Validation of Nanosensor Oxygen Measurement for Mitochondrial Myopathies
This study is testing a new device called a "nanosensor" to measure oxygen levels in muscle. This nanosensor is very small (1.8 mm wide x 6 mm long x 0.3 mm deep) and has not been tested in humans or approved by the FDA. The goal is to see if it can accurately measure mitochondrial function (how your cells produce energy) in people with mitochondrial myopathies (a type of mitochondrial disease) and healthy volunteers. Researchers hope this nanosensor can help determine how severe mitochondrial disease is, how it progresses, and how well new treatments work. You may be eligible if you are between 18 and 65 years old, can walk independently, and can perform bicycle exercise. For those with mitochondrial myopathy, additional criteria apply. The study aims to enroll 96 participants.
- Study design
- This is an interventional study testing a device. It will involve both healthy volunteers and individuals with mitochondrial myopathy.
- What's involved
- You would have a nanosensor placed in your forearm under local anesthesia. Researchers will measure muscle oxygen levels during handgrip exercises and after a cardiopulmonary exercise test (CPET). They will also assess your pain.
- Compensation
- Not stated in the trial record.
- Follow-up
- Nanosensor-muscle oxygen levels will be measured up to 4 hours or up to 40 days after the screening visit for handgrip exercises, and up to 1 hour after CPET.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Validation of Nanosensor Oxygen Measurement
At a glance
Conditions
NCT06819683
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Zarazuela Zolkipli-Cunningham, MBChB, MRCP · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Nanosensor-muscle oxygen (Torr) levels during handgrip exercisesbefore, during and after handgrip exercise up to 4 hours or up to 40 days after the screening visit
Nanosensor-muscle oxygen (Torr) levels will be measure in the (dominant) forearm muscle during handgrip exercises and correlated to the standard measure of venous oxygenation (VO2) levels using standard clinical indirect calorimetry as a measure of tissue oxygen consumption. This data will be reported as the Torr value at each time point during measurement.
- Nanosensor-muscle oxygen (Torr) levels post Cardiopulmonary Exercise Testing (CPET)After CPET exercise up to 1-hour
Nanosensor-muscle oxygen (Torr) levels before cardiopulmonary exercise testing (CPET) will be measured in the (dominant) forearm muscle by comparing exercised muscle oxygen levels to the venous oxygen (VO2max) levels recorded during the CPET exercise. This data will be reported as the Torr value at each time point during measurement.