An interventional study of Mild Intermittent Hypoxia and Sham in Spinal Cord Injuries and Autonomic Dysreflexia, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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Among 16 studies in Autonomic Dysreflexia with a site in United States — 4 open to participants now, 4 under way, none of them phase 3. Autonomic Dysreflexia · United States.
Among the 16 studies in Autonomic Dysreflexia with a site in United States, this one is the 4th largest by planned enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2022, is one of 7 with no phase, and was the 13th registered.
30 studies on the registry are indexed under Autonomic Dysreflexia; 10 are open to participants now.
Browse Autonomic Dysreflexia studies →4 of the 16 studies in Autonomic Dysreflexia with a site in United States are open now. Recruiting first, the newest first:
University of Louisville · Sites in United States
Ages 18+
Mayo Clinic · Sites in United States
Ages 18–50 · Healthy volunteers
University of Washington · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Autonomic Dysreflexia studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 1 · Phase 4 1
First in 2012; this study’s year is marked. 2 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is close to the median of 22 across 23 interventional studies indexed under Autonomic Dysreflexia.
Median enrollment 13 across the 11 interventional studies, 92 across the 5 observational. Of the 11 that completed or were terminated, 3 (27%) have results posted.
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None of the 16 has an industry lead sponsor. The 9 most frequent:
VA Office of Research and Development is the lead sponsor of 1,773 studies on the registry; 393 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
VA Office of Research and Development has 1 study filed under Autonomic Dysreflexia — fewer than ten, so there is no comparison to draw.
2 of the studies in Autonomic Dysreflexia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07012135Mayo ClinicDeciphering Preserved Autonomic Function After Multiple Sclerosis | 2026-12-31 |
| NCT05351827VA Office of Research and DevelopmentMild Intermittent Hypoxia: A Prophylactic for Autonomic Dysfunction in Individuals With Spinal Cord Injuries | 2027-10-29 |
Add all 2 to your calendar (.ics) → With an account.
Among the 16 studies in Autonomic Dysreflexia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The prevalence of autonomic dysfunction and sleep disordered breathing (SDB) is increased in individuals with spinal cord injury (SCI). The loss of autonomic control results in autonomic dysreflexia (AD) and orthostatic hypotension (OH) which explains the increase in cardiovascular related mortality in these Veterans. There is no effective prophylaxis for autonomic dysfunction. The lack of prophylactic treatment for autonomic dysfunction, and no best clinical practices for SDB in SCI, are significant health concerns for Veterans with SCI. Therefore, the investigators will investigate the effectiveness of mild intermittent hypoxia (MIH) as a prophylactic for autonomic dysfunction in patients with SCI. The investigators propose that MIH targets several mechanisms associated with autonomic control and the co-morbidities associated with SDB. Specifically, exposure to MIH will promote restoration of homeostatic BP control, which would be beneficial to participation in daily activities and independence in those with SCI.
Individuals with a spinal cord injury (SCI) above the 6th thoracic vertebrae experience severe autonomic dysfunction. These individuals lose the ability to control blood pressure (BP) during a noxious or non-noxious stimulus below the injury (Autonomic Dysreflexia [AD]) and during positional changes (Orthostatic Hypotension [OH]). The loss of descending autonomic control and subsequent loss of BP control are highly prevalent in individuals with SCI. More importantly, many individuals are unaware of the loss of BP control as most individuals remain asymptomatic. These potentially life-threatening oscillations in BP are known to induce further damage; creating a vicious cycle of continued autonomic and cardiovascular dysfunction which explains the increased cardiovascular related mortality. Unfortunately, there is no effect prophylaxis for autonomic dysfunction in these individuals. Furthermore, the prevalence of sleep disordered breathing (SDB) is high in individuals with SCI (tetraplegia can exceed 90%), and there is no current best clinical practice guidelines for treating SDB in individuals with SCI. The primary treatment is with continuous positive airway pressure (CPAP). Unfortunately, treatment adherence remains poor. Moreover, SDB is known to negatively impact autonomic, cardiovascular, and microvascular function in individuals without SCI. In individuals without an SCI, adherence to CPAP has shown to improve microvascular function. Although no direct evidence is available, individuals with SCI have shown to have a reduction in the frequency of AD when adherent to CPAP suggesting the microvasculature may be a pro-active therapeutic target for AD and OH. Both autonomic dysfunction and SDB are negatively impacted by the lack of motor function following SCI resulting in deconditioning, atrophy of the muscles and vessels, insulin resistance, and reduced metabolic rate. It has been suggested higher CPAP pressure during in-home treatment coupled with increased upper airway resistances are primary physiological barriers to CPAP treatment. Therefore, treatment options that directly improve the blood pressure response to sympathetic activation, upper airway function as well as improve microvascular function are imperative for those with a SCI. The overall goal of the present proposal is to investigate if daily exposure to mild intermittent hypoxia (MIH) can ameliorate autonomic dysfunction in persons with SCI as well as improve mitochondrial and microvascular function. The investigators will recruit individuals with SCI, concurrent SDB, and signs of autonomic dysfunction who will be randomly assign to one of two groups. Treatment will be administered for 8 days over a 2-week period. Both groups will be treated with nightly in-home CPAP over the 8 days. Lastly, individuals will be tested before, and after MIH as well as return to the laboratory 4 weeks later to undergo post-MIH autonomic, cardiovascular, and peripheral muscle function tests. Participants will return 4-weeks later to investigate if there is a sustained impact of therapeutic MIH on autonomic function and SDB. The dissemination of these outcomes could transform the approach to treating autonomic dysfunction and SDB in individuals with SCI. Therefore, this project will determine if MIH combined with CPAP can be used as prophylaxis for autonomic dysfunction in participants with SCI and autonomic dysfunction.
30 studies on the registry are indexed under Autonomic Dysreflexia; 10 are open to participants now.
This study's planned enrollment of 24 is close to the median of 22 across 23 interventional studies indexed under Autonomic Dysreflexia.
Browse Autonomic Dysreflexia studies →VA Office of Research and Development is the lead sponsor of 1,773 studies on the registry; 393 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Compared within Autonomic Dysreflexia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Spinal Cord Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This arm of the protocol will receive mild intermittent hypoxia (8% oxygen) with end-tidal carbon dioxide maintained 1-3 millimeters of mercury above baseline, while in the laboratory. If diagnosed with sleep apnea, participants will be treated with continuous positive airway pressure for the duration of the intervention.
Other: Mild Intermittent Hypoxia
This arm of the protocol will receive sham air (21% oxygen) while in the laboratory. No additional gases will be employed. If diagnosed with sleep apnea, participants will be treated with continuous positive airway pressure for the duration of the intervention.
Other: Sham
Participants will breathe 8% oxygen through a non-diffusible bag that is connected to a 5-way stopcock. The inspiration side of the system is then connected to a 2-way non-rebreathing valve which is connected to a pneumotachometer that is connected to a tight fitting facemask. 100% oxygen and carbon dioxide are titrated into the system to ensure the appropriate hypoxic and hypercapnic stimulus is delivered. The investigators will lower oxygen to 55-60 mmHg and maintain end-tidal carbon dioxide 1-3 mmHg above individual baseline values. The protocol starts with 10 minutes of baseline breathing (room air) then followed by 10 more minutes of breathing room air with the additional carbon dioxide. Thereafter, individuals undergo 12 2-minute bouts of hypoxia with 2 minutes of normoxia (room air) interspersed between episodes. The intervention protocol concludes with 20 minutes of monitoring all breathing and cardiovascular measurements.
Participants will breathe 21% oxygen through a non-diffusible bag that is connected to a 5-way stopcock. The inspiration side of the system is then connected to a 2-way non-rebreathing valve which is connected to a pneumotachometer that is connected to a tight fitting facemask. No supplemental oxygen or carbon dioxide will be used during the sham protocol. The protocol starts with 10 minutes of baseline breathing (room air) then followed by 10 more minutes of breathing room air with the additional carbon dioxide. Thereafter, individuals undergo 12 2-minute bouts of hypoxia with 2 minutes of normoxia (room air) interspersed between episodes. The intervention protocol concludes with 20 minutes of monitoring all breathing and cardiovascular measurements.
Autonomic Dysreflexia
Change in systolic blood pressure during thigh occlusion test.
Time frame: 6 minutes, Pre-Intervention, 1 Day after intervention (i.e. post intervention)
Orthostatic Hypotension
The change in systolic blood pressure following positional change (supine to seated)
Time frame: 6 minutes, Pre-Intervention, 1 Day after intervention (i.e. post intervention)
Mitochondrial Capacity
Oxygen consumption during thigh occlusion
Time frame: 6 minutes, Pre-Intervention, 1 Day after intervention (i.e. post intervention)
Microvascular function
Maximum hyperemic response following 6-minute occlusion test
Time frame: 6 minutes, Pre-Intervention, 1 Day after intervention (i.e. post intervention)
Plan to share: No
Started Oct 2022 (actual). Primary completion is estimated for Oct 2027, 60 months after the start.
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