Randomized Crossover Pilot Study Research Articles

Antibiotics Removal during Continuous Renal Replacement Therapy in Septic Shock Patients: Mixed Modality Versus "Expanded Haemodialysis".

Renal replacement therapy (RRT) plays a critical role in antimicrobial removal, particularly for low-molecular-weight drugs with low plasma protein binding, low distribution volume and hydrophilicity. Medium cut-off (MCO) membranes represent a new generation in dialysis technology, enhancing diffusive modality efficacy and increasing the cut-off from 30 to 45 kDa, crucial for middle molecule removal. This monocentric randomized crossover pilot study aimed to evaluate the impact of continuous haemodialysis with MCO membrane (MCO-CVVHD) on the removal of piperacillin, tazobactam and meropenem compared with continuous veno-venous hemodiafiltration with standard high-flux membrane (HFM-CVVHDF). Twenty patients were randomized to undergo MCO-CVVHD followed by HFM-CVVHDF or vice versa. Extraction ratio (ER), effluent clearance (Cleff) and treatment efficiency were assessed at various intervals. Antibiotic nadir plasma levels were measured for both treatment days. HFM-CVVHDF showed greater ER compared with MCO-CVVHD for meropenem (β = - 8.90 (95% CI - 12.9 to - 4.87), p < 0.001) and tazobactam (β = - 8.29 (95% CI - 13.5 to - 3.08), p = 0.002) and Cleff for each antibiotic (meropenem β = - 10,206 (95% CI - 14,787 to - 5787), p = 0.001); tazobactam (β = - 4551 (95% CI - 7781 to - 1322), p = 0.012); piperacillin (β = - 3913 (95% CI - 6388 to - 1437), p = 0.002), even if the carryover effect influenced the Cleff for meropenem and tazobactam. No difference was observed in nadir plasma concentrations or efficiency for any antibiotic. Piperacillin (β = - 38.1 (95% CI - 47.9 to - 28.3), p < 0.001) and tazobactam (β = - 4.45 (95% CI - 6.17 to - 2.72), p < 0.001) showed lower nadir plasma concentrations the second day compared with the first day, regardless the filter type. MCO demonstrated comparable in vivo removal of piperacillin, tazobactam and meropenem to HFM.

Feasibility of an enhanced low-fidelity ear simulator for otomicroscopy training.

Otoscopic skills are essential for ENT doctors. Early-stage doctors develop skills whilst treating patients, with minimal teaching, potentially increasing risk to patients. Simulation allows skill development without patient risk; however, simulation often requires subjective expert review of technique. This study compared enhanced low-fidelity simulation with performance feedback against standard simulation using a basic otoscopy skills simulator. Two low-fidelity ear simulators were created: a basic model without feedback and an enhanced model which alarms when the aural instrument tip touches the canal wall. Participants were evaluated in a randomised crossover pilot study, using both models to assess whether objective feedback reduced tip touches. The enhanced simulator reduced tip touches more than the control model, suggesting better and more sustained skill uptake. Participants reported that the enhanced model improved learning. Enhanced low-fidelity models provide a low-cost opportunity to improve otoscopy skills without patient risk or the need for subjective expert feedback.

Desktop Virtual Reality Offers a Novel Approach to Minimize Pain and Anxiety during Burn Wound Cleaning/Debridement in Infants and Young Children: A Randomized Crossover Pilot Study.

Although most scald burn injuries involve children under six, because of the challenges of using head mounted displays with young children there is very little research exploring the use of VR in children under six. The current clinical pilot study measured the analgesic effectiveness of our new desktop VR system (with no VR helmet) in children under six during burn wound care (a within-subjects design with randomized treatment order). Between December 2021-April 2022, nine children with burn injuries (10 months to 5 years age, mean = 18 months) participated. The mean burn size was 10% Total Body Surface Area, range 2-22%. Using nurse's ratings, VR significantly reduced children's pain during burn wound care by 40% on the observational Faces, Legs, Activity, Crying, and Consolability (FLACC) pain scale. Specifically, non-parametric within-subject sign tests compared nurse's ratings of the young patients' pain during burn wound care using usual pain medications with no VR = 6.67, (SD = 2.45) vs. adjunctive Animal Rescue World VR (VR = 4.00, SD = 2.24, p < 0.01). The observational Procedure-Behavior Checklist (PBCL) nurse's scale measured a 34% reduction in anxiety with VR as compared to pharmacologic treatment alone (p < 0.005). Similarly, when using single graphic rating scales the patients' parents reported a significant 36% decrease in their child's pain during VR (p < 0.05), a 38% (p < 0.005) decrease in their child's anxiety during VR, and a significant increase in patients' joy during VR. It can be concluded that during burn wound care with no distraction (traditional pain medications), children under 6 years old experienced severe pain during a 10 min burn wound cleaning session. During burn wound care combining desktop virtual reality and traditional pain medications, the same pediatric patients experienced only mild pain during burn wound cleaning/debridement. VR significantly reduced the children's pain and anxiety during burn wound care.

Measuring Oxygenation in Newborn Infants with Targeted Oxygen Ranges (MONITOR): a randomised crossover pilot study

ObjectiveThe Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration showed that high (91–95%) versus low (85–89%) SpO2 targets reduced mortality. Trials of higher targets are needed to determine whether any more survival...

Residual gastric volume after 3 h of the ingestion of an oral supplement containing carbohydrates alone or associated with whey protein: a randomized crossover pilot study

BackgroundNew formulas including a nitrogenous source to maltodextrin have been reported as preoperative beverages 2–3 h before anesthesia in the elective procedure. Whey protein is a potential candidate for the composition of this clear oral supplement. This study aimed to investigate the gastric residual volume (GRV) of healthy volunteers 3 h after the ingestion of an oral supplement containing carbohydrates (CHO) alone or combined with whey protein (WP).MethodsThis crossover clinical trial design includes young, healthy male volunteers with normal body mass index. Magnetic resonance imaging (MRI) scan of the upper abdomen to measure the GRV was performed in the participants in three phases: (1) after a fasting period of 8 h; (2) immediately after the ingestion of 200 mL of a clear supplement containing: (2a) 10 g of WP and 54 g of CHO (74% glucose and 26% maltodextrin)–WP + CHO group or (2b) 12.5% maltodextrin (25 g)–CHO group; and (3) after 3 h of the ingestion of both types of supplements. A week interval was programmed between phases 2a and 2b.ResultsThere was no significant difference (p = 0.91; within-group comparison) of the mean ± SD of the GRV between phase 1 (WP + CHO: 23.45 ± 14.01; CHO: 25.03 ± 15.17 cm3; p = 0.78; between-groups comparison) and phase 3 (WP + CHO: 25.66 ± 9.31; CHO: 23.45 ± 13.58 cm3, p = 0.86; between-groups comparison). The GRV of phase 2 (WP + CHO: 206.43 ± 23; CHO: 203.99 ± 12.18 cm3; p = 0.82; between-groups comparison) was significantly greater (p < 0.01; within-group comparison) than both other two phases.ConclusionThe GRV after 3 h of the ingestion of either WP + CHO or CHO oral supplement returns to basal fast condition implying that gastric emptying after this interval of time is significantly completed.Trial registrationRegistered and posted on the ClinicalTrials.gov public website with Identifier: NCT05573854.

Acute effects of different facemasks during High Intensity Interval Training in trained women. A randomized crossover pilot study

Acute effects of different facemasks during High Intensity Interval Training in trained women. A randomized crossover pilot study

Sucrose dampens caffeine-induced blood pressure elevations - A randomized crossover pilot study in healthy, non-obese men.

PurposeSales for sugar-sweetened and caffeinated beverages are still rising globally and their consumption has been linked to the development of cardiovascular diseases. However, direct evidence from human interventional studies in response to such beverages is still scarce.MethodsSeven young, non-obese men participated in a randomized crossover study where four test drinks [60 g sucrose + 50 mg caffeine, 60 g sucrose + caffeine-placebo, 50 mg caffeine, and caffeine-placebo] were investigated. Each drink was brought to a total volume of 500 mL with water. Continuous and beat-to-beat hemodynamic monitoring was conducted for 30 min baseline and continued for 90 min after the ingestion of each drink. Measurements included blood pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, index of contractility, and double product.ResultsTwo-factor ANOVA analysis revealed significant treatment-by-time effects for diastolic blood pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, index of contractility, and double product (all p < 0.01). Diastolic blood pressure and total peripheral resistance increased significantly to caffeine-only (all p < 0.05), while sucrose + caffeine-placebo and sucrose + caffeine both decreased resistance responses (all p < 0.05). Cardiac output increased significantly to sucrose + caffeine-placebo and sucrose + caffeine (all p < 0.05), and on trend for heart rate, stroke volume, and index of contractility (all p between 0.05 and 0.09).ConclusionIn young, non-obese men, a caffeinated and sucrose-sweetened beverage at concentrations similar to classical commercial Cola products exhibited distinct hemodynamic actions where the presence of sucrose dampened caffeine-induced blood pressure elevations, but at the expense of a tendency to increase cardiac work.

Different preoperative fluids do not affect the hemodynamic status but gastric volume: results of a randomized crossover pilot study

Background and objectiveInferior vena cava (IVC) examination has been reported as a noninvasive method for evaluating the hemodynamic state. We conducted this crossover pilot study to investigate the effects of the administration of water and high-carbohydrate-containing fluids on the hemodynamic status of volunteers through collapsibility index of IVC (IVCCI) measurement.MethodsTwenty volunteers were randomly assigned to a water or high-carbohydrate group according to computer-generated random numbers in a 1:1 ratio. In the water group, volunteers received water (5 mL/kg), and in the high-carbohydrate group, patients received carbohydrate drinks (5 mL/kg). Respiratory variations in the IVC diameter, gastric volume, and blood pressure and heart rates in erect and supine positions were measured at admission (T1), 1 h (T2), 2 h (T3), 3 h (T4), and 4 h (T5).ResultsWhen considering participants with an IVCCI of more than 42%, there were no significant differences between the water and carbohydrate drink groups at each time point (all p > 0.05). At T2, more participants had an empty stomach in water group than in carbohydrate drink group (p < 0.001). At T3, 30% of the participants could not empty their stomachs in carbohydrate drink group. However, with regard to the number of volunteers with empty stomach at T3, there was no significant difference between water and carbohydrate drink group. Repeated measures data analysis demonstrated that IVCCI showed no significant differences over time (p = 0.063 for T1-T5). There were no differences between water and carbohydrate drinks (p = 0.867).ConclusionOur results suggested that neither water nor carbohydrate drinking affected the hemodynamic status through IVCCI measurement over time, up to 4 h after drinking. Furthermore, carbohydrate drinking might delay gastric emptying at 1 h, but not 2 h after drinking, in comparison with water.

Dose-Response Transcranial Electrical Stimulation Study Design: A Well-Controlled Adaptive Seamless Bayesian Method to Illuminate Negative Valence Role in Tinnitus Perception.

The use of transcranial Electrical Stimulation (tES) in the modulation of cognitive brain functions to improve neuropsychiatric conditions has extensively increased over the decades. tES techniques have also raised new challenges associated with study design, stimulation protocol, functional specificity, and dose-response relationship. In this paper, we addressed challenges through the emerging methodology to investigate the dose-response relationship of High Definition-transcranial Direct Current Stimulation (HD tDCS), identifying the role of negative valence in tinnitus perception. In light of the neurofunctional testable framework and tES application, hypotheses were formulated to measure clinical and surrogate endpoints. We posited that conscious pairing adequately pleasant stimuli with tinnitus perception results in correction of the loudness misperception and would be reinforced by concurrent active HD-tDCS on the left Dorsolateral Prefrontal Cortex (dlPFC). The dose-response relationship between HD-tDCS specificity and the loudness perception is also modeled. We conducted a double-blind, randomized crossover pilot study with six recruited tinnitus patients. Accrued data was utilized to design a well-controlled adaptive seamless Bayesian dose-response study. The sample size (n = 47, for 90% power and 95% confidence) and optimum interims were anticipated for adaptive decision-making about efficacy, safety, and single session dose parameters. Furthermore, preliminary pilot study results were sufficient to show a significant difference (90% power, 99% confidence) within the longitudinally detected self-report tinnitus loudness between before and under positive emotion induction. This study demonstrated a research methodology used to improve emotion regulation in tinnitus patients. In the projected method, positive emotion induction is essential for promoting functional targeting under HD-tDCS anatomical specificity to indicate the efficacy and facilitate the dose-finding process. The continuous updating of prior knowledge about efficacy and dose during the exploratory stage adapts the anticipated dose-response model. Consequently, the effective dose range to make superiority neuromodulation in correcting loudness misperception of tinnitus will be redefined. Highly effective dose adapts the study to a standard randomized trial and transforms it into the confirmatory stage in which active HD-tDCS protocol is compared with a sham trial (placebo-like). Establishing the HD-tDCS intervention protocols relying on this novel method provides reliable evidence for regulatory agencies to approve or reject the efficacy and safety. Furthermore, this paper supports a technical report for designing multimodality data-driven complementary investigations in emotion regulation, including EEG-driven neuro markers, Stroop-driven attention biases, and neuroimaging-driven brain network dynamics.

Conventional Cervical Exercises Compared with a Mixed-Reality-Based Game in Asymptomatic Subjects: An Exploratory Crossover Pilot Study

Mixed reality presents itself as a potential technological tool for the management of people with musculoskeletal disorders, without having as many adverse side effects as immersive virtual reality. The objective of this study was to explore the possibilities of a mixed-reality game, performing task-oriented cervical exercises compared to conventional therapeutic exercises in sensorimotor outcome measures in asymptomatic subjects. A randomized crossover pilot study was performed with two intervention groups: a mixed-reality group (MRG) and a conventional exercise group (CEG). The cervical joint position error test (CJPET) and deep cervical flexor endurance test (DCFET) were measured as sensorimotor outcomes. Statistically significant differences were found in the pre–post comparison in the DCFET for both groups (MRG: t = −3.87, p &lt; 0.01; CEG: t = −4.01, p &lt; 0.01) and in the extension of the CJPET for the MRG (t = 3.50, p &lt; 0.01). The rest of the measurements showed no significant differences comparing both groups pre- and postintervention (p &gt; 0.05). Mixed reality has apparently the same positive effects as conventional exercises in sensorimotor outcomes in asymptomatic subjects. These results could help in future studies with mixed virtual reality in the management of people with musculoskeletal disorders.

Intravenous dexmedetomidine, morphine, or a combination can result in gallbladder wall thickening; with no significant association with plasma histamine concentrations.

The gallbladder is routinely evaluated during ultrasonographic examinations in dogs. However, published studies describing the effects of sedative agents on gallbladder wall thickness are currently lacking. The aims of this prospective, blinded, randomized crossover pilot study were to test hypotheses that IV morphine would result in gallbladder wall thickening, that morphine administration would increase plasma histamine concentrations, and that combining IV morphine with dexmedetomidine would potentiate gallbladder wall thickening. Six healthy Beagle dogs were sedated with intravenous (IV) morphine 0.4mg/kg (group M), dexmedetomidine 7 μg/kg (group D), or a combination of the two (group MD). Physiologic parameters were measured at baseline and at regular intervals until the last ultrasonographic scan. Ultrasonographic scans were performed at baseline, 90 s, and at 5, 15, 30, 45, 60, 90, and 120 min. Plasma histamine samples were taken at baseline, 90 s, and 5 and 60 min. Cochran's Q-test was used to compare gallbladder wall thickening between groups, while the association between histamine plasma concentration and gallbladder wall thickness was compared with a mixed-effects model. Baseline gallbladder wall thickness was not significantly different between groups. Six of 18 treatments/dogs (33%) developed gallbladder thickening, with no difference between groups. There was no significant difference in baseline plasma histamine concentrations between groups, and no association between plasma histamine concentration and gallbladder wall thickness. Gallbladder wall thickening was observed in at least one dog in each group, therefore caution is recommended for gallbladder wall thickness ultrasonographic interpretation in dogs when these drugs have been administered.

Traveling Across Time Zones With Type 1 Diabetes: A Pilot Study Comparing Insulin Degludec With Insulin Glargine U100.

For people with type 1 diabetes, there are limited evidence-based resources to support self-management when traveling across multiple time zones. Here, we compared glycemic control on insulin degludec versus glargine U100 as the basal insulin for adults using multiple daily injections (MDI) while traveling across multiple time zones. This randomized crossover pilot study compared insulin degludec versus glargine U100 for adults with type 1 diabetes using MDI insulin during long-haul travel to and from Hawaii to New York. Insulin degludec was administered daily at the same time regardless of time zone, and glargine was administered per travel algorithm. Primary end point was the percentage of time in range (TIR) between 70 and 140 mg/dL during the initial 24 h after each direction of travel. Secondary end points included standard continuous glucose monitoring metrics, jet lag, fatigue, and sleep. The study enrolled 25 participants (56% women, mean ± SD age of 35 ± 14.5 years, HbA1c of 7.4 ± 1.2% [57 ± 13.1 mmol/mol], and diabetes duration of 20.6 ± 15 years). There was no significant difference in glycemic outcomes between the two arms of the study, including TIR, hypoglycemia, or hyperglycemia. Neither group achieved >70% TIR 70-180 mg/dL during travel. Jet lag was greater on glargine U100 in eastward travel but not westward. Fatigue was greater after westward travel on glargine. Sleep was not significantly different between basal insulins. In adults with type 1 diabetes using MDI of insulin and traveling across multiple time zones, glycemic outcomes were similar comparing insulin degludec and glargine U100.

A randomized crossover pilot study comparing the efficacy of an auto-demand oxygen delivery system with that of a conventional demand oxygen delivery system in patients with chronic respiratory failure.

Introduction: When using portable oxygen, a demand oxygen delivery system (DODS), which senses the beginning of inhalation and delivers a bolus of oxygen, is often used. However, conventional DODS may not supply sufficient oxygen when reduced tidal flow fails to trigger the flow sensor. Recently, “auto-DODS,” which detects the negative pressure of inhalation and switches among 3 trigger sensitivity levels (standard, high, and extra high), has been developed to improve the efficacy of oxygenation. An auto-DODS can also supply pulsed-flow oxygen when it detects apnea, whereas a conventional DODS has only standard sensitivity. This randomized, open-label, crossover pilot study compared the performance of an auto-DODS with that of a conventional DODS.Methods: We recruited patients with chronic obstructive pulmonary disease (COPD) or interstitial pneumonia receiving long-term oxygen therapy. Interventions were performed on 2 different days for each participant. On each day, an auto-DODS or a conventional DODS were tested at rest for 30 minutes and during the 6-minute walk test. The primary outcome was mean oxygen saturation (SpO2). Secondary outcomes were the ratios of time for each sensitivity level and pulsed-flow oxygen when using the auto-DODS, total time desaturated below SpO2 90%, percentage of time desaturated below SpO2 90%, minimum SpO2, mean and maximum pulse rate, six-minute walk distance, recovery time after 6-minute walk test, modified Borg scale, comfort, and discomfort index.Results: When using the auto-DODS at rest, a high or extra high sensitivity level was observed in addition to standard sensitivity in 6 of 8 participants. During the 6-minute walk test, only standard sensitivity was observed in 6 participants. Mean SpO2 differences between the auto-DODS and conventional DODS at rest and during the 6-minute walk test were −0.6 [−4.5, 3.4] and 0.0 [−2.5, 2.5] ([95% confidence interval]), respectively, neither of which were significant (P = .73 and P = .99). There were no significant differences in secondary outcomes. There were no adverse events when using the auto-DODS.Conclusions: This study showed that the auto-DODS did not show superiority in oxygenation either at rest or during exercise compared to a conventional DODS. The auto-DODS was shown to supply oxygen safely and detect inhalations with various trigger sensitivities.

Efficacy of aqua-based plyometric exercises in the rehabilitation of patients with juvenile dermatomyositis: A randomized crossover pilot study.

Patients with juvenile dermatomyositis (JDM) experience muscle weakness, tiredness, and loss of energy, which restrict their abilities in performance of their daily living activities. To explore the effect of aquatic-based plyometric (Aqua-PLYO) exercises on muscle strength, fatigue, and functional ability in patients with JDM. This was a randomized, single-blind, crossover pilot study that included 16 patients with JDM (age 13.44±2.85years). They were assigned randomly to receive either the Aqua-PLYO exercises (n=8) or the standard outpatient care (SoC ; n=8) first. After a 1-month washout, the treatment was reversed. Lower limb muscle strength, fatigue perception, functional ability, and disease activity were evaluated before and after each treatment period. Irrespective of the treatment order, the Aqua-PLYO treatment yielded greater improvement in muscle strength (hip flexors and abductors [P<0.001] or knee flexors [P<0.001] and extensors [P=0.0008]), fatigue perception (P<0.001), functional ability (P=0.009), and disease activity (P=0.0001) than the SoC treatment. By using the shortest confidence intervals (100[1-2α]%) of the difference, the average bioequivalence of the Aqua-PLYO and SoC has not been established at P=0.05, because the upper and lower confidence bounds of all outcomes were not between the acceptance limits. No period or carryover effects were detected in all outcomes. The Aqua-PLYO exercise protocol as implemented in this study is safe, feasible, and well-tolerated in patients with JDM and seemingly useful to help increase muscle strength, reduce fatigue, and enhance functional ability in such a patient population.

Women with Fibromyalgia Prefer Resistance Exercise with Heavy Loads-A Randomized Crossover Pilot Study.

Fibromyalgia (FM) is a chronic pain condition associated with impaired muscle strength and exercise-induced pain. Physical exercise has been highlighted, by international clinical guidelines and stakeholders, as an essential component of rehabilitation in FM. Exposure to pain during exercise is generally correlated with elevated lactate levels and, additionally, is one known reason for persons with FM to avoid physical exercise and activity. A crossover design was used to test and evaluate an approach consisting of resistance exercise with heavy loads and a low number of repetitions among ten women with FM. The participants were consecutively recruited to test and perform exercise with two different resistance levels (A = light/moderate load, and B = heavy load) in a randomized crossover trial using an AB/BA setting. Results showed that the heavy load exercise session was experienced as more positive than the light/moderate load exercise session and that lower lactate levels followed exercise with heavier weight loads. This is promising and indicates that the approach of heavy weight loads and accustomed repetitions is accepted in FM and has the potential to attenuate hesitation to exercise due to exercise-induced pain. However, these effects need to be further investigated in more extensive studies.

Trazodone improves obstructive sleep apnea after ischemic stroke: a randomized, double-blind, placebo-controlled, crossover pilot study.

Low arousal threshold plays a part in the pathogenesis of obstructive sleep apnea (OSA) and may be improved by sedatives. Sedative antidepressants are frequently prescribed for stroke patients due to their high prevalence of insomnia and depression. However, the effect of sedative antidepressants on the severity of OSA in stroke patients has not been studied well. In a double-blinded randomized crossover pilot study, 22 post-acute ischemic stroke patients (mean age, 61.7 ± 10.6 y) with OSA received 100mg of trazodone or a placebo just before polysomnography, with approximately 1week between measures. The study also measured baseline heart rate variability and 24-h ambulatory blood pressure. Administration of trazodone significantly increased the percentage time of slow-wave sleep (31.5 ± 13.2 vs. 18.4 ± 8.7%; P < 0.001) and improved almost all the parameters of OSA severity, including the apnea-hypopnea index (AHI, 25.4 ± 15.4 vs. 39.1 ± 18.4 events/h; P < 0.001), the respiratory arousal index (9.8 (5.8-11.95) vs. 14.1 (11.3-18.7) events/h; P < 0.001), and the minimum oxygen saturation (80.2 ± 9.1 vs. 77.1 ± 9.6%; P = 0.016). Responders to therapy (AHI reduced by > 50%; n = 7/22) had predominant OSA during rapid-eye-movement sleep and decreased sympathetic tone, as reflected in significantly lower mean blood pressure, diastolic blood pressure, and normalized low-frequency power. Obstructive sleep apnea with comorbid ischemic stroke may be a distinctive phenotype which responds quite well to trazodone, decreasing OSA severity without increasing nocturnal hypoxia. Clinicaltrials.gov: NCT04162743, 2019/11/10.

Impact of Hybrid Closed Loop Therapy on Hypoglycemia Awareness in Individuals with Type 1 Diabetes and Impaired Hypoglycemia Awareness.

Objective: This study evaluated the efficacy of using a hybrid closed loop (HCL) system in restoring hypoglycemia awareness in individuals with impaired awareness of hypoglycemia (IAH). Research Design and Methods: Participants with IAH (Gold score ≥4) were recruited into a randomized crossover pilot study. They participated in two 8-week periods using a HCL system (Medtronic 670G™) (intervention) and standard insulin pump therapy (control). Hyperinsulinemic hypoglycemic clamp studies were undertaken at baseline and at the end of each study period for the evaluation of the counter-regulatory hormonal and symptomatic responses to hypoglycemia. Results: Seventeen participants (mean age [standard deviation] 35.8 years [11.2 years]) were included in the study. Peak epinephrine levels (median, interquartile range [IQR]) in response to hypoglycemia were similar postintervention and control periods; 234.7 pmol/L (109.2; 938.9) versus 188.3 pmol/L (133.7; 402.9), P = 0.233. However, both peak adrenergic and neuroglycopenic symptom scores were higher after intervention; 5.0 (4.5; 9.0) versus 4.0 (4.0; 5.5), P = 0.009, and 8.5 (6.0; 15.0) versus 6.5 (6.0; 7.0) P = 0.014, respectively. Self-reported hypoglycemia awareness improved: median (IQR) Gold score was 4.0 (3.0; 5.5) versus 5.5 (4.5; 6.0); intervention versus control, P = 0.033. Time spent <3.9 and <3.0 mmol/L was lower in the intervention group than in control, P = 0.002. Other patient-reported outcomes (hypoglycemia fear and diabetes treatment satisfaction) did not change. Conclusions: A short-term use of a HCL system failed to demonstrate an improvement in counter-regulatory hormonal responses. However, higher hypoglycemia symptom scores during controlled hypoglycemia, better self-reported hypoglycemia awareness, and less time spent in hypoglycemia suggest the potential benefits of a HCL system in people with IAH. Trial Registration: anzctr.org.au Identifier: ACTRN12616000909426.

A theory-based multicomponent intervention to reduce occupational sedentary behaviour in professional male workers: protocol for a cluster randomised crossover pilot feasibility study

BackgroundProlonged sitting, a significant risk factor for increased morbidity and mortality, is accumulated mostly in the workplace. There is limited research targeting specific at-risk populations to reduce occupational sedentary behaviour. A recent study found that professional males have the longest workplace sitting times. Current evidence supports the use of multi-level interventions developed using participative approaches. This study’s primary aims are to test the viability of a future definitive intervention trial using a randomised pilot study, with secondary aims to explore the acceptability and feasibility of a multicomponent intervention to reduce workplace sitting.MethodsTwo professional companies in Dublin, Ireland, will take part in a cluster randomised crossover pilot study. Office-based males will be recruited and randomised to the control or the intervention arms. The components of the intervention target multiple levels of influence including individual determinants (via mHealth technology to support behaviour change techniques), the physical work environment (via provision of an under-desk pedal machine), and the organisational structures and culture (via management consultation and recruitment to the study). The outcomes measured are recruitment and retention, minutes spent sedentary, and physical activity behaviours, work engagement, and acceptability and feasibility of the workplace intervention.DiscussionThis study will establish the acceptability and feasibility of a workplace intervention which aims to reduce workplace SB and increase PA. It will identify key methodological and implementation issues that need to be addressed prior to assessing the effectiveness of this intervention in a definitive cluster randomised controlled trial.

Semi-fixed versus fixed oral appliance therapy for obstructive sleep apnea: A randomized crossover pilot study

Background/purposeAlthough mandibular advancement oral appliances (OAs) are the most widely used and accepted therapeutic modality for obstructive sleep apnea (OSA), whether these maxillary and mandibular appliances should be semi-fixed or fixed remains uncertain. This randomized crossover pilot study compared the efficacy, side effects, and patient preference of semi-fixed and fixed OAs for the treatment of OSA. Materials and methodsPatients with mild to moderate OSA were recruited and randomly assigned to either the semi-fixed or fixed OA group, whereby they used their assigned OA for the first 4 weeks, followed by assessments for sleep parameters (including the Apnea-Hypopnea Index [AHI]) and temporomandibular joint pain as a side effect. After a two-week washout period, patients were switched to the alternative OA for 4 weeks, followed by repeated assessments. Patient preference was assessed at the end of the completed treatment period. ResultsFifteen patients were enrolled and completed the full study protocol. Both types of OAs were efficient in reducing the patient's AHI in comparison to baseline (i.e., without OA). However, there was no significant difference in AHI reduction between the semi-fixed and fixed OA devices. Regarding the side effect of temporomandibular joint pain and patient preference, the semi-fixed OA device was superior to the fixed OA device on both measures. ConclusionWhile both semi-fixed and fixed OAs are effective in treating patients with OSA, semi-fixed OAs are superior in regards to both patient preference and reduced side effects. Thus, semi-fixed OAs may be the preferred therapeutic modality for OSA.

Effects of Acute Experimental Stress on Pain Sensitivity and Cortisol Levels in Healthy Participants: A Randomized Crossover Pilot Study.

To investigate pain sensitivity in the masseter muscle and index finger in response to acute psychologic stress in healthy participants. Fifteen healthy women (23.7 ± 2.3 years) participated in two randomized sessions: in the experimental stress session, the Paced Auditory Serial Addition Task (PASAT) was used to induce acute stress, and in the control session, a control task was performed. Salivary cortisol, perceived stress levels, electrical and pressure pain thresholds (PTs), and pain tolerance levels (PTLs) were measured at baseline and after each task. Mixed-model analysis was used to test for significant interaction effects between time and session. An interaction effect between time and session occurred for perceived stress levels (P < .001); perceived stress was significantly higher after the experimental task than after the control task (P < .01). No interaction effects occurred for salivary cortisol levels, electrical PTs, or pressure PTLs. Although significant interactions did occur for electrical PTL (P < .05) and pressure PT (P < .001), the simple effects test could not identify significant differences between sessions at any time point. The PASAT evoked significant levels of perceived stress; however, pain sensitivity to mechanical or electrical stimuli was not significantly altered in response to the stress task, and the salivary cortisol levels were not altered in response to the PASAT. These results must be interpreted with caution, and more studies with larger study samples are needed to increase the clinical relevant understanding of the pain mechanisms and psychologic stress.