Transcranial direct current stimulation (tDCS) has been proposed as a new treatment in major depressive disorder (MDD). This is a fully remote, multisite, double-blind, placebo-controlled, randomized superiority trial of 10-week home-based tDCS in MDD. Participants were 18 years or older, with MDD in current depressive episode of at least moderate severity as measured using the Hamilton Depression Rating Scale (mean = 19.07 ± 2.73). A total of 174 participants (120 women, 54 men) were randomized to active (n = 87, mean age = 37.09 ± 11.14 years) or sham (n = 87, mean age = 38.32 ± 10.92 years) treatment. tDCS consisted of five sessions per week for 3 weeks then three sessions per week for 7 weeks in a 10-week trial, followed by a 10-week open-label phase. Each session lasted 30 min; the anode was placed over the left dorsolateral prefrontal cortex and the cathode over the right dorsolateral prefrontal cortex (active tDCS 2 mA and sham tDCS 0 mA, with brief ramp up and down to mimic active stimulation). As the primary outcome, depressive symptoms showed significant improvement when measured using the Hamilton Depression Rating Scale: active 9.41 ± 6.25 point improvement (10-week mean = 9.58 ± 6.02) and sham 7.14 ± 6.10 point improvement (10-week mean = 11.66 ± 5.96) (95 NCT05202119 A randomized, sham-controlled, superiority trial of a 10-week course of home-based transcranial direct current stimulation found greater improvements in depressive symptoms with active compared to sham stimulation in major depressive disorder.

BackgroundObstructive sleep apnoea (OSA) is common in commercial drivers, and associated with increased risk of crashes if untreated, making diagnosis and effective treatment crucial in this population.Study design and methodsThis is a retrospective summary of a clinical programme based on telemedicine and remote treatment monitoring developed with a national trucking company to screen new hires in the USA for OSA and implement positive airway pressure (PAP) management. New hires were informed of the programme and consented as part of their employment. Drivers who did not comply with the evaluation or with PAP after diagnosis were removed from driving commercial vehicles by the company or did not pursue further employment.ResultsA total of 975 drivers were enrolled. Among screened drivers, 35.5% were cleared without a sleep study, 15.0% were cleared following a sleep study (apnoea–hypopnoea index (AHI) <5 events·h−1), 22.1% had mild OSA (AHI 5–15) and 27.4% had moderate–severe OSA (AHI ≥15). Those with moderate–severe OSA were more obese (body mass index 36.2±6.3 kg·m−2) and had more comorbidities. Of 269 drivers starting PAP, 160 (59.5%) maintained participation in a care management programme, 80 (29.7%) resigned or were terminated, 23 (8.6%) were cleared to discontinue PAP and six (2.2%) were complex cases requiring transfer of care. Illustrating effectiveness, those that maintained participation had excellent PAP adherence (5.27±1.61 h·night−1; 88.5±12.9% days used; 79.7±17.7% days used ≥4 h).InterpretationRemote assessment of OSA and PAP management in commercial drivers is feasible and effective. This approach has wide-ranging applications, particularly in populations and areas with a lack of sleep medicine providers.

Background Transcranial direct current stimulation (tDCS) has been proposed as a novel treatment in major depressive disorder (MDD). However, efficacy and safety of home-based tDCS treatment have not been investigated. Methods Fully remote, multisite, double-blind, placebo-controlled, randomized superiority trial of home-based tDCS treatment in MDD was conducted in UK and USA. Participants were adults 18 years or older, having MDD diagnosis based on DSM-5 criteria, in current depressive episode of at least moderate severity, measured by score >=16 on 17-item Hamilton Depression Rating Scale (HDRS), without treatment resistant depression history. Protocol was 10-week blinded phase: 5 tDCS sessions per week for 3 weeks then 3 sessions per week for 7 weeks; followed by 10-week open label phase. tDCS montage was bifrontal, 30-minute sessions, active tDCS 2 mA, and sham tDCS 0 mA with brief ramp up and down to mimic active device. Primary outcome was HDRS change at week 10 in modified intention-to-treat analysis. Results 174 MDD participants were randomized: active (n=87; mean age 37.1 + 11.1 years) and sham (n=87; mean age 38.3 + 10.9 years) treatment. Significant improvement in HDRS was observed in active (9.4 + 6.25 points) relative to sham treatment (7.1 + 6.10 points) (95% CI 0.5 to 4.0, p = 0.012), with no differences in discontinuation rates between active (n=13) and sham (n=12). Conclusions Home-based tDCS with remote supervision is a potential first line treatment for MDD that is acceptable and safe. Consideration of continuing effective safety monitoring is required. Trial registration number NCT05202119

This study found no evidence that obesity significantly modifies the effect of 4 months of CPAP treatment on HOMA-IR. Longer duration of CPAP treatment may be needed in order to reduce insulin resistance and determine whether obesity modifies the effect. https://bit.ly/3CtX7jZ.

Objective To determine whether an 8-week, self-administered in-home, behavioral skills virtual reality program for chronic low back pain (RelieVRx) that trains diaphragmatic breathing, biofeedback, cognition and emotion regulation, mindfulness, and pain education skills, is superior to a strong active Sham at day 56 for improving pain intensity and pain interference, in a large real-world sample. Patients and Methods Participants included a national sample of demographically diverse individuals with self-reported nonmalignant chronic low back pain ≥3 months duration with an average pain intensity and pain interference of ≥4/10. Participants were randomized 1:1 to RelieVRx or active Sham, and data were collected from January 31, 2022, to October 31, 2022. We evaluated group differences in brief pain inventory, pain intensity, and pain interference to day 56 (end of treatment). Results Of the 1067 participants (772 women, 293 men, and 2 others; mean ± SD age, 50.8±13.2 years) randomized (1:1) into 2 groups: RelieVRx (n=536) and Sham (n=531) comprised the modified intention-to-treat analytic dataset. RelieVRx was superior to Sham for pain intensity and pain interference reductions from pretreatment to day 56 (difference from Sham, pain intensity: 0.406 [0.170-0.642] and pain interference: 0.523 [0.285-0.760]). Pain intensity and interference reductions for RelieVRx at day 56 were clinically meaningful (pain intensity: 2.0 [out of 10] points [1.73-2.06], pain interference: 2.3 points [1.99-2.33]). Conclusion An 8-week self-administered behavioral skills virtual reality program was found to impart clinically meaningful improvements above a strong active control comparison on pain intensity and pain interference in clinically severe and diverse adults with chronic low back pain. Trial Registration clinicaltrials.gov Identifier: NCT05263037

Continuous positive airway pressure (CPAP) therapy reduces circulating intercellular adhesion molecule 1 (ICAM-1) in adults with obstructive sleep apnea (OSA). ICAM-1 levels may affect the daytime sleepiness and elevated blood pressure associated with OSA. We evaluated the association of changes from baseline in ICAM-1 with changes of objective and subjective measures of sleepiness, as well as 24-h ambulatory blood pressure monitoring (ABPM) measures, following 4 months of CPAP treatment. The study sample included adults with newly diagnosed OSA. Plasma ICAM-1, 24-h ABPM, Epworth Sleepiness Scale (ESS), and psychomotor vigilance task (PVT) were obtained at baseline and following adequate CPAP treatment. The associations between changes in natural log ICAM-1 and changes in the number of lapses on PVT, ESS score, and 24-h mean arterial blood pressure (MAP) were assessed using multivariate regression models, controlling for a priori baseline covariates of age, sex, BMI, race, site, smoking status, physical activity, anti-hypertensive medications, AHI, and daily hours of CPAP use. Among 140 adults (83% men), mean (± SD) body mass index (BMI) was 31.5 ± 4.2 kg/m2, and apnea-hyopnea index (AHI) was 36.8 ± 15.3 events/h. Sleepiness measures, although not ICAM-1 or ABPM measures, improved significantly following CPAP treatment. We observed no statistically significant associations between the change in ICAM-1 and changes in sleepiness, MAP, or other ABPM measures. Changes in ICAM-1 levels were not related to changes in sleepiness or ABPM following CPAP treatment of adults with OSA. Future work should explore whether or not other biomarkers may have a role in mediating these treatment outcomes in adults with OSA.

Abstract Introduction Continuous positive airway pressure (CPAP) therapy may improve insulin sensitivity and glucose tolerance seen in individuals with obstructive sleep apnea (OSA), however there is a lack of studies on whether obesity modifies the effect. We examined the baseline and follow-up levels of insulin and glucose following 4 months of CPAP treatment among participants with body mass index (BMI) <30, 30≤ BMI<35, and BMI≥35 kg/m2. Methods We identified 221 adults (84% males) with newly diagnosed OSA in the Penn Icelandic Sleep Apnea (PISA) Study, with a mean (±SD) BMI 31.7 +- 4.2 kg/m2 and apnea-hypopnea index (AHI) of 35.7+-15.6 events/hour. Associations between changes in natural log of the biomarkers within BMI groups were explored, controlling for a priori baseline covariates of age, baseline BMI, race, sex, site, and current smoking status. Results The mean proportional change (from baseline to follow-up) in log-transformed glucose in CPAP adherent participants was significantly larger in the BMI ≥35 and 30≤ BMI<35 groups compared to BMI <30. Within the BMI ≥35 group, the baseline to follow up increase in glucose post-CPAP was 1.08 (95% CI 1.01–1.15), while there were no significant changes in the other 2 BMI groups. A mediation analysis was performed with models including BMI change, and glucose was found to be significantly different between groups. There was no statistically significant association for insulin. Conclusion Our findings show that obesity modifies the effect of four months of CPAP on glucose levels. Support (if any) 1P01-1HL094307

It is unknown whether obesity modifies the effect of obstructive sleep apnea (OSA) and positive airway pressure (PAP) therapy on cardiac remodeling and NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels. We compared NT-proBNP and cardiac magnetic resonance imaging in adults without OSA (n=56) and nonobese (n=73; body mass index <30 kg/m 2 ) and obese (n=136; body mass index ≥30 kg/m 2 ) adults with OSA. We also investigated these traits in nonobese (n=45) and obese (n=78) participants with OSA adherent to 4 months of PAP treatment. At baseline, left ventricular mass to end-diastolic volume ratio, a measure of left ventricular concentricity, was greater in both nonobese and obese participants with OSA compared with those without OSA. Participants with OSA and obesity exhibited reduced phasic right atrial function. No significant differences in baseline NT-proBNP were observed across groups. The effect of PAP treatment on NT-proBNP and left atrial volume index was significantly modified by obesity. In nonobese participants, PAP therapy was associated with a decrease in NT-proBNP ( P <0.0001) without a change in left atrial volume index, whereas in obese participants, PAP was associated with an increase in left atrial volume index ( P =0.006) without a change in NT-proBNP. OSA was associated with left ventricular concentric remodeling independent of obesity and right atrial dysfunction in participants who were obese. PAP treatment was associated with reduced NT-proBNP in nonobese participants with OSA, but left atrial enlargement in obese participants with OSA, suggesting that PAP-induced reduction in BNP release (which is known to occur during obstructive apnea episodes) may lead to volume retention in obese participants with OSA. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01578031.

Abstract Introduction Leptin and adiponectin are cytokines produced by adipocytes. Leptin is involved in the pathogenesis of obesity and adiponectin is cardioprotective. Previous studies in adults with obstructive sleep apnea (OSA) assessing the effect of continuous positive airway pressure (CPAP) on these cytokines are conflicting, and whether obesity modifies the effect remains unknown. We examined the baseline and follow up levels of changes in plasma leptin and adiponectin following 4 months of CPAP treatment among obese (BMI>30) and non-obese (BMI≤30) participants. Methods We evaluated 221 adults (84.6% males) in the Penn Icelandic Sleep Apnea (PISA) Study, with mean (±SD) body mass index (BMI) 31.7±4.9 kg/m2 and apnea-hypopnea index (AHI) 35.7±15.6 events/hour. Associations between changes in natural log of the biomarkers in obese and non-obese participants were evaluated, controlling for a priori baseline covariates of age, baseline BMI, race, sex, site, and current smoking status. Results The mean proportional change (from baseline to follow-up) in log-transformed adiponectin and leptin in CPAP adherent participants was not significantly different between BMI groups. The baseline to follow up change in leptin post-CPAP was 1.01 (95% CI 0.95–1.08) in obese participants and 1.05 (95% CI 0.96–1.14) in non-obese participants. For adiponectin, the change post-CPAP was 1.04 (95% CI 0.95–1.15) in obese participants and 1.08 (95% CI 0.96–1.22) in non-obese participants. Conclusion CPAP treatment did not have an impact on leptin or adiponectin levels. We also find no evidence for obesity modifying the effect of four months of CPAP on leptin or adiponectin. Support (if any) 1P01-1HL094307

Background: The primary goal of many computer-assisted surgical systems like robotics for total knee arthroplasty (TKA) is to accurately execute a preoperative plan. To assess whether the preoperative plan was executed accurately in 3D, one option is to compare the planned and postoperative implant placement using a preoperative and postoperative CT scan of the patient's limb. This comparison requires a 3D-to-3D surface registration between the preoperative and postoperative 3D bone models and between the planned and postoperative 3D implants. Hence, the present study aimed at validating this measurement technique by determining (I) the anatomical regions that result in the lowest 6-degree of freedom (DoF) errors for 3 D-to-3D surface registration of bone models, (II) the 6-DoF errors for 3D-to-3D surface registration of the implant models, and (III) the 6-DoF of the complete measurement technique. Methods: Four different regions of the femur were tested to determine which one would result in the most accurate 3D-to-3D registration of the bone models using 12 cadaveric lower limb specimens. Next, total knee arthroplasties were performed on six specimens, and the accuracy of the 3D-to-3D implant registration was evaluated against a gold standard registration performed using fiducial markers. Results: The most accurate 3D-to-3D bone registration was obtained when using the largest anatomical regions available after TKA, being the full 3D femur model or the femur model without the distal femur which resulted in root mean square errors within 0.2 mm for translations and 0.2 degrees for rotation. The accuracy of the 3D-to-3D femoral and tibial implant registration was within 0.7 mm for translations and 0.4 degrees-0.6 degrees for rotations, respectively. The accuracy for the overall procedure was within 0.9 mm and 0.6 degrees for both femur and tibia when using femoral regions resulting in accurate 3D-to-3D bone registration. Conclusions: In conclusion, this measurement technique can be used in applications where measurement errors up to 0.9 nun in translations and up to 0.6 degrees in rotations in component placement are acceptable.

BACKGROUND:Despite advances in the treatment, fewer than half of diabetic foot ulcers (DFUs) heal in 12 weeks and 85% of non-traumatic amputations follow the development of a DFU. The search for treatment options continues. Placental-derived products have shown promise in the treatment of DFUs. This study investigates Artacent (Tides Medical, US), a unique amniotic patch containing two layers of amnion and its potential to increase growth factor delivery.METHOD:This observational analysis included patients with DFUs with documented failure to heal by >50% after the protocol-defined run-in period (either two or four weeks) of standard of care (SOC), and who had been randomised in a larger clinical trial that had been discontinued earlier for logistical reasons. Patients were randomised to either weekly or biweekly application of the dual-layer amniotic membrane (DLAM) plus SOC and were included in per-protocol effectiveness analyses. Descriptive statistics were chosen for this analysis. Primary endpoint was complete closure at 12 weeks.RESULTS:A total of 26 patients were included in the analysis. Examination of baseline patient characteristics revealed that the ulcers were larger than in most DFU clinical trials (4.65±4.89cm2). For the primary endpoint, 17/26 (65%, 95% CI: 44-83%) of the combined treatment arms achieved complete closure. The small sample size precluded a meaningful comparison of healing between weekly and biweekly DLAM applications.CONCLUSION:The observations taken from the discontinued clinical trial suggest that the DLAM promotes healing of DFUs. The healing rates are similar to those in other placental-based tissue studies. In addition, the relatively larger size of the ulcers suggests that the DLAM may be effective in ulcers that are more resistant to standard of care. In the future, a revised clinical trial with a greater sample size is planned.

Abstract Introduction Previous studies have shown that continuous positive airway pressure (CPAP) therapy of adults with obstructive sleep apnea (OSA) reduces circulating levels of intercellular adhesion molecule 1 (ICAM-1). ICAM-1 levels may affect daytime sleepiness and elevated blood pressure associated with OSA. Our goals were to explore associations between changes in ICAM-1 and objective and subjective measures of sleepiness, as well as 24-hour ambulatory blood pressure monitor (ABPM) parameters in adults with OSA following 4 months of CPAP treatment. Methods We identified 140 adults with newly diagnosed OSA in the Penn Icelandic Sleep Apnea (PISA) Study, with a mean (±SD) body mass index (BMI) of 31.5±4.2 kg/m2 and apnea-hypopnea index (AHI) of 36.8±15.3 events/hour; 83.3% were males. Plasma ICAM-1 levels, 24-hour ABPM, Epworth Sleepiness Scale (ESS), and Psychomotor Vigilance Task (PVT) measures were obtained at baseline and after 4 months of CPAP treatment. Associations between changes in natural log ICAM-1 and both sleepiness and 24-hour mean arterial blood pressure (MAP) were assessed using multivariate regression models, controlling for a priori baseline covariates of age, sex, BMI, race, site, smoking status, physical activity, use of anti-hypertensive medications, AHI and hours/night of CPAP usage. Results Overall, there was no significant change in ICAM-1 from baseline to follow-up among all participants after 4 months (0.027 ng/ml, p=0.52). There were no statistically significant associations between the change in ICAM-1 and change in sleepiness measures (all p>0.05) or 24-hour MAP (1.124 mm Hg, p=0.07). A nominal association between increased ICAM-1 and increased daytime MAP after 4 months was observed (1.39 mm Hg, p=0.033), although this result was not significant after correction for multiple comparisons. Conclusion Our results do not support changes in ICAM-1 as the biological pathway linking changes in sleepiness or ABPM following CPAP treatment of adults with OSA. Support P01-HL094307 (NHLBI, PI: Pack AI)

Many patients with obstructive sleep apnea (OSA), but not all, have a reduction in blood pressure (BP) with positive airway pressure (PAP) treatment. Our objective was to determine whether the BP response following PAP treatment is related to obesity. A total of 188 adults with OSA underwent 24-hour BP monitoring and 24-hour urinary norepinephrine collection at baseline. Obesity was assessed by waist circumference, body mass index, and abdominal visceral fat volume. Participants adherent to PAP treatment were reassessed after 4 months. Primary outcomes were 24-hour mean arterial pressure (MAP) and 24-hour urinary norepinephrine level. Obstructive sleep apnea participants had a significant reduction in 24-hour MAP following PAP treatment (-1.22 [95% CI: -2.38, -0.06] mm Hg; P = .039). No significant correlations were present with any of the 3 obesity measures for BP or urinary norepinephrine measures at baseline in all OSA participants or for changes in BP measures in participants adherent to PAP treatment. Changes in BP measures following treatment were not correlated with baseline or change in urinary norepinephrine. Similar results were obtained when BP or urinary norepinephrine measures were compared between participants dichotomized using the sex-specific median of each obesity measure. Greater reductions in urinary norepinephrine were correlated with higher waist circumference (rho = -0.21, P = .037), with a greater decrease from baseline in obese compared to non-obese participants (-6.26 [-8.82, -3.69] vs -2.14 [-4.63, 0.35] ng/mg creatinine; P = .027). The results indicate that the BP response to PAP treatment in adults with OSA is not related to obesity or urinary norepinephrine levels.

An observational study of CMV drivers was undertaken to assess the operational, safety, health, and fatigue impacts of the restart provisions in Sections 395.3(c) and 395.3(d) of Title 49, Code of Federal Regulations. N=235 drivers (224 males, 20-69y) participated in an observational study for up to 5 months duration. All drivers held a valid CMV driver's license, worked >60 hours/week, completed drives during the day and night, and made use of the restart provisions. They were recruited to reflect diverse types of vehicles and operational distances. They reported either driving mostly during the day (10.2%), mostly during the night (14.9%), or a combination of day and night (74.9%). They were monitored via electronic devices to track driving (including safety critical events) and work hours. Smartphone apps were used to track their behavioral alertness on the Brief Psychomotor Vigilance Test (PVT-B), and their ratings of fatigue, sleepiness, stress, and sleep quality. Statistical comparisons were performed using linear and non-linear mixed-effects modeling. A total of 26,964 days of data were acquired, including >79,000 PVT-B tests. During on-duty days, drivers slept an average of 6.6h/day, compared to 8.7h/day during restart (off-duty) days (p<0.0001). During restart periods drivers rated their sleepiness higher (p<0.0001), their sleep quality higher (p<0.0001), and their stress lower (p<0.0001), compared to on-duty days. Drivers' fatigue ratings were higher, and sleep quality ratings were lower, during 1-night vs. 2-night restarts. They had more PVT-B lapses during restart periods than during on-duty periods (p<0.0001), and more lapses when restarts occurred after 168 hours than prior to 168 hours (p<0.0087). Although there were no safety critical events in the study, there was evidence that CMV drivers were in need of more sleep when they undertook a restart as they slept an average of 2h longer during restarts than when they were working. DTMC75-14-D-00011, Task Order #9

This study was performed to evaluate the early clinical results at one year for the Simplify™ Cervical Artificial Disc. We compared outcomes for 150 Simplify Disc subjects at one-year followup in a prospective, multicenter, FDA IDE clinical trial with 119 propensity score matched historical control subjects who received conventional anterior cervical discectomy and fusion (ACDF) for single-level cervical degenerative disc disease. The outcome measures included the change from preoperative baseline to one-year in Neck Disability Index (NDI) and visual analog scales (VAS) for neck and arm pain, with scores for the few missing oneyear follow-up implicitly imputed using mixed models for repeated measures (MMRM). The MMRM was used to estimate within group and between group differences controlling for propensity score subclass and the relevant baseline value. The adjusted mean changes (and standard errors) in NDI from baseline to one year were -46.7 (SE=1.7, p<0.001) and -38.1 (SE=1.9, p<0.001) for Simplify Disc subjects and ACDF control subjects, respectively. The adjusted Simplify Disc vs. control difference in mean NDI change at one year was -8.7 (SE=2.7) with p=0.002; the 95% confidence interval for the mean difference was -14.0 to -3.3. The adjusted mean changes in VAS neck and arm pain from baseline to one year were -62.4 (SE=2.0, p<0.001) and -55.2 (SE=2.3, p<0.001) for Simplify Disc and ACDF controls, respectively. The adjusted Simplify Disc vs. control difference in mean VAS neck and arm pain change at one year was -7.3 (SE=3.3) with p=0.029 (95% CI -13.8 to 0.8). Therefore, it can be concluded that the one-year clinical results of the Simplify Disc are superior to ACDF for both 1) improvement of NDI and 2) improvement in VAS neck and arm pain. Inspection of all eight prior FDA cervical total disc replacement studies indicates that these good results for the Simplify Disc can be expected to continue for five years and beyond, but longer term follow-up is necessary for verification.

Numerous studies have demonstrated that positive airway pressure (PAP) treatment of patients with obstructive sleep apnea (OSA) reduces blood pressure (BP), possibly by decreasing sympathetic activity. Obesity is a risk factor for OSA and hypertension and is characterized by increased sympathetic activity. In this study, we evaluated the impact of obesity on the BP response to PAP treatment in obese and non-obese OSA adults and the role of sympathetic activity in contributing to the BP response. We classified 188 subjects with OSA as obese (n=119) based on waist circumference (>107 cm in men and >96 cm in women) or non-obese (n=69). Participants underwent 24-hr ambulatory blood pressure monitoring (ABPM) and a 24-hr urinary catecholamine collection before and following 4 months of PAP treatment. Baseline apnea-hypopnea index was 37.3 ± 17.1[SD] and 34.2 ± 13.3 events/hr for obese and non-obese participants. There were no significant differences between groups in 24-hr mean arterial pressure (MAP, p=0.075) or 24-hr catecholamine excretion at baseline (p=0.769). Comparing changes from baseline between obese (n=65) and non-obese (n=35) OSA subjects adherent to PAP treatment, the two groups did not differ in the change in MAP (p=0.329), but the obese group had a greater reduction in nocturnal MAP (p=0.021), nocturnal diastolic BP (p =0.004), nocturnal-to-daytime ratios of MAP (p=0.043) and nocturnal diastolic BP (p=0.016). Mean 24-hr urinary norepinephrine decreased by 5.79 ng/mg creatinine (95% CI 8.04 to 3.54; p=0.0001) in obese OSA subjects, but no significant reduction occurred in non-obese OSA subjects. No significant relationship was observed between changes in log-transformed 24-hr urinary norepinephrine and changes in any ABPM measure. Compared to non-obese adults with OSA, obese adults with OSA had greater reductions in several nocturnal BP measures following 4 months of PAP treatment; however, these changes were not related to the large reduction in 24-hr urinary norepinephrine following PAP treatment in the obese group. Further studies are required to assess the physiologic basis of BP reduction induced by PAP in obese and non-obese OSA patients. NIH 1P01-1HL094307.

To examine the level of physical activity (PA) before and following positive airway pressure (PAP) treatment in adults who have obstructive sleep apnea (OSA) with obesity versus without obesity. Simultaneous waist accelerometer and wrist actigraphy recordings were obtained in 129 adults with obesity and 69 adults without obesity and who had OSA prior to and following 4 months of PAP therapy and in 52 patients in a control group. Primary PA measurements were average steps per day on waist accelerometry and average counts per minute (CPM) per day on wrist actigraphy. At baseline, participants with obesity and OSA exhibited fewer steps per day on waist accelerometer and fewer CPM per day on wrist actigraphy compared to participants without obesity and with OSA (despite similar apnea-hypopnea index between groups). Following PAP treatment, participants with OSA had modestly increased CPM per day on wrist actigraphy (17.69 [95 https://clinicaltrials.gov/ct2/show/NCT01578031 Feng Y, Maislin D, Keenan BT, Gislason T, Arnardottir ES, Benediktsdottir B, Chirinos JA, Townsend RR, Staley B, Pack FM, Sifferman A, Pack AI, Kuna ST. Physical activity following positive airway pressure treatment in adults with and without obesity and with moderate-severe obstructive sleep apnea. J Clin Sleep Med. 2018;14(10):1705–1715.

Study objectives:Debate persists as to whether obstructive sleep apnea (OSA) is an independent risk factor for atherosclerosis. The purpose of this study was to compare carotid intima-media thickness (IMT), an early sign of atherosclerosis, in obese and nonobese adults with OSA before and following positive airway pressure (PAP) treatment.Methods:A total of 206 adults newly diagnosed with OSA with an apnea-hypopnea index (AHI) of 15-75 events/hour and 53 controls with AHI <10 were studied. Waist circumference was used to classify participants as obese and nonobese. Bilateral common carotid artery B-mode ultrasound was performed at baseline to assess IMT, arterial diameter, arterial-wall mass, and circumferential wall stress. Measurements were repeated in 118 participants with OSA who completed a 4-month PAP treatment and had an average daily use over that period of ≥4 hours/day.Results:No significant differences in carotid IMT, diameter, or arterial-wall mass were present at baseline between participants with OSA and controls stratified by waist circumference, after adjusting for other cardiovascular risk factors. In participants with OSA, who had adequate PAP adherence over the 4-month treatment, carotid artery diameter significantly increased (mean change [95% confidence interval] = 0.13 [0.06, 0.20] mm; p = .0004), but no significant changes in carotid IMT, arterial-wall mass, and circumferential stress were observed in obese and nonobese participants.Conclusions:Regardless of obesity status, carotid IMT is not increased in adults with moderate to severe OSA versus controls and does not change following 4 months of PAP treatment.