[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659928":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":56,"studyPopulation":50,"armGroups":57,"interventions":68,"overallOfficials":74,"centralContacts":78,"locations":86,"responsibleParty":110,"collaborators":50,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":50,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":143,"whyStopped":50,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Riga Stradins University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"Reactive stress tolerance","Reactive stress tolerance will be assessed using the Vienna Test System (VTS) Determination Test, Form S1, in adaptive presentation mode (approximately 6-10 minutes). The primary measure will be the number of correct reactions, as defined by the VTS. This variable provides information on the participant's ability to respond under stress conditions. The corresponding VTS percentile rank will also be reported; a higher percentile rank indicates greater reactive stress tolerance relative to the applicable normative reference group.","Baseline, 6 weeks (immediately post-intervention)",[14,18,22,25,28,31,35,38,41,44,47],{"measure":15,"description":16,"timeFrame":17},"Intervention adherence","Attendance among participants allocated to MR intervention arm. Reported as the number of intervention sessions completed out of 12 scheduled sessions, expressed as a percentage.","During the 6-week intervention period",{"measure":19,"description":20,"timeFrame":21},"Retention rate","Proportion of enrolled participants who complete the post-intervention assessment. Reported as the number completing follow-up divided by the number enrolled.","Baseline through 6-week post-intervention assessment",{"measure":23,"description":24,"timeFrame":12},"Competitive state anxiety","Cognitive anxiety, somatic anxiety, and self-confidence subscale scores measured using the 17-item Revised Competitive State Anxiety Inventory-2 (CSAI-2R). Items are rated on a 4-point Likert scale.",{"measure":26,"description":27,"timeFrame":12},"Carbon dioxide tolerance","Exhalation duration in seconds measured using the CO₂ Tolerance Test during seated nasal breathing after a full inhalation.",{"measure":29,"description":30,"timeFrame":12},"Breathing pattern classification","Breathing pattern assessed using the Hi-Lo breathing assessment and classified as functional or dysfunctional.",{"measure":32,"description":33,"timeFrame":34},"Post intervention questionnaire","A study-specific 34-item post-intervention questionnaire assessing the acceptability, usability, engagement, perceived effects, technical performance, and tolerability of the MR intervention. Items address training integration, session duration, clarity of instructions, task difficulty, breathing-task experience, perceived effects on calmness, breathing, attention and stress, eye-gaze control, comfort, visual and audio experience, motivation, technical difficulties, and unpleasant physical symptoms. Responses include 5-point Likert-scale items (1 = completely disagree; 5 = completely agree), yes\u002Fno questions, and open-ended questions. Quantitative responses will be summarised descriptively, and open-ended responses will be analysed using qualitative content analysis.","Immediately after the intervention period, at the post-intervention assessment within 1-2 weeks after the final session.",{"measure":36,"description":37,"timeFrame":12},"Resting heart rate","Mean resting heart rate measured using a Polar H10 chest strap and Kubios HRV software\u002Fapp during a 3-minute supine morning recording, averaged across three consecutive days.",{"measure":39,"description":40,"timeFrame":12},"Heart rate variability","HRV indices measured using a Polar H10 chest strap and Kubios HRV software\u002Fapp: RMSSD, SDNN, high-frequency power, mean RR interval, and respiratory rate.",{"measure":42,"description":43,"timeFrame":12},"Cognitive response speed","Median reaction time, in milliseconds, for correct reactions on the VTS Determination Test, Form S1, in adaptive mode. Lower values indicate faster cognitive response speed under time pressure.",{"measure":45,"description":46,"timeFrame":12},"Incorrect reactions","Total number of incorrect reactions recorded during the VTS Determination Test, Form S1, in adaptive mode. Lower values indicate fewer response errors under adaptive time pressure.",{"measure":48,"description":49,"timeFrame":12},"Omitted reactions","Total number of omitted reactions, defined as stimuli for which no response is registered within the permitted response interval, during the VTS Determination Test, Form S1, in adaptive mode. Lower values indicate fewer missed responses or response lapses under time pressure.",null,{"allocation":52,"interventionModel":53,"interventionModelDescription":50,"primaryPurpose":6,"observationalModel":50,"timePerspective":50,"maskingInfo":54},"RANDOMIZED","PARALLEL",{"masking":55,"maskingDescription":50,"whoMasked":50},"NONE","The study will use a two-arm group design. Participants will be randomly assigned to either the Mixed Reality (MR) intervention group (Breathing MR) or to a control group. Randomisation will be performed at the individual level. The intervention period is planned for six weeks, with two sessions per week for the experimental group. Control participants will continue their regular basketball training without any additional intervention.\n\nThis is a follow-up, two-arm parallel-group randomised controlled trial of Breathing MR versus usual basketball training. The study is designed to recruit an anticipated 40-50 participants. Subject to confirmation of comparability of eligibility criteria, intervention delivery, outcome procedures, and data quality, data from this cohort may be combined with the Breathing MR and usual-training control groups from the completed feasibility RCT (Organisation's Unique Protocol ID: 2-PĒK-4\u002F1205\u002F2025-Feasibility) in prespecified exploratory pooled analyses. Models will include cohort as a fixed effect and assess the intervention-by-cohort interaction. Cohort-specific and pooled estimates with 95% confidence intervals will be reported.\n\nIn-person study activities will be conducted at participants' usual basketball training venues in Salaspils and Rīga, Latvia. Home-based HRV recordings will be completed by participants using loaned Polar H10 chest straps and the Kubios HRV application.\n\nInterventions will be delivered using the HTC VIVE Focus Vision standalone head-mounted display, requiring no external equipment or PC connection.\n\nAssessments will be conducted at two time points: at baseline (before the intervention period) and post-intervention (within one or two weeks of the final session). The assessment battery includes resting heart rate and heart rate variability (Polar H10 chest strap with KubiosHRV), CO₂ tolerance (CO2TT), breathing pattern (Hi-Lo test), reactive stress tolerance (Vienna Test System - Determination Test), and pre-competition anxiety (CSAI-2R-LV).\n\nResearch staff will supervise the pre-intervention assessment phase and the first intervention sessions in person. From week two onward, participants will access sessions independently using individual password-protected profiles on the headset. A midpoint visit will be conducted at week three.\n\nTo evaluate the physiological and cognitive efficacy of the standalone MR breathing biofeedback intervention across varying exposure levels, analyses will be structured around pre-specified exposure tiers and continuous dose-response modeling:\n\n1. Primary Per-Protocol (PP) Population (at least 4 sessions) - to evaluate efficacy among athletes receiving at least a minimum training exposure (at least 33% of scheduled volume) and maintain direct comparability with the filtering logic of the 2025 feasibility cohort (2-PĒK-4\u002F1205\u002F2025-Feasibility), primary efficacy models will analyze participants completing at least 4 intervention sessions.\n2. High-Adherence Sensitivity Analysis (at least 8 sessions) - a secondary high-adherence per-protocol analysis will evaluate outcomes among participants completing at least 8 sessions (at least 67% of scheduled volume) to test for enhanced physiological adaptation under higher intervention dosage.\n3. Continuous Dose-Response Evaluation - to directly investigate the relationship between intervention dose and outcome change without relying on binary attendance cutoffs, linear regression models will evaluate total completed sessions (0 to 12) as a continuous predictor of change in primary and secondary outcomes.\n\nThe study was approved by the Riga Stradiņš University Ethics Committee (original approval: 2-PĒK-4\u002F610\u002F2024; additional approvals covering extended details: 2-PĒK-4\u002F814\u002F2025 and 2-PĒK-4\u002F1205\u002F2025). Individual participant data, analytical code, and study documentation will be archived in the repository upon study completion.",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"Breathing MR Training","EXPERIMENTAL","Participants receive a 6-week MR breathing and gaze-control training program in addition to their usual basketball training. They complete two 7-minute sessions per week, for a maximum of 12 sessions and 84 minutes of total exposure. Sessions are delivered at the participant's usual basketball-training venue.",[63],"Behavioral: Breathing MR",{"label":65,"type":66,"description":67,"interventionNames":50},"Usual Basketball Training Control (No intervention)","NO_INTERVENTION","Participants continue their usual basketball training routine at their respective clubs. They complete baseline and post-intervention assessments on the same schedule as the intervention groups but receive no study-provided MR breathing training during the 6-week study period.",[69],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":50},"BEHAVIORAL","Breathing MR","Participants complete two 7-minute sessions weekly for 6 weeks (maximum 12 sessions; 84 minutes total exposure) using an HTC VIVE Focus Vision standalone head-mounted display. Seated within an approximately 1 × 1 m area, participants perform slow diaphragmatic breathing while completing a gaze-controlled virtual basketball-tracking task. Breathing pace progresses from 7 breaths\u002Fmin in minute 1, to 6.5 breaths\u002Fmin in minute 2, and 6 breaths\u002Fmin during minutes 3-7, using a 40:60 inhalation-to-exhalation ratio. A handheld controller placed horizontally on the upper abdomen detects abdominal movement to estimate breathing phase and adherence. Accurate breathing increases virtual-player responsiveness and speed, whereas departures from the prescribed pattern reduce performance. Research staff supervise baseline testing and the first two sessions; from week 2, participants use password-protected individual profiles independently.",[59],[75],{"name":76,"affiliation":5,"role":77},"Agris Liepa, PhD","STUDY_DIRECTOR",[79,84],{"name":80,"role":81,"phone":82,"phoneExt":50,"email":83},"Gints Peleckis, MSc Health Science","CONTACT","+371 29950000","gints.peleckis@rsu.lv",{"name":76,"role":81,"phone":50,"phoneExt":50,"email":85},"agris.liepa@rsu.lv",[87,100],{"facility":88,"status":50,"city":89,"state":50,"zip":50,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Basketbola skola Rīga","Riga","Latvia","LV",{"type":93,"coordinates":94},"Point",[95,96],24.10589,56.946,{"lat":96,"lon":95},[99],{"name":80,"role":81,"phone":82,"phoneExt":50,"email":83},{"facility":101,"status":50,"city":102,"state":50,"zip":50,"country":90,"countryCode":91,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Salaspils sporta skola","Salaspils",{"type":93,"coordinates":104},[105,106],24.36544,56.86014,{"lat":106,"lon":105},[109],{"name":80,"role":81,"phone":82,"phoneExt":50,"email":83},{"type":111,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"PRINCIPAL_INVESTIGATOR","Gints Peleckis","Research Assistant Intern; Junior Researcher (PhD Student)","100659928","eyebreathe-a-mixed-reality-game-with-eye-tracking-and-breathing-biofeedback-for-adolescent-basketball-players---a-randomised-controlled-trial-100659928",false,"NCT07871331","EyeBreathe: A Mixed Reality Game With Eye Tracking and Breathing Biofeedback for Adolescent Basketball Players - A Randomised Controlled Trial","EyeBreathe-RCT","Inclusion criteria\n\n* Adolescent basketball players aged 14-17 years\n* Organized basketball training for at least 5 years\n* Training at least 3 times per week\n\nExclusion criteria\n\n* Serious musculoskeletal injury or acute medical condition affecting sports performance in the previous month\n* Severe orthopedic, neurological, cardiovascular, or other medical disorders\n* Use of prescription medications affecting the central nervous system (e.g., psychotropic medication)\n* Symptoms of visually induced motion sickness (VIMS): nausea, dizziness, headache, or disorientation before or during participation",true,"ALL","14 Years","17 Years",{"count":126,"type":127},40,"ESTIMATED","INTERVENTIONAL",[130],"NA","This randomised controlled trial will evaluate the effects of integrating a standalone mixed-reality (MR) breathing and eye-gaze training intervention (EyeBreathe) into regular basketball practice for adolescent athletes in Latvia. Participants will be individually randomised to either a six-week MR intervention (two sessions per week) or to continue usual training. Assessments before and after the intervention will measure heart rate and heart rate variability, CO₂ tolerance, breathing pattern, reactive stress tolerance, and pre-competition anxiety. Sessions will be supervised at first, then completed independently via password-protected headset profiles. Intervention adherence will be monitored. The primary efficacy analysis will use a prespecified per-protocol population, defined as intervention participants who complete at least four of the twelve scheduled sessions.",[133],"Healthy Adolescents",[135,136,137,138,139,140,141,142],"Adolescent Athletes","Basketball","Mixed Reality","Eye Tracking","Stress","Breathing Biofeedback","Cognitive Function","Attention","NOT_YET_RECRUITING","2026-10-04",{"date":146,"type":147},"2026-10-13","ACTUAL",{"date":149,"type":127},"2026-10-05",{"date":151,"type":127},"2026-12",{"name":5,"class":6},2]