bluuebunny/crossref_metadata_2025 huggingface dataset:
0664 A Low Arousal Threshold Causes Bad Shift of Positive Airway Pressure Compliance Over Time in Obstructive Sleep Apnea Patients
Authors: Wu H , Wei Y , Fang F
Published: May 2020

Introduction

To determine the predictive factors of initial and long-term adherence to positive airway pressure (PAP) therapy and which factors leading a shift of good initial compliance to noncompliance.

Methods

In this follow-up study, A cohort of 166 adult patients who underwent polysomnography (PSG) between January 2017 and April 2019, newly diagnosed with obstructive sleep apnea (OSA) and were amenable to PAP therapy were selected. Information on basic demographics, comorbidities and sleep-related symptoms was collected. PAP adherence data were collected at the end of the first week and the third month. After 3 months of follow-up, 142 participants were included for final data analysis.

Results

Pressure levels were stable during 3 months of PAP treatment. Overall average daily usage time and percentage of PAP used days ≥4 hrs were lower for 3 months than that in the first week. After adjustment for age and gender, multinomial logistic regression analysis showed that less number of sleep-related symptoms (OR, 0.69; 95% CI, 0.52-0.91) and low arousal threshold (ArTH) (OR, 4.44; 95% CI, 1.52-12.98) were associated with a higher odds of consistent noncompliance of PAP; Low ArTH (OR, 2.87; 95% CI, 1.09-7.57) and less BIM (OR, 0.88; 95% CI, 0.78-0.99) increased the risk of compliance-to-noncompliance shift.

Conclusion

Different from the predictors of consistent PAP noncompliance of OSA patients, only less BMI and low ArTH would cause a good PAP compliance shift to noncompliance over time.

Support

Science and technology Beijing 100 leading talents (Z171100001117168)
0671 Combination Of Transoral Robotic Surgery And Oropharyngeal Myofunctional Therapeutic Training For Patients With Obstructive Sleep Apnea
Authors: Lai Y J , Hung C H , Lin C Y
Published: May 2020

Introduction

Obstructive Sleep Apnea (OSA) is a type of sleep disorder characterized by intermittent, partial or complete upper airway collapse. Mostly, moderate to severe OSA cases were recommended to treat with continuous positive airway pressure, however, some of them were withdrawn. Transoral robotic surgery (TORS) was considered for OSA patient with tongue base hypertrophy, but the success rate was only 66.9% and the symptoms might relapse because of aging and gaining weights. Myofunctional therapeutic training (MFTT) was also an alternative treatment for patients with mild to moderate OSA. In our study, we investigated the effect of TORS surgery and oropharyngeal MFTT for OSA patients.

Methods

Seven adult patients were recruited, who were newly diagnosed with moderate to severe OSA (Apnea-hypopnea Index, AHI, 49.8±27.7/h). Polysomnography, questionnaire (Pittsburgh sleep quality index, PSQI; Snore Outcomes Survey, SOS), and the muscle strengths over tongue and jaw-opening were assessed before TORS surgery, 6-week and 18-week after surgery. The components of MFTT program involved jaw opening, tongue protrusion, tongue left, tongue right, tongue up and tongue down. It began at 6th week after surgery and these patients underwent 12 weeks of the home-based oropharyngeal MFTT. During the training intervention period, subjects were interviewed every week for adjusting the treatment intensity.

Results

Mean age was 45.9 years old (SD 9.8) and body mass index (BMI) was 26.6 (SD 3.6). After combination treatment of TORS surgery and MFTT, AHI-supine was significantly decreased from 66.3/h to 26.8/h (p<0.05). PSQI and SOS scores were significantly improved (-2.1, 28.8, respectively). Compared with different components of MFTT program, muscle strength of tongue protrusion was the only significant predictor of AHI-supine reduction.

Conclusion

Our study presented that combination of TORS surgery and oropharyngeal MFTT could improve OSA severity and symptoms.

Support

This work was supported by National Cheng-Kung University Hospital (grant number NCKUH-10802018).
0672 The Effect Of Armodafinil On Sleep Spindles In Obstructive Sleep Apnea: Secondary Analysis Of A Randomized Placebo-controlled Trial
Authors: Emami L , Marshall N S , Chapman J L , Cho G , Grunstein R R , Yee B J , D’Rozario A L
Published: May 2020

Introduction

Armodafinil has been trialed in OSA patients to promote wakefulness and simulated driving performance. We have previously completed a 6-month trial of 150mg of armodafinil vs placebo in moderate-severe OSA patients not using CPAP (ACTRN# 12611000847910) observing that participants on armodafinil learned to perform better across a 90-minute driving simulator task faster than those on placebo. It is possible that this reduction in time-on-task decrement may have been due to increased learning on armodafinil.

Sleep spindles have previously been implicated in procedural learning and neurobehavioral performance. We hypothesized that armodafinil increases sleep spindle events during NREM sleep to enhance learning.

Methods

Sixty-three overweight severe OSA patients (mean BMI: 32.3kg/m2 (26.1-42.5); age 53.1 years (28-71), 52 males) underwent overnight in-lab polysomnography at baseline (0 months) and at a 6-month follow-up. All-night EEG signals were analyzed using a previously validated automated spindle detection algorithm. EEG recordings were visually inspected by an experienced sleep physician (LE), who was blinded to drug allocation. To minimize the likelihood of type 1 error we selected three key spindle variables detected at Cz for analysis of change between 0 and 6 months: 1) total number of spindle events (11-16 Hz) in NREM sleep 2) density of slow spindles (≥11 to ≤ 13Hz) per minute of NREM sleep, and 3) fast spindle density in NREM (>13 to ≤ 16Hz).

Results

The change in total spindle count in NREM sleep (armodafinil=11.6 vs Placebo =-17.1, p=0.57), fast spindle density (armodafinil=0.06 vs Placebo =-0.02, p=0.63) and slow spindle density (armodafinil=-0.00 vs. Placebo =-0.03, p=0.74) were not increased by armodafinil.

Conclusion

If armodafinil enhances simulated driving performance in a way that suppresses time-on-task effects it does not appear to be through a sleep spindle enhancing mechanism. Armodafinil is probably not a pharmacological method of enhancing sleep spindles.

Support

World Sleep Society (International Sleep Research Training Program)CIRUS, Centre for Sleep and Chronobiology, Woolcock Institute of Medical Research, University of Sydney
0676 Long-term Effects Of Upper Airway Stimulation For Treatment Of Obstructive Sleep Apnea On Measurements Of Central And Mixed Apneas
Authors: Myers S A , Sundar K M , Strollo P J
Published: May 2020

Introduction

Upper airway stimulation (UAS) of the hypoglossal nerve for obstructive sleep apnea (OSA) is well-tolerated and results in sustained reduction in the apnea-hypopnea index (AHI). Treatment-emergent CSA is reported to occur in 3.5-19.8% of OSA patients treated with CPAP. We aimed to examine the occurrence or emergence of central and mixed apneas in a cohort of participants that received UAS and were followed for 5 years post implantation.

Methods

The Stimulation Trial for Apnea Reduction (STAR) was a Phase III trial evaluating the safety and efficacy of UAS for CPAP-intolerant OSA. Major inclusion criteria were CPAP intolerance, AHI between 20-50, less than 25% central and mixed apneas and BMI <= 32. Polysomnography was performed at baseline, 12, 18, 36 and 60-month follow-up. Data were scored by a core lab and was then retrospectively analyzed via the STAR PSG database to measure the evolution of central and mixed apneas on UAS therapy.

Results

Baseline age was 54.5 ± 10.2 years, BMI was 28.4 ± 2.6 kg/m2 and 83% male (n=126). AHI data were non-normally distributed. Median AHI was 29.3/hr at baseline, that was reduced to 9/hr at 12-months and 6/hr at 60-months. Median central apnea index (CAI) was 0.8/hr at baseline, 0.4/hr at 12-months, and 0.2/hr at 60-months. Median mixed apnea index (MAI) was 0.2/hr at baseline, 0.7/hr at 12-months and 0.4/hr at 60-months. The 12- and 60-month CAI was significantly lower than baseline (p<0.05), but MAI was not. The percentage of central and mixed events remained stable throughout follow-up, approximately at 5% of the total AHI.

Conclusion

UAS reduced the overall AHI and results in a small but significant decrease in CAI. Given that OSA and CSA frequently co-exist, the role of UAS on reducing CSA in patients with combined OSA and CSA deserves further investigation.

Support

STAR study was sponsored by Inspire Medical Systems
0684 Overnight Fluid Shift In Apnea And Stroke: Does Being Physically Active Matter
Authors: Frange C , Coelho F M
Published: May 2020

Introduction

Obstructive sleep apnea (OSA) and physical inactivity are frequent in patients with stroke. Overnight fluid shift may increase the propensity to pharyngeal obstruction and thus predispose to OSA. Also, physical inactivity can lead to consequent edema in the hemiparetic side.

Methods

In 7 patients at 3 months following post-first-ever ischemic stroke, we measured change in AHI (PSG), neck circumference, and arms and legs fluid volume (bioelectric impedance), before and after PSG in two conditions during the day before PSG: (1) inactive (sitting/lying), and (2) physically active (standing, walking, climbing stairs and mild exercise for 30 mins/hour).

Results

Being physically active for one day decreased mean AHI (inactive: 17.9/h; active: 12.6/h). Mean neck circumference increased overnight in both conditions (active and inactive) but increased more when the participants were physically active (inactive: 38 to 38.5cm; active: 38.43 to 39.5cm). Mean paretic arm fluid volume increased after inactive condition and did not change after physically active condition (inactive: 1.33L to 1.45L; active: 1.82L). Mean non-paretic arm fluid volume increased after active and inactive conditions (inactive: 1.34L to 1.45L; active: 1.74 to 1.78L). In both conditions and for paretic and non-paretic arms, being physically active for one day increased arm fluid volume between pre- and post-sleep comparisons. Mean paretic leg fluid volume increased after both conditions but increased more when the participants were inactive (inactive: 6.08L to 6.52L; active: 6.12 to 6.24L). Mean non-paretic leg fluid volume increased after inactive condition and decreased after being physically active (inactive: 6.01L to 6.45L; active: 6.15 to 6.06L).

Conclusion

Being physically active for one day decreased AHI, despite the increased fluid accumulation in the neck, and contributed to leaving no edema in the hemiparetic side. Breaking up inactivity and increasing physical activity in patients following stroke may be a promising intervention to reduce edema and OSA.

Support

São Paulo Research Foundation (FAPESP, grant #2018/18952-1 to CF).
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

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>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>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

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

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

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>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<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<0.05). In addition, stepwise multivariate linear regression analysis further revealed an independent relationship between moderate OSA (1530) 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<15) (all with a p<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

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

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 < 5.

Methods

We have identified 38 patients with baseline polysomnograms performed from December 2019 to July 2019 with AHI < 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

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 (< 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

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<0.01) rather than the HSI-Impact score (p>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

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

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 <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.
0768 Time Course Of Improvement In Excessive Daytime Sleepiness And Cataplexy During Treatment With Pitolisant In Patients With Narcolepsy
Authors: Roy A , Davis C W , Vaughn B , Dayno J M , Dauvilliers Y , Schwartz J
Published: May 2020

Introduction

This analysis evaluated the efficacy of pitolisant over time in three 7- to 8-week, randomized, placebo-controlled studies of adults with narcolepsy.

Methods

Patients in all 3 studies (HARMONY-1, HARMONY-1bis, HARMONY-CTP) experienced excessive daytime sleepiness (EDS) at study baseline; patients in HARMONY-CTP also experienced ≥3 cataplexy attacks/week. Pitolisant was titrated to a maximum dose of 35.6 mg/day (HARMONY-1, HARMONY-CTP) or 17.8 mg/day (HARMONY-1bis). Change from baseline in mean Epworth Sleepiness Scale (ESS) score (3 studies) and mean weekly rate of cataplexy (WRC; 1 study) was compared for pitolisant versus placebo.

Results

In the higher-dose HARMONY-1 (pitolisant, n=31; placebo, n=30) and HARMONY-CTP (pitolisant, n=54; placebo, n=51) studies, ESS score improvement was significantly greater with pitolisant versus placebo beginning at Week 2 (LS mean difference, -2.8; P=0.015) and Week 3 (LS mean difference, -2.0; P=0.005), respectively. In the lower-dose HARMONY-1bis study (pitolisant, n=66; placebo, n=32), significant separation from placebo was first observed at Week 7 (LS mean difference, -2.3; P=0.044). At end-of-treatment, LS mean difference in ESS score change from baseline was -3.1 (P=0.022) in HARMONY-1, -3.4 (P<0.001) in HARMONY-CTP, and -2.2 (P=0.030) in HARMONY-1bis. In HARMONY-CTP, LS mean WRC with pitolisant was 11.7 at baseline, 4.6 at end-of-treatment, and 5.1 after a 1-week, placebo-washout period. Improvement in WRC was significantly greater with pitolisant versus placebo beginning at Week 2 (LS mean difference, -5.3; P=0.004) and continued through end-of-treatment (LS mean difference, -6.2; P<0.001); there was no evidence of rebound cataplexy after placebo-washout (LS mean difference, -4.9; P=0.027).

Conclusion

During pitolisant treatment, improvement in EDS occurred sooner (within first few weeks) and was more robust in studies that permitted titration to the maximum recommended dose (35.6 mg/day). The rate of cataplexy attacks decreased early during treatment, with no evidence of rebound when pitolisant was withdrawn.

Support

Bioprojet Pharma and Harmony Biosciences, LLC.
0770
Authors: Truzzi G M , Naufel M F , Coelho F M
Published: May 2020

Introduction

Narcolepsy is a sleep disorder characterized mainly by excessive daytime sleepiness, cataplexy, sleep paralysis, hypnagogic-hypnopompic hallucinations and sleep fragmentation. Besides those most known manifestations, other findings may be present in patients with narcolepsy, such as weight gain, reduction in eating satiety and psychological alterations. It is also observed that part of the hypocretin-producing cells projections are present in the olfactory bulb, and the conditions appears to be related to changes in olfaction.

Methods

a cross sectional study was performed in patients diagnosed with narcolepsy followed up by the excessive daytime sleepiness outpatient clinic of the discipline o Sleep Biology and Medicine of the Department of Psychobiology of the Federal University of São Paulo, Brazil. Olfaction was assessed by the University of Pennsylvania Smell Identification Test (UPSIT) following an interview and nasal cavity examination. Patients with conditions and disorders that may cause hyposmia were excluded.

Results

77 patients were assessed, of which 56 had type-1 narcolepsy and 21 with type-2 narcolepsy. The results were compared with the test’s reference data. Most patients with type-1 and type-2 narcolepsy presented scores compatible with some degree of olfactory impairment. No significant difference was observed between the scores of patients with type-1 and type-2 narcolepsy.

Conclusion

The present study shows most patients with narcolepsy have some degree of olfactory impairment. This impairment doesn’t appear to be explained by alterations in the hypocretineric cells as pointed out in previous studies. The changes in olfaction in people with narcolepsy may cause the satiety alterations often observed in them. Other mechanisms involved with the genesis of hyposmia in those patients should be studied further.

Support

AFIP - Associação Fundo de Incentivo à Pesquisa
0777 Variations in Vigilance and Sleep Among Underground Mine Workers During 14 Consecutive Night Shifts
Authors: Laberge L , Lavigne A A , Auclair J , Hébert M
Published: May 2020

Introduction

Adverse effects of night shift work are well known but there is scarce data on how vigilance and sleep vary across a large number of consecutive night shifts.

Methods

In summer, 38 underground miners (mean age (SD): 36.8 (13.9) years) wore an actigraph, filled out the Morningness-Eveningness questionnaire, and completed a Visual Analog Scale capturing subjective vigilance (very sleepy to very alert) 4 times per shift (19:00, 22:00, 02:00, and 05:30) for 14 consecutive night shifts. Mixed effects linear regression models were used to account for repeated measures.

Results

Mean vigilance level is lower at 22:00, 02:00 and 05:30 than at the beginning of the shift at 19:00 (p<0.001). Also, a more pronounced decrease in vigilance during the night was observed among older workers compared to younger workers (p<0.05). Moreover, workers with greater eveningness have higher vigilance at the beginning of the first night shift at 19:00 (p<0.001), but their decline in vigilance level during the night is faster than that observed in workers with greater morningness (p<0.01). Interestingly, the mean vigilance decline observed at 02:00 and 05:30 (compared to 19:00) is slowed down for each additional night shift (p<0.001). Furthermore, mean sleep efficiency is negatively associated with morningness and gradually decreases across consecutive night shifts (p<0.05). In addition, mean sleep duration is shorter in older workers and is positively associated with morningness (p<0.05).

Conclusion

Results show a progressive improvement in vigilance of mine workers assigned to a large number of consecutive 12-hour night shifts from 2 am onwards. This may probably be ascribed to an adjustment in homeostatic sleep propensity consecutive to the partial sleep deprivation associated with time spent traveling to the remote site before the first shift. However, circadian adjustment is unlikely considering the strong morning light exposure experienced daily after the night shift.

Support

College and Community Innovation Program of the Natural Sciences and Engineering Research Council of Canada (NSERC) (CUI2I 472201-14)
0778 Workplace Yoga Program Features and Associations With Shift Work and Sleep Among Nursing Staff
Authors: Zhang Y , Thind H , Kim S , Soup A , Punnett L , Duffy J
Published: May 2020

Introduction

Nursing staff are at risk for impaired sleep due to irregular schedules, long work hours, and other occupational stress. Yoga has demonstrated beneficial effects on sleep in healthy adults and patients with chronic diseases. However, yoga interventions are generally offered as 60-75-minute sessions; this long duration might not be suitable as a workplace program for nursing staff. The objective of this study is to examine workplace yoga program features and associations with shift work and sleep among nursing staff.

Methods

Online Qualtrics surveys were distributed among nurses and nursing assistants at a community hospital in the northeast U.S. Hypothetical workplace yoga program features were assessed including general interest, duration, frequency, timing with respect to work shift, and interest in home practice. Sleep duration and disturbances were assessed.

Results

Among the 541 participants (94% female; age 43±13y), over a third reported sleep ≤6hrs/day (38%) and sleep disturbances (38%), and 79% reported interest in workplace yoga. Among those reporting interest, after work (61%), 30min/session (73%), 3 sessions/week (56%), and interests in home practice (64%) were yoga features endorsed by nursing staff. Night or ≥12hr shift was associated with less interest in workplace yoga. Evening or ≥12hr shift was associated with less interest in yoga after work, while day or night shift was associated with less interest in yoga before work. Mild sleep disturbances were associated with more interest while severe disturbances were associated with less interest in yoga after work. Nursing staff with sleep≤6hrs/day reported less interest in yoga before work, but more interest in home yoga practice.

Conclusion

Nursing staff reported a high prevalence of short and disturbed sleep and interest in workplace yoga. Workplace yoga programs need to be designed according to nursing staff’s interest while considering the effect of shift work and sleep problems reported by nursing staff.

Support

Drs. Yuan Zhang and Jeanne F. Duffy were supported by NIH grant R01 AG044416.
0783 Relationship Between Chronotype And Sleep Duration Among Medical Students
Authors: Geoca A , Dowling M , Jain V
Published: May 2020

Introduction

Previous literature has supported the claim that longer sleepers have later chronotypes. It is also thought that later chronotypes may obtain less sleep during workdays. We aimed to study the association between sleep duration and chronotypes in The George Washington University (GWU) medical students.

Methods

Eighty-six medical students at GWU (62 F [71%], 24 M [29%]; ages 21-33 y [mean 24.4 y]) filled out the Munich Chronotype Questionnaire (MCTQ). Midpoint of the bedtime and wake times during workdays was used to determine chronotype. Subjects were split into two groupsbased on the median of the distribution (Md=7.5) of the self-reported sleep duration variable; those who sleep less than 7.5 hours (short sleepers), and those who sleep 7.5 hours or longer (long sleepers). Independent samples t-test was used to compare the chronotype measurementsof the long sleepers (n=39) versus short sleepers (n=41).

Results

Short sleepers had a mean of 6.48 (SD=0.72) hours of sleep while long sleepers had a mean of 8.11 (SD=0.53) hours of sleep. The range of chronotype measures was wider in the long sleepers (1.25 to 7.25; range=6) compared to that in the short sleepers group (1.42 to 5.280; range=3.86). We found no significant mean differences in chronotype between those who slept less than 7.5 hours (mean=3.188, SD=0.858) and those who sleep 7.5 hours or longer (mean=3.201, SD=1.20) [t(77)=0.056; p = .956].

Conclusion

Sleep duration among medical students was not associated with their chronotype. This is in opposition to other research findings of decreased sleep duration among later chronotypes. Our findings need to be replicated in a larger sample.

Support

NA
0785 Associations Between Circadian Preference And Sleep-related Thoughts: Data From The 2015 Sleep In America Poll
Authors: Jeon B , Luyster F S , Chasens E R
Published: May 2020

Introduction

Evening types of sleep tend to have poorer sleep quality and sleep habits than morning types. Maladaptive beliefs or thoughts about sleep can affect one’s sleep and may differ between evening and morning types. We examined the association between the circadian preference and sleep-related thoughts in U.S adults.

Methods

A secondary analysis used survey data from the 2015 National Sleep Foundation’s Sleep in America Poll. Questions included normal bedtime and wake-up time for week/work days and weekend/non-work days. Circadian preference was determined by midpoint of sleep calculated as midpoint of sleep on weekends corrected for average nightly sleep duration. Participants were excluded if their sleep midpoint was from noon to midnight. Midpoint of sleep was divided into two groups using median split (“earlier” vs. “later”). Sleep-related thoughts were “worry about getting a good sleep”, “overwhelming thoughts about getting enough sleep”, “motivation to get sleep”, and “concern about serious physical consequences due to poor sleep”; responded often/always or extremely to somewhat for these items were coded as maladaptive. Logistic regression analysis controlling for socio-demographics, sleep duration, and sleep disturbance (PROMIS Scale; higher scores = greater sleep disturbance) was conducted to examine the relationships between midpoint of sleep and sleep-related thoughts.

Results

The sample (N = 1011) was primarily White (73.6%), male (50.9%), college educated (62.2%), married/partnered (67.6%) with a mean age of 51.65 ± 17.05 years. Mean midpoint of sleep in “earlier” type was 2:33AM and 5:29AM in “later” type. “Later” type had shorter sleep duration on weekdays and longer sleep duration on weekends than “earlier” type (p < .01), but average sleep duration was similar between two types. “Later” type had more “worry” and “overwhelming thoughts” (p < .05) about sleep. In logistic models, midpoint of sleep was significant only for “concern” (p = .02).

Conclusion

In this study, late chronotype was associated with increased sleep disturbances and greater variability in sleep duration. The relationship between the timing of sleep and thoughts about the impact of impaired sleep remains unclear and an area for further study with objective measures.

Support
0788 Increased Rapid Eye Movement Density in Chinese Patients with Parkinson’s Disease and RBD
Authors: Zhang L , Zhu J
Published: May 2020

Introduction

Impaired rapid eye movement sleep is common among patients with Parkinson’s disease (PD). However, information on rapid eye movement density (REM density) among PD patients is currently lacking. The current study sought to characterize REM density in PD patients and to examine the associations between REM density sleep parameters and clinical manifestations.

Methods

We retrospectively recruited 172 PD patients. All participants were assessed with a two-night polysomnography, and REM density was calculated. Clinical assessments were completed in PD patients before polysomnography.

Results

Rapid eye movement sleep behavior disorder (RBD) were observed in 93 patients (54.1%). The disease duration, UPDRS part III score, Hoehn and Yahr (H-Y) stage, and HAMA, HAMD, and PDQ-39 scores in the Parkinson’s disease patients with rapid eye movement sleep behavior disorder (RBD) were significantly higher than in the patients without RBD (P<0.05). The REM density was also significantly higher in the RBD patients than in the patients without RBD (P<0.05). NREM sleep stage 3 time (N3 time) and percentage of N3 time of total sleep time (N3%) were higher in patients without RBD. The forward binary logistic regression model showed that REM density, UPDRS-III score and N3 sleep time were associated with RBD in the PD patients.

Conclusion

Our results confirm the high prevalence of RBD in patients with PD. Increased REM density was the main risk factor of RBD.

Support

Special Funds of the Jiangsu Provincial Key Research and Development Projects (grant No. BE2018610)