bluuebunny/crossref_metadata_2025 huggingface dataset:
0516 Chinese Patients with Insomnia Recruited from Traditional Chinese Medicine (TCM) Hospital Successfully Treated With Telehealth Group CBT-I in Mandarin
Authors: Xu Y , Barwick F , Li C
Published: May 2020

Introduction

Cognitive Behavioral Therapy for Insomnia (CBTI) is the recommended treatment for insomnia in the United States, Europe and China. Individual, group and online formats are effective, with moderate to large effect sizes in treatment outcomes. Although the prevalence of insomnia is 15% in China, most individuals do not seek CBTI and often prefer TCM. This study investigated whether CBTI delivered to Chinese in Mandarin via group telehealth showed similar outcomes compared to other countries.

Methods

Chinese patients > 18 years with insomnia > 7 on the ISI were recruited from a sleep clinic in collaboration with Chongqing TCM Hospital in China. CBTI was delivered via 4-session telehealth group. Components included sleep education, sleep restriction, stimulus control, cognitive reframing, and relaxation. TCM use was extracted from medical records. Scores on self-report questionnaires assessing insomnia symptoms, sleep effort, sleep beliefs, and depression were compared pre- and post-treatment using paired sample t-tests with correction for multiple comparisons.

Results

All patients (N=34) completed pre-post measures. Mean age was 44 years, sample was 82% female, and 91% had a bachelor or advanced degree. Average insomnia duration was 4.1 years, and 80% of sample used TCM during CBTI. Post-treatment outcomes showed significant decreases in insomnia symptoms (ISI Mdiff=4.0, SDdiff=6.4, p=.001, ES=.63), sleep effort (GSES Mdiff=2.3, SDdiff=3.2, p=.000, ES=.72), and unhelpful sleep beliefs (DBAS Mdiff=5.4, SDdiff=5.4, p=.000, ES=1.0), along with significantly lower depression symptoms (PHQ9 Mdiff =2.6, SD=3.8, p=.000, ES=.68) and improvement in daytime functioning (PSQI Mdiff.=0.6 SDdiff =1.2, p=.008, SE=.50). Medication use also decreased significantly (PSQI Mdiff=1.5 SDdiff =1.6, p=.000).

Conclusion

Chinese patients with insomnia can be recruited successfully and treated effectively using CBTI via telehealth. Outcomes and effect sizes are similar to those seen with CBTI in other countries. Future comparison of CBTI with and without concurrent TCM could provide clinically relevant information.

Support

None
0521 Daridorexant (ACT-541468), A Dual Orexin Receptor Antagonist for the Treatment of Insomnia Disorder: Double Blind, Randomized, Phase 3 Studies for Efficacy and Safety in Adult and Elderly Patients
Authors: Zammit G , Seboek Kinter D , Bassetti C , Leger D , Hermann V , Pain S , Roth T
Published: May 2020

Introduction

Daridorexant, a potent and selective orally administered dual orexin receptor antagonist (DORA), has shown dose-dependent efficacy and is well tolerated with minimal residual next-morning effects in two phase 2 studies in adult and elderly subjects with insomnia disorder. Following the favorable phase 2 results, clinical development was pursued with two pivotal phase 3 multi-center, double-blind, randomized, placebo-controlled studies to further assess efficacy and safety in adult and elderly subjects with insomnia disorder. Long-term safety and tolerability are being further evaluated in a double-blind placebo-controlled extension study.

Methods

Each of the pivotal studies include ~900 patients (~40% ≥65y), randomized 1:1:1 to one of two daridorexant arms or placebo. The studies differ in dose only (10 or 25 mg [NCT03545191], 25 or 50 mg [NCT03575104]). Both report objective primary outcomes at 1 and 3 months based on PSG (WASO and LSP). Secondary endpoints include self-reported nighttime benefit with Total Sleep Time (sTST), and daytime benefit using the validated Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). The patients undergo screening (7-13 d) and run-in (7-18 d) periods establishing eligibility and baseline, a 3-month double-blind treatment period, followed by a placebo run-out (7 d) to evaluate rebound insomnia and withdrawal effects and a 30-day safety follow-up. Additionally, subjects completing treatment could enroll in the 40-week double-blinded placebo-controlled extension trial [NCT03679884] to assess long-term safety.

Results

Enrollment in NCT03575104 (25/50 mg) was successfully completed and involves 76 sites across 10 countries; expected completion March 2020. Recruitment to study NCT03545191 (10/25 mg) is advanced; completion expected June 2020.

Conclusion

The comprehensive daridorexant phase 3 program includes 3 dose levels and replication of objective and subjective measurements at 1 and 3 months, while assessing self-reported nighttime benefit, and benefit during the day with a validated PRO instrument, as well as safety in insomnia disorder.

Support

Medical writing Randall Watson, (Idorsia). These studies were sponsored by Idorsia Pharmaceuticals Ltd.
0522 Subtypes of Insomniacs Treated by Cognitive-Behavioral Therapy
Authors: Sforza M , Castronovo V , Galbiati A , Zucconi M , Oldani A , Casoni F , Ferini-Strambi L
Published: May 2020

Introduction

Insomnia disorder (ID) is characterized by high degree of heterogeneity. Aim of our study was to identify ID patients subtypes in terms of sleep and non-sleep clinical baseline (BL) features and CBT-I efficacy.

Methods

294 chronic insomnia patients (61.6% female, mean age 40.7 ± 12.3 yrs) underwent 7-sessions group CBT-I. By use of latent class analysis (LCA) we identified ID subtypes according to BL score of Glasgow Sleep Effort Scale (GSES); Epworth Sleepiness Scale (ESS); Dysfunctional Beliefs and Attitudes about Sleep (DBAS -16); Morningness-Eveningness Questionnaire Self-Assessment (MEQ-SA); Perceived Stress Scale (PSS); Profile of Mood States (POMS); Beck Depression Inventory (BDI-II); Stay-Trait Anxiety Inventory (STAI-Y); Treatment effectiveness (Delta score of Insomnia Severity Index ISI between BL and end-of-treatment).

Results

We chose 3 latent classes as most parsimonious model. According to questionnaires’ cut-off, we labeled three classes: Class 1 (insomnia+anxiety+depression+stress) (n=62), Class 2 (insomnia+anxiety+depression) (n=153), Class 3 (only insomnia) (n=79). The variables that best differentiate the 3 classes were POMS (.772), STAY (.660), PSS (.545), BDI (.406) and ISI (.228) at BL. In particular, for ISI, the best item predicting groups differentiation was item 3 on the impact of insomnia on daytime functioning (.224). Moreover, we found a significant interaction between CBT-I treatment effect and the 3 classes at the ISI score (p=.001), GSES score (p=.002), DBAS score (p<.05), PSS score (p<.001), POMS score (p<.001), BDI score (p<.001) and STAI-Y score (p<.001).

Conclusion

Our data driven analysis results suggest that the heterogeneity of ID patients can be best represented by non-sleep scores, in particular those regarding depression, anxiety, stress and daytime functioning. These information can be useful in predicting the outcome of CBT-I.

Support

No
0529 Behavioral Therapy Components for Insomnia and Fatigue in COPD
Authors: Kapella M , Steffen A , Laghi F , Prasad B , Vispute S , Teixeira C , Kemner G , Peters T , Carley D
Published: May 2020

Introduction

Insomnia contributes to fatigue, a common symptom in COPD. Our study aims were: (1) to determine the efficacy of a) cognitive behavioral therapy for insomnia (CBT-I) and b) COPD education (COPD-ED) on insomnia and fatigue, and (2) to define potential mechanistic contributors to pre/post intervention change in insomnia and fatigue in patients with COPD and insomnia.

Methods

A randomized 2x2 factorial design was used with factors representing CBT-I (yes/no) and COPD-ED (yes/no). Attention control (health videos) were used in the absence of CBT-I or COPD-ED. All patients received 6, 75-minute weekly sessions. Dependent variables included insomnia severity (Sleep Impairment Index (SII), range 0-28) and fatigue (Chronic Respiratory Disease Questionnaire (CRQ) range 1-7) measured at baseline, just post-intervention, and at 3-months post-intervention.

Results

One hundred nine patients (FEV1% predicted 67 ± 24% (mean ± SD), age 65 ± 8 years, SII 15.9 ± 8, CRQ 3.7 ± 1.1) participated in the study. After 6 sessions, insomnia decreased more in patients who received CBT-I (-5.8) than those who did not (-2.2; p=0.0002). This effect was sustained at the 3-month follow-up (p=0.0003). Fatigue showed no significant differences for CBT-I at 6-weeks (p=.27) but at 3-months patients receiving CBT-I showed marginally better improvement (.75, a clinically important difference) compared to those who did not receive CBT-I (.43; p=.09). COPD-ED showed no effect on insomnia or fatigue. Two main effects suggest mechanisms for the pre-post efficacy of CBT-I: improved sleep beliefs (p=0.0257) and self-efficacy for sleep (p=0.0619) after 6 sessions which were sustained at 3 months (p=0.0184 and p=0.0431 respectively).

Conclusion

CBT-I produced sustained decreases in insomnia in patients with COPD. Results suggest that changes in beliefs about sleep and improved self-efficacy for managing sleep may mediate CBT-I associated decreases in insomnia.

Support

This research was supported by the National Institute of Nursing Research of the National Institutes of Health R01NR013937.
0534 Cognitive Behavioral Therapy for Perinatal Insomnia: Effects on Postpartum Depressive Symptoms
Authors: Manber R , Bei B , Simpson N , Rangel E
Published: May 2020

Introduction

Poor sleep during pregnancy is a risk for postpartum depression. Using data from an RCT of CBT-I for insomnia disorder during pregnancy, we examined whether improvement in insomnia reduced postpartum depression symptom severity. We hypothesized that better response to treatment during pregnancy would result in lower depressive symptom severity during the postpartum.

Methods

Pregnant women (N=179; gestation age 18-30 weeks) with insomnia disorder were randomized to CBT-I or an active control (CTRL) therapy (5 sessions during pregnancy, one at 6 weeks postpartum). Women with depressive disorders and those using prescription medications that impact sleep were excluded. The Insomnia Severity Index (ISI) and the Edinburgh Postpartum Depression Scale (EPDS) were administered at baseline, during pregnancy, and at 8, 18, and 30 weeks postpartum. The Perinatal Risk Questionnaire (PRQ) was administered at baseline. Included in the analyses were women who provided data for at least one of three postpartum assessments (62 in CBT-I; 55 in CTRL).

Results

Mixed effects models revealed that lower ISI following the pregnancy treatment phase (p < .001) and greater reduction in ISI during pregnancy (p = .053) predicted overall lower EPDS scores during postpartum; but these effects did not differ significantly between treatment arms. Average postpartum EPDS scores, which were low overall, were higher in women with ISI score at or above the median of 9 (6.6±3.9), compared to those below the median (3.5±3.3). Compared to CTRL, participants in the CBT-I condition were nearly twice likely to have ISI scores below the median following the pregnancy treatment phase (29.1% versus 56.5%). Although higher PRQ scores were associated with overall higher postpartum EPDS (p=.0026), PRQ did not moderate postpartum EPDS trajectories.

Conclusion

We have previously shown that CBT-I is effective for antenatal insomnia, which is a risk for postpartum depression. Our current findings suggest that improving insomnia in pregnancy may reduce the risk for postpartum depression. Limitations include a small sample and missing data during the postpartum follow-up. A larger study among women specifically at risk for postpartum depression could help identify patient related factors that predict therapeutic benefits of CBT-I on postpartum depression.

Support

NR013662
0537 Cognitive Functioning Before and After Insomnia Treatment in Women Veterans
Authors: Dzierzewski J M , Zhu R , Donovan E K , Perez E , Song Y , Kelly M R , Carlson G , Fung C H , Alessi C , Martin J L
Published: May 2020

Introduction

Women are at higher risk for cognitive impairment and dementia compared to men. Identifying potentially treatable risk factors such as insomnia is an important clinical goal. In a trial comparing two behavioral treatments for insomnia in women veterans, we hypothesized that 1) worse baseline insomnia severity would be associated with poorer cognitive function, and 2) improvement in insomnia severity with treatment would be associated with improvement in cognitive functioning.

Methods

347 women veterans with insomnia disorder [mean age 48.3 (12.9) years] completed baseline testing. Of these, 149 women were randomized to receive cognitive behavioral therapy for insomnia (CBT-I) or acceptance and commitment (ACT) based insomnia treatment (both treatments included sleep restriction, stimulus control, and sleep hygiene). Insomnia Severity Index (ISI) was assessed at baseline, post-treatment, and 3-month follow-up. Cognitive functioning was measured with Symbol Digit Coding (SDC) and Trail Making Test A and B (TMTA and TMTB). Pearson correlations were used to examine associations between insomnia severity and cognitive functioning at baseline and changes in both insomnia severity and cognitive functioning from before to after treatment.

Results

At baseline (N=347), mean ISI was 14.1 (5.3). Worse baseline ISI was associated with worse baseline cognitive functioning on TMTA (r=-.15, p<.01) and SDC (r=-.12, p<.05). In the randomized sample (N=149), ISI scores improved at post-treatment (mean ISI change= -9.0; p<.001) and 3-month follow-up (mean change= -8.0; p<.001) relative to baseline. Improvement in ISI from baseline to post-treatment was significantly associated with improvement in SDC from baseline to post-treatment (r=-.18, p<.05), but not improvement in TMTA and TMTB. Change in ISI was not significantly related to change in cognitive tasks from baseline to 3-month follow-up.

Conclusion

More severe insomnia is associated with worse cognitive functioning in women veterans. The magnitude of improvement in insomnia symptoms may be associated with improvement in cognition.

Support

NIH/NIA K23AG049955 (PI: Dzierzewski); VA/HSR&D IIR-HX002300 (PI: Martin), NIH/NHLBI K24HL143055 (PI: Martin).
0545 Bi-Layer Melatonin Tablet Provides Immediate and Extended Absorption to Address Primary Sleep Issues
Authors: Mun J G , Wang D , Doerflein Fulk D L , Fakhary M , Gualco S J , Grant R W , Mitmesser S H
Published: May 2020

Introduction

Melatonin is a naturally-occurring hormone that functions in the regulation of the sleep-wake cycle. Exogenous melatonin has demonstrated utility for the induction and maintenance of sleep. Modulation of tablet dissolution rates can be achieved by strategically using binding agents in two layers to rapidly raise melatonin levels and sustain elevated levels over time to better emulate normal nocturnal melatonin secretion.

Methods

A randomized, double-blind, controlled cross-over study was conducted in healthy adults (n=18) to investigate the pharmacokinetics of a 4.5 mg melatonin bi-layer tablet with either prolonged-release (PR) or immediate-release (IR) characteristics. Blood samples were collected at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 8 and 10 h post-ingestion and melatonin concentrations were quantified.

Results

The PR formulation had a lower maximum concentration (Cmax, p<0.002), but a longer time to reach maximum concentration (Tmax, p<0.001). Absorption rate constant (Ka) and terminal disposition rate constant (λ) were both lower in PR melatonin than the IR formulation (p<0.001), indicating slower absorption and elimination rates. These measures were consistent with significantly greater absorption (ta1/2, p<0.002) and elimination half-lives (t1/2, p<0.001) in the IR formulation compared to the PR formulation. Additionally, plasma melatonin concentrations reached pre-ingestion values by 8 h post-administration of the PR formulation, indicating that individuals sleeping for a recommended 7-9 hours will wake with normal melatonin levels, when taken an hour before bedtime.

Conclusion

Prolonged-release bi-layer melatonin tablet safely and effectively extends the absorption of exogenous melatonin compared to an immediate-release formulation.

Support

Pharmavite, LLC
0547 Insomnia in Veterans with COPD: Prevalence, Correlates, and Health Care Utilization
Authors: Luyster F S , Boudreaux-Kelly M Y , Bon J M
Published: May 2020

Introduction

Veterans with COPD are a vulnerable group for developing insomnia. The objectives of this study were to examine the prevalence and correlates of insomnia and its impact on health care utilization in a national sample of Veterans with COPD.

Methods

National data from electronic medical records of Veterans who utilized the Veterans Health Administration between FY2011 and FY2017 was accessed from the Veterans Affair Corporate Data Warehouse. COPD was based on International Classification of Diseases diagnostic codes (ICD-9/10). Insomnia was defined by ICD-9/10 codes or sedative-hypnotic prescription of >30 doses in a given fiscal year. ICD-9/10 codes for other conditions were documented. Outpatient and inpatient health care service utilization included number of physician encounters and emergency room visits and hospitalizations with a primary diagnostic code for COPD or COPD exacerbation. Bivariate comparisons between veterans with COPD and insomnia and COPD only were made for sociodemographic, comorbidities, and health care utilization variables using t-tests and Chi-square tests, as appropriate.

Results

A total of 1,542,642 Veterans with COPD were identified during the 6-year period. Of those with COPD, 575,539 (37.3%) were identified as having insomnia. Veterans with COPD and comorbid insomnia were younger (64 years vs. 69 years) and more likely to be female (6.3% vs. 3.7%), Black (14.0% vs. 11.0%), be a current smoker (46.1% vs. 35.5%), and have comorbidities including obstructive sleep apnea, diabetes, asthma, stroke, depression, or posttraumatic stress disorder compared to those without insomnia (all p’s <0.001). Compared to Veterans with COPD only, those with comorbid insomnia had a greater number of COPD-related outpatient (6.9 vs. 10.5) and emergency room (1.1 vs. 1.2) visits and hospitalizations (1.9 vs. 2.3) (p’s <0.001).

Conclusion

Insomnia is highly prevalent in Veterans with COPD and is associated with greater COPD-related health care utilization. Future research is needed to determine if targeted treatment for insomnia can improve COPD outcomes.

Support

This study was funded by the VA Competitive Career Development Fund.
0571 Repolarization Variability Predicts Cardiovascular Death in Obstructive Sleep Apnea
Authors: Patel S I , Zareba W , Couderc J , Xia X , LaFleur B , Torabzadeh E , Woosley R , Parthasarathy S
Published: May 2020

Introduction

Patients with untreated obstructive sleep apnea (OSA) have a 2-3—fold increased risk of cardiovascular mortality (CVD) compared with individuals without OSA. QTc prolongation and increased QT variability among OSA patients may contribute to this association.

Methods

Patients with OSA from the Sleep Heart Health study were identified based on polysomnography criteria and their continuous electrocardiograms (ECG) analyzed for QTc duration and QT variability. Both Fridericia’s and Bazett’s heart rate corrections were used to calculate QTc. QT variability was measured as standard deviation of QT intervals (SDQT) and normalized QT interval variance (QTVN) at 1- and 5-minute intervals and short-term interval beat-to-beat QT variability (STVQT) was measured at 5-minute intervals. Lasso with elastic-net regularization was used as the variable/covariate selection method. Cox proportional hazards regression models were used to determine predictors of CVD.

Results

Data from 365 patients with OSA were screened. Ninety-seven patients were excluded from analysis due to low quality ECG data (n=50) or extremely high (> ln (10)) variability in QT/QTc and/or QT variability (n=12). Fifty two percent of the sample was male with mean age 65 years (±10). Fifty-six of these patients died of CVD. The mean (SD) QTc in the group that died was 411 (30) ms and 416 (34) ms compared to 406 (24) ms and 411 (25) ms using Fridericia (Cox LR p-value 0.055) and Bazett (p=0.090), respectively. Gender, age, race, diabetes, SDQT and STVQT were significant predictors for CVD. We fit models with the covariates and SDQT (at both 1 and 5 min) and STVQT as three models and demonstrate that both SDQT and STVQT are significantly associated with CVD death (p-values of 0.0048, 0.0089, and 0.0113, respectively) and all models had high area under the curve (0.8095, 0.8085, and 0.8125, respectively).

Conclusion

In patients with OSA, QT variability was associated with CVD.

Support

American Academy of Sleep Medicine Foundation
0572 Using Anthropometric Measures to Screen for Obstructive Sleep Apnea in the Sleep Heart Health Study Cohort
Authors: Vana K D , Silva G E , Carreon J D , Quan S F
Published: May 2020

Introduction

Individuals at high risk for obstructive sleep apnea (OSA) may not access sleep clinics for reasons including immobility, transportation difficulties, or living in rural areas. An easy-to-administer OSA screening tool for different body types, independent of witnessed apneas or body mass index (BMI), is lacking to identify this group quickly. We compared the sensitivities (SNs), specificities (SPs), and receiving operator curves (ROCs) of the neck circumference/height ratio (NHR) and waist circumference/height ratio (WHR) in predicting moderate and severe OSA (apnea-hypopnea index [AHI] ≥15/hr) with the SN, SP, and ROC of the derived Stop-Bang Questionnaire (dSBQ), which was created from proxy variables from the Sleep Heart Health Study (SHHS).

Methods

Data from the SHHS baseline evaluation were used and included participants (N=5431) who completed polysomnograms and had neck and waist circumferences, height measurements, and the SHHS proxy variables. This data then was divided randomly into 1/3 for derivation and 2/3 for validation analyses.

Results

No statistical differences were seen for gender, age, or ethnicity between the derivation and validation samples. In the validation sample (n=3621), the NHR cut-point of 0.21 resulted in a SN of 91% and a SP of 26% for AHI ≥15/hr. The WHR cut-point of 0.51 resulted in a SN of 91% and a SP of 21% for AHI ≥15/hr. Comparing the validation NHR and the dSBQ ROC curves showed no significant difference (AUCs=0.69 and 0.70, respectively; p=0.22). However, the ROC curve for WHR was significantly lower than for the dSBQ (AUCs=0.63 and 0.70, respectively; p<0.0001). Comparing the derivation and validation ROCs showed no significant differences between NHR ROCs, p=0.81, or between WHR ROCs, p=0.67.

Conclusion

The NHR is a viable screening tool, independent of witnessed apneas and BMI, that can be used for different body types and is statistically comparable to the dSBQ.

Support

This work was supported by U01HL53938 and U01HL53938-07S (University of Arizona).
0585 C-Reactive Protein Improves the Ability to Detect Cardiometabolic Risk in Mild-to-Moderate Sleep Apnea
Authors: Vgontzas A N , Puzino K , Fernandez-Mendoza J , Criley C , He F , Krishnamurthy V B , Basta M , Bixler E O
Published: May 2020

Introduction

Mild-to-moderate obstructive sleep apnea (OSA) affects 15-40% of the adult general population. However, it remains unclear when and how best to treat mild-to-moderate OSA. It has been shown that mild-to-moderate OSA in general random samples is associated with incident hypertension. The aim of this study was to compare the relative utility of apnea/hypopnea index (AHI) versus a biomarker of inflammation, C-reactive protein (CRP), in identifying the presence and severity of hypertension and insulin resistance (IR).

Methods

A clinical sample of 148 adults (53.79±12.45) with mild-to-moderate OSA (AHI between 5 and 29 events per hour) underwent 8-hour polysomnography, a clinical history and physical examination, including measures of blood pressure, body mass index (BMI), fasting blood glucose, insulin and CRP plasma levels. Hypertension was defined by previous diagnosis, past or present treatment, or blood pressure ≥140/90. IR was defined by homeostatic model assessment. Individuals with diabetes and/or on diabetes medication were excluded from analyses with IR. All analyses were conducted controlling for age, gender and BMI.

Results

CRP levels (OR=2.62, 95% CI=1.35-5.04, p=0.004), age (OR=1.75, 95% CI=1.11-2.75, p=0.016), and BMI (OR=2.74, 95% CI=1.20-6.26, p=0.017) were independently associated with greater odds for hypertension, whereas AHI (OR=1.33, 95% CI=0.61-2.92, p=0.477) was not. Additionally, CRP levels (β=0.21; p=0.04) and BMI (β=0.24; p=0.02) were independently associated with higher IR, while AHI (β=-0.03; p=0.75) was not. There was a trend for this association to be stronger in non-obese patients.

Conclusion

These preliminary findings suggest that including a measure of inflammation improves the ability for clinicians to detect cases of mild-to-moderate OSA with true cardiometabolic risk. CRP may be a simple, easy-to-use biomarker that can improve prognosis assessment and clarify which treatment option is best for patients with mild-to-moderate OSA.

Support

Department of Psychiatry, Penn State College of Medicine
0596 Providers Rarely Assess Obstructive Sleep Apnea Symptoms Among Patients with Chronic Obstructive Pulmonary Disease
Authors: Donovan L M , Keller T , Stewart N H , Spece L J , Au D H , Feemster L C
Published: May 2020

Introduction

Professional societies recommend providers assess sleep symptoms in COPD, but it is unclear if this occurs. We aimed to evaluate OSA symptom assessment and documentation among patients with COPD, and the patient and provider characteristics associated with this assessment.

Methods

We conducted a cross-sectional study of adults aged ≥40 years with clinically diagnosed COPD and no prior diagnosis of OSA. We selected patients receiving care at two academic general internal medicine clinics between 6/1/2011 - 6/1/2013. We abstracted charts to assess how often OSA symptoms such as snoring, somnolence, witnessed apneas, or gasping/choking arousals were documented as present or absent. We performed multivariable mixed-effects logistic regression to assess associations of patient and primary care provider (PCP) factors with assessment of OSA symptoms. Patient factors included demographics, body mass index, comorbidities, healthcare utilization, and severity of COPD, and PCP factors including demographics, degree, and years of experience.

Results

Of 523 patients with COPD, only 26 (5.0%) had documentation of OSA symptom assessment within a one-year period. In mixed effects models, only referral to general pulmonary clinic was associated with the assessment of OSA symptoms (OR: 4.56, 95% CI 1.28-15.52). Among the 26 individuals who had OSA symptoms assessed, 9 (34.6%) reported snoring, 15 (57.7%) reported daytime somnolence, 2 (7.7%) reported gasping/choking arousals, and 5 (19.2%) reported witnessed apneas. Among those assessed for OSA symptoms, providers referred 11 (42.3%) for formal sleep consultation.

Conclusion

Providers rarely document OSA symptoms for patients with COPD in primary care clinic, but assessment is greater among those with pulmonary specialty consultation. Given time constraints in primary care, external facilitation of sleep symptom assessment may improve symptom recognition and receipt of appropriate services.

Support

NIH 5K23HL111116-05, VA Center of Innovation for Veteran-Centered and Value-Driven Care.
0597 Precision of Sleep-Disordered Breathing Event Classification Using Simulated Home Sleep Apnea Testing in Patients with Spinal Cord Injury, or Disease
Authors: Zeineddine S , Sankari A , Arvai k , Salloum A , Abu Awad Y , Martin J L , Badr M S
Published: May 2020

Introduction

Sleep-disordered breathing (SDB) is highly prevalent among patients with spinal cord injury or disease (SCI/D). In-laboratory polysomnography (PSG) is difficult for these patients due to functional limitations and the physical construction of most sleep laboratories. Our objective was to evaluate the concordance between simulated HSAT and PSG in identifying SDB severity and subtypes of respiratory events in this patient population.

Methods

Within a larger study, 33 Veterans with SCI/D completed one night of in-laboratory PSG. Limited-channel HSAT was simulated by extracting 5 channels from PSG signals to include nasal pressure, thermistor, thoracic and abdominal belts, and oxygen saturation.

Results

Mean age of patients was 59.8 ± 10.9 years; 87.9% were male, and the average BMI was 28.1 ± 6.3. The mean Apnea-Hypopnea Index (AHI) from PSG was 35.5 ± 22.7. The mean Respiratory Event Index (REI) based on simulated HSAT was 22.5 ± 18.6. Thirty-one patients (93.9%) had SDB defined as AHI ≥5/hour. Simulated limited-channel HSAT accurately identified 32 out of 33 patients (96.96%). When SDB was further classified into mild (AHI 5-15 events/hr), moderate (AHI 15-30 events/hr), and severe (AHI>30/hr), simulated HSAT consistently underestimated the severity of underlying SDB. Spearman correlation between estimating AHI (PSG-HSAT) and subtypes of respiratory events was primarily accounted for by the difference in the number of hypopneas (r=0.72, -0.021 and -0.001 for hypopneas, obstructive and central apneas, respectively).

Conclusion

Our findings support the diagnostic utility of HSAT in SCI/D patients with SDB; however, HSAT underestimation of SDB may lead to difficulties in optimizing therapy. The misclassification of SDB severity is mainly driven by the number of hypopneas. Classification of hypopneas as obstrcutive or central may shed further light on the nature of this difference. Further research on the usability of HSAT devices in this patient population is needed.

Support

VA Rehabilitation Research and Development Service (RX002116; PI Badr and RX002885; PI Sankari) and NIH/NHLBI (K24HL143055; PI: Martin)
0618 What are the Benefits of Remote Monitoring Polysomnography
Authors: Yagi T , Chiba S , Ito H
Published: May 2020

Introduction

The use of information and communication technology (ICT) for sleep testing is mainly aimed at improving the accuracy of out-of-center sleep testing (OCST) by remote monitoring. In this study, as the first achievement in Japan, we report the results of our sleep medical clinic and hospital unit. For the diagnosis of sleep disorders, monitoring polysomnography (PSG) attending sleep technologist is the gold standard and is positioned as Type I. On the other hand, diagnosis using OCST has become acceptable because many patients can be diagnosed quickly and cost can be reduced.When using Type II devices that measure electroencephalogram at home, the measurement accuracy is inevitable, including poor recording, because it is performed in a non-monitoring situation. As an attempt to improve this situation, our clinic and hospital unit have established a remote monitoring PSG system that can be upgraded from Type II to Type I level by remote monitoring by a sleep technologist to ensure recording accuracy.

Methods

During the period from April 2004 to December 2017, a total of 286 remote monitoring PSGs were performed by dedicated sleep technologists at the Ota Memorial Sleep Center for patients admitted to a private room at Ota General Hospital.

Results

The breakdown of the reasons for requesting remote monitoring tests is about 30% of patients scheduled to undergo surgerysuch as palatine tonsillectomy or soft palate plastic surgery the next day, and 24% of hospitalized patients with risky complications %, 17% of patients expected to have a high probability of nighttime seizures and abnormal behavior, and 15% were physically disabled or paralyzed.

Conclusion

Our remote monitoring PSG system is effectively used in the clinic for the general hospital for patients who need nighttime safety management and nursing management.

Support

non
0619 To Rely or No to Rely: Understanding the Demographics and Polysomnographic Features of False Negative Home Sleep Apnea Testing
Authors: Bollu P , Gurung P , Mehta T , Monegro A , Manjamalai S , Goyal M , Thakkar M , Sahota P
Published: May 2020

Introduction

The current gold standard for a definitive diagnosis of OSA is an in-center Polysomnography (PSG). Home Sleep Apnea Testing(HSAT) has become an important tool in identifying high-risk populations. One of the limitations of the study is the lack of Electroencephalographic (EEG) data. This prevents the inclusion of Respiratory Effort Related Arousals (RERAs). We attempted to identify the patients whose HSAT showed an REI of less than 5 but are at risk for having sleep apnea based on the presence of airflow and thoraco-abdominal fluctuations.

Methods

Patients in this study were those that underwent HSAT from September 2016 till June of 2019. The studies reviewed and interpreted by board certified Sleep Specialists. Studies were done using nox-T3 sleep monitor and Nomad portable Home Sleep Testing type III devices-Both are type 3 Portable Monitors. Only those patients whose REI in their HSAT less than 5 were included in this study. All these patients had multiple airflow fluctuations in their HSAT that raised the suspicion for the presence of RERAs. None of these patients had significant hypoxemia in the HSAT.Airflow fluctuations were defined by the presence of fluctuations in the signal in the airflow channel along with increasing thoracoabdominal channels. Those patients with REI of less than 5 and without airflow fluctuations were excluded from the study.

Results

A total of 178 patients were recommended to undergo an in-center polysomnogram. Of those, 92 patients completed their polysomnogram with 59 patients ending up with a diagnosis of sleep apnea while 33 did not suggesting a false negative rate of 64.13%. Of those who were positive, 39 were females while 20 were males. Both groups did not differ significantly. Females had a median BMI of 32.9(28.19 for males), a median ESS of 11(8 in males) and a median RDI of 14.8(13.25).

Conclusion

Our study shows that both Home Sleep apnea testing can have a high proportion of false-negative results in patients exhibiting thoraco-abdominal and airflow fluctuations. The interpreting physicians should understand the limitations of the HSAT and should have a low threshold to recommend an in-center polysomnogram.

Support

None.
0621 Utilization of the Ares to Predict OSA Among Blacks Using Home-Based Watchpat Recording
Authors: Rogers A , Seixas A , Moore J , Zizi F , Williams S , Gyamfi L , Pichardo Y , Jean-Louis G
Published: May 2020

Introduction

In two waves of data we collected in Brooklyn New York, we observed blacks were at high risk for obstructive sleep apnea (OSA). In the NIH-funded study ‘Metabolic Syndrome Outcome Study (MetSO), blacks enrolled from primary-care settings had a 59% risk of OSA. Similarly, blacks surveyed in churches and barbershops had a 43% risk of OSA. While these studies showed higher than expected risk as noted in the general population (29%), it remains uncertain how many of those blacks would be diagnosed with OSA in that population. The purpose of this study was to explore the rate of OSA using the WatchPat device in a community-based setting.

Methods

Data were collected from an NIH-funded study ‘Peer-Enhanced Education to Reduce Sleep Ethnic Disparities, designed to navigate blacks at risk of OSA to receive timely diagnosis and treatment using peer-delivered linguistically and culturally tailored sleep health education. Blacks were screened for OSA using the Apnea Risk Evaluation System (ARES) Questionnaire; a score ≥6 denoted moderate-high OSA risk. Individuals were asked to wear the WatchPAT 200 for one night during a week-long sleep assessment. WatchPat 200 measures SaO2 to determine respiratory-related arousals, defined as an Apnea-Hypopnea Index (AHI) ≥5, which is used to identify and diagnose OSA. We used SPSS 25.0 to perform logical regression analysis to assess associations between ARES and WatchPat AHI.

Results

A sample of 111 blacks provided valid ARES and WatchPat data for the present analyses. Of the sample, the mean age was 62.26 (SD=13.52 years; female = 55%); 49% reported annual income >20K and 79.5% reported a high school education. Moreover, 27% reported high blood pressure, 13%, diabetes, and 65% were overweight/obese. Multivariate-adjusted logical regression analyses indicated that blacks at risk for OSA were 66% more likely to receive an OSA diagnosis based on WatchPat AHI data (OR = 1.662, p < 0.01). The model adjusted for age, sex, income, and education.

Conclusion

The present study demonstrated that blacks at risk for OSA at the community level have a significant likelihood of receiving an OSA diagnosis using home-based recordings.

Support

NIH Support (T32HL129953, RO1MD007716, K01HL135452 and K07AG052685).
0634 Volume-Assured Pressure Support is Effective Treatment for Obstructive Sleep Apnea Patients Who Failed CPAP Titration
Authors: Watanabe N , Levri J , Peng V , Scharf S M , Diaz M
Published: May 2020

Introduction

Obstructive sleep apnea (OSA) is a common disease, often treated using continuous positive airway pressure (CPAP). In many cases, patients fail an attended CPAP titration study, often due to inadequate control of AHI, and treatment-emergent central apneas as CPAP is increased. Here, we report our experience using volume-assured pressure support (VAPS) for these patients.

Methods

We retrospectively reviewed records of 45 adults who had OSA diagnosed on polysomnography (PSG) in whom CPAP titration had failed. In these patients, VAPS-AE (adjustable expiratory pressure) titrations were performed. Patients with central sleep apnea on baseline PSG were excluded.

Results

Reasons for CPAP titration failure included: treatment emergent central apneas (25), failure of maximum CPAP pressure to treat OSA (18), and persistent hypoxia (2). Average age was 57.9±13.1, BMI was 40.2±8.7, 26 males, Epworth sleepiness score was 10.7±7.9. The following significant changes from baseline PSG to VAPS titration were observed: AHI: 65.3±29.3 to 22.3 ±16.1 (p<.001) events/hour. Time < 88% saturation: 63.7 (median) to 6.9 (median) min (p<.001). The number of patients with AHI<15 was 0 on PSG and 16 (36%) on VAPS-AE, while the number of patients with AHI<30 was 7 (16%) on PSG and 32 (71%) on VAPS-AE. Improvement in AHI was not related to gender, age, or narcotic use, but was correlated with BMI: ΔAHI = 12.2 - (1.4 * BMI); p=.05. VAPS resulted in improved sleep architecture: slow wave sleep increased (medians: 1.4% to 19.6% total sleep time (TST)) (p<.001), REM sleep increased (medians 6.4% to 13.6% TST) (p<.01).

Conclusion

For OSA patients for whom CPAP titration failed, titration with VAPS-AE was an effective treatment for many patients.

Support

N/A
0638 Evaluation of an Oral Drug Pyridostigmine Bromide in Patients with Mild to Moderate Obstructive Sleep Apnea
Authors: Fan J , Wu H , Chen G , Lv Q , Shi C , Ma X , Gao H , Palling D
Published: May 2020

Introduction

A randomized, double-blind, cross-over, placebo-controlled clinical study with pyridostigmine bromide (PYD) in obstructive sleep apnea (OSA) patients ranging from mild to moderate disease was conducted to evaluate its clinical efficacy and safety.

Methods

Six diagnosed male patients with averages of age 48 yr (38 - 57 yr), BMI 28 (26 - 33), AHI 19.2 (15 - 26.2), minimum oxygen saturation (Min SaO2) 81% (75 - 87%) were enrolled to the study. The study consisted one-night acclimatization period followed immediately by a 2-night double-blind treatment period when subjects received either a single dose of PYD (a cholinesterase inhibitor, 90 mg) or placebo before sleep. Subjects were required to maintain in a supine position, and monitored by a standard polysomnography all the time. Sleep questionnaires (The SMH Sleep Questionnaire and ESS) were taken daily immediately after sleep and at the evening to evaluate the sleep satisfaction and the day-time quality, respectively. Safety of the drug was monitored and evaluated.

Results

Reductions of AHI (28.1%, p < 0.01), apnea index (37.2%, p < 0.05), % of total apnea/hypopnea time (36.4%, p < 0.05) were observed in the treatment group compared with the placebo between 2-7 hours of sleep. Min SaO2 was increased, no change, or decreased by PYD in 3, 2, or 1 subject(s), respectively. PYD was generally well tolerated with minimum minor incidents. Subjects reported to have more satisfied sleep and more clear-headed in the treatment night, and more energy, more concentrated and less sleepy during the daytime following the treatment night.

Conclusion

This study demonstrated the initial effectiveness of the PYD treatment for OSA, indicating that it may provide a new treatment option if the efficacy can be maintained in a large-scale clinical trial.

Support

N/A
0649 Ultrasound Assessment of Tongue Movement as a Predictor of Response to Hypoglossal Nerve Stimulation (HGNS)
Authors: Korotun M , Hahn S , Quintero L , Rajan P , Iakovou A , Mayo P , Greenberg H
Published: May 2020

Introduction

HGNS is an approved therapy for obstructive sleep apnea (OSA). Initial setting of HGNS voltage is based on observation of anterior tongue movement, which may not reflect opening of the retroglossal airway. We developed an ultrasonographic (US) technique to assess tongue movement with HGNS. We correlated US measures of tongue movement at the initial HGNS voltage setting with the AHI determined by PSG/HSAT on HGNS therapy.

Methods

Eleven subjects implanted with INSPIRE™ (HGNS) were enrolled at least one month post-implantation. Initial HGNS voltage was determined while awake and semi-recumbent and set to achieve visualized anterior tongue protrusion at a tolerable stimulation voltage. A curvilinear probe (5-2MHz) was placed longitudinally in the submental region at the midline with the indicator pointed anteriorly. Hyoid bone excursion (HBE) with stimulation was used as a marker of base of tongue movement. PSG or HSAT was performed to determine AHI with HGNS. Responders were defined as those with a reduction in AHI ≥50% and an AHI <20 events/hr.

Results

N=11, 6M, 5F, Age=66.5 ±18.4 years, BMI=27.9±2.7 kg/m2. Pre-treatment AHI=38.8±13.4/hr, T-90%=10.5±16.7%. Mean HBE in responders=1.02±0.17cm vs 0.76±0.20cm in non-responders (p=0.006). Best subsets regression analysis performed using post-treatment AHI as the dependent variable and age, BMI, baseline AHI, HBE and HGNS voltage as independent variables showed that HBE (coef. -29.1, p=0.038) and BMI (coef. 2.6, p=0.018) were independent predictors of response.

Conclusion

We demonstrated that ultrasound assessment of HBE during HGNS may be a useful tool to predict response to therapy and guide HGNS settings. HBE, rather than voltage, predicted post-treatment AHI.

Support

None.
0661 Comparison Between Ventilator Detected Apnea Hypopnea Index and Manual Scored Results
Authors: Ni Y , Dunhsm K , Cunningham L , Thomas R
Published: May 2020

Introduction

The apnea hypopnea index and percentage of periodic breathing detected by the ventilator machine are often used by sleep doctors to evaluate whether sleep apnea has been adequately treated or need further interventions. There are concerns about the accuracy of this autodetection.

Methods

Patients with sleep apnea who were treated with positive airway pressure at the Beth Israel Deaconess Medical Center (Boston) and tracked by the EncoreAnywhere system were included. The machine detected AHI(AHIm) and PB(PBm) were extracted from the first week data in every month from the start of use. The manual scored AHI(AHIs) and PB(PBs) were calculated from the last waveform graph during every month. The apnea hypopnea index as well as periodic breathing in 1st, 2nd, 3rd,6th month AHIm, AHIs, PBm and PBs were compared respectively.

Results

A total of 128 patients were included. The mean age was 56.5 and 66% of them were male. In the first month, the mean AHIs was significantly higher than AHIm, 16.27 vs. 5.36, p<0.001. There was also a large difference between percentage of PBs and PBm, 15.55% vs. 1.96, p<0.001. 78% patients whose AHIm <5 were actually has AHIs >5. The Kappa value for the AHIm and AHIs were 0.074, p=0.069; the value of PBm and PBs was 0.216, p=0.015. In the 2nd, 3rd and 6th months, the mean difference between AHIs and AHIm was 10.58, 10.68, 10.12, respectively. The mean difference between PBs and PBm was 12.32%,11.53%,and 9.18%.

Conclusion

Autodetection of respiratory events consistently under-estimates the severity of residual events. Mean differences remained stable over 6 months. Caution is recommended when attributing non-apnea reasons for residual symptoms in patients with apparently low machine estimated AHI and PB.

Support

This study is supported by American Academy of Sleep Medicine Foundation, category-I award to RJT
0662 Hybrid Therapies to Improve Sleep Apnea Management
Authors: Pogach M , Cohn V , Thomas R J
Published: May 2020

Introduction

A one-size fits all approach to sleep apnea management, as is promoted by insurance requirements, pervades the field of sleep medicine but does not address individual differences in disease phenotype or treatment tolerance or attempt to achieve meaningful targets for adherence or disease optimization. Continuous positive airway pressure (CPAP) is considered to be the gold standard treatment for sleep apnea, yet CPAP nonadherence rates remain high (estimates at > 30%) while usage goals (at least 4 hours/night) and therapeutic success targets (machine detected AHI < 5) allow for substantial residual disease to persist. Hybrid therapy, combining mandibular advancement device (MAD) and positive airway pressure (PAP), has demonstrated additive effects on lowering the AHI, ODI, and therapeutic PAP pressure in severe OSA patients with pressure intolerance. This analysis explores the impact of hybrid therapy on treatment adherence and optimization, and identifies patient and data characteristics suggestive of benefit from combined therapies.

Methods

In a retrospective analysis, we reviewed the demographic data, medical histories, home sleep test, diagnostic and therapeutic attended polysomnography results, and PAP device settings and data (including usage, leak, residual event index, and waveforms) pre-and post-hybrid approach, in patients treated with hybrid therapy in our multidisciplinary academic sleep disorders clinic from 2014-2019.

Results

Hybrid therapies utilized include simultaneous (MAD worn together with PAP), alternating (MAD and PAP separately over parts of or on alternating nights), and anchoring (MAD to maintain mouth closure and jaw stability to minimize leak). Preliminary analysis (N=30) shows that hybrid therapy compared to PAP alone improves PAP adherence, lowers residual AHI, minimizes periodic breathing, reduces aerophagia, and lowers therapeutic PAP pressure in these patients. Patient and data characteristics suggestive of benefit include high loop gain sleep apnea, complex apnea, mouth breathing, and position dominance.

Conclusion

Individualizing treatment by combining therapies can result in improved PAP tolerance, usage, and disease control.

Support