bluuebunny/crossref_metadata_2025_split huggingface dataset:
444 Enhancing PAP Compliance Efficacy with Early Closer Follow-ups (2–3 days vs others): A Retrospective Single-Centre Review
Authors: Bandeali Almas , Khan Amir , Wyrick Brenda 
Published: May 2021

Abstract

Introduction
PAP is an effective gold standard for OSA treatment; however, compliance remains an issue. Centre for Medicare defines compliance as PAP usage of ≥4hrs daily and ≥70% in a 30-day period. This study aimed at evaluating the effectiveness of early patient-centred follow-ups (2–3 days mandatory versus 4 weeks mandatory and/or as needed basis).

Methods
Retrospective data analysis of 100 consecutive patients (≥18 years) over a year in an interrupted time series with pre-test (Group1) and post-test (Group2) of 50 patients each. All patients included were symptomatic (ESS ≥10), CPAP naive, diagnosed with OSA, and diagnostic AHI ≥5. All received a post diagnostic sleep questionnaire assessing their overall quality of sleep with PAP therapy. Therapeutic AHI was collected from updated 90-day compliance report thru web enabled online RESMED AIRVIEW’s secure database. Initial follow-up for Group1 was in 4 weeks and/or earlier if patient initiated and for Group2 in 2–3 days following PAP set up. Additionally, non-compliant patients in Group2 received monthly follow-ups.

Results
Following findings were reported for Group1 - (Male=24, Female=26), mean age 65.79±13.21, and BMI 36.12±7.50; and Group2 - (Male=25, Female=25), mean age 62.8±12.32, and BMI 36.90±9.29. During diagnostic testing &gt;50% patients in both groups rated their overall sleep to be worse than usual. Compliance for Group1 was significantly worst than Group2 (64% and 91%, respectively). Group1 had 8=AHI≥5, 29=AHI≤5 and had 13 lost to followup (11 behavioural in-adaptations, 2 financial constrains) soon after commencing CPAP. Group2 had 3 lost to financial constraints, 4=AHI≥5, and 43=AHI&lt;5. Chi-square (5.4265) indicated p-value=.019, chi-square Yates-correction (4.502) calculated p-value=.033. Significant at p&lt;.05, Chi-square test revealed dependant relationship between PAP unsatisfactory patient evaluation during diagnostic polysomnography to PAP non-compliance. Group1’s RR=3 and OR=4.45; Group2’s RR=0.33 and OR=0.22, indicated higher probability of non-compliance in Group1.

Conclusion
Provider-patient contact within 2–3 days versus any other intervals (4 weeks mandatory and/or as needed in this case), soon after commencing PAP therapy not only increases compliance efficacy but also reduces patient dropouts and anxiety with PAP therapy. Considerable fraction of patients are uncomfortable using CPAP; therefore, closer follow-ups versus 4 weeks is warranted to maintain CPAP adherence.
Support (if any):
447 Cost-Effectiveness of a 3-Year Tele-OSA Intervention
Authors: An Jaejin , Hwang Dennis , Shi Jiaxiao , Sawyer Amy , Chen Aiyu , Mazzotti Diego , Maislin Greg , Keenan Brendan , Arguelles Jessica , Pack Allan , Glick Henry 
Published: May 2021

Abstract

Introduction
Trial-based tele-obstructive sleep apnea (OSA) cost-effectiveness analyses have often been inconclusive due to small sample sizes and short follow-up. In this study, we report the cost-effectiveness of Tele-OSA using a larger sample from a 3-month trial that was augmented with 2.75 additional years of epidemiologic follow-up.

Methods
The Tele-OSA study was a 3-month randomized trial conducted in Kaiser Permanente Southern California that demonstrated improved adherence in patients receiving automated feedback messaging regarding their positive airway pressure (PAP) use when compared to usual care. At the end of the 3 months, participants in the intervention group pseudo-randomly either stopped or continued receiving messaging. This analysis included those participants who had moderate-severe OSA (Apnea Hypopnea Index &gt;=15) and compared the cost-effectiveness of 3 groups: 1) no messaging, 2) messaging for 3 months only, and 3) messaging for 3 years. Costs were derived by multiplying medical service use from electronic medical records times costs from Federal fee schedules. Effects were average nightly hours of PAP use. We report the incremental cost per incremental hour of PAP use as well as the fraction acceptable.

Results
We included 256 patients with moderate-severe OSA (Group 1, n=132; Group 2, n=79; Group 3, n=45). Group 2, which received the intervention for 3 months only, had the highest costs and fewest hours of use and was dominated by the other two groups. Average 1-year costs for groups 1 and 3 were $6035 (SE, $477) and $6154 (SE, $575), respectively; average nightly hours of PAP use were 3.07 (SE, 0.23) and 4.09 (SE, 0.42). Compared to no messaging, messaging for 3 years had an incremental cost ($119, p=0.86) per incremental hour of use (1.02, p=0.03) of $117. For a willingness-to-pay (WTP) of $500 per year ($1.37/night), 3-year messaging has a 70% chance of being acceptable.

Conclusion
Long-term Tele-OSA messaging was more effective than no messaging for PAP use outcomes but also highly likely cost-effective with an acceptable willingness-to-pay threshold. Epidemiologic evidence suggests that this greater use will yield both clinical and additional economic benefits.

Support (if any)
Tele-OSA study was supported by the AASM Foundation SRA Grant #: 104-SR-13
452 Patient Factors and Preferences in Decision for Sleep Surgery: A Qualitative Analysis
Authors: Ikeda Allison , Marsh Robin , McShay Crystina , Saini Shireen , Sardesai Maya , Weaver Edward , Boss Emily 
Published: May 2021

Abstract

Introduction
Patients with obstructive sleep apnea (OSA) are offered many treatment options spanning the spectrum of lifestyle modification, device therapy, and surgery. Sleep surgery, while often effective, results in moderate morbidity and has variable effectiveness on OSA improvement. Little is known about what patients consider when choosing treatment. We aim to identify factors that influenced the decision for sleep surgery among adults with OSA.

Methods
We conducted semi-structured virtual interviews with patients (≥18 years) with OSA (apnea-hypopnea index ≥5 events per hour of sleep) who underwent sleep surgery at a tertiary academic center, querying patients about factors in their decision for OSA treatment. Interviews were audio-recorded, transcribed, and analyzed for thematic content. We anticipate enrolling 10–18 total participants based on previously reported sample size in specialty groups for thematic saturation in specialty groups (ie, when no new concepts or factors emerge from interviews). Here we report pilot qualitative analysis results.

Results
Of nine eligible patients, eight enrolled (mean +/- standard deviation age 45.8 +/- 13.4 years, 2 female/6 males). Four patients underwent nasal surgery only, two patients underwent staged procedures, one underwent pharyngeal surgery only, and the last underwent nasal surgery with tori removal. Patients reported decision making duration of days to years for scheduling surgery. Reasons for pursuing sleep surgery included fatigue, quality of life, work performance, and safety. Overarching thematic domains related to decision for surgery were (1) major concerns, (2) external factors influencing decision, and (3) retrospective satisfaction/regret with decision. Major concerns involved factors beyond surgeon’s control, such as anesthesia and postoperative pain management, not surgery itself. Family and friends were reported to be highly influential in the process, both in favor and against surgery. Social media features and celebrity patients with OSA heightened awareness of sleep surgery and set preconceived expectations. Patients were mostly satisfied with outcomes, despite unanticipated acute recovery challenges.

Conclusion
This pilot qualitative analysis identifies factors influencing patients’ OSA treatment decisions. Understanding patients’ major concerns and sources of information may help to guide physician counseling, set realistic expectations, offer peri-operative support, and better engage parents in shared decision-making for sleep surgery.

Support (if any)
None.
455 Obesity modifies the effect of 4 months of CPAP on glucose levels in adults with obstructive sleep apnea
Authors: Pak Victoria , Maislin David , Keenan Brendan , Townsend Raymond , Benediktsdottir Bryndis , Guo Xiaofeng , Pack Allan , Gislason Thorarinn , Kuna Samuel 
Published: May 2021

Abstract

Introduction
Continuous positive airway pressure (CPAP) therapy may improve insulin sensitivity and glucose tolerance seen in individuals with obstructive sleep apnea (OSA), however there is a lack of studies on whether obesity modifies the effect. We examined the baseline and follow-up levels of insulin and glucose following 4 months of CPAP treatment among participants with body mass index (BMI) &lt;30, 30≤ BMI&lt;35, and BMI≥35 kg/m2.

Methods
We identified 221 adults (84% males) with newly diagnosed OSA in the Penn Icelandic Sleep Apnea (PISA) Study, with a mean (±SD) BMI 31.7 +- 4.2 kg/m2 and apnea-hypopnea index (AHI) of 35.7+-15.6 events/hour. Associations between changes in natural log of the biomarkers within BMI groups were explored, controlling for a priori baseline covariates of age, baseline BMI, race, sex, site, and current smoking status.

Results
The mean proportional change (from baseline to follow-up) in log-transformed glucose in CPAP adherent participants was significantly larger in the BMI ≥35 and 30≤ BMI&lt;35 groups compared to BMI &lt;30. Within the BMI ≥35 group, the baseline to follow up increase in glucose post-CPAP was 1.08 (95% CI 1.01–1.15), while there were no significant changes in the other 2 BMI groups. A mediation analysis was performed with models including BMI change, and glucose was found to be significantly different between groups. There was no statistically significant association for insulin.

Conclusion
Our findings show that obesity modifies the effect of four months of CPAP on glucose levels.

Support (if any)
1P01-1HL094307
458 The effect of cardioversion therapy for atrial fibrillation on AHI in obstructive sleep apnea patients
Authors: Zakhary Nardine , Mehra Reena , Monahan Ken , Sahadevan Jayakumar , May Anna 
Published: May 2021

Abstract

Introduction
Sleep apnea (SA) is known to be associated with development of atrial fibrillation (AF), and therapy ameliorates this risk. Case reports and small series raise the possibility of a bidirectional effect of AF on SA burden. We hypothesize that SA control, demonstrated either by residual apnea-hypopnea index (AHI) or pressure during positive airway pressure (PAP) therapy, improves after successful cardioversion.

Methods
The cohort included VA patients with SA on PAP therapy who underwent successful outpatient direct-current AF cardioversion. Only patients with good adherence in the peri-procedural period, defined as use most days in the week before and after procedure, were included in the study (n=17). We compared AHI prior to and after cardioversion using the sign test since values were not normally distributed. Since most participants were on auto-titrating PAP, the sign test was also used to compare mean pressure difference in the 7 days before and after the procedure.

Results
There was no statistical difference when comparing AHI before and after AF cardioversion therapy (AHI change = -0.45, 95% CI = [-0.94, 0.17]) There was also no difference between mean pressure used for PAP therapy before and after therapy (pressure change = 0.05, 95% CI = [-0.1, 0.33]).

Conclusion
This small study did not find an association between successful AF cardioversion and PAP residual AHI or pressure (for auto-titrating machines). A larger cohort may have improved power to detect subtle effects of AF therapy on SA burden.

Support (if any)
This study was supported by the Career Development Award IK2CX001882 from the United States (U.S.) Department of Veterans Affairs Clinical Sciences Research and Development Service.
486 Timing and Duration of Adverse Events in 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 2021

Abstract

Introduction
This analysis evaluated treatment-emergent adverse events (TEAEs) during a double-blind, placebo-controlled, randomized withdrawal trial (NCT03030599) of lower-sodium oxybate (LXB; Xywav™), an FDA-approved treatment for excessive daytime sleepiness or cataplexy in narcolepsy.

Methods
At study entry, participants were taking sodium oxybate (SXB) alone, SXB with other anticataplectics, other anticataplectics alone, or were anticataplectic treatment-naive. Participants taking SXB transitioned to the same LXB dose (gram-for-gram); oxybate-naive participants initiated LXB (4.5 g/night). TEAEs were analyzed in the safety population (N=201, received ≥1 study drug dose) during a 12-week open-label optimized treatment/titration period (while other anticataplectics were tapered/discontinued) and subsequent 2-week stable-dose period (SDP). TEAE duration was defined as time from TEAE start to end date (or end of SDP, if TEAE end date was unrecorded).

Results
LXB-emergent TEAEs varied by treatment at entry. Anticataplectic treatment-naive participants reported TEAEs including headache (n=36/90, 40%; median duration [range]=1 [1–76] day), nausea (n=19/90, 21%; duration=9 [1–37] days), and dizziness (n=15/90, 17%; duration=10 [1–117] days); peak incidence was week 2 (n=8/89, 9%) for headache, week 3 (n=3/88, 3%) for dizziness, and week 1 (n=6/90, 7%) for nausea. Anticataplectic treatment-naive participants (n=13/90, 14%) also reported decreased appetite, with relatively long duration (58 [2–358] days). Participants taking SXB alone reported TEAEs including headache (n=17/52, 33%; duration=1 [1–122] day) and diarrhea (n=4/52, 8%; duration=41 [2–101] days); peak headache incidence was week 4 (n=4/52, 8%); diarrhea had no peak. Participants taking other anticataplectics alone reported TEAEs including headache (n=14/36, 39%; duration=1 [1–94] day), nausea (n=9/36, 25%; duration=3 [1–16] days), and dizziness (n=9/36, 25%; duration=4 [1–29] days); peak incidence was week 1 (n=3/36, 8%) for headache, week 6 (n=2/32, 6%) for nausea, and week 4 (n=3/33, 9%) for dizziness. One participant taking SXB with other anticataplectics (n=1/23, 4%) reported headache in weeks 1–2 and 4; one reported nausea (4%) persisting from week 1 to 8. Overall, study discontinuations attributed to TEAEs were 20/57 (35%).

Conclusion
Most TEAEs with LXB treatment occurred early, were consistent with the known SXB safety profile, and were relatively short-lived (except decreased appetite). Participants previously taking SXB reported fewer TEAEs than oxybate-naive participants.

Support (if any)
Jazz Pharmaceuticals, Inc.
488 REST-ON: Efficacy of FT218 for Daytime Sleepiness, Sleep Quality, Hallucinations, and Sleep Paralysis in Patients With Narcolepsy
Authors: Thorpy Michael , Roth Thomas , Dauvilliers Yves , Kushida Clete , Shapiro Colin , Corser Bruce , Ajayi Akinyemi , Dubow Jordan , Seiden David , Rosenberg Russell 
Published: May 2021

Abstract

Introduction
Sodium oxybate (SO) is an effective treatment for narcolepsy; however, currently available formulations must be taken twice nightly. FT218 is an investigational once-nightly controlled-release formulation of SO. Here, we evaluated the efficacy of FT218 on excessive daytime sleepiness (EDS), self-reported sleep quality/refreshing nature of sleep, sleep paralysis (SP), and hypnagogic hallucinations (HH) in patients with narcolepsy.

Methods
In this phase 3, randomized, double-blind, placebo-controlled, multicenter study, patients aged ≥16 years with narcolepsy type 1 or 2 were randomized 1:1 to receive FT218 or matching placebo: 4.5 g/night (1 week), 6.0 g/night (2 weeks), 7.5 g/night (5 weeks), and 9.0 g/night (5 weeks). Secondary efficacy endpoints included EDS using the Epworth Sleepiness Scale (ESS), sleep quality/refreshing nature of sleep using a visual analog scale (VAS), and SP and HH using a sleep symptom diary.

Results
A total of 212 patients were randomized and received study medication (FT218, n=107; placebo, n=105). Patients receiving FT218 had significant improvement vs placebo in EDS on the ESS: LS mean difference on ESS score between FT218 and placebo was −3.86 for 9.0 g (week 13), −3.16 for 7.5 g (week 8), and −2.06 for 6.0 g (week 3) (all P&lt;0.001). Sleep quality/refreshing nature of sleep on VAS was also significantly improved with FT218 vs placebo (P&lt;0.001 for all doses). Patients receiving FT218 reported less SP vs placebo (P&lt;0.05 at all doses). Baseline values for HH were low in both treatment groups; HH was similar for both treatment groups at all study visits. The most common adverse reactions were nausea, dizziness, enuresis, headache, decreased appetite, and vomiting.

Conclusion
At all evaluated doses, treatment with FT218 significantly improved EDS, sleep quality/refreshing nature of sleep, and SP vs placebo. FT218 was generally well tolerated; the most common adverse events were consistent with known SO side effects.

Support (if any)
Avadel Pharmaceuticals.
492 Efficacy of FT218, a Once-Nightly Sodium Oxybate Formulation, by Stimulant Use: A Post Hoc Analysis From the REST-ON Study
Authors: Roy Asim , Morse Anne Marie , Dubow Jordan , Seiden David , Bogan Richard 
Published: May 2021

Abstract

Introduction
FT218 is an investigational, once-nightly, controlled-release formulation of sodium oxybate for the treatment of narcolepsy. The purpose of this post hoc analysis of the REST-ON study was to evaluate the effect of FT218 on measures of excessive daytime sleepiness (EDS) in patients with narcolepsy with or without stimulant use.

Methods
This was a randomized, double-blind, placebo-controlled, multicenter study in patients with narcolepsy ≥16 years old. Patients were stratified by stimulant use and randomized 1:1 to receive FT218 or matching placebo: 4.5 g/night for 1 week, 6.0 g/night for 2 weeks, 7.5 g/night for 5 weeks, and 9.0 g/night for 5 weeks (maximum treatment duration, 13 weeks). Assessments of EDS included mean sleep latency (minutes) on maintenance of wakefulness test (MWT) and Clinical Global Impression-Improvement (CGI-I) in sleepiness.

Results
A total of 190 patients were included in the modified intent-to-treat population (stimulants: FT218, n=66; placebo, n=53; no stimulants: FT218, n=31, placebo, n=40). Overall, 63% of patients were on concomitant stimulants. Patients receiving FT218 had significant improvement vs placebo in MWT regardless of stimulant use. LS mean difference in mean sleep latency vs placebo for stimulant use was 5.99 for 9.0 g (week 13), 5.51 for 7.5 g (week 8), and 5.35 for 6.0 g (week 3; all P&lt;0.001). For no stimulant use, LS mean difference was 6.28 for 9.0 g (P=0.001), 7.14 for 7.5 g (P&lt;0.001), and 4.19 for 6.0 g (P=0.007). More patients receiving FT218 rated sleepiness as much/very much improved on CGI-I vs placebo (stimulant use: 9.0 g, 80.5% vs 35.3%, odds ratio [OR] 7.55; 7.5 g, 66.3% vs 26.5%, OR 5.44; 6.0 g, 39.8% vs 4.4%, OR 14.27 [all P&lt;0.001]; no stimulant use: 9.0 g, 55.1% vs 27.2%, OR 3.29 [P=0.047]; 7.5 g, 54.5% vs 17.5%, OR 5.64 [P=0.006]; 6.0 g, 40.0% vs 7.7%, OR 8.04 [P=0.003]). FT218 was generally well tolerated.

Conclusion
FT218 had similar efficacy on EDS at all evaluated doses in narcolepsy patients with or without stimulant use, with improvement over placebo on MWT and CGI-I. FT218 may provide effective treatment for EDS in patients with narcolepsy regardless of stimulant use.

Support (if any)
Avadel Pharmaceuticals.
494 Placebo-Controlled, Double-Blind, Randomized Withdrawal Study of Lower-Sodium Oxybate in Adults With Idiopathic Hypersomnia
Authors: Dauvilliers Yves , Arnulf Isabelle , Foldvary-Schaefer Nancy , Chandler Patricia , Parvataneni Rupa , Chen Dan , Skobieranda Franck , Bogan Richard 
Published: May 2021

Abstract

Introduction
Idiopathic hypersomnia (IH) is a rare central hypersomnolence disorder characterized by excessive daytime sleepiness, prolonged nighttime sleep, and sleep inertia. No US/EU medication is approved for treatment of IH. Lower-sodium oxybate (LXB; Xywav™; previously designated JZP-258) is a novel oxybate treatment with 92% less sodium than sodium oxybate (Xyrem®). The efficacy and safety of LXB was evaluated in adults with IH.

Methods
Eligible participants aged 18–75 years with IH began once- or twice-nightly LXB treatment entering an open-label titration and optimization period (10–14 weeks), followed by a 2-week, open-label, stable-dose period (SDP); they were then randomized to placebo or to continue LXB treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP). The primary efficacy endpoint was change in Epworth Sleepiness Scale (ESS) score; key secondary endpoints were proportion of participants who reported worsening (minimally/much/very much worse) on Patient Global Impression of Change (PGIc) and change in Idiopathic Hypersomnia Severity Scale (IHSS) score, all from end of SDP to end of DBRWP.

Results
The study enrolled 154 participants (mean±SD age, 40±14 years; 68% female; mean±SD ESS, 16±3.6); mean±SD dose was 6.0±1.6 g/night. Mean±SD ESS score (n=115) decreased over open-label titration/optimization (15.7±3.8 at baseline, 9.8±4.5 at week 4, and 6.1±4.0 at the end of the SDP). At the end of the DBRWP, significant worsening was observed in participants randomized to placebo, compared with maintenance of improvement in participants randomized to continue LXB, in ESS scores (n=115; LS mean difference [95% CI] in change from SDP, −6.51 [−7.99, −5.03]; P&lt;0.0001), in the PGIc (88.1% for placebo vs 21.4% for LXB; P&lt;0.0001), and in IHSS scores (estimated median difference [95% CI], −12.00 [−15.0, −8.0]; P&lt;0.0001). Common adverse events (AEs) included nausea (21.4%), headache (16.2%), anxiety (14.9%), dizziness (11.7%), insomnia (11.7%), and vomiting (10.4%). Serious AEs occurred in 4 participants (non-cardiac chest pain, rhabdomyolysis, syncope, and nephrolithiasis/pyelonephritis); none were reported related to study drug.

Conclusion
In participants with IH, LXB demonstrated a clinically meaningful effect on excessive daytime sleepiness, self-reported global change, and overall IH symptom severity. The overall safety profile was consistent with that of LXB in narcolepsy.

Support (if any)
Jazz Pharmaceuticals