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Mitigating chronic respiratory disease through the lens of multimorbidity: the MARES mixed-methods study protocol

Por: Mendes · R. G. · Leonardi · N. T. · Castello-Simoes · V. · Kawakami · D. M. d. O. · Souza · J. V. R. · Schafauser-Segundo · N. S. · Simoes · R. P. · Pinto · F. G. · Araujo · G. H. G. · da Silva · M. M. C. · Moriguchi · C. S. · Franco · F. J. B. Z. · Pires Di Lorenzo · V. A. · Jor
Introduction

Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.

Objective

To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.

Methods and analysis

The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.

MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.

MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.

MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.

Ethics and dissemination

This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.

Trial registration number

NCT07050823/NCT07093021/NCT07134855.

Faster but less accurate: An explorative study on the effects of three weeks of ketogenic diet on cognitive functions in undergraduate students

by Gianluigi Serio, Consiglia Pacelli, Claudia Piccoli, Nazzareno Capitanio, Giuseppe Cibelli, Anna Antonia Valenzano, Francesca Landini, Leonardo Carlucci, Paola Palladino

The ketogenic diet (KD) is a low-carbohydrate diet that induces and sustains a ketosis state and minimizes somatic glucose levels. Several psychological studies have described the positive effects of ketosis on cognitive functions for a wide range of neuropsychiatric conditions (e.g., Alzheimer’s disease; epilepsy), leading to greater interest in the KD today. However, the psychological and cognitive effects of inducing ketosis via diet remain unclear, especially in healthy people. From an initial pool of thirty participants, eight undergraduate students performed a cognitive assessment before (baseline) and after three weeks (follow-up) of an isocaloric ketogenic diet. Several neuropsychological measures and psychometric tests have been administered to investigate psychological chronotype, sleep quality, eating habits, anxiety and cognitive components of attention, inhibition, and memory. Non-parametric Bayesian analysis showed that the ketogenic diet affected cognitive functions. Participants performed cognitive tests faster at follow-up than at baseline, showing improvements in visual-motor cognitive and processing speed components. However, they were less accurate on working memory tasks, suggesting a decreasing performance of higher cognitive functions. Finally, no differences in anxiety levels were found between baseline and follow-up. The results could have significant implications for identifying specific cognitive models of students based on specific lifestyle habits and nutritional patterns, allowing the implementation of targeted interventions to improve university learning conditions.

Sleep improvement strategies for people with vision impairment: a scoping review

Por: Leonard-Hawkhead · B. · Piyasena · M. P. · Peto · T. · Virgili · G. · van Nispen · R. M. A. · Curran · K.
Objectives

To explore existing strategies for managing sleep disorders in individuals with vision impairment (VI), identifying interventions, geographical trends and research gaps.

Design

Scoping review.

Data sources

Medline ALL (Ovid), Embase and Web of Science Core Collection, with supplementary searches in Google Scholar. The final search was completed on 28 November 2025.

Eligibility criteria for selecting studies

Original research studies examining strategies to manage sleep disorders in adults (≥18 years) with VI, published in English. Studies focusing on animal models or unrelated to sleep management were excluded.

Data extraction and synthesis

Two reviewers independently screened titles, abstracts and full texts using Covidence, extracted data using a predefined form and resolved discrepancies by consensus. A narrative synthesis approach was used to summarise findings by intervention type, study design and outcomes.

Results

Of 4368 records screened, 16 studies met inclusion criteria. Participants ranged from 18 years to 85 years (median 40.5). Most studies included individuals with no light perception, though VI definitions were often inconsistent. Pharmacological interventions dominated (13/16, 81.3%), mainly melatonin or melatonin receptor agonists, with some use of zopiclone, low-dose benzodiazepines and tricyclic antidepressants. Non-pharmacological approaches were under-represented, including bright light exposure (n=1), virtual Hatha yoga (n=1) and caffeine modulation (n=1). Substantial variation existed in sleep assessment methods.

Conclusions

This scoping review highlights the predominant focus on pharmacological treatments, especially melatonin, while non-pharmacological strategies remain underexplored. Future research should explore accessible, non-pharmacological interventions and address sleep health inequities faced by individuals with VI.

Registration

10.17605/OSF.IO/7E83R.

Non-invasive neuromodulation for alleviating dyspnoea: protocol for a feasibility sham-controlled randomised trial

Por: St-Pierre · J. · Mailhot-Larouche · S. · Garand · G. · Vezina · F.-A. · Leonard · G. · Iorio-Morin · C. · Couillard · S.
Introduction

Dyspnoea affects 10% of the general population, and 12% of hospitalised patients report experiencing dyspnoea at rest. It is a common and distressing symptom experienced by people living with chronic obstructive pulmonary disease (COPD). Neuromodulation, which uses electrical stimulation to modulate neural pathways, is a validated clinical procedure offering a potential therapeutic approach. We speculate that non-invasive transcutaneous vagus nerve stimulation (tVNS) and trigeminal transcutaneous electric nerve stimulation (TENS) could improve dyspnoea management by targeting relevant neural circuits.

Methods and analysis

We will conduct a feasibility cross-over trial in people with severe COPD and significant exertional dyspnoea referred for pulmonary rehabilitation. Patients will be recruited following the prerehabilitation assessment visit comprising a clinical evaluation and a maximal cardiopulmonary exercise testing on ergocycle. Subsequently, two study visits will be conducted within 2 weeks apart from each other. Eight participants will perform a submaximal constant work rate at 80% workload of the VO2 max, either with cervical tVNS (n=4) or trigeminal TENS (n=4). In a cross-over design, both patient groups will undergo sham and active treatment of the neuromodulation technique in a randomly assigned order. The main outcome will be feasibility, assessed by the percentage of patients who attend all visits and complete all tests. Secondary outcomes include other feasibility endpoints, the acceptability and suitability of the interventions (including an evaluation of sham as an exploratory outcome), and the incidence of adverse or undesirable events related to the procedures. Exploratory outcomes include changes in dyspnoea symptoms, measured using standardised questionnaires, such as Borg scale and the Visual Analogue Scale.

Ethics and dissemination

The protocol is approved by the institutional research ethics committee of the Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l’Estrie—CHUS, Sherbrooke, Quebec, Canada (#2025-5604) and follows 2013 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Results will be communicated in international meetings and submitted to peer-reviewed journals with respect to the 2010 CONsolidated Standards Of Reporting Trials (CONSORT) statement for feasibility studies.

Trial registration number

NCT06985628.

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