NCT07856121Not yet recruiting
The Precision Mito- Mito Map COMPASS Study
An AI-Enabled Longitudinal Study of Energy, Symptoms, Function, and Physiology Across Mitochondrial and Energy-Limiting Conditions
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 24 Sept 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Nov 2029
- Lead sponsor
- AI Agent Vault, Inc. d/b/a Precision Mito
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT07856121
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 Nov 2026 to the primary completion date, 1 Nov 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any condition identified by the medical monitor that makes grip or sit-to-stand testing unsafe.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Precision Mito Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.