bluuebunny/crossref_metadata_2025_split huggingface dataset:
0690 An Evaluation Of Genioglossus Strengthening On Obstructive Sleep Apnea Treatment Outcomes
Authors: Maghsoudipour M , Bosompra N , Jen R , Li Y , Moore S , DeYoung P , Fine J , Edwards B , Gilbertson D , Owens R , Morgan T , Malhotra A 
Published: May 2020

Abstract

Introduction
Obstructive sleep apnea (OSA) is characterized by repetitive episodes of pharyngeal collapse. The genioglossus is a major upper airway dilator muscle thought to be important in OSA pathogenesis. Upper airway (UA) muscle training has reported benefits in some OSA patients. Our goal was to assess the effect of upper airway muscle training on OSA outcomes.

Methods
Sixty five patients with OSA (AHI&gt;10/h) were divided in three subgroups: 1) Treated with auto-CPAP (n=21), 2) Previously failed or refused CPAP therapy (no treatment), (n=24), 3) Currently treated with an oral appliance who still have residual OSA (AHI&gt;10/h), (n=20). All subjects were given a custom-made tongue strengthening device. Within each group we conducted a prospective, randomized, controlled study examining the effect of upper airway muscle training. In each subgroup, subjects were randomized to UA muscle training (volitional protrusion against resistance) or sham group (negligible resistance), with 1:1 ratio over 6 weeks of treatment (twice daily for 20 min/session). In the baseline and the final visit, subjects completed home sleep testing, questionnaires (ESS, PSQI), acoustic pharynogometry, Iowa Oral Performance Instrument (IOPI), and Psychomotor Vigilance Test (PVT).

Results
Results remain blinded; 33 patients received treatment Y and 32 patients received treatment Z. To date, we have not observed a main effect of treatment group on several measures of OSA severity. Some changes in subjective measures over time were observed but difficult to interpret until unblinding occurs.

Conclusion
Treatment of OSA using upper airway muscle training exercises requires further study. Whether muscle training is a viable approach for a definable subset of OSA patients remains unclear.

Support
R01HL085188-05A1 (U.S. NIH Grant/Contract)
0695 Sleepwell24, A Smartphone Application To Promote PAP Therapy Adherence: Feasibility And Acceptability
Authors: Petrov M E , Hasanaj K , Hoffmann C M , Epstein D R , Krahn L , Park J G , Hollingshead K , Yu T , St. Louis E K , Morgenthaler T I , Buman M P 
Published: May 2020

Abstract

Introduction
We aimed to test the feasibility and acceptability of SleepWell24, a multicomponent, smartphone-delivered intervention to increase positive airway pressure (PAP) adherence among newly diagnosed OSA patients.

Methods
SleepWell24 targets PAP adherence along with other health behaviors through education, trouble-shooting, goal-setting, and near real-time biofeedback of PAP machine use, and sleep and physical activity levels (via Fitbit integration), and other chronic disease self-management components. Patients with a first-time diagnosis of OSA (AHI≥5) and prescribed PAP therapy were enrolled from the Centers for Sleep Medicine at Mayo Clinic in Rochester, MN and Phoenix, AZ. Patients were randomized to SleepWell24 or usual care (UC) and assessed for PAP use over 60 consecutive nights. UC patients received a Fitbit monitor to control for non-specific intervention effects related to the introduction of a new personal technology. Feasibility was assessed with recruitment and retention rates and acceptability was assessed post-intervention with the validated, 8-item Treatment Evaluation Questionnaire (TEQ; range:0-4). ANCOVA models, adjusting for age, sex, and AHI severity, compared intervention arms on acceptability ratings.

Results
OSA patients were consented and randomized (N=111). Before the intervention began 4 participants withdrew, 12 were lost to follow-up, and 5 could not start the trial due to durable medical equipment (DME) vendor barriers. Ninety OSA patients (n=41 SleepWell24, n=49 UC; age M±SD=57.2±12.2; 44.4% female, 61.1% AHI≥15) started the intervention, with 2 participants withdrawing, 1 becoming deceased (unrelated to treatment) and 7 with missing PAP data due to DME vendor barriers. There was no significant between-groups differences on post-treatment acceptability (SleepWell24 M±SD=2.7±1.1 vs. UC M±SD=3.1±0.9, F[1,73]=2.3, p=0.11), and 77% of SleepWell24 participants found the app to be moderately to totally acceptable.

Conclusion
Overall, SleepWell24 was found to be feasible for delivery in two large clinical sleep medicine centers, and patients found the app to be acceptable. A number of challenges in trial delivery were encountered that have implications for scaled-up efficacy testing: (a) partnerships with DME vendors for near real-time PAP data integration; (b) alignment with clinical practice (i.e., referral, medical record integration); and (c) patient engagement.

Support
National Institute of Nursing Research / National Institutes of Health: R21NR016046
0704 Treatment-emergent Central Sleep Apnea Predicts Residual Respiratory Instability During Cpap Use At 6 Months
Authors: Thomas R J 
Published: May 2020

Abstract

Introduction
The prevalence, severity, significance, and predictors of residual sleep apnea during use of continuous positive airway pressure (CPAP) remain uncertain. High loop gain is associated with or induces periodic breathing and central sleep apnea (CSA). Treatment-emergent CSA (TE-CSA) is often considered a transient phenomenon of no long-term clinical significance. Standard polysomnographic features were assessed as risk factors for high residual apnea during compliant CPAP use.

Methods
Patients with sleep apnea (mean AHI 53.6, SD:33/hour of sleep) who underwent split night studies were prospectively entered in a database. They were all treated with positive airway pressure at the Beth Israel Deaconess Medical Center (Boston) and tracked by the EncoreAnywhere system. Machine detected AHI (AHIm) was extracted for a week average at month 6. The manual scored AHI(AHIs) was calculated from the last waveform graph during every month. Logistic regression assessed predictors of elevated automated (5 or greater) or manual (10 or greater) residual events//hour of use.

Results
A total of 69 CPAP compliant (average of at least 4 hours) subjects were analyzed. Age: 59.5 (range 17-81), gender: 47/69 male. 44/69 had an elevated manual AHI, while 20/69 had an elevated autodetected AHI. The only predictors of high residual apnea were TE-CSA (5 or more central apneas and hypopneas/hour of sleep): Odds Ratio 3.6 (CI: 1.07-12-3), p: 0.39. and the treatment component arousal index: Odds Ratio 1.06 (CI: 1.01-1.11), p: 0.018. Machine estimated AHI, which under-detected events by a factor of 3 or more, was not associated with any measure.

Conclusion
Residual apnea is common after 6 months of compliant CPAP use, and the only predictors identified were TE-CSA and treatment component arousal index.

Support
This study is supported by American Academy of Sleep Medicine Foundation, Category-I award to RJT
0721 Coronary Atherosclerotic Plaque Burden and Composition in Patients with Obstructive Sleep Apnea by Coronary CT Angiography
Authors: Lu M , Wei Y , Wang Z , Fang F , John S E , Xu L 
Published: May 2020

Abstract

Introduction
OSA is closely associated with increased risk of coronary artery disease. Although previous small studies have investigated coronary plaque in OSA patients, limited data are available regarding the association of OSA with plaque morphology and composition. Therefore, we aimed to quantitatively characterize and compare coronary plaque burden and composition between patients with no or mild obstructive sleep apnea (OSA) and moderate-severe OSA using coronary computed tomography angiography (CTA) in a large-scale study.

Methods
We retrospectively analyzed consecutive patients who underwent sleep monitoring and coronary CTA. Metrics reflecting coronary plaque characteristics were compared between patients with no or mild OSA with apnea hypoxic index (AHI) ≤15 and moderate-severe OSA (AHI&gt;15). The associations of OSA with coronary plaque components were determined by logistic and linear regression analysis.

Results
A total of 854 patients were enrolled in the study. Of these, 162 did not meet the inclusion criteria and of the remaining 692 patients 400 (57.8%) had moderate-severe OSA and 292 had no or mild OSA. Patients with moderate-severe OSA had a significantly higher total plaque volume, total non-calcified plaque (NCP) volume and total low density non-calcified plaque (LD-NCP) volume, and corresponding burden than those with no or mild OSA (all with p&lt;0.05). Multivariate logistic regression analysis revealed that moderate-severe OSA patients are more likely to have any plaque, NCP and LD-NCP than those without no or mild OSA (p&lt;0.05). In addition, stepwise multivariate linear regression analysis further revealed an independent relationship between moderate OSA (15&lt;AHI≤30) and more so between severe OSA (AHI&gt;30) and, NCP volume, LD-NCP volume, NCP composition, and LD-NCP composition, following adjustment for traditional cardiovascular risk factors, compared to no or mild OSA (AHI&lt;15) (all with a p&lt;0.05). Moderate-severe OSA conferred a similar odds ratio for LD-NCPs (a high-risk plaque) as the usual cardiovascular risk factors.

Conclusion
In this large cross-sectional study, OSA severity was associated with high-risk plaque features independent of traditional cardiovascular risk factors, suggesting an increased risk for cardiovascular events.

Support
This study was supported by NSFC (Project 81870335), International Science & Technology Cooperation Program of China (No.2015DFA30160), Beijing Municipal Science & Technology Commission (No. Z141100006014057)
0727 Study Onthe Effect Of Obstructive Sleep Apnea-hypopnea Syndrome Onperioperative Management Inendoscopic Sinussurgerypatients
Authors: Xiaojun Z , Chan W , Hao W , Fang F , Wei X 
Published: May 2020

Abstract

Introduction
To determine the frequency of undiagnosed OSA patients in patients received endoscopic sinus surgery (ESS) and to investigate the effect of OSA on the perioperative management in those patients.

Methods
308 patients undergoing ESS from 2017-2019 were enrolled. The patients were divided into two groups according to whether OSA was combined. STOP-Bang questionnaire scoring system was used to classify patients into high risk and low risk for OSA. The differences between perioperative management and complications between the two groups were compared.

Results
308 consecutive cases were included, 46 cases (14.9%) combined with OSA and 108 cases (35.0%) were at high risk of OSA. OSA patients have higher morbidity of hypertension (OR, 2.05; CI, 1.07-3.92; P=0.03), hyperlipidemia (OR, 2.19; CI, 1.06- 4.51; P=0.03), longer hospitalization time(7.0±2.7 vs. 5.4±3.6, P≤0.01) and higher incidence of intubation difficulties (OR, 3.74; CI,1.39-10.1; P=0.01). Patients at high risk of OSA also had increased rates of hypertension, hyperlipidemia, coronary heart disease and post-operative cardiovascular and respiratory complications.

Conclusion
OSA or high scores of STOP-Bang are associated with increased perioperative complications in ESS patients. Preoperative OSA screening should be strengthened to improve the safety and prognosis of ESS surgery.

Support
National Natural Science Foundation of China under Grant [number 81670903]; and Beijing Municipal Administration of Hospitals Ascent Plan under Grant [number DFL20150602]
0731 Obstructive Sleep Apnea with Predominant Respiratory Effort Related Arousals: Theta Power in C3- M2 And C4-M1 Derivation Comparison in Male And Female
Authors: Hura K , Singh H , Sahota P , Thakkar M 
Published: May 2020

Abstract

Introduction
Theta power in electroencephalography has been studied as a correlate to REM sleep. An increase in theta power during REM sleep has been observed in patients during recovery sleep after sleep deprivation. Emotional memories appear to be processed and consolidated during REM sleep.The role of hippocampal theta wave activity during REM sleep on emotional memory processing is limited. The importance of theta power has not been well characterized in patients with obstructive sleep apnea (OSA) with predominant respiratory Effort Related Arousals (RERAs). This report aims to study the theta power in patients with OSA with predominant Respiratory Effort Related Arousals (RERAs) with an apnea-hypopnea index (AHI) of &lt; 5.

Methods
We have identified 38 patients with baseline polysomnograms performed from December 2019 to July 2019 with AHI &lt; 5 and a Respiratory Disturbance Index (RDI) of at least 5 or greater. Patients with chronic hypoxemic respiratory failure, hypoventilation and predominant central sleep apnea were excluded from the study. Total power of frequency in bands was obtained for theta waves (4-8 Hz) and total waves (1-30 Hz). Relative theta power was calculated on the last REM sleep using C3-M2 and C4-M1 derivations. Paired two-tailed t-Test was performed on the theta power in C3-M2 and C4-M1 in both the sexes.

Results
Initial analysis was performed in 38 patients out of which 20 were male and 18 female. Among males, (Mean ± SEM) age was 52.3 (±2.9); Epworth Sleepiness Scale (ESS) of 6.6 (±1.1), AHI of 2.1 (±0.3), and RDI of 7.3 (±0.3).Whereas in female (Mean ± SEM) age was 46.8 (± 2.8), ESS of 7.7 (±1.4), AHI of 2.3 (±0.35), and RDI of 6.9 (±0.4). Statistically significant difference was noted in the theta power between the C3-M2 and C4-M1 derivations with P value of 0.03 and 0.04 in male and female respectively. However, no significant difference was found when C3-M2 and C4 -M1 was compared between male and female. Further, statistical analysis will be performed after gathering data from a larger sample size.

Conclusion
There was significant difference between C3-M2 and C4-M1;overall no difference was found between sexes.

Support
none
0741 Diagnosing Narcolepsy Type II in the Active Duty Population
Authors: Villarreal B , Powell T , Hansen S 
Published: May 2020

Abstract

Introduction: Introduction
There is a high prevalence of sleep disturbances in U.S. military personnel which can significantly impact continued military service. Narcolepsy is a rare sleep disorder and testing results are often variable, especially when cataplexy is absent. Given the high incidence of confounding sleep disorders in military personnel, including insufficient sleep duration and sleep-disordered breathing, a narcolepsy diagnosis may be even more challenging. As this diagnosis is often incompatible with continued military service, extra attention should be given to confounding diagnoses in military personnel.

Methods
This is a retrospective study of patients aged 18-65, who were diagnosed with narcolepsy type 1 or type 2 at an outside location and subsequently underwent repeat evaluation at our facility. Polysomnography, actigraphy, and multiple sleep latency test results from the time of the original diagnosis, if available, and repeat evaluation were reviewed. The initial diagnosis was compared to the results of repeat testing and the prevalence of narcolepsy vs. another sleep disorder was assessed.

Results
Two of twenty-three patients retained a diagnosis of narcolepsy on repeat testing. 10 patients were diagnosed with insufficient sleep syndrome (&lt 7 hours sleep/night), 5 displayed significant circadian misalignment (including irregular sleep/wake periods or delayed sleep phase), and 8 were diagnosed with mild obstructive sleep apnea. 7 of the 8 OSA patients had supine predominate OSA, which may have contributed to not being diagnosed on initial testing. The average total sleep time of the group was 6 hours and 49 minutes, consistent with insufficient sleep duration.

Conclusion
Narcolepsy type 1 and type 2 are exceedingly rare disorders with diagnostic test results that may be influenced by the presence of other common sleep disorders. In this study, re-evaluation resulted in a changed diagnosis in 91 percent of patients, emphasizing the importance of ruling out these confounding diagnoses.

Support
0742 Hypersomnia Severity Index: Reliability and Validity in a Behavioral Sleep Medicine Clinical Sample
Authors: Amatrudo G , Puzino K , Bourchetin E , Calhoun S L , Fernandez-Mendoza J 
Published: May 2020

Abstract

Introduction
There is a need for patient-reported outcome measures of central disorders of hypersomnolence (CDH) that adequately assess both essential features and associated daytime impact. The Hypersomnia Severity Index (HSI) was designed to assess severity, distress and impairment of hypersomnolence in persons with psychiatric disorders. Little data is available regarding its psychometric properties in clinical samples with diverse sleep disorders, including CDH.

Methods
158 consecutive patients (44.11±16.38 years old, 70.9% female, 19.6% minority) who were evaluated at the Behavioral Sleep Medicine (BSM) program of Penn State Hershey Sleep Research & Treatment Center completed the HSI and the Epworth Sleepiness Scale (ESS). All patients were diagnosed using ICSD-3 criteria, with 10 % receiving a diagnosis of CDH, 54% of insomnia disorder (ID) and 36% of other sleep disorders (oSD).

Results
The HSI showed satisfactory internal consistency (Cronbach’s α=0.79) and item-total correlations (r=0.42-0.67), except for item 1 (r=0.17). Principal component analysis provided a 2-factor structure (HSI-Symptoms and HSI-Impact) explaining 56.20% of the variance. Convergent validity with ESS was optimal (r=0.65) but greater for HSI-Symptoms (r=0.69) than HSI-Impact (r=0.39). Criterion validity showed significantly higher scores in subjects with CDH (22.63±7.57) and significantly lower scores in subjects with ID (16.96±5.96) as compared to those with oSD (18.65±6.65); however, these divergent scores were primarily driven by the HSI-Symptoms score (p&lt;0.01) rather than the HSI-Impact score (p&gt;0.12).

Conclusion
The HSI shows satisfactory indices of reliability and validity in a clinically-diverse sleep disorders sample. Its criterion validity is supported by its divergent association with insomnia vs. hypersomnia disorders. Future studies should examine cut-off score for the HSI to reliably identify CDH and test its sensitivity to treatment effects.

Support
Department of Psychiatry, Penn State College of Medicine
0752 JZP-258 Dose Titration and Transition from Sodium Oxybate in a Placebo-Controlled, Double-Blind, Randomized Withdrawal Study in Adult Participants With Narcolepsy With Cataplexy
Authors: Foldvary-Schaefer N , Bogan R K , Thorpy M J , Huang L , Skowronski R , Dauvilliers Y 
Published: May 2020

Abstract

Introduction
Sodium oxybate (SXB) is a standard of care for the treatment of cataplexy and excessive daytime sleepiness in narcolepsy. JZP-258 is an oxybate product candidate (at same concentration as SXB) with 92% less sodium. JZP-258 dose adjustment during titration was evaluated.

Methods
At study entry, participants were taking SXB only, SXB+other anticataplectics, anticataplectics other than SXB, or were cataplexy treatment-naive. JZP-258 treatment began during a 12-week, open-label optimized treatment and titration period. Participants taking SXB only or SXB+other anticataplectics transitioned to JZP-258 at the same gram-for-gram dose as SXB and titrated to an efficacious and tolerable (optimal) dose from weeks 3-12. Participants taking other anticataplectics or who were anticataplectic-naive initiated JZP-258 at 4.5 g/night and were titrated to an optimal dose at 1-1.5 g/night/week (maximum total dose, 9 g/night). A 2-week stable-dose period and 2-week, double-blind, randomized withdrawal period followed.

Results
During the stable-dose period, total nightly JZP-258 dose (median [range]) was higher in participants taking SXB at study entry (SXB-only, 7.5 g [4.5-9.0], n=45; SXB+other anticataplectics, 9.0 g [6.0-9.0], n=14) compared with those not taking SXB (other anticataplectics, 7.5 g [4.5-9.0], n=23; anticataplectic-naive, 7.0 g [3.0-9.0], n=67), and dose adjustments were fewer. In most (69%) participants taking SXB at study entry who entered the stable-dose period, no change in dose was required (median [range] number of adjustments was 0 ([0-8]); for those with a change in dose, most changes were within one titration step (1.5 g/night). In participants not taking SXB at study entry, the median (range) number of adjustments was 3.0 (0-7).

Conclusion
Most participants taking SXB at study entry transitioned to JZP-258 treatment at the same dose with retained effectiveness. Participants not previously taking SXB achieved a tolerable and efficacious dose of JZP-258 after a median of 3 adjustments.

Support
Jazz Pharmaceuticals
0764 Pitolisant In The Treatment Of Patients With Narcolepsy: A 2-year, Prospective, Observational, Single-center Study
Authors: Triller A , Hof zum Berge A , Finger B , Kallweit U 
Published: May 2020

Abstract

Introduction
Pitolisant, a selective histamine H3 receptor antagonist/inverse agonist, increases histamine release in the brain. The efficacy of pitolisant in adults with narcolepsy was demonstrated in randomized, placebo-controlled trials. This study evaluated long-term use of pitolisant in clinical practice.

Methods
This prospective, open-label, 2-year, observational study was conducted at a major narcolepsy center in Germany and enrolled adults with a diagnosis of narcolepsy who had no prior treatment with pitolisant. Assessments included excessive daytime sleepiness (Epworth Sleepiness Scale [ESS]), weekly rate of cataplexy (WRC), and health-related quality of life (Short-Form Veterans RAND [VR-36]).

Results
The study enrolled 147 patients: mean age, 29.9 years; 57.1% female, 65.3% with cataplexy, and 66.7% with disrupted nighttime sleep. In patients who were tested, CSF hypocretin-1 was &lt;110 pg/mL in 70.8% (51/72), and 79.4 % (77/97) were HLA-DQB1*0602 positive. The pitolisant dose was 35.6 mg/d in 38.1% of patients at Month 3, and 73.5% at Month 24. Most patients received concomitant narcolepsy medications (63.3% at baseline; 79.6% at month 24). Mean ESS score decreased from 16.2 at baseline to 12.4 at Month 12 and 12.6 at Month 24. Mean WRC was reduced by 31% at Month 24. Significant improvement in quality of life was noted at Months 12 and 24 on VR-36 subscales that assess general health perception, vitality, and social function. In all, 38 patients (25.8%) discontinued from the study before Month 24: 15.0% for lack of efficacy and 10.8% due to adverse events. The most common adverse events were disrupted nighttime sleep (29.3% of patients), headache (15.5%), and nausea (12.2%).

Conclusion
These real-world data show that long-term treatment with pitolisant (usually with 35.6 mg/d) was efficacious for reducing EDS and cataplexy and improving quality of life in patients with narcolepsy. Treatment was generally well tolerated.

Support
Writing support funded by Harmony Biosciences, LLC.