JMIR Research Protocols最新文献

{"title":"Effect of Sleep Hygiene on Metabolic Syndrome in an Adult Rural Population in India: Protocol for a Cross-Sectional Study.","authors":"Rishabh Kothari, Sonali Choudhari","doi":"10.2196/90117","DOIUrl":"https://doi.org/10.2196/90117","url":null,"abstract":"<p><strong>Background: </strong>Metabolic syndrome (MetS) refers to a group of conditions including high blood pressure, excess weight, high blood glucose, and abnormal cholesterol and triglyceride levels that together substantially increase the risk of heart disease and diabetes. Poor sleep hygiene is associated with a higher likelihood of type 2 diabetes, while sleep duration can affect the development of various MetS components. Approximately 25% of adults worldwide currently have MetS, and this prevalence is projected to increase to 50% by 2035. However, there is a distinct lack of evidence about the specific impact of sleep hygiene on cardiometabolic health within the rural Indian population. This study will focus on addressing this literature gap by evaluating these risk factor associations by using validated tools to help develop targeted community interventions.</p><p><strong>Objective: </strong>This study aims to estimate the prevalence of poor sleep quality and cardiometabolic risk factors in a rural Indian population and to determine the association between sleep hygiene and cardiometabolic risk factors.</p><p><strong>Methods: </strong>This study will be a community-based, cross-sectional, analytical study, and data collection will be carried out by trained personnel using validated tools during house-to-house visits. In this cross-sectional study of 281 rural Indian adults aged ≥40 years, sleep quality will be assessed via the Pittsburgh Sleep Quality Index (a score >5 indicates poor sleep), alongside direct measurements of blood pressure, fasting plasma glucose, BMI (≥25 kg/m² for obesity), waist circumference, and the Madras Diabetes Research Foundation-Indian Diabetes Risk Score for diabetes risk. Data will be collected through a door-to-door approach, with informed consent entered into Google Forms, and quality checked via training and regular reviews. Using R software, analyses will include prevalence estimates with 95% CIs; chi-square or t tests for associations between poor sleep and cardiometabolic risks; and logistic regression (P<.05) adjusted for confounders such as diet, stress, and physical activity.</p><p><strong>Results: </strong>This study began in January 2025 with conceptualization and ethics approval obtained in June 2025. Data collection commenced in August 2025 following Clinical Trial Registry-India registration, with 53 participants enrolled as of May 5, 2026. Standardized tools (GAD-7, PHQ-9, and GPAQ) were incorporated to assess key confounding variables. Data collection is projected to finish by January 2027, with final analysis and study conclusion expected by March 2027.</p><p><strong>Conclusions: </strong>The relationship between MetS and sleep hygiene warrants greater attention, particularly as poor sleep habits become increasingly prevalent alongside MetS. This study will deepen the understanding of their connection, paving the way for targeted interventions and prevention strategies.</p><p><strong>Trial","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e90117"},"PeriodicalIF":1.6,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149227776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of the Clinical Usefulness of a Bioartificial Urethral Substitute Generated by Tissue Engineering in Laboratory Rabbits: Protocol for an In Vivo Study.","authors":"David Sánchez-Porras, Fernando Campos, Jesús Chato-Astrain, Miguel Alaminos, M Carmen Sánchez-Quevedo, Ricardo Fernández-Valadés","doi":"10.2196/93091","DOIUrl":"https://doi.org/10.2196/93091","url":null,"abstract":"<p><strong>Background: </strong>Surgical management of diseases compromising the integrity of the human urethra remains a major clinical challenge, and congenital conditions, such as hypospadias and epispadias, and acquired diseases, such as trauma, tumors, and strictures, are difficult to treat, highlighting the need for novel regenerative approaches capable of restoring urethral architecture and function. Recent advances in tissue engineering have allowed the generation of bioartificial tissues, including several models of artificial urethra generated with different types of cells and biomaterials. Although potentially useful, these models cannot reproduce the multilayered native human urethra structure. One biomaterial showing excellent biocompatibility for use in tissue engineering is fibrin-agarose hydrogel, which has been used with promising results in patients with severe alterations of the cornea, skin, and oral mucosa, suggesting its potential use for multilayered urethral substitutes.</p><p><strong>Objective: </strong>This study aims to evaluate the biosafety and efficacy of a multilayered artificial urethra generated by tissue engineering using fibrin-agarose biomaterials in laboratory rabbits to determine its clinical potential as an advanced therapy medicinal product.</p><p><strong>Methods: </strong>Five study groups will be established, including a positive control group of rabbits with a native (ie, normal) urethra, a negative control group of rabbits in which the ventral side of the urethra will be surgically sectioned and left unrepaired, a gold standard group in which the ventral side of the urethra will be surgically sectioned and repaired with an oral mucosa autograft, an acellular group in which the urethral defect will be repaired using an acellular multilayered fibrin-agarose biomaterial, and a cellular group of rabbits in which a multilayered cellular bioartificial urethra will be used to repair the urethral defect. The cellular group will allow us to assess the usefulness of a biomimetic urethral substitute generated by tissue engineering, as demonstrated in previously published models of bioartificial tissues, whereas the acellular group will allow us to determine whether the effects observed for the artificial urethra are attributable to the biomaterial itself, which could act as a physical barrier, or to the action of the cells. In all cases, animals will be observed for 3 months, and variables related to biosafety, functionality, and the histological structure of the urethral grafts will be determined.</p><p><strong>Results: </strong>This study was approved by the ethics committee for animal research (Junta de Andalucía; 17/12/2024/178) on December 20, 2024. The in vivo study began in February 2025 and is expected to be completed by December 2026. The study was funded in January 2023, and data collection is expected to be completed by December 2026. The results are expected to be published in 2026 and 2027.</p><p><str","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e93091"},"PeriodicalIF":1.6,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149227797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association Between Dynamic Changes in the Sling-Pubis Gap and Urinary Symptoms After Tension-Free Vaginal Tape Surgery: Protocol for a Prospective Observational Pilot Study.","authors":"Yaman Degirmenci, Ceren Efe Sayın, Annette Hasenburg, Gilbert Georg Klamminger","doi":"10.2196/95847","DOIUrl":"10.2196/95847","url":null,"abstract":"<p><strong>Background: </strong>Stress urinary incontinence (SUI) is one of the most common pelvic floor disorders in women and is frequently treated surgically using midurethral sling procedures. Despite the high success rates of these procedures, postoperative voiding dysfunction remains a clinically relevant complication that may negatively affect patient satisfaction and quality of life. The underlying mechanisms are multifactorial and not completely understood. In particular, the interaction among sling position, urethral mobility, and pelvic floor dynamics during increases in intra-abdominal pressure may influence postoperative urinary function. Dynamic transperineal ultrasound has emerged as a valuable imaging modality for evaluating sling position and urethral mobility; however, the relationship between dynamic sonographic sling parameters and postoperative urinary symptoms has not yet been sufficiently clarified.</p><p><strong>Objective: </strong>This study aims to investigate the association between dynamic sonographic sling parameters and postoperative changes in patient-reported lower urinary tract symptoms following retropubic tension-free vaginal tape surgery.</p><p><strong>Methods: </strong>This prospective, noninterventional observational pilot study will be conducted at the Department of Obstetrics and Gynecology, University Medical Center Mainz, Germany. Female patients scheduled for retropubic tension-free vaginal tape surgery for SUI will be recruited consecutively. Preoperative assessment will include clinical examination, completion of the International Prostate Symptom Score (IPSS) questionnaire, and standardized transperineal ultrasound imaging at rest and during the Valsalva maneuver. Postoperative follow-up will be performed 3 months after surgery and will include repeat ultrasound examination and IPSS assessment. Sonographic parameters will include urethral mobility, sling-pubis gap, tape-urethra distance, and sling morphology. The primary outcome will be the correlation between changes in the sling-pubis gap during the Valsalva maneuver and changes in IPSS scores. Secondary outcomes will include associations among clinical variables, sonographic findings, and postoperative voiding symptoms.</p><p><strong>Results: </strong>Ethics approval for this study has been obtained from the Ethics Committee of the State Medical Association of Rhineland-Palatinate (reference number 2025-18448). At the time of manuscript submission, participant recruitment had not yet begun and was scheduled to begin in August 2026. The target sample size for this pilot study is 55 participants. Data collection is expected to take approximately 24 months, and the final study results are anticipated to be available in 2028.</p><p><strong>Conclusions: </strong>This study will investigate dynamic sonographic parameters associated with postoperative urinary symptoms following midurethral sling surgery. A better understanding of sling-urethra interaction","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e95847"},"PeriodicalIF":1.6,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13682679/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149227906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical, Economic, and System-Level Outcomes of Bariatric Surgery in Adults: Protocol for a Systematic Review.","authors":"Michał Bystram, Marlena Robakowska, Monika Proczko-Stepaniak","doi":"10.2196/98976","DOIUrl":"10.2196/98976","url":null,"abstract":"<p><strong>Background: </strong>Obesity affects approximately 880 million adults worldwide and carries substantial health, economic, and social consequences. Although bariatric surgery achieves sustained weight loss and metabolic improvement, existing systematic reviews largely predate 2020 and rarely integrate clinical, economic, and system-level perspectives within a single synthesis.</p><p><strong>Objective: </strong>This study aims to identify, critically appraise, and synthesize evidence published between 2020 and 2025 on the clinical effectiveness and economic impact of bariatric surgery in adults with obesity. A secondary, exploratory objective is to address system-level resource utilization, specifically length of stay, preoperative pathway duration, and outpatient care burden.</p><p><strong>Methods: </strong>This protocol follows the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) 2015 guidance and is registered with the International Prospective Register of Systematic Reviews (PROSPERO: CRD420261351022). Eligible studies will enroll adults aged 18 years or older with obesity (BMI ≥30 kg/m<sup>2</sup>) undergoing any primary bariatric procedure, including Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), one-anastomosis gastric bypass (OAGB), adjustable gastric banding (LAGB), and biliopancreatic diversion with or without duodenal switch (BPD±DS); revisional procedures are excluded as the index intervention. Eligible designs include randomized controlled trials, cohort, case-control, cross-sectional, and economic evaluation studies published in English. MEDLINE (via PubMed), Embase, Scopus, and Web of Science will be searched using predefined, database-tailored strategies; records will be managed in Zotero (Corporation for Digital Scholarship). A single primary reviewer will perform screening, extraction, and risk-of-bias (RoB) assessment, with at least 20% independently duplicated by a second reviewer, weighted toward full-text and included studies. RoB will be assessed with RoB 2 and ROBINS-I (Risk of Bias in Nonrandomized Studies of Interventions); economic evaluations will be appraised for completeness of reporting with the CHEERS (Consolidated Health Economic Evaluation Reporting Standards) 2022 statement and for methodological quality with the CHEC (Consensus on Health Economic Criteria) checklist. The primary synthesis will be narrative; meta-analysis will be considered only where prespecified comparability criteria are met. Certainty of evidence will be rated using GRADE (Grading of Recommendations Assessment, Development, and Evaluation).</p><p><strong>Results: </strong>This protocol describes a review that is currently in progress. Registration with PROSPERO was completed on April 15, 2026, and database searches were run on August 1, 2026, identifying 9400 records. Title-and-abstract screening is scheduled to begin on August 15, 2026. Data extraction and synthesis are expected to b","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e98976"},"PeriodicalIF":1.6,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13679864/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149224070","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Effectiveness of AI-Based Cardiac Arrest Prediction System for General Ward Patients (VITAL-MD): Protocol for a Multicenter Pragmatic Stepped Wedge Cluster Randomized Controlled Trial.","authors":"Mincheol Kim, Kyung Hoon Kim, Minsoo Kim, Sun Jung Kwon, Myung Soo Park, Ah Jin Kim, Man-Jong Lee, Mi Hwa Park, Hyung Keun Cha, Minhyeok Lee, In Beom Jeong, Soon Joo Wang, Sung Bak An, Jeen Hwa Lee, Kyung-Jae Cho, Jinhui Jang, HyoJin Jeong, Yoon Young Lee, Woori Han, Jung Soo Kim, Dongjoon Yoo","doi":"10.2196/104230","DOIUrl":"10.2196/104230","url":null,"abstract":"<p><strong>Background: </strong>In-hospital cardiac arrest (IHCA) remains a frequent and devastating event, and conventional early warning scores (EWSs) coupled with rapid response systems (RRSs) have shown inconsistent effects on patient-centered outcomes, largely owing to limited predictive accuracy and high false-alarm burden. AI-based EWSs (AI-EWSs) have demonstrated superior discrimination retrospectively, but high-quality prospective evidence in true external validation environments remains scarce. Existing AI-EWS trials have either been confined to internal-development settings or bundled the algorithm with specific implementation infrastructure, leaving the stand-alone effect of AI-based software as a medical device (AI-SaMD) on patient outcomes uncharacterized.</p><p><strong>Objective: </strong>This trial will evaluate whether implementation of AI-SaMD (VUNO Med-DeepCARS) as a stand-alone clinical decision-support tool in routine general-ward care reduces IHCA compared with usual care based on conventional EWSs.</p><p><strong>Methods: </strong>The VITAL-MD trial (validation of an AI-based clinical deterioration prediction model on patient outcomes through a stepped-wedge cluster randomized trial [SW-CRT] multicenter evaluation of DeepCARS) is a pragmatic, multicenter, SW-CRT conducted at 4 tertiary academic hospitals in the Republic of Korea. Six tertiary academic hospitals were assessed for eligibility based on inpatient capacity, RRS operating hours aligned with the national RRS pilot program, and no prior AI-SaMD use. All adult patients aged 19 years or older admitted to general wards during the 12-month trial period are included; patients younger than 19 years, or with no documented vital signs throughout hospitalization, are excluded. The 4 sites are randomized to sequentially transition from preimplementation (usual care) to postimplementation (AI-SaMD-guided care) in 4 steps separated by 7-day washout periods. DeepCARS generates real-time risk scores from 4 vital signs and integrates into the existing electronic medical record interface without altering RRS workflows. The primary outcome is the incidence of general-ward IHCA, defined per the Utstein guidelines, among the target cohort (defined as patients exceeding the alert threshold at least once). Assuming a baseline IHCA incidence of 6.70%, a 40% relative risk reduction, an intracluster correlation coefficient of 0.01, and 350 patients per cluster-period, 7002 target-cohort patients (total enrollment approximately 72,695) provide 80% power. Analyses follow the intention-to-treat principle using generalized linear mixed models adjusting for prespecified covariates, with prespecified sensitivity, subgroup, and compliance analyses.</p><p><strong>Results: </strong>The trial was registered with the Clinical Research Information Service (KCT0010243) on February 28, 2025. Recruitment was conducted from April 1, 2025, to March 31, 2026. All 4 sites completed transition to the postimpl","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e104230"},"PeriodicalIF":1.6,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13679675/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149224139","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Uncovering the Experiences of Basti-Dwelling Adolescent Girls Who Menstruate in Hyderabad, India: Protocol for a Multimethod Critical Qualitative Study.","authors":"Snigdha Velugu, Erica Di Ruggiero, Nanda Kishore Kannuri, Anushka Ataullahjan","doi":"10.2196/94012","DOIUrl":"10.2196/94012","url":null,"abstract":"<p><strong>Background: </strong>Rapid urbanization in India is straining the government's capacity to provide basic amenities such as housing, sanitation, electricity, and water. One group of people who are deeply affected are adolescent girls who menstruate. In urban slums, referred to as bastis in Telugu and Hindi, this reality is worsened by spatial congestion and limited water, sanitation, and hygiene (WASH) resources. This study is situated in the populous slum colonies of Film Nagar, Hyderabad, where residents navigate precarious living conditions and a scarcity of basic amenities.</p><p><strong>Objective: </strong>In this context, we argue that menstrual experiences are profoundly shaped by an interplay of biological, sociopolitical, and environmental factors. This study aims to examine how these intersecting dimensions shape the menstrual experiences of slum-dwelling adolescent girls (aged 8-18 years) in Film Nagar by understanding the (1) sociocultural and political discourse, (2) intergenerational household power dynamics, and (3) the enabling environment.</p><p><strong>Methods: </strong>Guided by biopolitics and poststructuralist feminist theory, we use a critical ethnographic approach involving intergenerational households (adolescent girls, mothers, fathers, and unmarried brothers aged 15-24 years). Approximately 18-28 informants across 5-8 households will be recruited using maximum variation, purposive, and snowball sampling, targeting. Data generation includes rapport-building, participant observation (journaling, voice recordings, photography, or transect walks), document analysis, focus group discussions (FGDs), and in-depth interviews (IDIs). Analysis occurs concurrently using frame analysis: transcripts undergo value or narrative coding to inductively identify codes, followed by axial and selective coding to group codes into discourses interpreted through our theoretical framework, yielding dominant frames addressing each research question. Findings will inform a digital storytelling output along with a 3-paper thesis and peer-reviewed journal publication.</p><p><strong>Results: </strong>This study is part of the primary author's doctoral dissertation, funded by the Social Sciences and Humanities Research Council (SSHRC) Doctoral Fellowship (2023-2026) and the International Development Research Centre (IDRC) International Doctoral Research Award (2024-2025). Ethics approval was obtained from the University of Toronto and University of Hyderabad research ethics boards in January 2025. Recruitment closed in September 2025 with 18 households enrolled. Data collection closed in March 2026. Protocol deviations included narrowing the study from 5 to 2 slum colonies due to time constraints, resequencing methods to begin with maternal focus groups to build trust, shifting to small group discussions in participants' homes, adding ethnographic interviews, and permitting verbal consent; 3 of these changes required Research Ethics Board (R","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e94012"},"PeriodicalIF":1.6,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13679868/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149224142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Virtual Reality for Enhancing Self-Compassion and Reducing Burnout Among Mental Health Care Professionals: Protocol for a Pilot Feasibility Randomized Controlled Trial.","authors":"Rawan Iriqat, Andre Faro, Stephanie Tarle, Shavon Moore, Wael Al-Delaimy","doi":"10.2196/105754","DOIUrl":"10.2196/105754","url":null,"abstract":"<p><strong>Background: </strong>Mental health care professionals working in high-demand clinical environments are frequently exposed to patient suffering and trauma, placing them at increased risk for burnout and secondary traumatic stress. Compassion-focused cognitive behavioral therapy (CF-CBT) has shown promise in reducing psychological distress and enhancing self-compassion; however, traditional delivery methods may be limited by time, accessibility, and resource constraints. Virtual reality (VR) may provide an immersive and accessible approach for delivering compassion-focused interventions.</p><p><strong>Objective: </strong>The primary objective is to evaluate the feasibility and acceptability of a self-administered VR-enhanced CF-CBT (VR-CF-CBT) intervention for mental health care professionals. Secondary exploratory objectives are to estimate changes in self-compassion, burnout, and secondary traumatic stress (STS), as well as between-group differences that can inform the design of a future definitive trial.</p><p><strong>Methods: </strong>A 2-arm randomized controlled pilot trial will be conducted among mental health care professionals. Participants will be randomized to either a VR-CF-CBT intervention or an active comparison condition consisting of self-guided CF-CBT delivered via digital booklets. Participants will complete 8 brief sessions (approximately 10 minutes each) over a 4- to 6-week period. Exploratory clinical outcomes will include changes in self-compassion, burnout, and STS measured using validated self-report instruments. Primary feasibility and acceptability outcomes will include recruitment, retention, intervention adherence, session completion, participant satisfaction, and scores on the Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure.</p><p><strong>Results: </strong>The study was funded in April 2026. As of October 2026, 38 participants had provided consent and enrolled. Recruitment for a second wave of participants is ongoing, and data collection is in progress. Enrollment and data collection are expected to continue through 2026, with data analysis and dissemination of findings anticipated by spring 2027.</p><p><strong>Conclusions: </strong>This pilot study will provide information on the feasibility and acceptability of delivering CF-CBT through immersive VR to mental health care professionals. Findings will help identify whether modifications are needed before a larger trial and provide preliminary estimates to inform the design of future efficacy testing.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT07666867; https://clinicaltrials.gov/study/NCT07666867.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/105754.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e105754"},"PeriodicalIF":1.6,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149224049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vitamin D Supplementation and Improvement in Insomnia Symptoms Among Malaysian Women With Vitamin D Deficiency: Protocol for a Randomized Controlled Trial.","authors":"Rara Merinda Puspitasari, Zaswiza Mohamad Noor, Didik Setiawan, Norkasihan Ibrahim","doi":"10.2196/63804","DOIUrl":"10.2196/63804","url":null,"abstract":"<p><strong>Background: </strong>Insomnia is a prevalent sleep disorder associated with adverse physical, psychological, and functional outcomes. Emerging evidence suggests that vitamin D deficiency may contribute to sleep disturbances. Women are more likely to have lower serum vitamin D (25-hydroxyvitamin D [25(OH)D]) levels than men, and they also report a higher prevalence of insomnia. Although several studies have proposed that vitamin D supplementation may improve insomnia symptoms, findings remain inconsistent, and evidence from Southeast Asian populations is limited.</p><p><strong>Objective: </strong>This study aims to evaluate the effectiveness of weekly vitamin D₃ supplementation in improving insomnia symptoms, sleep quality, sleep efficiency, and functional outcomes among Malaysian women with vitamin D deficiency.</p><p><strong>Methods: </strong>This study is a double-blind, parallel-group, randomized placebo-controlled trial conducted among women aged 19-50 years with serum 25(OH)D levels <20 ng/mL and insomnia symptoms. Participants are randomized to receive either vitamin D₃ capsules (50,000 IU/wk) or placebo (1 capsule/wk) for 9 weeks. The study is conducted in a community setting. Primary outcomes include insomnia severity assessed using the Insomnia Severity Index (ISI), sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI), and sleep efficiency objectively assessed using actigraphy. Secondary outcomes include daytime sleepiness measured using the Epworth Sleepiness Scale (ESS) and functional outcomes assessed using the Functional Outcomes of Sleep Questionnaire (FOSQ-10). Assessments are conducted at baseline, midintervention, and postintervention.</p><p><strong>Results: </strong>Participant recruitment commenced in December 2023 and is expected to conclude in December 2026. As of July 2026, 42 participants had been screened, 33 eligible participants had been enrolled, 22 had completed the study procedures, 4 were in the intervention phase, and 1 had withdrawn due to loss of contact.</p><p><strong>Conclusions: </strong>If the efficacy of vitamin D3 supplementation in alleviating insomnia symptoms is demonstrated, it might be proposed as a supplementary approach to cognitive behavioral therapy (CBT) for insomnia. Screening for vitamin D deficiency may also be considered in individuals presenting with insomnia symptoms prior to initiating pharmacological treatment.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e63804"},"PeriodicalIF":1.6,"publicationDate":"2026-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13679859/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149224106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and Validation of a Multimodal Artificial Neural Network Model for the Diagnosis of Bladder Outlet Obstruction and Detrusor Underactivity in Men with Lower Urinary Tract Symptoms: Protocol for a Diagnostic Study.","authors":"Andika Afriansyah, Harrina Erlianti Rahardjo, Muhammad Febrian Rachmadi, Irfan Wahyudi, Aria Kekalih, Kadek Budi Santosa, Rakha Abid Bangsawan, Sri Saras Widhiasari, Putu Risky Angga","doi":"10.2196/110023","DOIUrl":"https://doi.org/10.2196/110023","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Bladder outlet obstruction (BOO) and detrusor underactivity (DU) can produce overlapping clinical and uroflowmetric presentations in men with lower urinary tract symptoms (LUTS). Pressure-flow studies (PFS) provide reference diagnoses, but their invasiveness and cost constrain access. Building on a single-center model that used only structured clinical, uroflowmetric, and ultrasonographic variables, this protocol adds uroflowmetry waveforms and cystoscopic images within multimodal artificial neural networks (ANNs). Whether these inputs improve diagnostic estimation beyond structured-data-only models requires evaluation in men undergoing clinically indicated cystoscopy, a selected population distinct from the broader LUTS population for whom noninvasive screening is ultimately intended.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To develop and internally validate a multimodal ANN that estimates separate, non-mutually exclusive probabilities of BOO and DU; to compare its discrimination with structured-data-only and modality-ablation models; and to evaluate the version-locked model prospectively against PFS-based reference diagnoses.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This two-phase study was approved by the Persahabatan General Hospital Ethics Committee (0222/KEPK-RSUPP/07/2026). Models are developed retrospectively using records of adult men with LUTS evaluated at Persahabatan General Hospital, Indonesia, in 2024-2025, and evaluated prospectively in a separate cohort enrolled from 2026 at the development site and three additional tertiary hospitals. Predictors include the International Prostate Symptom Score, comorbidities, prostate volume, free-uroflowmetry curves, and cystoscopic images. Two models are developed, one for each diagnostic target, each using parallel neural encoders with intermediate feature fusion. Reference diagnoses are assigned from PFS recordings using prespecified bladder outlet obstruction index and bladder contractility index criteria, with blinded expert review and adjudication. Internal validation uses patient-level nested stratified five-fold cross-validation, with preprocessing and hyperparameter tuning confined to training partitions. Comparators include penalized logistic regression and modality-ablation models. After internal validation, the model architecture, hyperparameters, and decision thresholds will be locked before any prospective enrollment or exposure to prospective outcome data; the lock date and version will be reported, and no prospective data, including interim performance, will be used to modify the models, which will be applied to new participants without retraining. Discrimination, calibration, and decision-curve net benefit will be reported separately for each diagnostic target and study phase.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Retrospective cohort assembly and data curation were completed in August 2026, 250 participants enrolled. Development and internal validation of the multimo","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":" ","pages":""},"PeriodicalIF":1.6,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149220387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility of High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumor and Young Adults With Isocitrate Dehydrogenase-Mutant Gliomas (HYPE): Protocol for a Randomized Controlled Trial.","authors":"Elizabeth Cox, Meghan Tahbaz, Ellaney Matarese, Rebekah L Wilson, L Nicolas Gonzalez Castro, Hajime Uno, Tabitha Cooney, Jordan Lane, Mary K Norris, Kira Bona, Rahela Aziz-Bose, Christina M Dieli-Conwright","doi":"10.2196/88718","DOIUrl":"10.2196/88718","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Young adult survivors of pediatric brain tumors and young adult patients with isocitrate dehydrogenase (IDH) mutant gliomas are at risk for cognitive impairment, reduced physical fitness and function, as well as poor health-related quality of life (HRQOL) and psychosocial health. Exercise improves these outcomes; however, both populations remain understudied with respect to exercise interventions. High-intensity interval training (HIIT) is a promising intervention, as it is time-efficient, safe, tolerable, enhances cognition in healthy young adults, and improves physical fitness and quality of life in adult patients and survivors with cancer. However, the feasibility of HIIT is not yet understood in survivors of pediatric brain tumors and patients with IDH-mutant glioma.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The HYPE study is a pilot randomized controlled trial that aims to (1) determine the feasibility of a HIIT exercise intervention for young adult survivors of pediatric brain tumors and patients with IDH-mutant glioma, (2) determine the preliminary efficacy of HIIT to improve physical fitness and function, cognition, HRQOL, and psychosocial health, and (3) explore exercise sustainability and the impact of social determinants of health on study outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A total of 30 young adult survivors of pediatric brain tumors and patients with IDH-mutant glioma (18-45 years of age) will be randomized to an exercise or control group. The exercise group performs virtually supervised HIIT 3 times per week for 16 weeks, followed by 16 weeks of self-directed exercise. Exercise involves indoor cycling, and sessions include 20 minutes of high- and low-intensity intervals (high intensity=60-s 60%-90% peak power output; low intensity=60-s 10% peak power output), and a 5-minute warm-up and cool-down. The control group performs a 16-week stretching program. Feasibility of the HIIT intervention is measured by the number of exercise sessions completed, including total minutes and intensity, and barriers to exercise adherence. Cognition, physical fitness and function, HRQOL, and psychosocial health are measured using standardized assessments and self-report questionnaires. Exercise sustainability is measured by change in study outcomes following the self-directed follow-up period, and social determinants of health are assessed using a self-report questionnaire.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Baseline data collection began in February 2024, and 13 participants have been enrolled as of June 2026. The projected study end date is December 2026. Data analysis is planned to begin in January 2027, and findings will be published in the fall of 2028.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;To our knowledge, this study is the first to use a virtually supervised HIIT intervention in young adult patients and survivors of brain tumor. The findings will elucidate the feasibility of HIIT to design and power a randomized control","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e88718"},"PeriodicalIF":1.6,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13671388/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149194097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}