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.

NCT06819683

Validation of Nanosensor Oxygen Measurement

Recruiting
PHASE1Ages 18–65InterventionalDiagnostic
Children's Hospital of Philadelphia
~96 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Nanosensor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Nanosensor-muscle oxygen (Torr) levels during handgrip exercises
Measured over before, during and after handgrip exercise up to 4 hours or up to 40 days after the screening visit
+1 more outcome measured
MItochondrial Myopathies
Mitochondrial Disease

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.

  • Zarazuela Zolkipli-Cunningham, MBChB, MRCP · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia
Zarazuela Zolkipli-Cunningham, MBChB, MRCP
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

  • 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.