The Precision Mito- Mito Map COMPASS Study

NCT07856121 | Not Yet Recruiting

• 1 other identifier: MM-OBS-001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Within-participant association between canonical Energy Score and full Measured Function Score

  Baseline through week 12

• Within-participant association between canonical Energy Score and grip strength

  Baseline through week 12

• Within-participant association between canonical Energy Score and five-times sit-to-stand performance

  Baseline through week 12

• Energy Score test-retest reliability during clinically stable intervals

  Adjacent assessments from baseline through week 12

• Assessment completion

  Baseline and Weeks 2, 4, 6, 8, 10, and 12

Other Outcomes (9)

• Between-participant association between mean Energy Score and mean objective home function

  Baseline through week 12

• Incremental prediction of the next objective functional assessment

  Weeks 2 through 12

• Variation in the primary association across prespecified cohorts

  Baseline through week 12

Study Arms (7)

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.

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.

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.

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.

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.

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.

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.

Other: Mito Map Energy Score and Home Functional Assessments

Interventions

Mito Map Energy Score and Home Functional Assessments OTHER

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.

Cancer and cancer survivorship; Healthy comparison participants; Lyme disease and post-treatment Lyme disease syndrome; Mitochondrial disease; Other persistent energy-limiting conditions; POLG-related disease; Post-infectious and autonomic illness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AI Agent Vault, Inc. d/b/a Precision Mito: lead

Study Sites (1)

Precision Mito

Fort Myers, Florida, 33908, United States

Location

MeSH Terms

Conditions

Mitochondrial Diseases; Postural Orthostatic Tachycardia Syndrome; Lyme Disease; Post-Lyme Disease Syndrome; Fibromyalgia; Neuromuscular Diseases; Fatigue

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Signs and Symptoms

Study Officials

• Andrew Friedl, MS, MBA

  Precision Mito

  PRINCIPAL INVESTIGATOR

• Deborah Manst, MD

  Precision Mito

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Friedl, MS, MBA

CONTACT

224-442-4247; afriedl@precisionmito.com

Deborah Manst, MD

CONTACT

224-442-4247; dmanst@precisionmito.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Sharing may begin after completion of the primary analysis and disclosure review. Availability duration will follow the final retention and commercial-data-use terms stated in the approved consent and governing agreements.
• Access Criteria: Access may be provided to qualified academic, nonprofit, governmental, pharmaceutical, biotechnology, diagnostic, medical-device, digital-health, data, or other commercial recipients, including independent analysts, research organizations, and publication collaborators, for permitted research, analysis, interpretation, regulatory, publication, product-development, or commercialization purposes. Access requires sponsor review and an appropriate written agreement containing use, security, confidentiality, onward-transfer, re-identification, conflict-disclosure, and publication provisions. Controlled access, license, or transfer will be administered by the sponsor or its authorized data-governance service. No public participant-level download is promised.

Locations

US (1)