JMIR Research Protocols最新文献

Background: Voluntary behaviors and socioeconomic factors, such as social jetlag and shift work, can lead to insufficient or disrupted sleep, resulting in drowsiness among active individuals. In occupational and driving contexts, drowsiness poses a serious safety risk by impairing alertness, slowing reaction times, and increasing the likelihood of accidents. Developing automatic and easy-to-implement tools for drowsiness detection or prediction is essential in the management of sleepy patients or in high-risk environments where sustained vigilance is critical.

Objective: This study aims to validate continuous or predictive methods for assessing drowsiness using automated analysis of a limited number of electroencephalogram (EEG) channels.

Methods: Designed as a single-center, nonrandomized, single-group study, this investigation will evaluate drowsiness and cognitive performance in 40 healthy volunteers exposed to 2 sleep deprivation conditions simulating real-world occupational scenarios. The primary outcome will be the Objective Sleepiness Scale (OSS) and its automated analysis, with a focus on its ability to measure objective wakefulness as assessed by the maintenance of wakefulness test (MWT). Secondary outcomes will include multimodal resting-state EEG markers, subjective and objective sleepiness measures, performance on a simulated driving task, attention, executive function, and vigilance assessments, as well as sleep quality, sleep quantity, and mind-wandering. The influence of sociodemographic and clinical variables on the measurement and prediction of drowsiness will also be systematically examined.

Results: This study received funding from Physip and ANR (Agence Nationale de la Recherche, National Research Agency) in 2019, with ethical committee (Comité de Protection des Personnes, Committee for the Protection of Persons) approval in May 2022. Recruitment began in March 2023 and was completed in May 2025, with a database lock in June 2025. Data analysis started in June 2025 and is still ongoing.

Conclusions: By validating these novel EEG-based measures, this study aims to lay the groundwork for proactive strategies for drowsiness management in occupational, transportation, and clinical settings.

Background: Fat-soluble vitamins (FSVs)-vitamins A, D, E, and K-are essential micronutrients involved in key physiological processes. Both deficiency and excess can influence nutritional assessment and disease risk. In China, clinical evaluation of FSVs often relies on reference intervals (RIs) derived from Western populations, and no large-scale study has comprehensively evaluated all 4 FSVs in healthy Chinese adults.

Objective: The aim of this study is to establish population-specific RIs for vitamins A, D, E, and K in healthy Chinese adults, thereby supporting more accurate clinical assessment of vitamin status and the prevention of related diseases.

Methods: This ongoing multicenter cross-sectional study aims to recruit 100,000 adults (≥18 y) from 20 hospitals across China. Participants undergo a standardized questionnaire, physical examination, and blood sample collection. FSV concentrations are quantified using liquid chromatography-tandem mass spectrometry. Group differences are assessed using the chi-square test or Fisher exact test. Nested ANOVA evaluates variation across subgroups. RIs will be established using parametric or nonparametric percentile methods following rigorous outlier removal to accurately determine the 2.5th and 97.5th percentile limits.

Results: As of October 2025, 13,545 adults have been enrolled, and 1690 participants have met the inclusion criteria. Recruitment began on 1 July 2024 and is expected to conclude by 30 June 2026.

Conclusions: This study will generate the first large-scale, population-specific RIs for FSVs in healthy Chinese adults. The findings are expected to be published in 2027 and will provide an important evidence base for clinical nutrition assessment and disease prevention in China.

Background: Oral disease remains a global public health concern, disproportionately affecting socioeconomically disadvantaged populations. Adults with disabilities or health conditions face additional barriers to dental care, including physical accessibility, communication challenges, and heightened anxiety. These factors contribute to care avoidance and poorer oral health outcomes. While virtual reality (VR) has shown promise in reducing procedural anxiety in pediatric and private dental settings, its application in adult public dentistry, particularly for people with disabilities, remains underexplored.

Objective: This study aims to evaluate the feasibility, usability, and acceptability of Smileyscope, a Therapeutic Goods Administration-approved head-mounted VR headset, in reducing dental anxiety and enhancing care experiences for adults with disabilities in public dental clinics.

Methods: A mixed methods convergent design will be implemented across community dental sites in Victoria, Australia. In total, 50 adult patients and up to 10 dental staff members will be recruited. Primary feasibility indicators include recruitment rate (≥60% consent), completion rate (≥80% System Usability Scale [SUS] completion), and usability threshold (mean SUS ≥68). The primary analysis will be descriptive, with 95% CIs reported. Quantitative data will be collected using the visual analog scale for willingness, the SUS, and the technology acceptance model questionnaire. Qualitative data from semistructured interviews will be thematically analyzed. The study is co-designed with a disability advocate and integrates lived experience throughout all phases, including recruitment, evaluation, and dissemination.

Results: The project was funded in 2025, and ethics approval was granted by Peninsula Health Human Research Ethics Committee (project ID 117565). Data collection is scheduled for October 2025 to March 2026 at the participating community dental sites. Primary feasibility estimates and qualitative themes are expected to be submitted for publication in mid‑2026.

Conclusions: This protocol outlines a feasibility study that will inform scalable models for VR integration into public dental services. The findings will contribute to improved oral health equity and patient-centered care, advancing the evidence base for inclusive digital health innovation in dentistry.

International registered report identifier (irrid): PRR1-10.2196/85916.

Background: Hispanic and Latino individuals represent 14.6% of rheumatoid arthritis (RA) cases in the United States and experience significant disparities in access to rheumatologic care, disease management, and health outcomes. Mobile health (mHealth) apps are promising tools to improve patient-provider communication and self-management among populations with language and literacy barriers. However, few RA-focused digital health interventions (DHIs) have been culturally adapted for Spanish-speaking Hispanic and Latino individuals.

Objective: This study aims to assess the health literacy, eHealth literacy, technology trust, and digital self-efficacy of Hispanic and Latino individuals with RA, and to evaluate the cultural relevance, usability, and patient satisfaction of the Spanish-language RunRA app. Additionally, it will explore health care providers' perceptions of the app's usefulness for clinical decision-making and communication with Hispanic and Latino patients.

Methods: A prospective, iterative convergent mixed methods design integrated with the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) will be used. We will recruit 25 Hispanic and Latino patients with RA and 7 Spanish-speaking health care professionals. Quantitative data will include standardized questionnaires (SAHL-S, eHEALS, Human-Computer Trust Scale, Digital Self-Efficacy Scale) and app analytics. Qualitative data will be collected via interviews and focus groups using the Cultural Relevance Questionnaire (CRQ), System Usability Scale (SUS), and Mobile Application Rating Scale (uMARS). Data will be analyzed using an independent intramethod strategy, with integration guided by FRAME to inform culturally relevant app modifications.

Results: We anticipate enrolling 32 participants (25 patients and 7 providers). This study will be the first to evaluate the cultural relevance and usability of an mHealth app specifically designed for Spanish-speaking Hispanic and Latino individuals living with RA.

Conclusions: Our long-term goal is to assess the potential for the mHealth app to act as a vehicle for the dissemination of accurate, useful, usable, and understandable health information to populations that experience health disparities and their health care providers. Findings will inform iterative refinements to RunRA and contribute to the development of culturally responsive DHIs aimed at improving communication, shared decision-making, and health outcomes in underserved populations.

Background: In the United States, Asian American people represent the fastest growing population group, and are highly diverse linguistically, culturally, and demographically. Yet, in most national studies, Asian American groups are aggregated, masking potential health disparities. Racial and ethnic minorities, especially first-generation immigrants, are also at a particularly elevated risk of cognitive impairment.

Objective: The Aging in Kerala Americans Research (AKKARE) study aims to examine both positive and negative migration effects on health in the first-generation Kerala American population, focusing on cognition and dementia. We will assess the effect of immigrant and cultural factors and social relations on cognitive aging from epidemiological, biological, and vascular perspectives. This protocol describes the study design and procedures for the AKKARE study.

Methods: The AKKARE study proposes to enroll 400 older first-generation Kerala American individuals from the tristate area. A smaller subset of these participants will complete blood tests (n=360) and neuroimaging studies (n=160). We will assess the role of immigration and cultural effects on cognitive function, mood, and quality of life, as well as biological and vascular aging. We will conduct follow-up assessments at 12-month intervals for up to 5 years.

Results: The AKKARE study (grant #1R01AG084567-01) was funded by the US National Institutes of Health in 2024 and received approval from the Stony Brook University Institutional Review Board to start the study in 2025. Enrollment began in September 2025.

Conclusions: As there is presently a lack of fundamental data on the epidemiology in diseases of aging in Indian American immigrants, the AKKARE study will provide new insights into factors of risk and resilience associated with cognitive impairment in this group and in the broader older adult population.

International registered report identifier (irrid): DERR1-10.2196/85493.

Background: Endocrine-disrupting chemicals, such as parabens, are commonly found in personal care products (PCPs). Exposure to parabens is linked to several significant health risks, such as reproductive disorders, breast cancer, infertility, and hormone imbalances. Women are particularly vulnerable to these effects due to their higher use of PCPs containing parabens. Despite these risks, Canada lacks regulatory frameworks for the use of parabens in PCPs, relying instead on consumer awareness for reducing exposure. Previous studies have highlighted that many women remain unaware of parabens, exhibiting low risk perception and limited knowledge, which restricts behavior change toward safer choices.

Objective: To address this gap, this project developed the Paraben-Free & Me educational toolkit using the integrate, design, assess, and share framework.

Methods: Toolkit development methodology involved empathizing with target users, defining specific behaviors, grounding the data in the health belief model, ideating implementation strategies, prototyping, gathering user feedback, and building a minimum viable product.

Results: The Paraben-Free & Me toolkit includes multimedia resources such as blog posts, interactive quizzes, videos, podcasts, and forums aimed at increasing knowledge, risk perceptions, and health beliefs and facilitating paraben-free behaviors.

Conclusions: This toolkit shows potential to inform women about endocrine-disrupting chemicals, reduce exposures, and improve health outcomes.