An AI-Enabled Longitudinal Study of Energy, Symptoms, Function, and Physiology Across Mitochondrial and Energy-Limiting Conditions
AI Agent Vault, Inc. d/b/a Precision Mito
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 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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 sy…
Interventions
- OtherMito 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.
Location
- Precision MitoFort Myers, Florida