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Sleep, Stress, and Symptoms Among People With Heart Failure During the COVID-19 Pandemic.
O'Connell, M, Jeon, S, Conley, S, Linsky, S, Redeker, NS
The Journal of cardiovascular nursing. 202301;38(2):E55-E60
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COVID-19 pandemic raised concerns about the effects of stress on mental health and sleep deficiency. Cognitive behavioural therapy for insomnia (CBT-I) has been shown to improve sleep quality and insomnia severity, as well as anxiety and depression, and may be protective during times of stress, including the COVID-19 pandemic. The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with heart failure (HF). This study was a randomised controlled trial of the effects of CBT-I compared with HF self-management education (attention-control condition), the “HeartSleep Study.” Results showed that improvements in insomnia severity, sleep quality, latency, and efficiency, sleep-related cognitions and stress, anxiety, and depression after participation in CBT-I or an HF self-management class were sustained during the pandemic. Authors conclude that their findings confirm the clinical benefits of CBT-I for people with HF and comorbidities and also suggest the potential benefits of HF self-management education.
Abstract
BACKGROUND The COVID-19 pandemic raised concerns about the effects of stress on sleep and mental health, particularly among people with chronic conditions, including people with heart failure (HF). OBJECTIVE The aim of this study was to examine changes in sleep, sleep-related cognitions, stress, anxiety, and depression among people with HF who participated in a randomized controlled trial of cognitive behavioral therapy for insomnia before the COVID-19 pandemic. METHODS Participants self-reported sleep characteristics, symptoms, mood, and stress at baseline, 6 months after cognitive behavioral therapy for insomnia or HF self-management education (attention control), and during the pandemic. RESULTS The sample included 112 participants (mean age, 63 ± 12.9 years; 47% women; 13% Black; 68% New York Heart Association class II or III). Statistically significant improvements in sleep, stress, mood, and symptoms that occurred 6 months post treatment were sustained during the pandemic. CONCLUSIONS Improving sleep and symptoms among people with HF may improve coping during stressful events, and cognitive behavioral therapy for insomnia may be protective.
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Washing Illness Away: A Systematic Review of the Impact of Nasal Irrigation and Spray on COVID-19.
Gandhi, K, Paczkowski, F, Sowerby, L
The Laryngoscope. 2025;(2):517-528
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OBJECTIVE Nasal irrigation is a common treatment for sinonasal disorders; however, it is unknown if it can reduce SARS-CoV-2 nasopharyngeal viral load (NVL). This systematic review investigated the efficacy of nasal irrigation with saline, povidone iodine (PVP-I), and intranasal corticosteroids (INCS) at reducing SARS-CoV-2 NVL and transmissibility. DATA SOURCES Databases including Embase, MEDLINE, Web of Science, and ClinicalTrials.gov. REVIEW METHODS A systematic review was completed with pre-defined search criteria using keywords related to nasal irrigation and COVID-19 from 1946 through January 2024. This review followed PRISMA reporting guidelines and was registered on PROSPERO. Only in-vivo studies testing nasal irrigation with either saline, PVP-I, or INCS for reducing NVL were included. RESULTS Nine out of ten studies on saline-based solutions reported positive effects in reducing NVL, with benefits noted in earlier time to negative nasopharyngeal PCR and a greater decline in NVL during early study time points, compared with controls. Isotonic and hypertonic saline mediums were found to be effective with three studies demonstrating enhanced efficacy with additives. Four out of seven studies on PVP-I showed a positive effect on reducing NVL, but results were heterogenous. Four studies demonstrated reduction of transmission with saline or PVP-I. No studies were found on INCS. CONCLUSION Saline nasal irrigation showed the best efficacy in reducing SARS-CoV-2 NVL. Additives to saline may have a clinical benefit, but further studies are needed to elucidate their isolated impacts on NVL. Data on PVP-I is inconclusive and further studies are warranted to determine the ideal concentration for irrigation. Laryngoscope, 135:517-528, 2025.
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A Systematic Review: The Impact of COVID-19 Policy Flexibilities on SNAP and WIC Programmatic Outcomes.
Crespo-Bellido, M, Headrick, G, López, MÁ, Holcomb, J, Khan, A, Sapkota, S, Hollis-Hansen, K
Advances in nutrition (Bethesda, Md.). 2025;(2):100361
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In response to the coronavirus disease 2019 (COVID-19) public health emergency (PHE), the federal government deployed policy flexibilities in food and nutrition assistance programs including the Supplemental Nutrition Assistance Program (SNAP) and Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) to meet the needs those experiencing economic hardship. Emergent literature evaluates the impact of these flexibilities on program outcomes. The objective of this study was to explore the impact of policy flexibilities deployed during the COVID-19 PHE on access, enrollment/retention, benefit utilization, and perceptions of SNAP and WIC. Keyword searches were performed in November 2023, February 2024, and August 2024. The search included peer-reviewed literature from 2020 to 2024, following Johanna Briggs Institute (JBI) and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, resulting in 37 eligible articles. Twelve studies evaluated policy flexibilities in SNAP only, 21 in WIC only, and 4 in both programs. Across these, 12 studies explored program access, 7 enrollment/retention, 13 benefit utilization, and 15 program perceptions. JBI critical appraisal tools were used to assess risk of bias. The reviewed articles show that although SNAP and WIC participants identified challenges to access, there were increases in enrollment/retention due to policy flexibilities enabling remote services and reducing administrative burden in both programs. Benefit increases led to greater purchase of preferred foods in SNAP and greater access to fruit and vegetables in WIC. Overall, participants were satisfied with the flexibilities and reported most were beneficial for their households. Some implementation challenges were identified by participants and staff. A few studies showed potential risks of bias, including selection bias and confounding bias. COVID-19-related policy flexibilities in SNAP and WIC demonstrated significant improvements in selected program outcomes; however, challenges communicating policy flexibilities to authorized vendors and participants created difficulties to benefiting from the flexibilities. Findings from the evaluations of these flexibilities can inform future program enhancements and long-term regulatory changes. This study was registered in PROSPERO (CRD42023493302).
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Efficacy and Safety of Sodium Oxybate in Isolated Focal Laryngeal Dystonia: A Phase IIb Double-Blind Placebo-Controlled Cross-Over Randomized Clinical Trial.
Simonyan, K, O'Flynn, LC, Hamzehei Sichani, A, Frucht, SJ, Rumbach, AF, Sharma, N, Song, PC, Worthley, A
Annals of neurology. 2025;(2):329-343
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OBJECTIVE To examine the efficacy and safety of sodium oxybate versus placebo in a phase IIb randomized double-blind placebo-controlled 2-period cross-over clinical trial in patients with isolated laryngeal dystonia (LD). METHODS The study was conducted from January 2018 to December 2021, pausing during the COVID-19 pandemic, at Massachusetts Eye and Ear in 106 patients with alcohol-responsive (EtOH+) and alcohol-non-responsive (EtOH-) LD (53 to receive 1.5g of sodium oxybate first, 53 to receive matching placebo first). The primary outcome was a change from baseline in LD symptom severity 40 minutes after drug intake. Safety was based on vital signs, cognitive function, suicidality, daytime sleepiness, and adverse events. Patients, investigators, and outcome assessors were masked to study procedures. RESULTS Compared to baseline, EtOH+ but not EtOH- patients had a statistically significant improvement in LD symptoms following sodium oxybate versus placebo (EtOH+: 98.75% confidence interval [CI] = 0.6-26.9; p = 0.008; EtOH-: 98.75% CI = -6.2 to 18.7; p = 0.42). Statistically significant minimum drug efficacy in EtOH+ patients was found at ≥16% symptom improvement (OR = 2.09; 98.75% CI = 0.75-5.80; p = 0.036), with an average of 40.81% benefits (98.75% CI = 34.7-48.6). Drug efficacy waned by 300 minutes after intake without a rebound. No changes were found in cognitive function, suicidality, or vital signs. Common adverse events included mild dizziness, nausea, and daytime sleepiness. INTERPRETATION Sodium oxybate showed clinically meaningful improvement of symptoms in EtOH+ LD patients, with acceptable tolerability. Sodium oxybate offers the first pathophysiologically relevant oral treatment for laryngeal dystonia. ANN NEUROL 2025;97:329-343.
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Can nebulised heparin reduce acute lung injury in patients with SARS‑CoV‑2 requiring advanced respiratory support in Ireland: the CHARTER‑Ireland phase Ib/IIa, randomised, parallel-group, open-label study.
Cosgrave, D, McNicholas, B, Hanley, C, Sheehan, JR, Calpin, P, Kernan, M, Murphy, D, Alvarez-Iglesias, A, Ferguson, J, Giacomini, C, et al
Intensive care medicine experimental. 2025;(1):15
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BACKGROUND Nebulised unfractionated heparin may attenuate COVID-19 ARDS by reducing pulmonary microvascular thrombosis, blocking SARS-CoV-2 entry into cells, and decreasing lung inflammation. COVID-19 patients with a raised D-dimer have areas of pulmonary hypoperfusion on CT perfusion scans of the lung and have increased mortality risk. METHODS This was a phase Ib/IIa open-label multi-centre, randomised controlled trial. The study was designed to evaluate whether nebulised unfractionated heparin decreased D-dimer concentrations, with safety as a co-primary outcome. RESULTS Forty patients were recruited, with 20 patients into each group. Mean age was 56.6 (SD 11.5) in the heparin group and 51.3 (SD 14.7) in the standard care group, while 60% of participants were male. There was no change in D-dimers from baseline to day 10 (heparin group mean change - 316.5, [SD 1840.3] and control group mean change - 321.7 [SD 3589.4]; p = 0.996). Fourteen patients suffered at least one serious adverse event, 9 patients the Heparin group and 5 in the control group. Eight patients had one or more bleeding events, 5 in the heparin group and 3 in the control group, but were no cases of pulmonary bleeding, of severe haemorrhage or of heparin-induced thrombocytopenia. Patients receiving heparin therapy had lower PaO2/FiO2 ratios, increased oxygenation indices, and decreased ROX index profiles, up to day 10. The time to separation from respiratory support, and the time to ICU or hospital discharge was similar in both groups. There were 3 deaths in the Heparin group and 2 in the control group. CONCLUSIONS Nebulised unfractionated heparin was safe and well tolerated, but did not reduce D-dimer concentrations, and worsened oxygenation indices in patients with COVID-19 ARDS.
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Metabolic acidosis with elevated anion gap and euglycemic ketoacidosis in pregnant and postpartum women with severe Covid-19.
Melo Mendes, IC, Martins de Oliveira, AL, Pinheiro Trindade, PM, Mendes da Silva, W, Pimentel, C, Perlingeiro, RM, Melo Guedes, C, Caminha Escosteguy, C, Galliez, RM
Annals of medicine. 2025;(1):2445189
Abstract
BACKGROUND/OBJECTIVES Pregnant and postpartum women have a higher risk for developing severe Covid-19 and other clinical and obstetric complications. This study aims to evaluate the frequency of metabolic acidosis with elevated anion gap and describe a case series of euglycemic ketoacidosis (EKA) in pregnant and postpartum women with severe confirmed or suspected Covid-19. MATERIALS AND METHODS Observational retrospective study carried in a reference intensive care unit from May 2020 to June 2022. Cases were confirmed with positive RT-PCR or rapid antigen test. Cases with compatible clinical and radiologic findings were also included. Ketoacidosis was defined as the presence of metabolic acidosis with high anion gap (bicarbonate < 15 mEq/L and AG > 10 mEq/L) and ketonuria (2+ or more in urine test). Statistical analyses were made with R software. RESULTS Of 101 admissions, 61 (60.4%) presented metabolic acidosis with high anion gap. The median age was 29 years, and most were in the third trimester. Evolution to invasive mechanical ventilation (54.0%) and obstetric complications (78.0%) were frequent. The prevalence of metabolic acidosis with high anion gap and absence of hyperlactatemia was of 43.6% (44/101). Six (5.94%) women met the criteria for EKA. Despite severity, there were no deaths. CONCLUSIONS The prevalence of metabolic acidosis and EKA in pregnant and postpartum women with severe Covid-19 was high. This condition should be routinely, so it can be promptly treated.
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Vitamin D, acute respiratory infections, and Covid-19: The curse of small-size randomised trials. A critical review with meta-analysis of randomised trials.
Autier, P, Doi, G, Mullie, P, Vankrunkelsven, P, D'Ecclesiis, O, Gandini, S
PloS one. 2025;(1):e0303316
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BACKGROUND Randomised trials conducted from 2006 to 2021 indicated that vitamin D supplementation (VDS) was able to prevent severe COVID-19 and acute respiratory infections (ARI). However, larger randomised trials published in 2022 did not confirm the health benefits of VDS in COVID-19 patients. OBJECTIVE To examine through a systematic review with meta-analysis the characteristics of randomised trials on VDS to COVID-19 patients and admission to intensive care unit (ICU), and of randomised trials on VDS for the prevention of ARI. METHOD A systematic search retrieved randomised trials on VDS to COVID-19 patients and admission to ICU. Data on VDS and ARI were extracted from the meta-analysis of Jolliffe et al. 2021. Groups were formed including trials with total numbers of patients below or above the median size of all trials. The associations between VDS vs no VDS, and admission to ICU were evaluated using random-effects models from which summary odds ratios (SOR) and 95% confidence intervals (CI) were obtained. Meta-analyses were done for all trials and for each group of trials, which allowed testing a possible effect modification of trial size. Publication bias was assessed using the Louis-Furuya-Kanaruori (LFK) index (no bias if index between -1 and +1) and the trim and fill method. RESULTS Nine trials on VDS for preventing admission to ICU were identified, including 50 to 548 patients. The summary odds ratio (SOR) was 0.61 (95% CI: 0.39-0.95) for all trials, 0.34 (0.13-0.93) for trials including 50 to <106 patients and 0.88 (0.62-1.24) for trials including 106 to 548 patients (interaction p = 0.04). The LFK index was -3.79, and after trim and fill, the SOR was 0.80 (0.40-1.61). The SOR for the 37 trials on VDS for ARI prevention included 25 to 16,000 patients. The SOR was 0.92 (0.86-0.99) for all trials, 0.69 (0.57-0.83) for trials including 25 to <248 patients and 0.98 (0.94-1.03) for trials including 248 to 16,000 patients (interaction p = 0.0001). The LFK index was -3.11, and after trim and fill, the SOR was 0.96 (0.88-1.05). CONCLUSION Strong publication bias affected small randomised trials on VDS for the prevention of severe COVID-19 and of ARI. Systematic reviews should beware of small-size randomised trials that generally exaggerate health benefits.
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Effectiveness of Mobile Health Applications for Cardiometabolic Risk Reduction in Urban and Rural India: A Pilot, Randomized Controlled Study.
Ranjani, H, Avari, P, Nitika, S, Jagannathan, N, Oliver, N, Valabhji, J, Mohan, V, Chambers, JC, Anjana, RM
Journal of diabetes science and technology. 2025;:19322968241310861
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INTRODUCTION mHealth technology has the potential to deliver personalized health care; however, data on cardiometabolic risk factors are limited. This study aims to assess the effectiveness of mobile health applications (apps) on cardiometabolic risk factor reduction in adults aged 25 to 60 years in urban and rural India. METHODS The study design was a pilot randomized controlled trial conducted in Tamil Nadu, India. Smartphone users (25-60 years) with basic literacy and at high risk of developing diabetes (Indian Diabetes Risk Score ≥30 and/or fasting blood sugar [FBS] 100-125 mg/dL) were recruited. Four mobile apps (two commercially available, two novel) for cardiometabolic risk reduction were evaluated. Primary outcome (weight loss) was analyzed using intention-to-treat analysis with post hoc analysis and logistic regression models adjusted for confounders. RESULTS A total of 5264 participants were screened, and 610 were recruited into the study. Participants (7%) dropped out largely due to the COVID-19 pandemic. Data from 567 participants were used for the final analysis. In the intention-to-treat analysis, a significant reduction in body weight was observed in the intervention group as compared with control, more so in the urban (-2.40 kg, 95% confidence interval [CI] = [-3.10, -1.69], P < .001) compared with rural population (-1.19 kg, 95% CI = [-1.55, -0.82], P < .001). Intervention group participants showed significant reductions in body mass index, waist circumference, blood pressure, FBS, total serum cholesterol, and a positive effect on dietary and physical activity behaviors compared with controls. CONCLUSIONS mHealth interventions can reduce diabetes risk, improve cardiometabolic health, and improve lifestyle behaviors in South Asian populations. TRIAL REGISTRATION The trial is registered with the Central Trials Registry, India (CTRI/2020/03/024327).
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Incidence and Association of Uveitis with COVID-19 Vaccination: A Systematic Review and Meta-Analysis.
Padhi, BK, Gupta, PC, Al Kaabi, NA, Al-Subaie, MF, Alrasheed, HA, Sulaiman, T, Rabaan, AA, Khatib, MN, Gaidhane, S, Zahiruddin, QS, et al
Ophthalmic epidemiology. 2025;(1):112-120
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PURPOSE In the wake of the COVID-19 pandemic, vaccines have been pivotal in curbing disease spread and severity. However, concerns over post-vaccination adverse events, including uveitis, an inflammatory ocular condition, have been noted. This systematic review and meta-analysis aimed to evaluate the incidence and association of uveitis following COVID-19 vaccination. METHODS A literature search was performed across several databases on October 21, 2023. Human studies examining the incidence of uveitis post-COVID-19 vaccination were included. The Newcastle-Ottawa Scale was used for quality appraisal of the included studies. Meta-analysis was performed to assess the overall incidence of uveitis and the relative risk of developing the condition post-vaccination. All statistical analyses were performed using R software version 4.3. RESULTS Six studies involving over 2 billion vaccine doses were included. The overall incidence of uveitis was 0.016% (95% CI: 0.010 to 0.026). No significant association was found between vaccination and the onset of uveitis (Relative Risk: 1.45 (95% CI: 0.82 to 2.57, p = 0.12) from four studies. The evidence quality was rated very low due to the limited number of studies and imprecision. CONCLUSION This analysis indicates a low incidence of uveitis following COVID-19 vaccination and no significant association with the vaccine. The findings are constrained by the small number of studies and low certainty of evidence, underscoring the need for further research. Comprehensive and longitudinal studies are necessary to confirm these findings and reinforce public confidence in COVID-19 vaccination programs.
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Comparison of the role of vitamin D in normal organs and those affected by COVID-19.
Peramaiyan, R, Anthony, J, Varalakshmi, S, Sekar, AK, Ali, EM, A, AHS, Abdallah, BM
International journal of medical sciences. 2025;(2):240-251
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The outbreak of COVID-19 has opened up new avenues for exploring the importance of vitamin D in immunity, in addition to its role in calcium absorption. Recently, vitamin D supplementation has been found to enhance T regulatory lymphocytes, which are reduced in individuals with COVID-19. Increased risk of pneumonia and increases in inflammatory cytokines have been reported to be major threats associated with vitamin-D deficiency. Although vaccination reduces the threat of COVID-19 to a certain extent, herd immunity is the long-term solution to overcoming such diseases. Co-administration of vitamin D with certain inactivated vaccines has been reported to enhance the systemic immune response through stimulation of the production of antigen-specific mucosal immunity. COVID-19 was found to induce multiple organ damage, and vitamin D has a beneficial role in various organs, such as the intestines, pancreas, prostate, kidneys, liver, heart, brain, and immune cells. The consequences that occur after COVID-19 infection known as long COVID-19 are also a concern as they accumulate and target multiple organs, leading to immune dysregulation. The present review covers the overall role and impact of vitamin D and its deficiency for various organs in normal conditions and after COVID-19 infection, which is still a serious issue.