Non-invasive Therapy to Drive Nerve Regeneration

NCT05848778 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Alberta

Phase

Not applicable

Started

2025-07-01

Last updated

2026-02-09

Condition(s) studied

Peripheral Nerve Injuries

Investigational drug(s) / intervention(s)

Acute Intermittent HypoxiaNormoxia

Acute Intermittent Hypoxia: The acute intermittent hypoxia protocol will consist of 15 cycles of 1.5 min of inspiring ambient air (21% O2) alternating with 1.5 min of hypoxic air (9% O2)

Normoxia: The normoxia protocol will consist of 15 cycles of 3 min of inspiring ambient air (21% O2)

Study summary

Peripheral nerve injuries are common and often associated with poor outcomes including incomplete repair, debilitating pain states and compromised function. Although nerve regeneration can be enhanced by brief electrical nerve stimulation at the time of or before surgical repair in rodents and humans, this approach is invasive. Acute intermittent hypoxia, breathing alternate cycles of regular air and air with \~50% normal oxygen levels (11% O2) is an emerging, promising non-invasive therapy promoting respiratory and non-respiratory muscle function in spinal cord injured rats and humans. Because the entire body is exposed to this therapy, it has the potential to globally impact the nervous system beyond just controlling respiratory and leg function in spinal cord injured patients. Thus, the investigators hypothesized that an acute intermittent hypoxia paradigm similar to that used for spinal cord repair will improve peripheral nerve repair in a manner akin to electrical stimulation, including its impact on expression of regeneration-associated proteins - a predictor of nerve growth states. In recent studies the investigators found this to be the case and now propose to continue these promising studies by performing a pilot clinical trial evaluating this form of treatment on patients with compromised hand function due to severe carpal tunnel syndrome. The goal is to improve nerve repair outcomes in the least invasive and optimal manner.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: i) sensory impairments including numbness and pain; ii) nocturnal awakening by these symptoms; iii) weakness and wasting of the thenar musculature and, iv) loss of hand dexterity. v) Motor unit loss greater than 2 SD below the mean for the age group Exclusion Criteria: i) Chronic lung or cardiac disease ii) Other nerve disorders, previous carpal tunnel release or systemic illness including diabetes

Primary outcome measure(s)

Motor unit number estimation — At 3, 6 and 12 months compared to baseline
The number of motor units in the median innervated thenar muscles.

Trial sites (1)

Facility	City	Region	Status
University of Alberta	Edmonton	Alberta

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05848778 on ClinicalTrials.gov ↗ ← All trials in Canada