Acute Intermittent Hypoxia for Peripheral Nerve Injury

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, non-invasive treatment called Acute Intermittent Hypoxia, designed to help individuals with severe carpal tunnel syndrome, which causes hand weakness, numbness, and pain. Researchers believe this treatment could enhance nerve repair by using cycles of low oxygen air, similar to techniques used for spinal cord injuries. Participants should experience symptoms like numbness, hand pain that disrupts sleep, and difficulty using their hands. The study aims to determine if this method is as effective as more invasive treatments for improving hand function. As an unphased trial, it offers an opportunity to contribute to innovative research that could lead to new treatment options.

What prior data suggests that acute intermittent hypoxia is safe for peripheral nerve injury?

Research has shown that acute intermittent hypoxia (AIH) is generally safe for people. In past studies, researchers tested AIH on individuals with brain injuries to ensure its safety. These studies suggest that AIH can be used without causing significant harm. Another study found that briefly breathing air with lower oxygen levels, as in AIH, is safe and helps improve nerve and muscle function.

Although the treatment involves breathing air with about half the normal oxygen level, it has not caused serious problems in the studies reviewed. Participants in these studies did not report major issues, indicating that AIH is a promising and non-invasive therapy.12345

Why are researchers excited about this trial?

Acute Intermittent Hypoxia (AIH) is unique because it offers a non-invasive approach to helping nerves recover function, which could be a game-changer for people with peripheral nerve injuries like carpal tunnel syndrome. Unlike traditional treatments such as surgery or corticosteroid injections, AIH involves short bursts of reduced oxygen levels, which can stimulate nerve repair and improve muscle strength. Researchers are excited about AIH because it targets the nervous system's natural ability to adapt and heal, potentially providing quicker and less invasive relief for patients.

What evidence suggests that acute intermittent hypoxia is effective for peripheral nerve injury?

Research has shown that breathing air with less oxygen for short periods, known as acute intermittent hypoxia (AIH), can help repair nerves. In mice, AIH aided in fixing damaged nerves, making it a promising option for treating nerve injuries. This method improves nerve function, similar to electrical nerve stimulation, but without surgery. Studies on spinal cord injuries in both rats and humans indicate that AIH can enhance muscle function and might benefit the nervous system more broadly. In this trial, participants will be randomly assigned to receive either AIH or a normoxia control. These findings suggest AIH could aid nerve repair in conditions like severe carpal tunnel syndrome.26789

Are You a Good Fit for This Trial?

This trial is for individuals with severe carpal tunnel syndrome affecting hand function. Participants should have sensory impairments, pain, nocturnal symptoms, muscle weakness and wasting in the thumb area (thenar musculature), and reduced hand dexterity. They must also show significant motor unit loss.

Inclusion Criteria

I experience numbness and pain due to sensory impairments.
Nocturnal awakening by these symptoms
I have weakness and loss of muscle in the palm of my hand.
See 2 more

Exclusion Criteria

I have a nerve disorder.
I have a long-term lung or heart condition.
I have had surgery for carpal tunnel syndrome.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acute intermittent hypoxia or normoxia control treatment before and/or after carpal tunnel release surgery

12 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Visits at 3, 6, and 12 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Acute Intermittent Hypoxia

Trial Overview

The study tests a non-invasive therapy called Acute Intermittent Hypoxia which involves breathing cycles of normal air and air with lower oxygen levels to promote nerve regeneration. It's compared against Normoxia—breathing regular air—to see if it improves outcomes like electrical stimulation does.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Acute Intermittent HypoxiaActive Control1 Intervention
Group II: Normoxia controlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Royal Alexandra Hospital

Collaborator

Trials
20
Recruited
9,300+

Citations

Carpal Tunnel Syndrome in Obstructive Sleep Apnea Patients

This study aimed to determine the frequency of CTS in OSA patients and evaluate the causative relation between the two diseases.

Hand Pain and Sensory Deficits: Carpal Tunnel Syndrome

Grades of recommendation have been provided for areas related to clinical practice, including diagnosis, outcomes assessment, and interventions.

Acute intermittent hypoxia enhances regeneration of ...

AIH can increase neural activity and under moderately severe hypoxic conditions improves repair of peripherally crushed nerves in mice.

The Effects of Intermittent Hypoxia on Acute Hypoxic Injury

Previous studies have found that short-term intermittent hypoxia can increase the sensitivity of hypoxia and reduce the severity of acute hypoxia injury, and ...

Research progress in different physical therapies for ...

Physical therapy is gaining recognition as an effective therapeutic approach in the realm of peripheral nerve injury (PNI) research.

Safety and potential benefits of acute intermittent hypoxia in ...

Our clinical trial aimed to establish if AIH can be safely administered in patients with traumatic brain injury (TBI) and to collect preliminary data about its ...

Acute intermittent hypoxia improves nerve repair in ...

Researchers presented data from a study that aimed to assess the repair potential of acute intermittent hypoxia (AIH) treatment for compression injuries.

Safety and potential benefits of acute intermittent hypoxia ...

Objective Our clinical trial aimed to establish if AIH can be safely administered in patients with traumatic brain injury (TBI) and to ...

Acute Intermittent Hypoxia on Leg Function Following ...

Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment ...