Recruiting

Mild Intermittent Hypoxia

Sponsor:

VA Office of Research and Development

Code:

NCT05351827

Conditions

Spinal Cord Injuries

Autonomic Dysreflexia

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Mild Intermittent Hypoxia

Sham

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries

Autonomic Dysreflexia

Study ID

NCT05351827

Start date

Oct 1, 2022

Status verified date

Aug, 2026

Completion date

Oct 29, 2027

Anticipated

Primary completion date

Oct 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Motor incomplete spinal cord injury at or above the 12th thoracic vertebrae
  • Signs or symptoms of autonomic dysfunction (this will be determined by the Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI) and ISAFSCI questions. The ADFSCI requires a score of 1 on questions 16 and 22, and the International Standards to document Autonomic Function following SCI (ISAFSCI) requires a score of 1 on any parameter)
  • Chronic injuries (>1 year post injury)

Exclusion Criteria:

  • Pregnant
  • Smoker
  • Drug addiction
  • Complete spinal cord injury
  • Spinal cord injury below the 6th thoracic vertebrae
  • Insulin dependent diabetes
  • Shift workers (i.e., disrupted circadian rhythm)
  • Active skin breakdown or pressure sores

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mild Intermittent Hypoxia

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.

sham comparator: Sham

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.

Interventions

Mild Intermittent Hypoxia

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.

Sham

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.

Primary outcome measure

  • Autonomic Dysreflexia [ Time Frame: 6 minutes, Pre-Intervention, 1 Day after intervention (i.e. post intervention) ]

Central Contacts and Locations

Central contacts

Gino Panza, PhD

(313) 576-1000Gino.Panza@va.gov

Locations

John D. Dingell VA Medical Center, Detroit, MI

Recruiting

Detroit, Michigan, United States, 48201-1916

Contacts

Gino Panza, PhD

(313) 576-1000Gino.Panza@va.gov

Erin Olgren, PhD MS

(313) 576-4448erin.olgren@va.gov

Principal Investigator:

Gino Panza, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-14.