Intermittent Hypoxia Therapy for Spinal Cord Injury

Overseen By Stella Barth, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Disqualifiers: Cardiovascular disease, Osteoporosis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether breathing low-oxygen air for short periods, known as Acute Intermittent Hypoxia (AIH) therapy, can help individuals with incomplete spinal cord injuries improve leg strength and walking ability. Researchers aim to determine if these brief low-oxygen sessions can strengthen leg muscles and enhance reflexes. Two groups will be compared: one will breathe low-oxygen air, while the other will breathe normal room air as a control. Individuals with incomplete spinal cord injuries who can take a step without assistance might be suitable for this study. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance mobility and quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for spinal cord injury patients?

Studies have shown that acute intermittent hypoxia (AIH) is generally safe and well-tolerated. Research indicates that AIH sessions can improve movement abilities without causing major side effects. For example, one study found that using oxygen levels as low as 9% was safe for people with long-term conditions like traumatic brain injuries.

In people with spinal cord injuries, AIH has been linked to temporary improvements in breathing and limb strength. The treatment involves breathing short bursts of low oxygen, which appears to quickly boost strength and coordination. Although some heart and blood vessel effects require further research, AIH is considered a safe option for enhancing nerve function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intermittent Hypoxia Therapy for spinal cord injury because it offers a novel approach by using short bouts of low oxygen to potentially enhance recovery. Unlike traditional treatments such as physical therapy or medications that focus on managing symptoms, this therapy might stimulate neural pathways and improve motor functions directly. The method is non-invasive and works through a new mechanism of action, which could provide significant benefits without the need for surgical intervention. This innovative approach is especially promising because it targets the body's natural adaptive responses to low oxygen, potentially leading to improved outcomes for individuals with chronic spinal cord injuries.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

This trial will compare Acute Intermittent Hypoxia (AIH) with a sham treatment. Research has shown that breathing low-oxygen air for short periods, known as AIH, can improve leg function in individuals with partial spinal cord injuries in the neck area. Studies have found that AIH boosts leg strength and walking ability. This method activates the nervous system and strengthens muscles, offering hope for those with motor-incomplete spinal cord injuries seeking to enhance leg strength and mobility. ^{6 7 8 9 10}

Who Is on the Research Team?

Randy D Trumbower, PT, PhD

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with incomplete spinal cord injury from C2-L5, medically stable and able to take a step without help. It's been over 6 months since their injury. People can't join if they have heart or lung issues, are in physical therapy, have severe pain or infections, fractures due to osteoporosis, leg nerve damage, cognitive impairment (score <24 on Mini-Mental), are pregnant or at risk of frequent autonomic dysreflexia.

Inclusion Criteria

It has been over 6 months since my spinal cord injury.

I can walk and take a step without help from another person.

I have a spinal cord injury that is not getting worse, between my neck and lower back.

Exclusion Criteria

I do not have severe ongoing illnesses like unhealed wounds, chronic pain, heart disease, weak bones with fractures, abnormal bone growth, or nerve damage in my legs.

You scored less than 24 on the Mini-mental Exam.

I have experienced repeated episodes of sudden high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo daily sessions of intermittent hypoxia for 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for changes in walking speed and endurance

4 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Acute Intermittent Hypoxia
• SHAM - Intermittent Room Air

Trial Overview The study tests how low oxygen periods (AIH) affect leg muscle control and strength in people with cervical spinal cord injuries compared to normal air breathing (SHAM). The goal is to see if AIH improves voluntary leg strength, reflexes in the legs, and walking ability.

How Is the Trial Designed?

Group I: Intermittent Hypoxia (AIH) Active Control 1 Intervention

Subjects with chronic, motor-incomplete SCI will breath mild bouts of low oxygen. Intervention: AIH - Intermittent Hypoxia - hypoxia air mixture Dosage: 10% oxygen Frequency: 1.5 minutes bouts of low oxygen with 1.0 minute intervals of room air Duration: 38 minutes

Group II: Intermittent Room Air (SHAM) Placebo Group 1 Intervention

Subjects with chronic, motor-incomplete SCI will breath mild bouts of room air. Intervention: SHAM - Intermittent Room Air - room air mixture Dosage: 21% oxygen Frequency: 1.5 minutes bouts of room air with 1.0 minute intervals also of room air Duration: 38 minutes

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Foundation Wings For Life

Collaborator

Trials

14

Recruited

1,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8530358/

Efficacy and time course of acute intermittent hypoxia effects in ... These findings demonstrate the potential of AIH to improve upper-extremity function in persons with chronic SCI, although follow-up studies are needed to ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138325000713

Effects of acute intermittent hypoxia on muscle strength in ... AIH is a promising therapeutic modality for enhancing muscle strength post-SCI, specifically in patients with motor-incomplete injuries.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02274116

Acute Intermittent Hypoxia on Leg Function Following ... Acute intermittent hypoxia (AIH) exposure will increase maximum voluntary leg strength in persons with incomplete cervical spinal cord injury (SCI); AIH ...

4. brooksrehab.org brooksrehab.org/resources/researchers-receive-grant-to-study-improved-breathing-for-sci/

Researchers Receive $3.6 Million Grant for Study to ... A new treatment known as therapeutic acute intermittent hypoxia (AIH) has shown promise for improving breathing ability in people living with chronic spinal ...

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.047261

Acute Intermittent Hypoxia With High-Intensity Gait Training ... Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014;82:104–113. doi: 10.1212 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41117316/

Effect of acute intermittent hypoxia to enhance motor ... The review indicates that acute intermittent hypoxia is safe and has good treatment adherence, with low drop-out rates for acute intermittent ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03071393

Intermittent Hypoxia to Enhance Motor Function After ... A single session of acute intermittent hypoxia has also been shown to temporarily enhance breathing and limb strength in people with spinal cord injury. Further ...

8. medrxiv.org medrxiv.org/content/10.1101/2025.09.24.25336487v1

Safety and potential benefits of acute intermittent hypoxia ... Conclusions AIH dosage as low as 9% O2 appears safe to use in chronic TBI, but its potential benefits remain to be investigated. Competing ...

9. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.046620

Acute Intermittent Hypoxia in People Living With Chronic ... Published results in spinal cord injured patients have shown enhanced strength and coordination rather quickly after AIH, which opens a window ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1569904824001514

Safety and effectiveness of acute intermittent hypoxia ... Acute intermittent hypoxia is generally safe and effective at producing neural plastic responses, but further examination of co-occurring cardiovascular ...