Background: Evening technology use (ETU) has been associated with sleep disturbances, often attributed to blue light exposure and cognitive arousal. However, most of the existing evidence focuses on younger populations and relies primarily on subjective measures. As older adults increasingly engage with both passive and active technology use, it is important to investigate how ETU impacts objective sleep. Currently, there is also a limited understanding of how particular evening digital activities, especially active versus passive engagement, affect objective sleep in older adults.
Objective: This study aims to investigate the impact of exposure to ETU on both objective and subjective sleep outcomes in older adults.
Methods: This is a randomized crossover trial involving approximately 55 adults aged 60-75 years from the ongoing Swedish National Study on Aging and Care - Blekinge. Each participant will undergo 3 one-week intervention periods: active ETU, passive ETU, and a nondigital activity (book reading), with one-week washout periods in between. The order of interventions will be randomized. Sleep will be assessed using a home-based electroencephalography device (MUSE headband) and daily self-reports. Primary outcomes are sleep onset latency and wake after sleep onset. Secondary outcomes include objective measures such as total sleep time, sleep efficiency, and time spent in REM, deep, and light sleep, subjective sleep quality, adherence, and perception of the intervention and comfort of using the objective measurement tool, that is, the electroencephalography headband. Linear mixed-effects models (with fixed effects for condition and period and a random participant intercept) were used to analyze crossover effects on sleep outcomes.
Results: Participant recruitment and data collection began in the fall of 2025 and will continue through summer 2026 or until the target sample size is reached. Data collection is scheduled to be completed by spring 2027. Results will include participant flow, baseline characteristics, adherence data, and comparative analyses of the 3 intervention conditions. Within-subject statistical models will be used to evaluate differences in sleep outcomes and investigate the associations between ETU and sleep quality.
Conclusions: This crossover study will clarify how active and passive ETU, compared with a nondigital activity, relate to objective sleep in older adults. Findings will inform simple, practical recommendations for technology use before bed in late life.
Background: The growing digitization of health data has expanded opportunities for professional learning and performance improvement. While they provide new means for improving the quality and safety of health care, these new capabilities for data analysis and performance monitoring come with risks and may exacerbate existing ethico-legal concerns about fairness, accountability, privacy, and more.
Objective: This study aims to develop an ethico-legal framework for the evaluation of professional performance that is cognizant of these concerns and addresses the needs of relevant stakeholders. The study will assess the acceptability, comprehensiveness, and potential utility of the framework from the perspective of end users and subject matter experts.
Methods: This study will use existing evidence on ethico-legal considerations surrounding secondary uses of health data for performance improvement and management to draft the framework. We will conduct 2 focus groups with end users (eg, health professionals and administrators) and subject matter experts (eg, clinical ethicists and legal practitioners). These focus groups will ask participants to reflect on the framework's structure and comprehension, intended audience, comprehensiveness and relevance regarding ethical and legal principles, limitations, and utility and acceptability as a step-by-step guide. Study participants may also opt for one-on-one interviews for any reason. This feedback will be thematically analyzed using open coding and verified by an independent reviewer at the focus groups, followed by constant comparisons of feedback from this study to concepts and interrelationships in data previously collected.
Results: Recruitment for this study is scheduled from August to December 2025. The analysis, compilation, and dissemination of higher-order themes, concepts, and outcomes is planned for after publication of this protocol, after each interview or focus group has been transcribed and coded line by line.
Conclusions: This study seeks to create an actionable tool that is readily translatable to clinical practice in collaboration with end users and subject matter experts. The proposed methodology is a low-resource coapproach that could be iteratively refined to ensure that the proposed framework continues to support robust and efficient use of performance data while respecting the different contexts in which practice analytics may be delivered. This systematic approach to principle-led evaluation of performance and conduct could inform technology-neutral governance capable of addressing perennial concerns about fairness, privacy, and transparency when using health data for professional learning and performance management.
Background: Selective serotonin reuptake inhibitors are first-line antidepressants; however, only approximately 60% of patients can benefit from them. There is insufficient evidence for using acupuncture for symptom relief or for improving tolerance to selective serotonin reuptake inhibitors.
Objective: This randomized controlled trial aims to assess the effects of acupuncture combined with citalopram hydrobromide on mild to moderate depression in older people.
Methods: This study is a 2-arm, parallel, randomized controlled trial. A total of 132 participants aged 60 to 80 years diagnosed with major depressive disorder were divided into an acupuncture and medication group or a medication group. Participants in both groups take citalopram hydrobromide at a dose of up to 20 mg daily for 12 weeks. The acupuncture and medication group additionally receives 36 sessions of acupuncture treatment over 12 weeks. The primary outcome is the response rate of the 17-item Hamilton Depression Scale at the twelfth week. The secondary outcomes include changes in scores on the 17-item Hamilton Depression Scale and Mini-Mental State Examination at various time points. Adverse events will be recorded in detail.
Results: The study commenced on June 30, 2023, and as of October 17, 2024, a total of 132 participants had been enrolled. Data collection has been completed. Currently, data analysis is in progress, with preliminary findings anticipated to be available by October 2025. The findings of this study are expected to be submitted for publication in 2026.
Conclusions: This pilot study is expected to provide critical insights into the feasibility of integrating acupuncture with standard medication for managing mild to moderate depression in older people. By generating preliminary evidence on its potential benefits, the study aims to inform the design and sample size estimation of future multicenter trials, potentially advancing nonpharmacological treatment options for depression.
Background: Sexual minority youth (SMY) are significantly more likely to use alcohol compared with their heterosexual peers. Recent national data also suggest a turning point in alcohol use disparities: Latinx youth now report higher alcohol use than non-Latinx youth. Despite this, little is known about the social context and reasons why Latinx SMY may engage in alcohol use.
Objective: This manuscript describes the protocol for a study designed to assess real-time exposure to minority stressors and protective factors, and their relationship to alcohol use among Latinx and non-Latinx White SMY.
Methods: The project is being conducted in 3 phases with a combined sample of approximately 140 participants. Phase 1 (completed) involved cognitive interviews with 23 SMY participants, which refined and adapted survey measures to ensure cultural and developmental appropriateness for the next study phases. Phase 2 was a pilot ecological momentary assessment (EMA) survey with 20 participants to evaluate feasibility, acceptability, and compliance (completed). Phase 3 will recruit approximately 100 SMY aged 15-19 years, with equal representation of Latinx and non-Latinx White SMY. Participants will complete a baseline survey and repeated EMA surveys to capture daily experiences of stressors, protective factors, and alcohol use.
Results: Results for the study sample, recruitment (between April 2022 and November 2023), and challenges confronted are presented for Phase 1. Findings showed that the study sample included 23 Latinx and non-Latinx SMY, split almost in half by ethnicity. Participants were mostly female and affluent. Recruitment efforts showed that certain flyers and locations (eg, Facebook/Instagram) performed better at recruiting this sample. We present issues faced with screening out ineligible participants and bots, recruiting participants assigned male at birth, recruiting 15- to 17-year-old participants, and building overall trust with this population. Results from the rest of the data in this study will be analyzed and disseminated through peer-reviewed scientific journals.
Conclusions: This study will provide novel data on the real-time contexts of alcohol use among SMY with particular attention to Latinx youth, an understudied and marginalized population. By identifying stress and protective mechanisms linked to alcohol use, findings can inform tailored prevention and intervention strategies. Furthermore, the protocol offers a replicable framework for future EMA research on intersectionality, minority stress, and alcohol use among diverse SMY populations.
International registered report identifier (irrid): DERR1-10.2196/87201.
Background: One in 10 preschoolers (aged 3-4 y) meet the three 24-hour Movement Guidelines, that is, (1) physical activity, (2) sedentary screen time, and (3) sleep.
Objective: The overarching aim of this study is to evaluate the effectiveness and feasibility of a 12-week mobile health home-based intervention on 24-hour movement behaviors in preschoolers who meet few guidelines (zero or 1 guideline).
Methods: We will conduct a 12-week randomized controlled trial with a wait-list control in 80 families (40 per arm). Preliminary studies in this population informed intervention app content, features, and app development. Behavior change theories, including transfer theory and the multi-process action control framework, helped inform content presentation and topics. Primary outcomes include device-based and parent-report measures of 24-hour movement behaviors, and the secondary outcome is the feasibility and acceptability of the app. Exploratory outcomes include preschoolers' cognitive and motor skills, changes within the home environment, and behavioral control processes.
Results: This 2-phase study (K99/R00) received initial funding in March 2022, and preliminary studies were concluded in December 2023. The main grant received institutional review board approval in April 2024, and the grant funding began in May 2024. The study was registered in Clinical Trials in October 2024 and enrolled its first participant in January 2025. As of October 2025, the study has enrolled 39 families. We anticipate the trial will be completed in late 2026.
Conclusions: This research is designed to test a novel approach to improve all three 24-hour movement behaviors in preschoolers in home settings by using a mobile app. Results from this study will have implications for future 24-hour movement interventions, our understanding of improving all 3 behaviors, and ultimately, improvements in preschoolers' health.
Trial registration: Clinicaltrials.gov NCT06667661; https://clinicaltrials.gov/study/NCT06667661.
International registered report identifier (irrid): DERR1-10.2196/75621.
Background: California has the largest number of people living with HIV in the United States, and in 2022, there were 4882 new diagnoses. Veterans with histories of substance use, viral hepatitis, sexually transmitted infections, and homelessness carry substantial HIV burden. Testing is essential, yet approximately 12% of Californians with HIV were undiagnosed in 2020, and 50% of veterans in care had never been tested as of 2023. HIV self-tests (HIVSTs) can mitigate stigma, confidentiality, and access barriers, and vending machines (VMs) offer private, convenient distribution. However, the use of VM-dispensed HIVST has not been evaluated for veterans or within Veterans Affairs (VA) settings.
Objective: We describe a Reach, Evaluation, Adoption, Implementation, and Maintenance-guided pre-implementation protocol to evaluate VM-dispensed HIVSTs in Northern California VA clinics and supportive housing settings.
Methods: Fifteen VMs will stock oral-fluid HIVSTs (n=900). Program data (de-identified dispense logs), veteran electronic surveys (n=90), and qualitative interviews (n=15) will quantify reach (uptake), early effectiveness proxies (use, results, and next steps), adoption (machine/site dispensing), implementation (stockouts, restocking interval, and costs), and maintenance (dispensing trends).
Results: Ethics approval activities (study material development and Institutional Review Board submission) began 2 months prior to the receipt of award funding (January to February 2025). Following funding, the project is planned for over a total of 18 months (12 months original project period + 6 months no-cost extension; March 2025 to August 2026). Ethics approval was obtained in August 2025. Veteran feedback was incorporated into study materials, and HIVSTs were purchased and packaged in September to November 2025. HIVSTs were added to VMs, and data collection is projected to occur from December 2025 through June 2026. Results are anticipated to be available in August 2026.
Conclusions: This study will generate practice-ready evidence on the feasibility, acceptability, and early behavioral impacts of VM-dispensed HIVSTs for veterans. By pairing a stigma-responsive delivery channel with pragmatic measures, findings can inform equitable scale-up across VA and community settings, guide comparative evaluations of distribution channels (VMs, mail-to-home, or clinic pick-up), and support privacy-preserving linkage strategies to confirmatory testing, HIV pre-exposure prophylaxis, and treatment. Results will address a critical evidence gap for veteran-focused HIV prevention and provide parameters for multi-site evaluations.
Background: Despite advances in surgical resection, radiotherapy, and chemotherapy, the prognosis of recurrent malignant gliomas (rMG) remains poor, with limited efficacy of conventional treatments due to the blood-brain barrier (BBB) hindering drug delivery to the tumor site. Studies have demonstrated that albumin-bound paclitaxel (ABX), while potent in vitro, is restricted in its intravenous use due to BBB limitations. To overcome this, specific-mode electrical stimulation (SMES) has shown promise in transiently opening the BBB, enhancing the accumulation of ABX in glioma tumors. Therefore, this protocol designs a single-center, single-arm, prospective phase II clinical trial aiming to evaluate the safety and clinical efficacy of SMES combined with ABX (SMES+ABX) for treating rMG.
Objective: This study primarily evaluates the safety of SMES+ABX therapy in treating patients with rMG and assesses whether it can improve the 4-month progression-free survival (4m-PFS) rate, while providing data support for future large-scale clinical trials.
Methods: In this study, 20 eligible patients will receive intravenous ABX (135-175 mg/m²) per 21-day cycle for 6 cycles, combined with SMES for BBB modulation. A Simon 2-stage design will be employed, with the primary end point being the 4m-PFS. Secondary end points include adverse events, disease control rate, objective response rate, duration of disease control, duration of response, Neurological Assessment in Neuro-Oncology score, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, progression-free survival, and overall survival.
Results: The results will determine the 4m-PFS rate, overall safety profile, secondary efficacy outcomes, and patient-reported quality of life measures. The data will be analyzed upon trial completion. Patient enrollment is scheduled to begin in May 2025. The treatment and primary efficacy assessment phases are anticipated to be completed by January 2027 (allowing for staggered enrollment and a 4-month treatment period for the last enrolled patient). The final survival follow-up for all patients is anticipated to be completed by January 2028 (ie, 1 year after the last patient completes treatment). Data management is currently ongoing, and formal statistical analyses have not yet been performed.
Conclusions: This study aims to evaluate the efficacy and safety of SMES combined with ABX in the treatment of rMG. If successful, the combination could offer a promising therapeutic strategy for this challenging patient population.
Background: Dental fear and anxiety (DFA) affects approximately a quarter of children and adolescents. It significantly contributes to pediatric patients avoiding dental care later in adulthood. Lack of cooperation due to DFA can create a stressful environment, often forcing dentists to end appointments prematurely and consider alternative pharmacological treatments. The use of virtual reality (VR) during dental procedures, offering an immersive sensory experience, may serve as an additional nonpharmacologic tool to better manage DFA in children with special health care needs (SHCN) undergoing dental treatment.
Objective: This study aims to assess the effectiveness of VR immersion in reducing anxiety and pain among pediatric patients with SHCN undergoing dental procedures. The study also seeks to understand the satisfaction of parents and health care providers with the use of VR during dental appointments.
Methods: This randomized controlled trial follows a parallel design with two groups: a control group receiving standard care and an experimental group using VR. A sample size of 400 participants was calculated. Participants will be randomly assigned equally to each group. Recruitment will take place at the dental clinic of the Centre Hospitalier Universitaire Sainte-Justine, a tertiary- and quaternary-care center that primarily serves pediatric patients with SHCN. The two primary outcomes will include both observed and objective biomarker-based measures of anxiety. DFA will be evaluated using the Venham Anxiety Rating Scale as well as changes in mean levels of salivary alpha-amylase. Sociodemographic characteristics, parents' and health care professionals' satisfaction levels, participants' pain intensity and behavior during the procedure, changes in heart rate, occurrence of side effects, procedure duration, and any deviations from normal procedural length will also be collected. Descriptive and comparative statistics will be conducted for demographic and clinical comparisons and will be used to present sociodemographic and clinical data, parents' and health care professionals' satisfaction levels, child satisfaction with the game, and procedural time.
Results: This study will be conducted from November 2023 to December 2025. As of November 2025, 300 participants have been recruited. Results are expected to be available in June 2026.
Conclusions: We believe that the results of this study will confirm the efficacy of VR in reducing DFA in children with SHCN, providing an additional nonpharmacological alternative for better managing this condition in pediatric hospital settings.
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