bluuebunny/crossref_metadata_2025_split huggingface dataset:
0641 Effects of Weight Loss During Long-Term Solriamfetol Treatment on Cardiometabolic Indices
Authors: Malhotra A , Strollo P , Pepin J , Schweitzer P , Lammers G , Hedner J , Redline S , Chen D , Chandler P , Bujanover S , Menno D , Strohl K 
Published: May 2020

Abstract

Introduction
Increased prevalence of obesity has been reported in patients with narcolepsy and obstructive sleep apnea (OSA). Results from a 1-year open-label extension (OLE) study showed ≥5% weight loss in 4.5%, 17.3%, and 32.4% of participants with narcolepsy or OSA receiving solriamfetol 75, 150, or 300mg/d. We examined whether clinically significant weight loss (≥5%) in this population had favorable effects on biomarkers of cardiometabolic risk compared to no such weight loss.

Methods
We evaluated changes in weight and BP (parent study baseline to OLE week 40) and clinical laboratory assessments (OLE baseline to week 40) in participants with narcolepsy (n=124) or OSA (n=250) from the OLE study.

Results
Of 374 participants, 96 (25.7%) had ≥5% weight loss and 34 (9.1%) had ≥5% weight gain. Demographics were similar in those with and without (n=278) ≥5% weight loss. From baseline to week 40, among participants with weight loss, there were decreases in percentage with high (ie, &gt;ULN) serum glucose (36.6% to 28.1%) or triglycerides (26.6% to 21.9%), whereas among participants without weight loss, there was an increase in percentage with high glucose (43.3% to 50%) and no change in percentage with high triglycerides (37.1% to 37.2%). The percentage of participants with high total cholesterol was stable among participants with weight loss (22.3% to 22.9%) and increased (32.7% to 37.2%) in participants without weight loss. Participants with weight loss had mean±SD reductions in SBP (-2.6±11.4mmHg) and DBP (-1.0±9.0mmHg), whereas participants without weight loss had increases of +0.65±12.5mmHg and +1.2±8.7mmHg, respectively.

Conclusion
Among solriamfetol-treated participants with ≥5% weight loss, there
were decreases in BP and percentage of participants with high glucose and triglycerides. Further research is required to examine prospective long-term effects of solriamfetol on specific biomarkers of cardiometabolic risk.

Support
Jazz Pharmaceuticals
0642 A Novel Daytime Intra-Oral Neuromuscular Stimulation Therapy in Simple Snorers: Objective Improvement in Snoring
Authors: Kotecha B 
Published: May 2020

Abstract

Introduction
The reduction in pharyngeal muscle tone in the upper airway is a pivotal factor in snoring and obstructive sleep apnoea (OSA).There is accumulative evidence that pharyngeal exercises can reduce snoring and OSA. We present a novel device SnooZeal® that uses daytime awake neuromuscular electrical stimulation (NEMS) as an application to induce toning of the tongue muscles. This study investigates objective changes in snoring and respiratory parameters with this device.

Methods
Prospective cohort study of 100 simple snorers was conducted. Objective snoring and respiratory parameters were recorded with 2 consecutive WatchPat sleep studies before and after treatment. SnooZeal® device was used for 20 minutes once a day for a 6 week period. Secondary outcome measures using visual analogue scale reporting of snoring by patient and Epworth Sleepiness Score (ESS) were recorded.

Results
Objective reduction of snoring was noted on the sleep studies in 95% with an average reduction of 48%. Subjectively, the visual analogue scale reported by partners similarly demonstrated reduction in 95% of the patients with an average reduction of 40%.

Conclusion
This prospective cohort study demonstrates a notable improvement in both objective and subjective parameters of snoring and respiratory indices. SnooZeal® offers a novel approach to reduce snoring by utilising intra-oral neuromuscular electrical stimulation. This could be a preferred option for patients as it alleviates the need of using an oral device during sleep.

Support
0645 The Association of Hypoglossal Nerve Stimulator Adherence and Insomnia
Authors: Sharma M , Chacko A , Rosenthal M , Khan M 
Published: May 2020

Abstract

Introduction
The gold standard for treatment of Obstructive sleep apnea (OSA) is continuous positive airway pressure (CPAP). However, CPAP adherence is less than 50%. An alternative treatment is the hypoglossal nerve stimulator (HNS) which displaces the tongue anteriorly to treat upper airway obstruction. Difficulties tolerating HNS are related to stimulation discomfort. In this study, we investigated insomnia as a barrier to adherence.

Methods
Patients implanted and activated with HNS at The Ohio State University Wexner Medical Center between 2015 and 2019 were eligible. Patient usage data from the previous six months was obtained and subjects were asked to complete an Insomnia Severity Index (ISI). Participants were divided into adherent (defined as use ≥28 hours/week) and non-adherent (use &lt;28 hours/week).

Results
32 subjects were enrolled, 22 in the adherent group and 10 in the non-adherent group. There was a significant decrease in mean treatment AHI in both groups: 36.25 to 11.14 in the adherent group and 36.30 to 15.69 in the non-adherent group (p&lt;0.0001). The mean ISI score in the adherent group was 6.84 which is consistent with no clinically significant insomnia and 8.67 in the non-adherent group consistent with subthreshold insomnia. However, there was not a statistically significant difference between the two groups (p=0.441). There was a statistically significant higher score for the question “Do you worry about your sleep problems?” in the non-adherent group (1.78, SD1.39 vs 0.74. SD 0.81) (p =0.018).

Conclusion
This study suggests that patients who have difficulty with sleep may have more difficulty with HNS adherence than those who do not. In particular the question stating “Do you worry about your sleep problems” had a statistically higher score in the non-adherent group. Prospective studies are needed to further explore a possible relationship between insomnia and HNS adherence.

Support
N/A
0652 A Novel Cognitive-Behavioral Therapy to Increase PAP Adherence in Veterans With Posttraumatic Stress Disorder: Preliminary Results
Authors: Kinoshita L , Blank E , Chen M , Doudell K , Day Y , Alipio Jocson V , Lazzeroni L , Noda A , Hernandez B , Holty J , Kuschner W , Kushida C , Yaffe K , Cheng J , Yesavage J A 
Published: May 2020

Abstract

Introduction
The occurrence of obstructive sleep apnea (OSA) is high in veterans with posttraumatic stress disorder (PTSD). Our previous research on OSA in Vietnam-era veterans found that 69% had an AHI≥10 (Yesavage, 2012). Efficacious treatments are available for OSA, PAP therapy; however, veterans with OSA frequently fail to use them (Yesavage, 2012; Kuna, 2011). Of the veterans diagnosed with OSA, 63% were not using their prescribed PAP device. The reasons for low PAP adherence include discomfort using PAP and psychological barriers. We developed a novel cognitive-behavioral therapy (CBT) intervention to increase PAP adherence in veterans with PTSD and OSA, called CBT-OSA.

Methods
Participants included 37 veterans age 18+ from clinics at VA Palo Alto. Participants were randomly assigned to CBT-OSA or an education arm. All participants received treatment as usual in VA Pulmonary Service or a community-based Sleep Medicine Center. Participants in CBT-OSA received therapy from a Clinical Psychologist. The other veterans received education sessions. All participants received weekly, individual sessions during the first four weeks of PAP treatment. Average mask on time was calculated for each participant during week 1-4 of PAP use.

Results
An independent samples t-test was conducted to compare average mask on time in the CBT-OSA and education conditions. There was a significant difference in the average mask on time for CBT-OSA (M=235.33, SD=139.22) and education (M=136.68; SD=149.19); t(35)=-2.08, p=0.045. These results suggest that veterans who received the CBT treatment increased their PAP use compared to the veterans in the education condition.

Conclusion
CBT-OSA has shown early efficacy. CBT-OSA increased PAP adherence in veterans with PTSD compared to veterans in the education condition. Veterans receiving CBT-OSA demonstrated a longer average mask on time compared to veterans in the education condition. We are following the participants for one year to examine if CBT-OSA fosters long-term PAP adherence.

Support
This research is supported by the Research Service of the Department of Veterans Affairs (Grant Number 1I01RX001799-01A2).
0655 CBT-I and CPAP in Comorbid Insomnia and Sleep Apnea: Effects on Daytime Functioning
Authors: Tu A Y , Crawford M R , Dawson S C , Fogg L F , Turner A D , Wyatt J K , Crisostomo M I , Chhangani B S , Kushida C A , Edinger J D , Abbott S M , Malkani R G , Attarian H P , Zee P C , Ong J C 
Published: May 2020

Abstract

Introduction
This study examines the effects of treatment sequences using cognitive-behavioral therapy for insomnia (CBT-I) and continuous positive airway pressure (CPAP) therapy on daytime functioning in people with comorbid insomnia and sleep apnea (COMISA).

Methods
118 participants with COMISA (Age=49.99±13.12; 53.4% female) were randomized to one of the three study arms: Arm A- CBT-I followed by CPAP, Arm B- CBT-I concurrent with CPAP, and Arm C- CPAP only. Participants were assessed at four time points [baseline/ start of phase 1 (A1), CPAP titration/ start of phase 2 (A2), 30 days (A3) and 90 days (A4) after CPAP initiation]. This study examined secondary outcome measures of daytime functioning, including the Functional Outcomes of Sleep Questionnaire (FOSQ), Epworth Sleepiness Scale, and Flinders Fatigue Scale (FFS).

Results
Linear mixed model analyses showed a main effect of time on improving functional outcomes in all measurements, with all p&lt; 0.001. There were also arm by time interactions on FOSQ [F(6, 105.36)=4.21, p=0.001] and FFS scores [F(6, 106.95)=3.10, p=0.008]. Pairwise comparisons with Bonferroni adjustment showed improved FOSQ scores in Arm A from A1 to A2 (p=0.011) and A2 to A3 (p=0.005), Arm B from A2 to A3 (p&lt; 0.001), and Arm C from A2 to A3 (p=0.006). For FFS scores, improvements were shown in Arm A from A1 to A2 (p=0.003), and Arm B from A2 to A3 (p &lt; 0.001).

Conclusion
The results show daytime functioning improvements in patients with COMISA following CPAP and CBT-I. In addition, CBT-I appears to facilitate improvement in sleepiness-related functional status and daytime fatigue. The findings suggest that the combination of CBT-I and CPAP may have a beneficial effect on daytime functioning in patients with COMISA.

Support
This study was supported by the National Institutes of Health (R01HL114529).
0657 Impact of Treatment With Mandibular Advancement Oral Appliance on Respiratory Parameters, Sleep and Cardiometabolic Risk Factors of CPAP Non-Adherent Patients With Severe Obstructive Sleep Apnea
Authors: Giannasi L , Gomes M , Oliveira L , Nacif S , Oliveira E , Rezende T , Dutra M , Bacigalupo E , Soviero L , Nazário L , Oliveira W , Rode S , Amorim J , Salgado M , Meira e Cruz M 
Published: May 2020

Abstract

Introduction
Obstructive sleep apnea (OSA) may trigger systemic changes linked to important cardiometabolic risk factors such as hypertension, stroke and diabetes II. As a life-threatening, multifactorial disorder, OSA demands a multiprofessional approach. The most common worldwide treatments are Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Oral Appliance (OAm). The aim of this study was to evaluate the impact of OAm treatment on CPAP non-adherent patients with severe OSA, comparing objective and subjective data between baseline and follow up.

Methods
A prospective study was carried out including non-adherent severe OSA patients, which were referred to OAm therapy evaluation. Patients presenting with snoring, gasping/choking during sleep, fatigue and daily sleepiness were evaluated by a sleep medicine specialist and the diagnosis of severe OSA with a basal polysomnography (PSG). All the patients were treated with a standard OAm (PMPositioner®). Baseline and Follow up (6 months) sleep parameters (PSG and Epworth Sleepiness Scale - ESS) were compared to assess treatment efficacy.

Results
Seventeen patients (9 with hypertension and 8 with hypertension + diabetes) met the inclusion criteria and 13 finished the protocol. After treatment with OAm the following parameters improved significantly: OSA severity (44.5±13.5 to 9.0±4.3, p≤0.001), ODI (46.8±11.6 to 12.1±9.1(p&lt;0.05)), REM (18.4± 4.8 to 21.5± 2.9 (p&lt;0.05)) and SaO2nadir (75.7± 9.4 to 87.0±3.6, p&lt;0.001), ESS (p&lt;0.005). Ten patients (58%) reported a reduction either in systolic and diastolic blood pressure with 3 of them (30%) reduced the hypertensive drug dose.

Conclusion
Our findings show that OAm is a safe and effective treatment option to CPAP non-adherent severe OSA patients. Furthermore OAm therapy had also a positive impact on cardiometabolic risk factors which are particularly relevant outcomes in OSA patients.

Support
State of Sao Paulo Research Support Foundation (FAPESP).
0678 Objective Efficacy Of Oral Appliance Therapy In An Integrated Care Model
Authors: Stothard E R , Deol L I , Hickey M G , McCarty D E , Wertz A T 
Published: May 2020

Abstract

Introduction
Custom-fabricated Oral Appliance (OA) therapy is a recommended alternative to positive airway pressure for the treatment of obstructive sleep apnea (OSA). However, objective efficacy outcomes are limited as dental sleep medicine professionals often work independently of sleep clinics. The integrated care model (ICM) of sleep medicine includes a full-time dentist (diplomate of the American Academy of Dental Sleep Medicine), making it uniquely positioned to examine the efficacy of OA therapy in reducing apnea-hypopnea index (AHI) and creating individualized, patient-centered treatment plans.

Methods
All patients who completed initial consult for OA therapy with the ICM from 2014-2018 were considered. Patients who declined OA were excluded. Diagnostic testing for sleep apnea was completed prior to OA therapy initiation and efficacy testing was prescribed post-OA therapy.

Results
795 patients met inclusion criteria. Efficacy testing was completed in 482 patients (60.6%; 33.9% of patients with treatment follow-up but no efficacy testing reported clinical improvement). 99 were excluded due to insufficient data. 383 patients (55% male; 48.4±0.6 years (±SEM), BMI 28.4±0.3) were included in final analyses. AHI improved in 82.5% of patients (12.5±0.5 to 7.0±0.4, p&lt;0.0001). AHI was reduced &lt;5 in 47.5% of patients (9.9±0.4 to 2.6±0.1, p&lt;0.0001); AHI was reduced by &gt;50% in 51.4% of patients (13.9±0.7 to 3.5±0.2, p&lt;0.0001). 32.1% of patients completed more than one efficacy test to reevaluate adjustment of OA therapy, which significantly reduced final treatment AHI (13.7±0.9 to 7.6±0.8, p&lt;0.0001). Among patients with treatment AHI &lt;5 or &gt;50% reduction in AHI, 28.6% and 32.0% of patients, respectively, required multiple adjustments and efficacy tests to achieve optimal results.

Conclusion
Custom-fabricated OA therapy through the ICM significantly reduced AHI and approximately half of patients achieved AHI &lt;5 and/or &gt;50% reduction in AHI as demonstrated by objective efficacy testing. To optimize therapy response, multiple adjustments were required to significantly improve AHI in a subset of patients. This demonstrates the variability of objective efficacy of OA therapy in the management of OSA, and the necessity of repeated objective testing for treatment optimization.

Support
N/A
0679 Effects Of Cannabimimetic Enhancement On Subjective Sleep Quality And Function In Obstructive Sleep Apnea
Authors: Yin G - , Reid K , Carley D , Prasad B , Zee P 
Published: May 2020

Abstract

Introduction
We previously reported that dronabinol a tetrahydrocannobinol, reduced the apnea hypopnea index (AHI) in patients with obstructive sleep apnea (OSA) in a dose-dependent manner. The aim of this report is to assess the effects of dronabinol on subjective sleep quality and daytime function in the Pharmacotherapy of Apnea by Cannabimimetic Enhancement (PACE) II trial.

Methods
By random assignment, 73 adults with moderate or severe OSA received either placebo (N = 25), 2.5 mg dronabinol (N = 21), or 10 mg dronabinol (N = 27) daily, 1 hour before bedtime for 6 weeks. Participants completed the Pittsburgh sleep quality index (PSQI) and Functional Outcomes of Sleep Questionnaire (FOSQ-10) at baseline and at the end of intervention.

Results
Between group comparisons were performed using a one-way ANOVA. At baseline, there were no significant difference between groups in the PSQI or FOSQ-10. When compared to placebo, the 10 mg group had a significant reduction in the global PSQI score (p=0.039). Paired t-test analysis showed, in comparison to the baseline, the subscale and total score of the FOSQ-10 were significantly increased (P=0.005); the global PSQI score, subjective sleep quality score, habitual sleep efficiency score and daytime dysfunction score were significantly reduced (p&lt;0.001, p&lt;0.001, p=0.024, p=0.007 respectively) in the 10 mg group, while no improvement was found in the 2.5 mg or placebo groups. Bivariate correlational analysis was used to identify the relationship between the changes of variables. Both ∆ global PSQI and ∆ total FOSQ were correlated with ∆ESS, but not with change in AHI or sleep parameters such as sleep stage percentage, sleep efficiency, arousal index, minutes of wake after sleep onset, time and duration of oxygen saturation below 90% percent.

Conclusion
These findings indicate that in addition to its ability to reduce the AHI, dronabinol can improve subjective sleep quality and daytime function in patients with moderate to severe OSA.

Support
This study was funded by National Institutes of Health, National Heart Lung and Blood Institute Grant Number UM1-HL112856 and National Center for Advancing Translational Sciences, Grant Numbers UL1TR001422 and UL1TR002003.
0692 Difference In Improvement Of ESS Score After CPAP Use In Patients From Different Workforces
Authors: Mehta T R , Gurung P , Digala L , Nene Y , Bollu P C 
Published: May 2020

Abstract

Introduction
Obstructive sleep apnea (OSA) is characterized by recurrent occurrences of apnea and hypopnea throughout the night during sleep. Reported to prevail in 23.4% women and 49.7% men aged 40 years or older, OSA is considered to be the most preventable cause of excessive daytime sleepiness.

Methods
After obtaining approval from the institutional review board (IRB) for this retrospective study, a total of 825 patient records from a prospective registry of obstructive sleep apnea from our sleep lab affiliated with the University of Missouri Hospital were searched for variables including but not limited to age, race, gender, occupation, medications any sleep-related comorbidities, psychiatric comorbidities, cardiovascular comorbidities, pre CPAP ESS score and post CPAP ESS score. The mean improvement score of ESS in both these populations was compared and possible causes for the difference in these groups were analyzed.

Results
Initial analysis from 22 patients belonging to the white-collar and 22 patients belonging to the blue-collar workforce with a mean age of 49.27 (±14.28) years and a mean BMI of 37.60 (±9.41) showed a mean improvement of -1.27 and 0.63 respectively with no significance statistically. Statistical analysis will be performed after gathering data from a larger sample size.

Conclusion
Although insignificant, the blue-collar workforce showed more improvement than the white-collar workforce in the initial analysis.

Support
No support, financial or otherwise was used for this study.
0693 Effects Of Solriamfetol On 24-hour Blood Pressure Patterns In Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea
Authors: Strollo P J , Malhotra A , Strohl K , Pepin J , Schweitzer P , Lammers G , Hedner J , Baladi M , Carter L , Bujanover S , Menno D , Dauvilliers Y 
Published: May 2020

Abstract

Introduction
Solriamfetol is a dopamine and norepinephrine reuptake inhibitor indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with obstructive sleep apnea (OSA; 37.5-150 mg/d) or narcolepsy (75-150 mg/d). Previous studies reported small mean increases in blood pressure (BP); however, the time course of these effects has not been evaluated. In addition, effects on BP dipping, which has been shown to be a risk factor for adverse cardiovascular outcomes have not been evaluated. These analyses evaluated the effects of solriamfetol treatment on BP using 24-hour ambulatory blood pressure monitoring (ABPM) and on the percentage of OSA patients with a non-dipping BP profile.

Methods
Twenty-four-hour ABPM was conducted at baseline and week 8 in a 12-week randomized controlled trial in participants with OSA (n=474).

Results
At week 8, increases in BP were apparent in the 75 and 300 mg dose groups from ~6 AM until 8 PM. At baseline, 58% (placebo) and 55% (combined solriamfetol) of participants were non-dippers (defined as &lt;10% decrease in mean arterial pressure [MAP] during sleep). There was no increase in the percentage of non-dippers at week 8 relative to baseline (placebo, 56%; combined solriamfetol, 53%). Results were similar when dipping was defined by changes in systolic BP and diastolic BP.

Conclusion
The effects of solriamfetol on BP at the highest approved dose of 150 mg/d are transient across the day. Solriamfetol was not observed to have an increase in non-dipping classification in participants with OSA at any dose studied.

Support
Jazz Pharmaceuticals
0696 The O2VERLAP Study: High Cpap Use Levels Found In Overlap Syndrome (OSA And COPD) Patients
Authors: Martinez S , Deering S , Sullivan J , Pasquale C , Shumard T , Clark B , Amdur A , Malanga V , Malanga E , Yawn B , Stepnowsky C 
Published: May 2020

Abstract

Introduction
CPAP therapy is prescribed to help manage disordered breathing during sleep time periods. Most users, especially those with non-severe obstructive sleep apnea (OSA), use it only for some portion of their sleep period. Patients with Overlap Syndrome have both OSA and chronic obstructive pulmonary disease (COPD). While there has been some research on CPAP use levels in this patient population, there has been little indication that they use CPAP any differently than those with OSA only.

Methods
The O2VERLAP Study was a large comparative effectiveness trial enrolling people with COPD and OSA and using two different methods of providing information and support to current users of CPAP therapy. The study utilized an electronic national recruitment strategy and 332 participants were enrolled. CPAP data from the 12-week study period was analyzed. The Pittsburgh Sleep Quality Index was used to determine both estimated total sleep period (TSP) and total sleep time (TST). Because participants were all current users of CPAP, data from the total sample was combined and used. The percentage of TST and TSP that CPAP was used was calculated as CPAP use divided by either TST or TSP.

Results
The mean TST was 6.8 hours, TSP was 8.1 hours, and CPAP use was 6.7 hours. CPAP was used during 98.5% of the TST and during 82.7% of the TSP. Over 35% of the sample used CPAP at a level that was equal to or greater than their total sleep period.

Conclusion
Most OSA study populations use CPAP for some fraction of their night’s sleep. This COPD/OSA study population used CPAP to a markedly high level, including over one-third of the sample (n=~100) who used CPAP more than their self-reported sleep period. Further research on the extent and reasons for non-sleep period (i.e., daytime) CPAP use in COPD patients is warranted.

Support
PPRND #1507-31666.