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Efficacy and safety of transcutaneous auricular vagus nerve stimulation in patients with acute mountain sickness: a study protocol for a double-blind, randomised, sham-controlled trial

Por: Tian · Y.-k. · Wang · X. · Cao · X. · Ji · H.-m. · Wang · B.-Q. · Liu · J.
Introduction

Acute mountain sickness (AMS) commonly occurs during rapid ascent to high altitudes and significantly affects the health and cognitive function of travellers and specialised personnel in high-altitude environments. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive, safe and portable neuromodulation technique with potential benefits for AMS. This protocol evaluates taVNS efficacy for AMS and associated cognitive impairment and explores its mechanisms via multiomics analyses.

Methods and analysis

This is a single-centre, randomised, double-blind, sham-controlled study involving ≥158 participants with AMS, who will be randomly assigned to receive either active or sham taVNS for five consecutive days. The primary outcome is the change in the 2018 Lake Louise AMS Score at 24 hours. Secondary outcomes are the Visual Analogue Scale for headache, Stanford Sleepiness Scale, Groningen Sleep Quality Questionnaire, resting heart rate, resting blood pressure, peripheral oxygen saturation, cerebral oxygen saturation, Corsi task score and the Picture Recall Subscale of the Wechsler Adult Memory Scale, which collectively assess symptom relief, physiological responses and cognitive function. The exploratory outcomes include faecal and urinary metabolomics.

Ethics and dissemination

All investigations performed in this study were reviewed and approved by the Ethics Committee of the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences (reference number: P24013-PJ13). The findings will be disseminated through peer-reviewed publications, conference presentations and feedback for the study participants.

Trial registration number

http://itmctr.ccebtcm.org.cn/; number: TMCTR2024000642.

Social Isolation but not Loneliness Influences Heart Failure Patients Self-Care in the Postpandemic era

Por: Shih · Y.-H. · Chen · H.-M.

Commentary on: Effects of social isolation and loneliness on heart failure self-care: A cross-sectional analysis. J Cardiovasc Nurs. 9900:10.1097/JCN.0000000000001123.

Implications for practice and research

  • Fostering existing relationships and creating new connections can significantly enhance patients’ ability to manage self-care for heart failure.

  • Developing comprehensive tools and confirming the mechanisms among social isolation, loneliness and heart failure self-care can help improve self-care practices in patients with heart failure.

  • Context

    Adequate self-care practice is vital to stabilise physical functioning, maintain quality of life and reduce unplanned readmissions and mortality in patients with heart failure (HF).1 2 Better social support can facilitate patients’ engagement in self-care.3 4 In contrast, lack of social support, such as social isolation and loneliness, can undermine self-care practices.3–5 Social isolation is a similar but distinct concept to...

    Efficacy and safety of Doxycycline versus Macrolides for Mycoplasma pneumoniae INfectiOn in Children (DOMINO): a protocol for a multicentre, randomised, open-label, superiority trial

    Por: Choi · Y. Y. · Kang · C. · Choe · Y. J. · Yoo · Y. · Shin · A. · Kim · D. R. · Ahn · B. · Eun · B. W. · Kim · G. · Kang · H.-M. · Kim · Y. J. · Cho · Y. K. · Lee · H. · Kim · Y. K. · Choi · J. H. · Yun · K. W. · Jo · K. J. · Kim · K.-R. · Lee · T. J. · Choi · U. Y. · Yoon · Y. S. · Kim · J. · Kang
    Introduction

    Mycoplasma pneumoniae (MP) is a major cause of community-acquired pneumonia in children. In East Asia, the prevalence of macrolide-resistant MP (MRMP) has surged, leading to treatment failures and prolonged illness. While doxycycline is an effective alternative, its use in young children has historically been limited due to concerns about tooth discolouration. This study aims to evaluate the efficacy and safety of doxycycline compared with azithromycin as a first-line treatment for children with pneumonia suspected of MRMP infection.

    Methods and analysis

    This is a multicentre, randomised, open-label, parallel-group superiority trial conducted at 14 tertiary hospitals in South Korea. A total of 208 children (aged 3–17 years) with pneumonia and confirmed or suspected MP infection will be randomised 1:1 to receive either doxycycline (4 mg/kg/day in two divided doses for 7–14 days) or azithromycin (10 mg/kg on day 1, then 5 mg/kg on days 2–5) (). Randomisation will be stratified by age (3–7 years vs 8–17 years). A standardised ‘rescue therapy’ protocol ensures patient safety by allowing control group patients to switch to doxycycline if no clinical improvement is observed within 48–72 hours. The primary outcome is the defervescence rate within 72 hours after randomisation. Secondary outcomes include treatment failure rate, length of hospital stay, symptom duration and adverse events. Safety assessment will specifically include tooth discolouration evaluation at Day 28, focused on children aged

    Ethics and dissemination

    This study has been approved by the Institutional Review Boards (IRB) of all participating centres. Written informed consent will be obtained from parents or legal guardians, and assent will be obtained from children aged 7 years and older. Results will be disseminated through peer-reviewed publications and conference presentations.

    Trial registration number

    NCT07306234.

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