bluuebunny/crossref_metadata_2025_split huggingface dataset:
0683 CPAP Adherence Relative To Sleep Duration And Sleep Period In Different Study Populations
Authors: Deering S , Shumard T , Zamora T , Martinez S , Stepnowsky C J 
Published: May 2020

Abstract

Introduction
CPAP is intended for use during sleep to alleviate disordered breathing. Most patients who use CPAP do so for only a portion of their sleep period, although anecdotally it is known that some also use CPAP while awake. We compared the unusually high levels of CPAP adherence found in a recent study of patients with Overlap Syndrome to a VA clinical population and to participants from the APPLES study.

Methods
CPAP adherence levels were taken from three sources: (1) The O2VERLAP Study, a large comparative effectiveness trial that used two different methods of providing information and support to current CPAP users diagnosed with both OSA and COPD. (2) Combined data from the four most recent clinical CPAP trials conducted at VA San Diego Healthcare System. (3) The APPLES study. Total sample sizes were 332, 957, and 405, respectively. Total sleep time (TST) and total sleep period (TSP) were assessed via the Pittsburgh Sleep Quality Index (PSQI) for (1) and (2) and via polysomnography for (3).

Results
Mean CPAP use, TST, and TSP for each source were: (1) 6.7, 6.8, & 8.1; (2) 4.0, 6.1, & 7.5; (3) 4.5, 6.6, & 8.0. We examined the ratios of adherence over either TST or TSP, and the ratios for each source were: (1) 98% & 83%; (2) 66% & 55%; (3) 68% & 56%.

Conclusion
This comparison demonstrates that unlike many CPAP users who tend to use therapy for only a fraction of time spent asleep, patients with COPD and OSA exhibit higher levels of adherence which often exceed sleep time and may be obtaining additional benefits from CPAP use during non-sleep periods. More research is needed both to improve CPAP delivery and support for patients who are using CPAP sub optimally and to understand the factors that account for the heightened levels of CPAP adherence in COPD.

Support
PPRND #1507-31666; IIR 02-275; IIR 07-163; IIR 12-069; PULM-028-12F.
0685 Safety Evaluation Of An Algorithm Determining Needs For Treatment In Obese Sleep Apnea Patient Awaiting Bariatric Surgery: Results Of A Prospective 1103 Patients Cohort Study
Authors: Sériès F , genest C , Boutin I , Marceau S , Bussieres J , Minville C 
Published: May 2020

Abstract

Introduction
Screening for obstructive sleep apnea (OSA) is recommended before bariatric surgery. We developed an algorithm based on results of nocturnal oximetry and capillary gas. According to this algorithm, CPAP/BiPAP is prescribed only in severe OSA (ODI ≥ 25/h) and/or with features of hypoventilation. The objective of this prospective cohort study was to determine the safety of our algorithm comparing peri and post-operative outcomes in patients not receiving pre-operative treatment (without/mild OSA (ODI &lt; 10 /h: controls or ODI 10-24 /h: OSA untreated) and in those receiving CPAP/BiPAP (severe OSA: OSA treated or hypoventilation).

Methods
We collected data from 1103 subjects undergoing bariatric surgery (447 controls; 358 OSA untreated, 289 OSA treated and 9 hypoventilation). For treated patients, a good CPAP/BiPAP compliance was mandatory for surgery with treatment installed immediately after extubation and continued after. Peri and post-operative outcomes were compared according to apnea status with adjustment for the type of surgery when applicable.

Results
Patients with severe OSA/hypoventilation were significantly older and heavier than other patients. Hypertension and diabetes were less prevalent in controls than in the other groups. No difference was found between the 3 groups regarding occurrence of 10 days reoperation and 30 days rehospitalisation. No difference was found regarding occurrence of cardiopulmonary complications except that admission to ICU was more frequent in patients with hypoventilation and occurrence of cardiac arrhythmia was higher in the OSA/hypoventilation treated patients than in the other groups (2.4%, 11.1 %, 0.4% and 0.6%, p = 0.01). OSA/hypoventilation patients had a longer length of stay in the recovery room (1.7 ± 0.5, 1.9 ± 0.6, 1.5 ± 0.5 and 1.5 ± 0.5 hours p&lt;0.0001) and longer length of hospital stay (2.8 ± 1.8, 3.2 ± 1.1, 2.6 ±2.1 and 2.6 ±1.8 days, p&lt;0.0001) than controls and OSA untreated patients.

Conclusion
Our algorithm safely selects patients who don’t need treatment before surgery, with no increase in risk of complications following bariatric surgery not treating OSA patients with mild/moderate sleep apnea without hypoventilation. Patients with severe OSA/hypoventilation, even when correctly treated remain at higher risk of complications.

Support
Fondation IUCPQ-UL
0707 “What We’Ve Got Here Is Failure To Communicate”: Apnea Patients And Their DME Suppliers
Authors: Thapa S , Agrawal S , Kryger M 
Published: May 2020

Abstract

Introduction
Successful treatment of obstructive sleep apnea requires adherence to positive airway pressure (PAP) therapy. A key factor is the relationship between the DME provider and the patient so that treatment can be initiated and continued in a timely manner. Our quality improvement project aims to empower and enable patients towards active participation in their sleep apnea care. Our goal is to ultimately increase patients’ knowledge of their Durable Medical Equipment (DME) supplies company, and thus improve their treatment. The first step was to determine patients’ familiarity with their DME.

Methods
Forty-one patients with sleep apnea on PAP therapy volunteered to be questioned about their DME company during clinic visits at the Yale North Haven Sleep Center, Connecticut, starting November 2019. Patients were asked if they knew the name or the contact of their DME; whether they received adequate training on PAP therapy initiation; if they were receiving timely and correct PAP therapy supplies. They were asked to rate their satisfaction with the DME on a scale of 1 to 5; one being very dissatisfied and five being very satisfied.

Results
Only 12 out of 41 patients (29.3 percent) knew the names of their DME companies. The average satisfaction rating was 3 (neutral); 44% of patients were dissatisfied, or very dissatisfied with the performance of their DME. Detailed comments were mostly related to poor contact and communication with the DME.

Conclusion
Most apnea patients had difficulty identifying and contacting their DME. As the next step of this quality improvement project we plan to intervene to ensure that the patients have the name and contact information of their DME available and attached to their PAP machine equipment. We plan to repeat this questionnaire after this intervention to study the impact of this quality improvement project.

Support
None
0711 Select Symptoms From The Epworth Sleepiness Scale Questionnaire And Response To Therapy Of Central Sleep Apnea With Phrenic Nerve Stimulation
Authors: Javaheri S , McKane S , Meyer T E , Germany R 
Published: May 2020

Abstract

Introduction
Some subjects with central sleep apnea (CSA) complain of subjective excessive daytime sleepiness (EDS), as assessed by the Epworth Sleepiness Score (ESS). However, there is considerable variability in the level of chances of dozing for each of the 8 ESS questions, as each reflects a different situation. The aim of this analysis was to examine individual situations of the ESS and determine if transvenous phrenic nerve stimulation (TPNS) resulted in improvements of individual ESS situations which were scored moderate to high (2 and 3) at baseline. Patient Global Assessment (PGA) was also assessed.

Methods
All 151 subjects enrolled in the randomized (Treatment vs Control) remedē System pivotal trial were included in the analysis. All subjects were implanted, but activation in Control arm was delayed 6 months.

Results
Greater than or equal to 50% of patients scored moderate-high on several individual ESS situations: chance of dozing while sitting and reading (57%), watching television (62%), while lying down to rest in the afternoon when circumstances permit (76%). In the active arm, 68%, 44% and 29% of patients with moderate-high at baseline, respectively, for sitting and reading, watching television, and lying down to rest in the afternoon shifted to less than moderate at 6 months. Respective shifts for the control arm were 29%, 23% and 13%. Seventy-two percent of treated subjects with baseline ESS&gt;10 shifted to ≤10 at 6 months compared to 26% of control patients. Additionally, 72% of treated compared to 7% of control subjects with baseline ESS&gt;10 reported markedly or moderately improved QoL.

Conclusion
Results of this randomized controlled trial shows that compared to the control arm, TPNS leads to improvements in various situations of the ESS as well as QoL. The most improved situations were less chance of dozing while reading and watching television.

Support
Respicardia
0719 The Association of Sleep Apnea and Cardiorespiratory Fitness with Long-Term Major Cardiovascular Events
Authors: Barillas-Lara M , Medina-Inojosa J , Kolla B , Smith J R , Bonikowske A R , Allison T G , Olson T , Lopez-Jimenez F , Somers V K , Caples S M , Mansukhani M P 
Published: May 2020

Abstract

Introduction
Sleep disordered breathing (SDB) is associated with adverse cardiovascular outcomes and decreased cardiorespiratory fitness (CRF). The risk of long-term major adverse cardiovascular events (MACE) when SDB and decreased CRF co-occur has not been determined.

Methods
We included consecutive patients that underwent a symptom-limited cardiopulmonary exercise test followed by first-time diagnostic polysomnography within 6 months. Patients were stratified based on the presence of moderate-severe SDB (apnea/hypopnea index ≥15/hour) and decreased CRF defined as &lt;70% predicted peak oxygen consumption (VO2). MACE was a composite outcome of myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), stroke/transient ischemic attack (TIA) and death. Cox-proportional hazard models adjusting for factors known to influence CRF and MACE were constructed.

Results
Of 498 included patients (60±13 years, 28.1% female), 175 (35%) had MACE (MI=17, PCI=14, CABG=13, stroke=20, TIA=12, deaths=99) at a median follow-up of 8.7 years (interquartile range=6.5-10.3 years). After adjusting for age, sex, beta-blockers, systemic hypertension, diabetes mellitus, coronary artery disease, cardiac arrhythmia, chronic obstructive pulmonary disease, smoking and positive airway pressure (PAP) usage, decreased CRF alone (HR=1.91, 95%CI=1.15-3.18, p=0.012), but not SDB alone (HR=1.26, 95%CI=0.75-2.13, p=0.389) was associated with increased risk of MACE. Those with SDB and decreased CRF had increased risk of MACE compared to patients with decreased CRF alone (HR=1.85, 95%CI=1.21-2.84, p&lt;0.005) after accounting for these confounders; the risk was attenuated after additionally adjusting for adequate adherence to PAP (HR=1.85, 95%CI=0.99-3.05, p=0.05).

Conclusion
The incidence of MACE, including mortality, was high in this sample. Moderate-severe SDB with concurrent decreased CRF was associated with higher risk of MACE than decreased CRF alone. These results highlight the importance of including CRF in the risk assessment of patients with SDB, and conversely, that of screening for SDB in patients with low peak VO2.

Support
None.
0745 The Pharmacokinetics of FT218, Once Nightly Sodium Oxybate: Food Effect and Bioavailability Compared to Twice Nightly Sodium Oxybate
Authors: Thorpy M , Seiden D , Grassot J , Monteith D , Dubow J , Corser B 
Published: May 2020

Abstract

Introduction
Sodium oxybate is an effective treatment for excessive daytime sleepiness and cataplexy in patients with narcolepsy. The FDA approved formulation requires twice-nightly dosing; at bedtime and 2.5 - 4 hours later. FT218 is a controlled-release formulation of sodium oxybate intended for once-nightly dosing, using Avadel’s proprietary Micropump™ technology. The objective of this study was to evaluate the relative bioavailability of investigational once-nightly sodium oxybate, FT218, 6 g, compared to commercially available twice-nightly sodium oxybate and the food effect of FT218.

Methods
Two crossover, single-dose pharmacokinetic studies were conducted in healthy volunteers. The first, a relative bioavailability study (n=28) was completed comparing FT218 6 g to twice-nightly sodium oxybate 6 g (in two divided doses of 3 g). The second, evaluated the food effect (n=16) of FT218 6g in the Fed vs. Fasted state.

Results
FT218 had a lower overall Cmax than twice-nightly sodium oxybate, while AUC was equivalent. C8h level and variability was comparable between FT218 and twice-nightly sodium oxybate. In the Fed, compared to the Fasted state, FT218 had a longer Tmax, lower Cmax and decreased AUC (Cmax 67%, AUC 86%, Tmax 1-hour slower than Fasted values). Adverse Events with FT218 were mostly mild or moderate in severity, non-serious and known AEs associated with sodium oxybate. The safety profiles of FT218 and twice-nightly sodium oxybate at 6 g appeared similar.

Conclusion
Once-nightly FT218 at 6 g demonstrated a lower overall Cmax and similar exposure to twice-nightly sodium oxybate, with similar C8h plasma levels and C8h variability. In the Fed state, AUC and Cmax of FT218 was lower than in the Fasted State. FT218 was generally safe and well tolerated and the safety profile appeared comparable to twice-nightly sodium oxybate.

Support
This work was supported by Avadel Pharmaceuticals.
0746 Dynamics of Sleep Stage Transitions in Patients with Narcolepsy and Other Hypersomnias
Authors: Kishi A , Kitajima T , Kawai R , Hirose M , Iwata N , Yamamoto Y 
Published: May 2020

Abstract

Introduction
Narcolepsy is a chronic sleep disorder characterized by excessive daytime sleepiness and abnormal REM sleep phenomena. Narcolepsy can be distinguished into type 1 (NT1; with cataplexy) and type 2 (NT2; without cataplexy). It has been reported that sleep stage sequences at sleep-onset as well as sleep-wake dynamics across the night may be useful in the differential diagnosis of hypersomnia. Here we studied dynamic features of sleep stage transitions during whole night sleep in patients with NT1, NT2, and other types of hypersomnia (o-HS).

Methods
Twenty patients with NT1, 14 patients with NT2, and 35 patients with o-HS underwent overnight PSG. Transition probabilities between sleep stages (wake, N1, N2, N3, and REM) and survival curves of continuous runs of each sleep stage were compared between groups. Transition-specific survival curves of continuous runs of each sleep stage, dependent on the subsequent stage of the transition, were also compared.

Results
The probability of transitions from N1-to-wake was significantly greater in NT1 than in NT2 and o-HS while that from N1-to-N2 was significantly smaller in NT1 than in NT2 and o-HS. The probability of transitions from N2-to-REM was significantly smaller in NT1 than in o-HS. Wake and N1 were significantly more continuous in NT1 than in NT2; specifically, N1 followed by N2 was significantly more continuous in NT1 than in NT2 and o-HS. N2 was significantly less continuous in NT1 and NT2 than in o-HS; this was specifically confirmed for N2 followed by N1/wake. REM sleep was significantly less continuous in NT1 than in NT2 and o-HS; specifically, REM sleep followed by wake was significantly less continuous in NT1 than in o-HS. Continuity of N3 did not differ significantly between groups.

Conclusion
Dynamics of sleep stage transitions differed between NT1, NT2, and o-HS. Dynamic features of sleep such as sleep instability, persistency of wake/N1, and REM fragmentation may differentiate NT1 from NT2, while N2 continuity may differentiate narcolepsy from o-HS. The results suggest that sleep transition analysis may be of clinical utility and provide insights into the underlying pathophysiology of hypersomnia and narcolepsy.

Support
JSPS KAKENHI (18K17891 to AK).
0747 Study Design of an Open-Label Extension and Switch Study for Once Nightly Sodium Oxybate, FT218, in NT1 and NT2 Patients
Authors: Wells C , Dubow J , Fenton M , Patel D , Tyler C , Seiden D 
Published: May 2020

Abstract

Introduction
Avadel Pharmaceuticals has developed FT218, a once nightly sodium oxybate (SO) formulation for the treatment of excessive daytime sleepiness (EDS) and cataplexy in narcoleptic patients. REST-ON, a pivotal efficacy/safety study is expected to be completed in the first half of 2020. Previous Phase 1 studies have demonstrated FT218 delivers a pharmacokinetic profile needed for once-nightly dosing. The purpose of this study is to evaluate long-term safety of FT218 in REST-ON completers and dosing strategy when switching from twice-nightly SO to FT218.

Methods
The study will enroll NT1/NT2 patients who completed REST-ON or patients switching from stable dose of twice-nightly SO to FT218. REST-ON completers will initiate FT218 at 4.5 g and increase by 1.5 g to the highest tolerated dose or the dose deemed effective (up to 9 g). Switch patients will initiate FT218 at the equivalent/closest dose to their current twice-nightly SO and titrate in accord with safety/efficacy. The study will enroll approximately 250 patients for a duration of two years.

Results
The primary endpoint for REST-ON completers will be safety and tolerability. Secondary endpoints for REST-ON completers will include changes in ESS, reported cataplexy and other REM associated phenomena as well as changes in clinician and patient global impression. For switch patients, endpoints will include percentage of subjects that stay on the same, higher or lower dose of FT218 compared to twice-nightly SO, as well as the percentage of subjects who report a preference for the once-nightly dosing regimen.

Conclusion
The results of this open label extension/switch study will further elucidate the potential benefits of once-nightly FT218 regarding long term safety/tolerability, nocturnal safety/tolerability and efficacy, and importantly provide dosing and preference data for patients switching from twice-nightly SO to once-nightly FT218.

Support
This work was supported by Avadel Pharmaceuticals.
0748 A Novel, Non-Pharmacological Treatment Option for Patients With Idiopathic Hypersomnia
Authors: Paech G M , Pradeepan S , Suthers B 
Published: May 2020

Abstract

Introduction
There is some evidence suggesting that patients with hypersomnia have delayed circadian timing, which could explain, at least in part, the excessive sleepiness and impaired daytime performance experienced by these individuals. This study investigated the effects of bright light treatment on improving daytime alertness in patients with idiopathic hypersomnia.

Methods
Participants were scheduled to two in-laboratory sessions (baseline and treatment) consisting of overnight sleep monitoring (polysomnography) followed by maintenance of wakefulness tests (MWT) and performance testing (10-min psychomotor vigilance task (PVT)). MWTs were performed at 10:00, 12:00, 14:00 and 16:00 and PVTs were performed at 11:00, 13:00, 15:00 and 15:00. In-laboratory sessions were separated by a two-week at-home treatment period during which participants were instructed to use commercially available light devices for 30-60 min each morning. Participants also completed the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) at baseline and after treatment. Paired t-tests were performed to assess differences in sleep architecture, sleep quality, performance (lapses; reaction time &gt;500ms) and alertness (MWT mean sleep latency) between baseline and treatment.

Results
To date, three participants (2 male) aged 62.7±13.2 (mean±SD) years have completed the study. Lapses (baseline: 17.9±11.9; treatment: 6.3±5.4), ESS (baseline: 17.3±3.1; treatment 12.3±6.8) and PSQI (baseline: 7.7±3.8; treatment: 4.0±1.0) all improved with light treatment, although this did not reach statistical significance. There were no statistical differences between baseline and treatment with regards to sleep architecture or mean sleep latency.

Conclusion
Although preliminary, results suggest that bright light treatment may improve subjective sleepiness, subjective sleep quality and performance. There was some variability between individuals, indicating that this treatment may not offer the same benefits to all patients. Although ongoing, this study suggests that light therapy could be used as an alternative, non-pharmacological treatment option to improve waking functions and sleepiness in hypersomnia patients.

Support
This project is supported by a Hunter Medical Research Institute Research Project Grant
0753 Cataplexy-Free Days in a Phase 3, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study of JZP-258 in Adults With Narcolepsy With Cataplexy
Authors: Dauvilliers Y , Foldvary-Schaefer N , Bogan R K , Šonka K , Profant J , Huang L , Thorpy M J 
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 with 92% less sodium. This analysis evaluated cataplexy-free days/week, as a measure of treatment impact, in a placebo-controlled randomized withdrawal study of JZP-258 treatment in patients with narcolepsy.

Methods
Treatment for cataplexy at study entry included 1) SXB (SXB-only); 2) SXB plus other anticataplectics (SXB+other); 3) anticataplectics other than SXB (other anticataplectics); or 4) cataplexy treatment-naive (anticataplectic-naive). Participants (aged 18-70 years with narcolepsy with cataplexy) began JZP-258 treatment during a 12-week, open-label, optimized treatment and titration period (OLOTTP), followed by a 2-week stable-dose period (SDP). Participants were randomized to receive placebo or continue JZP-258 treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP).

Results
Of 201 enrolled participants, 134 comprised the efficacy population (placebo, n=65; JZP-258, n=69). Median (Q1, Q3) cataplexy-free days/week at first week of OLOTTP (while initiating JZP-258) by prior treatment were SXB-only, 5.8 (2.0, 7.0); SXB+other, 6.4 (5.0, 7.0); other anticataplectics, 4.0 (1.8, 6.0); anticataplectic-naive, 3.5 (0, 5.8). At end of SDP (on stable dose of JZP-258), median (Q1, Q3) cataplexy-free days/week were 6.0 (3.5, 7.0), 6.1 (1.4, 7.0), 6.0 (2.6, 7.0), and 6.2 (4.0, 7.0), respectively. Prior to randomization, there was no difference in median cataplexy-free days/week between participants to be randomized to placebo (6.0 [3.5, 7.0]) or JZP-258 treatment (6.0 [3.0, 7.0]); during DBRWP, median cataplexy-free days/week decreased in participants randomized to placebo (3.5 [0, 5.83]) but remained similar in participants randomized to continue JZP-258 treatment (5.6 [2.8, 7.0]). The overall safety profile of JZP-258 was similar to SXB.

Conclusion
Number of cataplexy-free days/week increased with JZP-258 treatment in participants previously naive to oxybate. Number of cataplexy-free days/week decreased during placebo exposure in participants randomized to placebo.

Support
Jazz Pharmaceuticals