scholarly journals 0673 Effects Of Solriamfetol On Driving Performance In Participants With Excessive Daytime Sleepiness Associated With Obstructive Sleep Apnea

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A257-A257
Author(s):  
F Vinckenbosch ◽  
J Asin ◽  
N De Vries ◽  
P Vonk ◽  
C Donjacour ◽  
...  

Abstract Introduction Excessive daytime sleepiness (EDS) in patients with obstructive sleep apnea (OSA) is associated with an increased risk of driving accidents. Solriamfetol, a dopamine/norepinephrine reuptake inhibitor, is approved in the US (Sunosi®) for EDS associated with OSA (37.5-150 mg/day). This study evaluated solriamfetol’s effects on on-road driving performance in participants with EDS associated with OSA. Methods In each period of this randomized, double-blind, placebo-controlled, crossover study (NCT 02806895; EudraCT 2015-003930-28), driving performance during an on-road driving test was assessed at 2 hours and 6 hours postdose following 7 days of treatment with solriamfetol (150mg/day × 3, then 300mg/day × 4) or placebo. The primary endpoint—standard deviation of lateral position (SDLP), a measure of “weaving,” at 2 hours postdose—was compared between solriamfetol and placebo per time point using a repeated mixed-effects analysis of variance model. Results The study included 34 participants. Baseline characteristics reflected the broader OSA population (88% male; mean age=52 years; mean Epworth Sleepiness Scale score=14.4). SDLP at 2 hours postdose was statistically significantly lower following solriamfetol (least squares [LS] mean [standard error; SE], 18.83cm [0.63]) compared with placebo (19.92cm [0.63]): LS mean difference, -1.08cm; 95% confidence interval (CI), -1.85, -0.32; P=0.0062 (incomplete driving tests: solriamfetol, n=1; placebo, n=4), indicating better performance with solriamfetol. At 6 hours postdose, SDLP following solriamfetol (LS mean[SE], 19.24cm [0.63]) was statistically significantly lower compared with placebo (20.04cm [0.63]): LS mean difference, -0.80cm; 95% CI, -1.58, -0.03; P=0.0432 (incomplete driving tests: solriamfetol, n=3; placebo, n=7). Common adverse events (≥5%) with solriamfetol were headache, nausea, insomnia, dizziness, and agitation. Conclusion Solriamfetol (300mg/day) improved SDLP, an important measure of driving performance, at 2 and 6 hours in participants with EDS associated with OSA. Support Jazz Pharmaceuticals

Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
Rachel P Ogilvie ◽  
Kamakshi Lakshminarayan ◽  
Sanjay R Patel ◽  
Pamela L Lutsey

Background: Although excessive daytime sleepiness (EDS) is a common symptom of obstructive sleep apnea (OSA), and both EDS and OSA have separately been associated with increased risk of cardiovascular disease (CVD), their joint association with CVD risk is unknown. Examining the association of EDS and OSA with CVD risk may help refine the OSA phenotype. Methods: Among 3,874 Sleep Heart Health Study participants without prevalent CVD, moderate to severe OSA was defined by an apnea hypopnea index (AHI) ≥ 15 events per hour on in-home polysomnography. EDS was defined as an Epworth Sleepiness Scale score ≥ 11. Incident CVD events included adjudicated myocardial infarction, coronary revascularization and stroke. Cox proportional hazards models adjusted for age, sex, alcohol, smoking, and body mass index. Results: Mean age was 63.0 years with 55.4% female, mean AHI 9.3 events/hour, and 23.4% with EDS. Over a median of 10.4 years of follow-up, we identified 653 incident cases of CVD. In adjusted analyses, EDS (Hazard ratio: 1.22, 95% CI 1.01-1.47) but not moderate-severe OSA (HR: 0.98, 0.81-1.20) was associated with incident CVD. In stratified analyses, the CVD incidence rate varied from 15.6/1000 person-years in those with no OSA or EDS to 26.0/1000 person-years in those with OSA and EDS (figure). In multivariable analyses, the hazard ratio for moderate-severe OSA and EDS compared to no OSA and no EDS was 1.26 (0.91-1.73). Formal tests of statistical significance of the OSA and EDS interaction were not significant on either the additive or multiplicative scales. Conclusions: Having both EDS and moderate-severe OSA was not associated with an increased risk of CVD in our data.


Sleep Science ◽  
2016 ◽  
Vol 9 (2) ◽  
pp. 106-111 ◽  
Author(s):  
Michael B. Fawale ◽  
Olanrewaju Ibigbami ◽  
Ishaq Ismail ◽  
Adekunle F. Mustapha ◽  
Morenikeji A. Komolafe ◽  
...  

Life ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. 368
Author(s):  
Leeba Rezaie ◽  
Soroush Maazinezhad ◽  
Donald J. Fogelberg ◽  
Habibolah Khazaie ◽  
Dena Sadeghi-Bahmani ◽  
...  

Objective: Individuals with obstructive sleep apnea (OSA) are at increased risk to suffer from further somatic and sleep-related complaints. To assess OSA, demographic, anthropometric, and subjective/objective sleep parameters are taken into consideration, but often separately. Here, we entered demographic, anthropometric, subjective, and objective sleep- and breathing-related dimensions in one model. Methods: We reviewed the demographic, anthropometric, subjective and objective sleep- and breathing-related data, and polysomnographic records of 251 individuals with diagnosed OSA. OSA was considered as a continuous and as categorical variable (mild, moderate, and severe OSA). A series of correlational computations, X2-tests, F-tests, and a multiple regression model were performed to investigate which demographic, anthropometric, and subjective and objective sleep dimensions were associated with and predicted dimensions of OSA. Results: Higher apnea/hypopnea index (AHI) scores were associated with higher BMI, higher daytime sleepiness, a higher respiratory disturbance index, and higher snoring. Compared to individuals with mild to moderate OSA, individuals with severe OSA had a higher BMI, a higher respiratory disturbance index (RDI) and a higher snoring index, while subjective sleep quality and daytime sleepiness did not differ. Results from the multiple regression analysis showed that an objectively shorter sleep duration, more N2 sleep, and a higher RDI predicted AHI scores. Conclusion: The pattern of results suggests that blending demographic, anthropometric, and subjective/objective sleep- and breathing-related data enabled more effective discrimination of individuals at higher risk for OSA. The results are of practical and clinical importance: demographic, anthropometric, and breathing-related issues derived from self-rating scales provide a quick and reliable identification of individuals at risk of OSA; objective assessments provide further certainty and reliability.


2021 ◽  
Vol 10 (15) ◽  
pp. 3413
Author(s):  
Afrouz Behboudi ◽  
Tilia Thelander ◽  
Duygu Yazici ◽  
Yeliz Celik ◽  
Tülay Yucel-Lindberg ◽  
...  

Obstructive sleep apnea (OSA) is common in patients with coronary artery disease (CAD), in which inflammatory activity has a crucial role. The manifestation of OSA varies significantly between individuals in clinical cohorts; not all adults with OSA demonstrate the same set of symptoms; i.e., excessive daytime sleepiness (EDS) and/or increased levels of inflammatory biomarkers. The further exploration of the molecular basis of these differences is therefore essential for a better understanding of the OSA phenotypes in cardiac patients. In this current secondary analysis of the Randomized Intervention with Continuous Positive Airway Pressure in CAD and OSA (RICCADSA) trial (Trial Registry: ClinicalTrials.gov; No: NCT 00519597), we aimed to address the association of tumor necrosis factor alpha (TNF-α)-308G/A gene polymorphism with circulating TNF-α levels and EDS among 326 participants. CAD patients with OSA (apnea–hypopnea-index (AHI) ≥ 15 events/h; n = 256) were categorized as having EDS (n = 100) or no-EDS (n = 156) based on the Epworth Sleepiness Scale score with a cut-off of 10. CAD patients with no-OSA (AHI < 5 events/h; n = 70) were included as a control group. The results demonstrated no significant differences regarding the distribution of the TNF-α alleles and genotypes between CAD patients with vs. without OSA. In a multivariate analysis, the oxygen desaturation index and TNF-α genotypes from GG to GA and GA to AA as well as the TNF-α-308A allele carriage were significantly associated with the circulating TNF-α levels. Moreover, the TNF-α-308A allele was associated with a decreased risk for EDS (odds ratio 0.64, 95% confidence interval 0.41–0.99; p = 0.043) independent of age, sex, obesity, OSA severity and the circulating TNF-α levels. We conclude that the TNF-α-308A allele appears to modulate circulatory TNF-α levels and mitigate EDS in adults with CAD and concomitant OSA.


2017 ◽  
Vol 19 (12) ◽  
pp. 1384-1384
Author(s):  
Camila Gosenheimer Righi ◽  
Denis Martinez ◽  
Sandro Cadaval Gonçalves ◽  
Miguel Gus ◽  
Leila Beltrami Moreira ◽  
...  

2021 ◽  
Vol 12 ◽  
Author(s):  
Danwei Zhang ◽  
Zhen Zhang ◽  
Huihua Li ◽  
Kaimo Ding

Excessive daytime sleepiness (EDS) is a significant public health concern, with obstructive sleep apnea (OSA) being a common cause, and a particular relationship exists with the severity of depression. A literature search on OSA, depression, and EDS was performed in PubMed. The chosen evidence was limited to human studies. Available evidence was systematically reviewed to ascertain the association of EDS with depression and OSA according to the general population and some specific population subgroups. In addition, effectiveness of continuous positive airway pressure (CPAP) was analyzed as a standard therapy for improving EDS and depression in patients with OSA. In the general population, patients with OSA, and some other subpopulations, the review contributed to: (1) delineating the prevalence of EDS; (2) substantiating the relationship of EDS and depression; (3) presenting the relationship between EDS and OSA; and (4) revealing that the duration of CPAP is crucial for its therapeutic effects in improving EDS and depressive symptoms in patients with OSA.


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