improve rates of PAP follow-up and PAP adherence.

Support (If Any)
There were higher rates of PAP follow-up and PAP adherence among patients seen via face-to-face encounters occurring prior to the onset of the COVID-19 pandemic. While utilization of telehealth in our center did not result in improved outcomes, there may still be utility in offering telehealth to the sleep patient population. Additional studies are needed to identify effective interventions that can be implemented to improve rates of PAP follow-up and PAP adherence.
0361 PennPALS: An Innovative, Bidirectional Text Messaging System Using PAP Usage Data to Increase Patient Adherence with PAP Therapy
Authors: Jimenez David , Cadman Sara , Watach Alexa , Khan Neda , Hahn Lauren , Bae Charles 
Published: May 2022

Abstract

Introduction
Cloud-based systems that collect PAP data provide patients and providers with near real-time usage information, but a system that identifies/intervenes with patients at risk of PAP non-adherence has not been available to date. The Penn PAP Automated Learning System (PennPALS) is an automated, bidirectional text messaging system that uses PAP data to initiate text messaging conversations to patients in a timely manner.

Methods
PennPALS was created using Way to Health, an evidence-based patient engagement platform, to leverage PAP data, such as daily average hours of use and time spent with a large mask leak, to identify and initiate automated text messages to help patients troubleshoot issues. Depending on their responses, patients were given a pre-defined recommendation via text or escalated to a clinical provider contacting them via phone-call. Two 30-day pilots were conducted, which collectively enrolled 33 patients who were prescribed PAP for the first time.

Results
Most patients were White, Non-Hispanic (54.8%, n=17), males (64.5%, n=20), with a mean age of 52 years. Two patients did not receive a PAP machine by the end of the pilot. PennPALS engaged patients via text message 115 times. Of the 31 patients who started PAP, 7 (22.6%) were adherent from the start of enrollment and only received positive enforcement text messaging. Across the 24 (77.4%) patients that experienced issues, there were 58 text message conversations, which resulted in 32 clinical escalations. Twenty-one (67.7%) patients triggered text messaging interventions for using PAP for &lt; 4 hours/night on average over a 7-day period or experiencing a large mask leak, n=10 (32.3%) and n=11 (35.5%) respectively. At 30-days, 17 (70.8%) of the 24 patients were adherent (i.e. using their PAP at least 4 hours/night on average over the last 7-days). Patient feedback was generally favorable with a Net promoter score (likelihood to recommend) of 68.4 (n=19).

Conclusion
PennPALS effectively identified/intervened with patients at risk of non-adherence to PAP therapy, and the bidirectional text messaging system helped patients become adherent in the first 30 days of treatment. Further testing and longer-term monitoring is needed to examine the effectiveness of PennPALS on long-term PAP adherence.

Support (If Any)
0380 A Pilot Study to Test Patient-Reported Outcomes Visualization Methods in the EHR Note Template for Sleep Medicine Clinicians
Authors: Yar Wail , Kazaglis Louis 
Published: May 2022

Abstract

Introduction
Patient-Reported Outcomes (PROs) are standardized assessments of patient-specific health measures for physical, mental, and social well-being reported directly by patients without provider interpretations. Providers use PROs to efficiently improve the quality of care and empower patients through structured communication. Patient factors are widely acknowledged to affect PROs; however, there is very little data on the effect of provider PRO visualization methods on patient outcomes. This pilot study compares PRO visualization methods to improve readability, provider satisfaction, and patient outcomes in a comprehensive sleep center. We hypothesize that detailed PRO with color-based formatting will improve the clinical diagnoses and provider satisfaction with PRO metrics.

Methods
Twenty-four sleep providers from the Sleep Disorders Center at Cleveland Clinic, consisting of physicians (n=14), fellows (n=3), and nurse practitioners (n=7), were randomly assigned to two equal groups. All sleep providers completed the online pre-intervention survey (71% female), and 23 providers (96%) completed the post-intervention survey four weeks after randomization. Survey questions utilizing 5-point Likert scales inquired about current use and perceived benefit of 3 PROs accompanying new visits: International Restless Leg Syndrome Scale (IRLS), Insomnia Severity Index (ISI), and Epworth Sleepiness Scale (ESS). The standard presented only total scores, while the intervention group received detailed tables of IRLS, ISI, and ESS components with color-stratified total scores. ANCOVA statistical analysis was performed to compare satisfaction, usage, and clinical utility between groups over time.

Results
Current PRO templates were used by 79% of providers. PROs were reported as helpful or extremely helpful by 87% of providers, while only 38% were satisfied or extremely satisfied by the presentation. Compared to controls, the enhanced-visualization group scores improved but did not display significant differences in the likelihood of use (p=0.8), helpfulness (p=0.7), or overall satisfaction (p=0.9); utility in reaching diagnosis demonstrated a trend towards improvement (p=0.051).

Conclusion
PRO enhanced visualization did not demonstrate improvements in provider utility or satisfaction in this study. However, effects are likely limited by small sample sizes. Direct measurement of effects on test ordering and clinical diagnoses may provide further clarity. Future research is needed to enhance the usage of PROs to assess the decision-making process during clinical practice.

Support (If Any)
0386 Long-term Safety During a Clinical Trial of Lower-Sodium Oxybate in Participants With Narcolepsy With Cataplexy
Authors: Bogan Richard , Foldvary-Schaefer Nancy , Skowronski Roman , Chen Abby , Thorpy Michael 
Published: May 2022

Abstract

Introduction
Treatment-emergent adverse events (TEAEs) were analyzed during a 6-month open-label extension (OLE) of a double-blind, placebo-controlled, randomized withdrawal trial (NCT03030599) of lower-sodium oxybate (LXB; Xywav™). LXB is FDA approved for treating cataplexy or excessive daytime sleepiness in patients with narcolepsy aged ≥7 years and for treating idiopathic hypersomnia in adults.

Methods
Participants entered the OLE following rescreening (re-entry) after discontinuing LXB treatment or directly after completing the main study (rollover). Re-entry participants initiated LXB (4.5 g/night) or, if taking sodium oxybate (SXB) during rescreening, transitioned to identical LXB doses (gram-for-gram). Participants titrated (1‒1.5 g/night/week) to a maximum of 9 g/night. TEAEs were assessed in all participants receiving ≥1 LXB dose. TEAE duration represents time from TEAE start to end date (or end of OLE, if TEAE end date unrecorded).

Results
In the analysis population (N=74, mean±SD age=37.6±12.6 years, 66.2% female, 91.9% White), 27 (36.5%) re-entered (after a median [range] of 15.0 [4.0‒33.0] days), and 47 (63.5%) rolled over. Most reported ≥1 TEAE (overall, 58.1%; re-entry, 59.3%; rollover, 57.4%). Overall, the most commonly reported TEAEs were headache (n=7, 9.5%; peak incidence was month 3 [n=5/72]; median [range] duration=1.0 [1‒25] day), nasopharyngitis (n=6, 8.1%; peak incidence was month 6 [n=2/69]; median [range] duration=9.0 [1‒24] days), and dizziness (n=5, 6.8%; peak incidence was month 1 [n=3/74]; median [range] duration=26.0 [1‒181] days). TEAEs were most prevalent in month 3 (n=11/72 [15.3%] reporting a TEAE). No participant reported fall or enuresis; 1 reported nausea (rollover). Most TEAEs were mild or moderate; 2 participants had severe TEAEs (invasive ductal carcinoma [IDC], n=1; dizziness, n=1). Few participants (14.9%) had LXB-related TEAEs, most frequently dizziness (overall, 5.4%; re-entry, 7.4%; rollover, 4.3%). LXB-related TEAEs were more common in participants who re-entered (re-entry, 22.2%; rollover, 10.6%). Seven participants discontinued (re-entry, n=2; rollover, n=5), 3 due to TEAEs (IDC, n=1; apathy, n=1; sleep apnea syndrome, n=1); only apathy was treatment related.

Conclusion
In this long-term study of LXB, safety and tolerability profiles were generally consistent with the known safety profile of SXB. The most common TEAEs were headache, nasopharyngitis, and dizziness.

Support (If Any)
Jazz Pharmaceuticals.
0393 Weight Changes During Treatment With Lower-Sodium Oxybate in a Phase 3 Clinical Study in Patients With Narcolepsy
Authors: Foldvary-Schaefer Nancy , Skowronski Roman , Hickey Luke , Chen Abby , Measey Thomas , Dauvilliers Yves 
Published: May 2022

Abstract

Introduction
Treatment with sodium oxybate (SXB) has been associated with weight loss in patients with narcolepsy. Lower-sodium oxybate (LXB) contains the same active moiety as SXB, with 92% less sodium, and is approved in the US for treatment of cataplexy or excessive daytime sleepiness in patients ≥7 years of age with narcolepsy and for treatment of adults with idiopathic hypersomnia. This analysis assessed weight changes after 14 weeks of open-label LXB treatment in a phase 3 clinical study in patients with narcolepsy (NCT03030599).

Methods
Participants 18‒70 years of age with narcolepsy with cataplexy (taking SXB only, SXB+other anticataplectics, or other anticataplectics, or who were anticataplectic-naive at study entry) began LXB treatment in a 12-week, open-label, optimized treatment and titration period, followed by a 2-week stable-dose period (SDP) on LXB.

Results
Study participants (N=201) had a mean (SD) age of 37.2 (12.2) years. At baseline, mean (SD) weight and body mass index (BMI) were 83.7 (19.2) kg and 28.8 (6.1) kg/m2, respectively; 31.8% of participants (64/201) were normal weight (BMI 18.5 to &lt;25 kg/m2), 31.8% (64/201) were overweight (BMI 25 to &lt;30 kg/m2), and 35.3% (71/201) were obese (BMI ≥30 kg/m2). At the end of SDP, mean (SD) weight and BMI changes in SXB-only (n=45 weight; n=44 BMI), SXB+anticataplectics (n=14), other-anticataplectics (n=23), and anticataplectic-naive (n=65) participants were, respectively, −0.2 (2.5) kg and 0.0 (0.9) kg/m2, −1.0 (1.9) kg and −0.3 (0.6) kg/m2, −2.3 (4.0) kg and −0.8 (1.4) kg/m2, and −2.5 (3.8) kg and −0.9 (1.3) kg/m2. Weight loss ≥5% at the end of SDP occurred in 6.7% of SXB-only, 0.0% of SXB+anticataplectics, 21.7% of other-anticataplectics, and 27.7% of anticataplectic-naive participants. In normal weight, overweight, and obese participants at baseline, mean (SD) decreases in weight at the end of SDP were −1.5 (3.1) kg, −3.3 (3.5) kg, and −2.6 (4.7) kg, respectively (participants who were oxybate-naive at study entry), and −0.1 (1.8) kg, −1.0 (2.4) kg, and 0.2 (2.8) kg, respectively (participants taking SXB at study entry).

Conclusion
In this study, adults with narcolepsy who were oxybate-naive at study entry experienced greater weight loss during LXB treatment compared with adults previously taking SXB.

Support (If Any)
Jazz Pharmaceuticals.