bluuebunny/crossref_metadata_2025_split huggingface dataset:
0411 Long-term efficacy of lemborexant on objective sleep measures in clinical practice
Authors: Miyata Seiko , Iwamoto Kunihiro , Okada Ippei , Fujimoto Akihiro , Kogo Yuki , Amano Manabu , Matsuyama Nao , Ozaki Norio 
Published: May 2023

Abstract

Introduction
In the treatment of insomnia, both subjective and objective evaluations are essential. The orexin receptor antagonist, lemborexant, has a favorable profile in terms of efficacy, acceptability, and tolerability for adults diagnosed with insomnia. To date, the long-term efficacy of lemborexant has been evaluated solely on a subjective basis, with no long-term objective measures under natural sleeping conditions. Therefore, a small, lightweight sleep electroencephalograph monitor was used to evaluate sleep objectively at home after 4 and 12 weeks of lemborexant treatment.

Methods
Adults and elderly subjects with insomnia disorder per DSM-5 were enrolled in an open-label, single-arm, single-center trial. Participants took lemborexant (5/10 mg) at bedtime for 12 weeks. In addition, they underwent a home-based sleep study at baseline and weeks 4 and 12. Sleep ­efficiency (SE), total sleep time (TST), latency to persistent sleep (LPS), and wake after sleep onset (WASO) were ­evaluated at home. Sleep disturbance (Pittsburgh sleep quality index: PSQI), ­sleepiness (Epworth sleepiness scale: ESS), and depressive symptoms (Beck depression index: BDI) were examined.

Results
31 subjects completed the 4-week and 29 completed the 12-week assessments. Subjects showed significant improvements in objective SE at weeks 4 and 12 of treatment compared to untreated baseline. Objective TST tended to increase with the treatment at week 12. Mixed-effects linear analysis revealed that the poorer the sleep measures (SE, TST, LPS, and WASO) were at baseline, the more these measures improved with lemborexant. Scores of PSQI, ESS, and BDI significantly decreased (improved) with lemborexant treatment compared to those at baseline.

Conclusion
The findings from the analyses demonstrate objective improvement of SE with lemborexant treatment across 12 weeks and support the previously reported benefit of lemborexant using polysomnography.

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0414 Pain in Your Day? Get Sleep Treatment Anyway! The Benefits of Behavioral Treatments for Insomnia Despite Pain Symptoms
Authors: Erickson Alexander , Ravyts Scott , Mitchell Michael , Dzierzewski Joseph , Alessi Cathy , McGowan Sarah Kate , Carlson Gwendolyn , Kelly Monica , Lee Diane , Song Yeonsu , Fung Constance , Martin Jennifer 
Published: May 2023

Abstract

Introduction
Sleep-related problems and pain affect millions of U.S. adults. Sleep-focused interventions improve both sleep and pain-related outcomes. However, pain can be a barrier to insomnia care due to perceptions that insomnia treatment may not be as effective in the presence of ongoing pain. This study evaluated whether pain severity and pain interference in daily life moderate the effects of behavioral treatments for insomnia on sleep outcomes (e.g., insomnia symptoms, perceived sleep quality, sleep effort, daytime sleepiness).

Methods
Secondary data analysis was conducted on a sample of 149 women veterans with insomnia disorder who completed either Cognitive Behavior Therapy for insomnia (CBT-I) or Acceptance and Behavioral Changes to treat Insomnia (ABC-I) treatment, both of which showed overall benefit in treating insomnia in women veterans. In the original study, sleep outcomes (ISI, PSQI, GSES, ESS), pain factors (BPI), and other outcomes were measured at baseline, posttreatment, and at 3-months follow-up. Linear and quadratic mixed effects models with random intercepts (subject-level) were conducted to examine the influence of treatment phase, pain-related severity and interference, and their interaction on sleep outcomes.

Results
All models were statistically significant (92.13≤Χ2≤519.55). No significant interactions were present between treatment phase and pain severity or interference in relation to sleep outcomes. Across analyses, treatment phase, both from baseline to posttreatment (-2.22≤b≤-8.31, p&lt;.001) and from baseline to 3-month follow-up (-2.67≤b≤-8.17, p&lt;.001), illustrated significant improvement of sleep quality outcomes.

Conclusion
Neither pain severity nor pain interference had a significant impact on outcomes of behavioral treatments for insomnia in women veterans. Findings have clinical implications in that they support the encouragement of individuals with co-morbid chronic pain and insomnia symptoms to engage in non-pharmacological interventions for insomnia disorder. Future research could expand on this study by including pain-related interventions concurrent with behavioral interventions for insomnia disorder.

Support (if any)
Data used was from an original project funded by VA/HSR&D IIR-HX002300 (PI: Martin), NIH/NHLBI K24HL143055 (PI: Martin). Dr. Erickson was supported by the VA Office of Academic Affiliations through the Advanced Fellowship Program in Geriatrics. Support was also provided by the VA Greater Los Angeles Geriatric Research, Education and Clinical Center.
0415 Predictors of treatment response and remission after CBT-I among adolescents with insomnia and eveningness
Authors: Sit Hao Fong , Cheung Forrest Tin Wai , Chan Ngan Yin , Chan Joey , Zhang Jihui , Li Albert Martin , Gradisar Michael , Espie Colin , Wing Yun Kwok , Li Shirley Xin 
Published: May 2023

Abstract

Introduction
Despite the efficacy of cognitive behavioural therapy for insomnia (CBT-I) for treating youth insomnia, there remain individual differences in treatment outcomes. Previous studies found that demographic (e.g., age) and clinical features (e.g., depression, anxiety) could potentially affect treatment responses in adults but there has been limited research conducted in youth. This study aimed to identify potential predictors of treatment response and remission of insomnia following CBT-I in a sample of adolescents with insomnia and eveningness.

Methods
The sample consisted of 57 adolescents with insomnia with eveningness (Age: 20.21 ± 1.95, 15-24, female: 56.14%) who had completed a 6-session group-based cognitive behavioural therapy (CBT-I) with (n = 27) or without bright light therapy (n=30). Assessments were conducted at baseline and one-week post-intervention. Insomnia Severity Index (ISI) was used to measure self-reported insomnia symptoms. Treatment response was defined as a reduction in ISI score ≥ 6 after treatment, and remission was defined as an ISI score &lt; 9 at post-treatment. Backward stepwise logistic regression was conducted to explore baseline demographic and clinical factors (e.g., comorbid depression or anxiety, suicidality) that might contribute to treatment response and remission of insomnia.

Results
About 64.9% and 68.4% of the participants achieved treatment response and remission of insomnia, respectively. There was no significant difference in response (60.0% vs. 73.4%) and remission (63.3% vs. 74.1%) rates between participants with and without adjunctive light therapy. Treatment response was significantly predicted by lower suicidality (p&lt;.05) and less eveningness (p&lt;.05), while being male (p=.09) and having greater insomnia symptoms (p=.06) were associated with treatment response at a marginal significance. Participants with older age (p&lt;.05) and greater insomnia symptoms (p&lt;.05) were more likely to achieve a remission. Moreover, greater anxiety symptoms (p=.09) and adjunctive bright light therapy (p=.07) predicted insomnia remission with a trend towards significance.

Conclusion
CBT-I is more effective in adolescents with less eveningness, elevated insomnia symptoms, and less suicidality. Future research should explore whether addressing these factors in the delivery of CBT-I could improve treatment outcomes in youths with insomnia.

Support (if any)
This work was funded by General Research Fund (Ref. 17608918), Research Grants Council, University Grants Committee, Hong Kong SAR, China.
0420 Sleep onset misperception in youths with insomnia: Correlates and implications for treatment
Authors: Wang Ran , Chan Ngan Yin , Cheung Forrest Tin Wai , Chan Joey , Zhang Jihui , Li Albert Martin , Espie Colin , Wing Yun Kwok , Li Shirley Xin 
Published: May 2023

Abstract

Introduction
Individuals with insomnia often show subjective-objective sleep discrepancy, especially an overestimation of their sleep onset latency (SOL) while the factors associated with such discrepancy remained unclear. Whilst cognitive behavioral therapy for insomnia (CBT-I) has been recommend as the first-line treatment for insomnia, there has been limited research to investigate the effects of CBT-I on sleep onset perception in youths with insomnia. The present study aimed to identify potential variables related to sleep onset misperception and explore the effects of CBT-I on sleep onset misperception among youths with insomnia.

Methods
Sixty treatment-seeking youths with insomnia (mean: 19.74 ±2.42, female: 55%) were recruited to assess for their sleep and clinical characteristics using self-report questionnaires and 7-days sleep diary and actigraphy (T1). A subset of the sample (N=19) further completed an 8-week CBT-I programme and assessed at one-week post-treatment (T2) and 6-month follow-up (T3). Sleep misperception index was computed by subtracting actigraphy-measured SOL from sleep diary reported SOL, where a higher value indicates a higher degree of SOL overestimation. Demographic, clinical and sleep-related variables were compared between high versus low sleep onset misperception groups as divided by the mean of the sample. Changes in sleep onset misperception after CBT-I were analyzed using repeated measures ANOVA.

Results
High sleep onset misperception group demonstrated a significantly higher degree of anxiety symptoms (t(28)=-3.92, p&lt;.01) and pre-sleep cognitive arousal (t(28)=-0.49, p&lt;.05) as compared to low sleep onset misperception group. Participants who completed CBT-I showed a significant decrease in subjective-objective SOL discrepancy (T1=19.52, T2=6.96, T3=-1.37). A post-hoc pairwise comparison using the Bonferroni correction suggested a significant decrease in subjective-objective SOL discrepancy from T1 to T3 (p&lt;.05). Significant improvement in pre-sleep cognitive arousal was found from T1 to T3 (&lt;.001) and such an improvement was found to be significantly correlated with the reduction in sleep onset misperception (r=0.16, p&lt;.05).

Conclusion
Sleep onset misperception is associated with anxiety symptoms and pre-sleep cognitive arousal in youths with insomnia. Preliminary evidence supports that CBT-I is effective in improving sleep onset misperception in youths with insomnia. Future research should explore the neurophysiological mechanism underlying sleep onset misperception and the changes of such a discrepancy upon intervention.

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0423 The Role of Fear of Sleep in Cognitive Behavioral Therapy for Insomnia and Cognitive Processing Therapy
Authors: Youngren Westley , Heffner Kathi , Bishop Todd , Cerulli Catherine , Gallegos Autumn , Crane Hugh , Pigeon Wilfred 
Published: May 2023

Abstract

Introduction
Fear of sleep (FoS) is linked to symptoms of PTSD. Additionally, cognitive behavioral therapy for insomnia (CBTi) can reduce FoS. Utilizing data from a randomized controlled trial of CBTi followed by Cognitive Processing Therapy for PTSD (CPT), this secondary data analysis sought to examine the relationship between FoS and PTSD symptoms, and how FoS is impacted by CBTi, in individuals exposed to interpersonal violence with PTSD. Additionally, we sought to extend the literature by examining whether FoS predicts the effect of subsequent CPT on PTSD severity or if CPT further reduces FoS.

Methods
A sample of 83 participants were randomly assigned to either receive sequential delivery of four weekly sessions of CBTi, which included modules to address FoS, followed by 12 weekly sessions of CPT (Group 1: CBTi+CPT) or receive four weekly phone check-ins (CTRL) followed by CPT (Group 2: CTRL+CPT). Participants were assessed at baseline (T1), after CBTi/CTRL (T2), and after CPT (T3). Relevant measures included the Fear of Sleep Inventory (FoSI) and Clinician Administered PTSD Scale (CAPS). Analyses included correlations, mean differences tests, and regression-based analyses.

Results
At T1 FoSI and CAPS were positively correlated (r = 0.47, p &lt; 0.001). At T2 a significant reduction in FoSI scores was observed after CBTi/CTRL for Group 1 (t = 4.81, p &lt; 0.001), but not Group 2, and a significant difference in FoSI scores between Group 1 and Group 2, all while controlling for baseline differences (F (1, 80) = 3.99, p &lt; 0.05). Lastly, for the entire sample lower T2 FoSI scores predicted lower T3 CAPS scores (B = 0.42, p &lt; 0.01) and FoS was not further reduced following CPT.

Conclusion
Results replicate previous work by demonstrating a positive relationship between FoS and PTSD severity. Additionally, FoSI was significantly reduced after CBTi. Lastly, lower levels of FoS predicted reduced PTSD symptoms following CPT, although CPT was not associated with significant reductions in FoS. Results highlight that CBTi that explicitly addresses FoS may reduce FoS, and findings also suggest that effectively reducing FoS prior to PTSD treatment may improve treatment outcomes.

Support (if any)
NIH/NINR R01 NR013909; VA Center of Excellence for Suicide Prevention
0439 Patient-Reported Experience with Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea – Influence of symptom improvements
Authors: Braun Marcel , Schoebel Christoph , Wollny Mathias 
Published: May 2023

Abstract

Introduction
Hypoglossal Nerve Stimulation (HNS) is routinely used as an alternative treatment for patients with obstructive sleep apnea (OSA). Significant and clinically relevant improvements in disease severity and OSA symptoms such as daytime sleepiness as well as overall quality of life have been reported in randomized-controlled trials and large real-world cohort studies. However, so far little data exists on patient-relevant experience with the treatment.

Methods
A structured survey with 22 questions was constructed using five-level Likert scales (1 = no agreement, 5 = complete agreement) to evaluate patient experience with HNS in the dimensions “Overall experience with therapy”, “Experience with treatment process” and “Side effects”. Additional data was collected on current symptom status and OSA disease history.

Results
45 patients from Germany that received a breathing-synchronized HNS system were enrolled (mean age 57.8 years, 78% male). Two-thirds of participants had an OSA history of 5 years or longer (67%). Of all patients, 76% had normalized OSA symptoms at time of the study (ESS: 6.4 ± 5.0) and 97.6% reporting every night use of stimulation therapy. Patients with normalized daytime sleepiness, reported significantly more positive experience across all major domains investigated, compared to patients with residual daytime sleepiness (ESS ≤ 10 versus ESS &gt; 10). HNS therapy was well tolerated in all patients, though patients with higher ESS values reported significantly less improvements of sleep quality and more often waking up from therapy. Only 2.2% of participants though had side effects that made them reduce or even discontinue stimulation therapy.

Conclusion
Overall patient-reported experience with HNS therapy is positive and high satisfaction with the treatment process was observed. Subjective experience is influenced by residual daytime sleepiness under stimulation. Side effects occur, but rarely impact subjective therapy use. Additional studies are warranted to confirm the findings from this evaluation in larger cohorts.

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0445 Real-world Evaluation of Upper Airway Stimulation system survival using post-market surveillance data
Authors: Huntley Colin , Chio Eugene , Soose Ryan , Huyett Phillip , Steffen Armin , Heiser Clemens , Boon Maurits 
Published: May 2023

Abstract

Introduction
Upper airway stimulation (UAS) has become a viable treatment alternative for well selected patients with moderate to severe obstructive sleep apnea (OSA) who struggle to tolerate positive pressure (PAP) therapy. Post-market surveillance is required of medical device manufacturers to assess treatment outcomes, complications, and device failure. We aim to utilize this surveillance data to assess rates of revision and removal of the Inspire (Minneapolis, MN) UAS system in a real-world setting.

Methods
Post market surveillance data was compiled from manufacturer’s complaint handling system for explants and revisions of the hypoglossal nerve stimulator. Data collection began in January 2018 and was available through September 30 2022 at the time of analysis. Implant procedures from January 2018 through September 2021 were analyzed for events within one year of implant. Events were classified into categories. A subset of these devices implanted before September 30 2019 were analyzed for events between one and three years after implant.

Results
Between Jan 01 2018 and Sep 30 2021, 15282 devices were implanted. Within one year of the implant, 121 devices (0.8%) were explanted for: infection (66), elective (32), MRI (10), other (10), and twiddler syndrome (3). Surgical revisions were required for 245 patients (1.6%) for: surgical correction (139), device defect (81), other (21), cardioversion (2), twiddler syndrome (1), and MRI (1). A subset of 5080 of these devices were implanted prior to September 30 2019. Between one year and three years following implant 119 devices (2.3%) were explanted for: elective (58), MRI (35), infection (15), Other (9), and twiddler syndrome (2). Surgical revisions were performed for 160 patients (3.1%) for: surgical correction (64), device defect (57), other (32), twiddler syndrome (5), and cardioversion (2).

Conclusion
As with any implantable medical device, a certain rate of revision and explant is expected for device, patient, and medical indications. The rate of UAS revision and explantation is low at both the 1 year and 3 year time points. UAS implantation is a safe alternative to CPAP for well selected patients with a low rate of unexpected reoperation for either revision or hardware explantation.

Support (if any)
Inspire Medical
0447 Study of PAP response and compliance in patients with ILD and OSA: A case-control single center cohort
Authors: Herberts Michelle , Vadiyala Mounika , Bryan Kelly , Moua Teng , Escalante Patricio 
Published: May 2023

Abstract

Introduction
Interstitial lung disease (ILD) is a heterogenous group of parenchymal lung disorders with multiple etiologies. ILD often affects the quality of life and survival of patients. OSA is commonly diagnosed among ILD patients with reported prevalences of 50-90%, and a prevalence of moderate to severe OSA as high as 65%. There is also concern that patients with ILD may be less tolerant of PAP therapies. We aim to identify differences in PAP treatment response and adherence in patients with ILD and OSA compared with a group of matched OSA controls.

Methods
A retrospective cohort analysis was conducted on patients ≥ 18 years-old that were evaluated at Mayo Clinic Center for Sleep Medicine between July 2012 to June 2022. Inclusion criteria were patients with a diagnosis of ILD per ATS criteria also diagnosed with OSA by HSAT or PSG. Control OSA patients were matched to ILD/OSA patients by age, BMI, and AHI ranges. Exclusion criteria included comorbid conditions of asthma or COPD. Patients with early non-adherence to CPAP or those who didn't have sleep follow up were also excluded. Follow-up sleep visits were assessed to determine CPAP adherence, change in PAP pressure, addition of oxygen, and change in Epworth sleepiness scale.

Results
We compared 51 patients with ILD/OSA and 51 OSA matched-controls. Twenty-five ILD/OSA patients were diagnosed by PSG and 26 by HSAT. Median treatment follow-up for the ILD group was 7 months (IQR of 3 to 18 months). Baseline characteristics, including oxygen desaturation index (ODI), oxygen saturation, time spent below 89% during overnight oximetry, and baseline Epworth scale, were similar between ILD/OSA and non-ILD OSA patients. Importantly, there was no statistically significant difference in PAP adherence, median PAP levels, PAP pressure change, residual AHI, or change in Epworth after treatment

Conclusion
There was no significant difference in baseline OSA characteristics, treatment response, and PAP adherence in ILD patients with OSA compared with matched non-ILD OSA controls. Outcome assessment may be limited by sample size and the shorter follow-up period. Future studies should include longer-term follow-up with a larger ILD cohort to assess the impact of ILD progression on PAP adherence over time.

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0449 Unbiased Examination of Metabolomic Signatures in Sleep Disordered Breathing and Group 1 PAH in the (PVDOMICS) Cohort
Authors: Ahmad Imama , Grunig Gabriele , Hemnes Anna , Finet Emanuel , Erzurum Serpil , Hill Nicholas , Barnard John , Mehra Reena ,   PVDOMICS Study Group
Published: May 2023

Abstract

Introduction
Metabolic alterations have been identified as a novel driver of pulmonary arterial hypertension (PAH) pathogenesis. Sleep disordered breathing (SDB), characterized by intermittent hypoxemic episodes, has also been implicated in PAH, particularly when associated with more profound degrees of hypoxia, and metabolic dysfunction. We hypothesize to observe in SDB and PAH in humans a similar pattern of metabolic alterations as previously described in animal models of PAH.

Methods
Pulmonary Vascular Disease Phenomics (PVDOMICS,NCT02980887), a multicenter study, was designed in part to elucidate molecular signatures in PH. We analyzed data from Group 1 PAH participants who underwent home sleep apnea testing with circulating plasma metabolomic measures (Metabolon). We conducted an unbiased analysis of SDB measures: apnea-hypopnea index (AHI, 3% oxygen desaturation hypopnea definition) and % recording time&lt; 90% SpO2 (TRT&lt; 90%), with metabolites (954 after qc filtering) using a flexible and robust semi-parametric proportional hazards model adjusted for age, sex, body mass index (BMI), diabetes mellitus (DM), race and study site. Metabolites with False discovery rate (FDR) adjusted p-values &lt; 0.1 were called significant. Closed-set testing with the Simes method and Metabolon provided annotations (90 sets) was used to test metabolite sets.

Results
The cohort (n=175) was 72% female, 81% White and 16% DM with (1st Quartile/Median/3rd Quartile) Age: 42/54/63 years, BMI: 24.6/29.1/34.1 kg/m2, AHI: 0.9/4.3/12.6 and TRT&lt; 90%: 2.3/37/87.4. 21 metabolites showed significant association with TRT&lt; 90% (8 with positive direction/13 negative) and 0 with AHI. Among metabolite sets, Pregnenolone steroids had the strongest association with TRT&lt; 90% (6 members; adjusted p=0.038; True Discovery Proportion (TDP)=0.33) followed by Fatty Acid Metabolism (Acyl Choline) (7 members; adjusted p-value=0.046; TDP=0.71) and Polyamine Metabolism (7 members; adjusted p-value p=0.054; TDP=0.14).

Conclusion
Three primary metabolite pathways were associated with sleep-related hypoxia in Group 1 PAH. Polyamine metabolism and fatty acid metabolism changes have previously been observed in a rat PAH model, consistent with our findings. Findings specific to metabolic biomarkers in SDB and PAH are novel and may lead to insights that broaden our understanding of PAH pathobiology and potential therapeutic targets.

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