[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658657":3},{"organization":4,"outcomesModule":7,"designInfo":66,"detailedDescription":70,"studyPopulation":71,"armGroups":72,"interventions":102,"overallOfficials":108,"centralContacts":115,"locations":122,"responsibleParty":137,"collaborators":67,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":147,"sex":148,"minAge":149,"maxAge":67,"enrollmentInfo":150,"targetDuration":67,"studyType":153,"phases":67,"briefSummary":154,"conditions":155,"keywords":167,"overallStatus":179,"whyStopped":67,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"AI Agent Vault, Inc. d\u002Fb\u002Fa Precision Mito","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Within-participant association between canonical Energy Score and objective home function composite","Coefficient for within-person centered canonical Energy Score in a participant fixed-effects model of the participant-self-administered, unblinded objective home function composite, adjusted for centered elapsed week and locked measurement-condition covariates, with participant-cluster-robust sandwich standard errors. The anchor is algorithmically independent because it shares no inputs with the Energy Score; it is not independently administered or blinded.","Baseline through week 12",[14,17,20,23,27,31],{"measure":15,"description":16,"timeFrame":12},"Within-participant association between canonical Energy Score and full Measured Function Score","Fixed-effect coefficient for within-person centered canonical Energy Score in the longitudinal model of the locked Measured Function Score that includes fatigue. Interpretation will explicitly acknowledge shared symptom inputs and possible circularity.",{"measure":18,"description":19,"timeFrame":12},"Within-participant association between canonical Energy Score and grip strength","Fixed-effect coefficient for within-person centered canonical Energy Score in the longitudinal model of maximum valid grip force from three protocolized attempts. Grip force is natural-log transformed; device, hand, and measurement-condition covariates are recorded.",{"measure":21,"description":22,"timeFrame":12},"Within-participant association between canonical Energy Score and five-times sit-to-stand performance","Fixed-effect coefficient for within-person centered canonical Energy Score in the longitudinal model of natural-log five-times-sit-to-stand seconds, direction aligned so higher values indicate better performance.",{"measure":24,"description":25,"timeFrame":26},"Energy Score test-retest reliability during clinically stable intervals","Absolute-agreement single-measure ICC(A,1) from a two-way mixed-effects model and standard error of measurement for adjacent assessments with no acute infection, hospitalization or urgent visit, function-altering medication change in the prior 7 days, unusual exertion in the prior 48 hours, or major measurement-protocol deviation.","Adjacent assessments from baseline through week 12",{"measure":28,"description":29,"timeFrame":30},"Assessment completion","Number and percentage of seven scheduled assessments completed with usable matched canonical Energy Score and objective functional data. Reasons for missing or unusable assessments will be summarized.","Baseline and Weeks 2, 4, 6, 8, 10, and 12",{"measure":32,"description":33,"timeFrame":34},"Adverse events during home measurement","Counts and percentages of participants with adverse events and serious adverse events temporally associated with study measurement procedures, summarized by event type, severity, relatedness, and action taken.","From informed consent through participant closeout after the Week 12 assessment (approximately 12 weeks of scheduled follow-up from baseline).",[36,39,43,46,50,53,56,60,63],{"measure":37,"description":38,"timeFrame":12},"Between-participant association between mean Energy Score and mean objective home function","Association between each participant's mean canonical Energy Score and mean objective home function composite, reported separately from the primary within-person estimand.",{"measure":40,"description":41,"timeFrame":42},"Incremental prediction of the next objective functional assessment","Difference in root mean squared prediction error under participant-grouped 10-fold cross-validation between a model containing current objective function and elapsed time and a model that additionally contains current canonical Energy Score. This exploratory analysis does not establish prognosis or clinical utility.","Weeks 2 through 12",{"measure":44,"description":45,"timeFrame":12},"Variation in the primary association across prespecified cohorts","Energy Score-by-cohort interaction estimates and cohort-specific coefficients with confidence intervals. The study is not powered for interaction detection; results are exploratory, and absence of significance will not be interpreted as equivalence between cohorts.",{"measure":47,"description":48,"timeFrame":49},"Quality-qualified longitudinal transition yield","Number and percentage of up to six adjacent scheduled assessment intervals per participant that qualify. Both assessments must occur within the prespecified visit windows and contain the canonical Energy Score, objective functional anchor, timestamps, and required completeness fields. Qualification describes analyzable longitudinal coverage and does not imply clinical change or causality.","Adjacent scheduled assessments from baseline through week 12",{"measure":51,"description":52,"timeFrame":12},"Longitudinal transition depth","Median and distribution of quality-qualified adjacent scheduled intervals per participant, plus the percentage of participants with at least four qualified intervals. Reasons for nonqualification will be summarized by prespecified category.",{"measure":54,"description":55,"timeFrame":49},"Naturally occurring exposure-linked transition yield","Number and percentage of quality-qualified adjacent scheduled intervals containing a prospectively recorded participant-initiated, clinically directed, or otherwise naturally occurring change in a prespecified exposure category. The study assigns no treatment and does not interpret this measure as a causal treatment effect.",{"measure":57,"description":58,"timeFrame":59},"Optional Flic symptom-event capture feasibility","Among participants consenting to the optional Flic module: activated devices; active participant-weeks; event count and event days per participant-week; percentage of events received within 24 hours; and delayed, duplicate, unmapped, test, corrected, and failed-event rates. No minimum event count is required because absence of a press cannot be interpreted as absence of symptoms.","From optional-module activation through week 12",{"measure":61,"description":62,"timeFrame":59},"Optional Flic confirmed intervention-marker yield","Among Flic events mapped to an intervention: number and percentage followed by participant confirmation of intervention identity, occurrence, timing, and required exposure details; time to confirmation; and number linked to a quality-qualified adjacent assessment interval. Unconfirmed markers are not counted as intervention exposures, adherence, or perturbation-linked transitions.",{"measure":64,"description":65,"timeFrame":59},"Optional Flic symptom-annotation completion","Percentage of eligible Flic events with a completed requested follow-up annotation, median time from event to annotation, and distribution of participant-selected symptom or context labels. Analyses are descriptive and do not treat button events as validated symptom severity or clinical outcomes.",{"allocation":67,"interventionModel":67,"interventionModelDescription":67,"primaryPurpose":67,"observationalModel":68,"timePerspective":69,"maskingInfo":67},null,"COHORT","PROSPECTIVE","COMPASS is a prospective, remote, longitudinal observational cohort study designed to externally evaluate the measurement behavior and longitudinal criterion validity of the frozen canonical Mito Map Energy Score. Participants complete seven matched assessments from baseline through week 12.\n\nThe primary objective is to estimate the average within-person association between changes in the Energy Score and changes in a separately constructed objective home-function anchor based on protocolized grip-strength and five-times sit-to-stand measurements. The primary anchor excludes fatigue and shares no inputs with the Energy Score.\n\nThe initial enrollment target is 400 adults across seven prespecified cohorts: healthy comparison; broad mitochondrial disease; POLG-related disease; post-infectious or autonomic illness; cancer and cancer survivorship; other persistent energy-limiting conditions; and Lyme disease or post-treatment Lyme disease syndrome. Participants meeting the dedicated POLG cohort definition are assigned to that cohort rather than the broad mitochondrial cohort. The 50-person POLG cohort is prespecified for descriptive and exploratory subgroup analyses and is not separately powered for confirmatory POLG-specific, variant-level, prognostic, or treatment-response claims.\n\nSecondary objectives include characterizing between-person association, test-retest reliability, adherence, missingness, assessment failures, participant burden, and safety during home measurement. Exploratory analyses will examine prediction of the next functional assessment, longitudinal transition yield, naturally occurring exposure changes, optional wearable measures, optional Flic symptom, context, and confirmed intervention markers, and variation across the seven cohorts. Cohort comparisons are exploratory and are intended to help distinguish shared and condition-specific patterns across complex energy-limiting illnesses.\n\nThe study is non-interventional. It does not assign medications, supplements, devices, exercise, diet, or other treatment. Results will not establish diagnosis, treatment efficacy, clinical utility, prognosis, mitochondrial ATP production, or a minimum clinically important difference. The same dataset will not be used both to tune the Energy Score or functional anchor and to claim locked external validation.","Community-dwelling adults who volunteer through approved digital outreach, disease-community or nonprofit outreach, an existing research-interest list, or authorized clinician and research-partner referrals. Participants must reside in an approved jurisdiction and qualify for one of seven prespecified cohorts. The anticipated enrollment is 400: 100 in the broad mitochondrial cohort and 50 in each of the other six cohorts, including the dedicated POLG cohort. These are planning targets rather than enrollment caps.",[73,78,82,86,90,94,98],{"label":74,"type":67,"description":75,"interventionNames":76},"Healthy comparison participants","Adults without a diagnosed or suspected mitochondrial disorder, active cancer, Lyme disease, or a persistent energy-limiting condition. Participants complete the same schedule and safety screening as the patient cohorts.",[77],"Other: Mito Map Energy Score and Home Functional Assessments",{"label":79,"type":67,"description":80,"interventionNames":81},"Mitochondrial disease","Adults with confirmed or suspected primary mitochondrial disease or clinically documented mitochondrial dysfunction who do not meet the dedicated POLG cohort definition. Participants meeting the POLG cohort definition are assigned to the dedicated POLG cohort rather than this broad mitochondrial cohort. Diagnostic certainty, genetic findings, syndrome, phenotype, and severity are recorded without representing suspected disease as genetically confirmed disease.",[77],{"label":83,"type":67,"description":84,"interventionNames":85},"Post-infectious and autonomic illness","Adults with ME\u002FCFS, Long COVID, POTS or dysautonomia, or a related post-infectious or autonomic energy-limiting illness. Lyme disease participants whose current index condition is Lyme-related are assigned to the separate Lyme cohort.",[77],{"label":87,"type":67,"description":88,"interventionNames":89},"Cancer and cancer survivorship","Adults with active cancer, a history of cancer, or treatment-related fatigue for whom remote functional testing is appropriate. Disease status, treatment status, time since treatment, and major fatigue confounders are recorded.",[77],{"label":91,"type":67,"description":92,"interventionNames":93},"Other persistent energy-limiting conditions","Adults with neuromuscular disease, fibromyalgia, complex chronic illness, or another qualifying persistent energy-limiting condition that is not assigned to another predefined cohort.",[77],{"label":95,"type":67,"description":96,"interventionNames":97},"Lyme disease and post-treatment Lyme disease syndrome","Adults with clinician-diagnosed Lyme disease, including persistent symptoms following recommended treatment when documented. Diagnostic basis, treatment history, time since treatment, symptom duration, coinfections, and alternative explanations are recorded. Enrollment does not imply persistent infection.",[77],{"label":99,"type":67,"description":100,"interventionNames":101},"POLG-related disease","Adults with confirmed or suspected POLG-related disease based on documented genetic findings or a specialist clinical diagnosis. Participants meeting this dedicated cohort definition are assigned here rather than to the broad mitochondrial cohort. Genetic findings, variant classification, zygosity, phenotype, diagnostic certainty, and disease severity are recorded without representing suspected disease or uncertain variants as genetically confirmed disease. This 50-person planning cohort is intended for descriptive and exploratory analyses and is not separately powered for confirmatory POLG-specific, variant-level, prognostic, or treatment-response claims.",[77],[103],{"type":104,"name":105,"description":106,"armGroupLabels":107,"otherNames":67},"OTHER","Mito Map Energy Score and Home Functional Assessments","Observational measurement package completed at baseline and approximately every two weeks through week 12. It includes the canonical Mito Map Energy Score and protocolized home measures of objective function, including grip strength and five-times sit-to-stand when safe and feasible. Participants are not assigned treatment, and these measurements are not used for diagnosis or clinical decision-making.",[87,74,95,79,91,99,83],[109,113],{"name":110,"affiliation":111,"role":112},"Andrew Friedl, MS, MBA","Precision Mito","PRINCIPAL_INVESTIGATOR",{"name":114,"affiliation":111,"role":112},"Deborah Manst, MD",[116,120],{"name":110,"role":117,"phone":118,"phoneExt":67,"email":119},"CONTACT","224-442-4247","afriedl@precisionmito.com",{"name":114,"role":117,"phone":118,"phoneExt":67,"email":121},"dmanst@precisionmito.com",[123],{"facility":111,"status":67,"city":124,"state":125,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":134,"contacts":135},"Fort Myers","Florida","33908","United States","US",{"type":130,"coordinates":131},"Point",[132,133],-81.84059,26.62168,{"lat":133,"lon":132},[136],{"name":110,"role":117,"phone":118,"phoneExt":67,"email":119},{"type":138,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR","100658657","the-precision-mito--mito-map-compass-study-100658657",false,"NCT07856121","The Precision Mito- Mito Map COMPASS Study","An AI-Enabled Longitudinal Study of Energy, Symptoms, Function, and Physiology Across Mitochondrial and Energy-Limiting Conditions","COMPASS","Inclusion Criteria:\n\n* Age 18 years or older and able to provide legally effective informed consent.\n* Located in a jurisdiction approved by the study team and applicable human-subjects oversight for remote participation.\n* Meets the definition for one of seven prespecified cohorts: healthy comparison; broad mitochondrial disease (excluding participants assigned to the dedicated POLG cohort); POLG-related disease; ME\u002FCFS, Long COVID, POTS, or a related post-infectious or autonomic illness; cancer, cancer survivorship, or treatment-related fatigue; Lyme disease or post-treatment Lyme disease syndrome; or another neuromuscular or persistent energy-limiting condition.\n* Access to the required internet-capable device and ability to complete at least one approved home functional protocol.\n* Willingness to complete baseline and repeated assessments for 12 weeks and to avoid intentional treatment changes solely for this study.\n\nExclusion Criteria:\n\n* Any condition identified by the medical monitor that makes grip or sit-to-stand testing unsafe.\n* Acute medical instability, recent hospitalization, or current symptoms requiring urgent evaluation.\n* Inability to consent or follow the protocol without an approved legally authorized representative process.\n* Planned participation in a conflicting interventional study during the observation window.\n* No usable approved functional protocol after safety screening.\n\nParticipants meeting the dedicated POLG cohort definition are assigned to that cohort rather than the broad mitochondrial cohort. Final eligibility and cohort assignment are determined by qualified study personnel. Software may collect and flag screening information but does not make the final enrollment decision.",true,"ALL","18 Years",{"count":151,"type":152},400,"ESTIMATED","OBSERVATIONAL","Mito Map is a research tool that produces an Energy Score from information provided by a participant. This remote observational study has an initial enrollment target of 400 adults across seven prespecified cohorts: healthy comparison participants; broad mitochondrial disease; POLG-related disease; post-infectious or autonomic illness; Lyme disease or post-treatment Lyme disease syndrome; cancer or cancer-survivorship related fatigue; and other neuromuscular or persistent energy-limiting conditions. The broad mitochondrial cohort has an initial target of 100 participants, and each other cohort has an initial target of 50 participants. These are planning targets rather than caps.\n\nParticipants complete a baseline assessment and repeated assessments about every two weeks for 12 weeks. Routine activity is designed to take about 5-10 minutes per week, although screening, consent, baseline setup, troubleshooting, or safety follow-up may take longer. Assessments include the Energy Score and protocolized home measures of physical function such as grip strength and five-times sit-to-stand performance, with an approved alternative when grip testing is unsuitable. Participants assigned to grip testing receive a study-provided hand-grip dynamometer at no cost. Optional compatible wearable data may be collected continuously when authorized and technically available.\n\nThe study does not assign treatment, and research scores will not be used to make clinical decisions. The primary hypothesis is that, within the same participant, higher-than-usual Energy Score values will be associated with better-than-usual objective functional performance at matched assessments. Cohort comparisons, including POLG-specific analyses, are exploratory. A separately consented subset may use a study-provided Flic button to create timestamped symptom, context, or intervention markers with optional follow-up confirmation. The device module is not continuously monitored, does not assign treatment, and is not an emergency service.",[156,157,158,159,160,161,162,163,164,165,166],"Mitochondrial Diseases","Myalgic Encephalomyelitis Chronic Fatigue Syndrome","Post-COVID-19 Condition","Postural Orthostatic Tachycardia Syndrome","Lyme Disease","Post-Treatment Lyme Disease Syndrome","Fibromyalgia","Cancer-Related Fatigue","Neuromuscular Diseases","Fatigue","POLG-Related Disorders",[168,169,170,171,172,173,174,175,176,177,99,178],"home functional testing","grip strength","five-times sit-to-stand","longitudinal study","digital health","patient-generated health data","energy limitation","Lyme disease","post-treatment Lyme disease syndrome","POLG","polymerase gamma","NOT_YET_RECRUITING","2026-09-30",{"date":182,"type":183},"2026-10-02","ACTUAL",{"date":185,"type":152},"2026-11-01",{"date":187,"type":152},"2029-11-01",{"name":5,"class":6},1]