Peripheral Nerve InjuriesNCT05848778
Non-invasive Therapy to Drive Nerve Regeneration
A study testing Acute Intermittent Hypoxia and Normoxia in people with Peripheral Nerve Injuries, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Peripheral Nerve Injuries
- What is being tested?
- Acute Intermittent Hypoxia and Normoxia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Chronic lung or cardiac disease ii) Other nerve disorders, previous carpal tunnel release or systemic illness including diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Novel Non-invasive Therapy to Drive Robust and Sustained Peripheral Nerve Regeneration
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.
Read the detailed description
Peripheral nerve injuries are frequent and disabling, often with irreversible consequences. Injured sensory and motor neurons induce cellular and molecular events we refer to as the intrinsic repair program, linked to their regeneration capacity. Regrettably, regeneration of these nerves is challenging. Issues include whether the intrinsic repair program is robust enough, or is sustained long enough, to ensure repair over long distances. This can result in incomplete repair and/or pain states. The investigators will exploit acute intermittent hypoxia (intermittent periods of reduced oxygen), a novel treatment to condition/prime peripheral nerves and induce an enhanced intrinsic repair program. Acute intermittent hypoxia is non-invasive and has a systemic effect which is a major advantage in cases where there are multiple nerve injured in a widespread distribution, as opposed to electrical stimulation that only impacts the individual nerve stimulated. However, the full potential of acute intermittent hypoxia in nerve repair remains unknown. This will be a Phase I randomized control trial of carpal tunnel syndrome associated with severe median nerve compression/injury. This is designed to test the hypothesis that acute intermittent hypoxia before and/or after nerve decompression will result in more effective nerve regeneration and restoration of function.
Methods:
Using a double blinded randomized controlled trial design, we will recruit 80 adult patients (50% male; 50% female) >18 yrs old with severe carpal tunnel syndrome.
Statistical analysis:
Distribution of the outcome data will be analyzed using the Shapiro-Wilk test. For parameters that are normally distributed, differences between the groups will be compared using 2-way analysis of variance (ANOVA) with time and treatment allocation being the independent factors. When a statistically significant difference (p<0.05) is found, post hoc testing will be done using the Tukey test. For data that is not normally distribution, the Kruskal-Wallis test will be used instead, followed by post hoc analysis with Dunn's test when a significant difference is found. Sample size estimation - Assuming that AIH has a modest treatment effect size of 0.6 compared to the Normoxia control group, with type I error set at 0.05 and type II error at 0.80, appropriately 20 subjects are needed in each group to provide sufficient power for the study.
- Conditions
- Peripheral Nerve Injuries
- Being tested
- Acute Intermittent Hypoxia, Normoxia
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Intermittent HypoxiaDevice
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)
NormoxiaDevice
The normoxia protocol will consist of 15 cycles of 3 min of inspiring ambient air (21% O2)
| Study group | Role | What they receive |
|---|---|---|
| Acute Intermittent Hypoxia | Active comparator | Patients with hand weakness and numbness secondary to median nerve entrapment and scheduled for carpal tunnel release surgery will be randomly assigned to receive acute intermittent hypoxia Receives: Device: Acute Intermittent Hypoxia |
| Normoxia control | Placebo comparator | Patients with hand weakness and numbness secondary to median nerve entrapment and scheduled for carpal tunnel release surgery will be randomly assigned to receive normoxia Receives: Device: Normoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor unit number estimation
The number of motor units in the median innervated thenar muscles.
Measured: At 3, 6 and 12 months compared to baseline
Secondary outcomes (5)
Two point discrimination
Testing the A-beta sensory fibers using the Dellon-MacKinnon Disk
Measured: At 3, 6 and 12 months compared to baseline
Fine touch sensation
Testing the A-beta fibers using Semmes-Weinstein monofilaments
Measured: At 3, 6 and 12 months compared to baseline
Quantitative sensory testing
Cold threshold (A-beta fibers) and pain threshold (C fibers) using CASE IV quantitative sensory testing equipment
Measured: At 3, 6 and 12 months compared to baseline
Boston Carpal Tunnel Symptom Severity
Self administered questionnaire
Measured: At 3, 6 and 12 months compared to baseline
Moberg Pick-up Test
To measure hand dexterity and functional performance
Measured: At 3, 6 and 12 months compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 Jul 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will investigate AIH's potential to condition and promote enhanced repair in a Phase I randomized control trial (RCT) of carpal tunnel syndrome (CTS) associated with severe median nerve compression/injury. We predict AIH will have better outcomes than current ES strategies and we aim to non-invasively condition/prime the IRP in compressed nerves by AIH treatment prior to nerve decompression and/or post-nerve decompression.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Royal Alexandra Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848778
- Sponsor's protocol ID
- Pro00128891
- Status last verified
- Feb 2026
- First submitted
- 5 Apr 2023
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Non-invasive Therapy to Drive Robust and Sustained Peripheral Nerve Regeneration
- ClinicalTrials.gov ID
- NCT05848778
- Acronym / sponsor ID
- Pro00128891
- Conditions
- Peripheral Nerve Injuries
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Royal Alexandra Hospital
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Peripheral nerve injuries are frequent and disabling, often with irreversible consequences. Injured sensory and motor neurons induce cellular and molecular events we refer to as the intrinsic repair program, linked to their regeneration capacity. Regrettably, regeneration of these nerves is challenging. Issues include whether the intrinsic repair program is robust enough, or is sustained long enough, to ensure repair over long distances. This can result in incomplete repair and/or pain states. The investigators will exploit acute intermittent hypoxia (intermittent periods of reduced oxygen), a novel treatment to condition/prime peripheral nerves and induce an enhanced intrinsic repair program. Acute intermittent hypoxia is non-invasive and has a systemic effect which is a major advantage in cases where there are multiple nerve injured in a widespread distribution, as opposed to electrical stimulation that only impacts the individual nerve stimulated. However, the full potential of acute intermittent hypoxia in nerve repair remains unknown. This will be a Phase I randomized control trial of carpal tunnel syndrome associated with severe median nerve compression/injury. This is designed to test the hypothesis that acute intermittent hypoxia before and/or after nerve decompression will result in more effective nerve regeneration and restoration of function.
Methods:
Using a double blinded randomized controlled trial design, we will recruit 80 adult patients (50% male; 50% female) >18 yrs old with severe carpal tunnel syndrome.
Statistical analysis:
Distribution of the outcome data will be analyzed using the Shapiro-Wilk test. For parameters that are normally distributed, differences between the groups will be compared using 2-way analysis of variance (ANOVA) with time and treatment allocation being the independent factors. When a statistically significant difference (p<0.05) is found, post hoc testing will be done using the Tukey test. For data that is not normally distribution, the Kruskal-Wallis test will be used instead, followed by post hoc analysis with Dunn's test when a significant difference is found. Sample size estimation - Assuming that AIH has a modest treatment effect size of 0.6 compared to the Normoxia control group, with type I error set at 0.05 and type II error at 0.80, appropriately 20 subjects are needed in each group to provide sufficient power for the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study will investigate AIH's potential to condition and promote enhanced repair in a Phase I randomized control trial (RCT) of carpal tunnel syndrome (CTS) associated with severe median nerve compression/injury. We predict AIH will have better outcomes than current ES strategies and we aim to non-invasively condition/prime the IRP in compressed nerves by AIH treatment prior to nerve decompression and/or post-nerve decompression.
| Arm | Type | Receives |
|---|---|---|
| Acute Intermittent Hypoxia | Active comparator | Device: Acute Intermittent HypoxiaPatients with hand weakness and numbness secondary to median nerve entrapment and scheduled for carpal tunnel release surgery will be randomly assigned to receive acute intermittent hypoxia |
| Normoxia control | Placebo comparator | Device: NormoxiaPatients with hand weakness and numbness secondary to median nerve entrapment and scheduled for carpal tunnel release surgery will be randomly assigned to receive normoxia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Chronic lung or cardiac disease ii) Other nerve disorders, previous carpal tunnel release or systemic illness including diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Intermittent HypoxiaThe 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) | Device | Acute Intermittent Hypoxia |
| NormoxiaThe normoxia protocol will consist of 15 cycles of 3 min of inspiring ambient air (21% O2) | Device | Normoxia control |
Primary outcome
Motor unit number estimation
Time frame: At 3, 6 and 12 months compared to baseline
The number of motor units in the median innervated thenar muscles.
5 secondary outcomes
Two point discrimination
Time frame: At 3, 6 and 12 months compared to baseline
Fine touch sensation
Time frame: At 3, 6 and 12 months compared to baseline
Quantitative sensory testing
Time frame: At 3, 6 and 12 months compared to baseline
Boston Carpal Tunnel Symptom Severity
Time frame: At 3, 6 and 12 months compared to baseline
Moberg Pick-up Test
Time frame: At 3, 6 and 12 months compared to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Intermittent Hypoxia and Normoxia in people with Peripheral Nerve Injuries, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor unit number estimation (time frame: At 3, 6 and 12 months compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.