Phase 1Recruiting
Validation of Nanosensor Oxygen Measurement
The Validation of Minimally Invasive Oxygen Nanosensor Technology to Quantify Mitochondrial Function in Human Muscle
- Sponsor
- Children's Hospital of Philadelphia (Academic or other)
- Enrolment
- 70 planned
- Conditions
- MItochondrial Myopathies; Mitochondrial Disease
- Interventions
- Nanosensor
- Ages
- adults, older adults
- Registry
- NCT06819683
Full record on ClinicalTrials.gov
From the registry
Past mitochondrial disease treatment studies have been unsuccessful in determining treatment efficacy, and a major factor has been the lack of validated biomarkers in mitochondrial myopathy (MM). There is currently a growing number of potential new treatments to be tested through MM clinical intervention trials, which has created a pressing need for quantitative biomarkers that reliably reflect MM disease severity, progression, and therapeutic response. The purpose of the study is to measure the efficacy of an electrochemical oxygen nanosensor to measure in vivo mitochondrial function in human muscle tissue, and its ability to discriminate MM patients from healthy volunteers. The data and results from this nanosensor study may contribute to current and future research, including improved diagnostic and therapeutic approaches for patients with mitochondrial disease.
Primary outcomes
- Nanosensor-muscle oxygen (Torr) levels during handgrip exercises
- Nanosensor-muscle oxygen (Torr) levels post Cardiopulmonary Exercise Testing (CPET)
History
Primary completion expected
Last registry update
Registered
Started