Mitochondrial DiseasesCOMPASSNCT07856121
The Precision Mito- Mito Map COMPASS Study
An observational study of Mitochondrial Diseases and Myalgic Encephalomyelitis Chronic Fatigue Syndrome, run by AI Agent Vault, Inc. d/b/a Precision Mito at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome, Post-COVID-19 Condition
- What is being tested?
- Mito Map Energy Score and Home Functional Assessments
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age 18 years or older and able to provide legally effective informed consent.
- Located in a jurisdiction approved by the study team and applicable human-subjects oversight for remote participation.
- 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/CFS, 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.
- Access to the required internet-capable device and ability to complete at least one approved home functional protocol.
- Willingness to complete baseline and repeated assessments for 12 weeks and to avoid intentional treatment changes solely for this study.
Who cannot join
- Any condition identified by the medical monitor that makes grip or sit-to-stand testing unsafe.
- Acute medical instability, recent hospitalization, or current symptoms requiring urgent evaluation.
- Inability to consent or follow the protocol without an approved legally authorized representative process.
- Planned participation in a conflicting interventional study during the observation window.
- No usable approved functional protocol after safety screening.
- Participants 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Precision Mito
Fort Myers, Florida, 33908
Andrew Friedl, MS, MBA, 224-442-4247, afriedl@precisionmito.com
About this study
Official title: An AI-Enabled Longitudinal Study of Energy, Symptoms, Function, and Physiology Across Mitochondrial and Energy-Limiting Conditions
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.
Participants 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.
The 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.
Read the detailed description
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.
The 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.
The 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.
Secondary 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.
The 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.
- Conditions
- Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome, Post-COVID-19 Condition, Postural Orthostatic Tachycardia Syndrome, Lyme Disease, Post-Treatment Lyme Disease Syndrome
- Being tested
- Mito Map Energy Score and Home Functional Assessments
- Keywords
- 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, POLG-related disease, polymerase gamma
- Medical subject headings
- Mitochondrial Diseases, Postural Orthostatic Tachycardia Syndrome, Lyme Disease, Post-Lyme Disease Syndrome, Fibromyalgia, Neuromuscular Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mito Map Energy Score and Home Functional AssessmentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mito Map Energy Score and Home Functional Assessments | |
| 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. Receives: Other: Mito Map Energy Score and Home Functional Assessments | |
| Post-infectious and autonomic illness | Adults with ME/CFS, 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. Receives: Other: Mito Map Energy Score and Home Functional Assessments | |
| 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. Receives: Other: Mito Map Energy Score and Home Functional Assessments | |
| 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. Receives: Other: Mito Map Energy Score and Home Functional Assessments | |
| 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. Receives: Other: Mito Map Energy Score and Home Functional Assessments | |
| 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. Receives: Other: Mito Map Energy Score and Home Functional Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline through week 12
Secondary outcomes (6)
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.
Measured: Baseline through week 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.
Measured: Baseline through week 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.
Measured: Baseline through week 12
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.
Measured: Adjacent assessments from baseline through week 12
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.
Measured: Baseline and Weeks 2, 4, 6, 8, 10, and 12
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.
Measured: From informed consent through participant closeout after the Week 12 assessment (approximately 12 weeks of scheduled follow-up from baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AI Agent Vault, Inc. d/b/a Precision Mito
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Friedl, MS, MBA, Principal investigator, Precision MitoDeborah Manst, MD, Principal investigator, Precision Mito
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856121
- Sponsor's protocol ID
- MM-OBS-001
- Acronym
- COMPASS
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded or de-identified participant-level data underlying approved analyses may be shared together with an approved data dictionary, protocol, statistical analysis plan, and analytic code when available. Direct identifiers are not included unless separately and specifically authorized and legally permitted.