Recruiting

Intermittent Hypoxia

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT02323945

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

AIH

Walk

Strength

Study Details

Brief summary:

Accumulating evidence suggests that repeatedly breathing low oxygen levels for brief periods (termed intermittent hypoxia) is a safe and effective treatment strategy to promote meaningful functional recovery in persons with chronic spinal cord injury (SCI). The goal of the study is to understand the mechanisms by which intermittent hypoxia enhances motor function and spinal plasticity (ability of the nervous system to strengthen neural pathways based on new experiences) following SCI.

Conditions

Spinal Cord Injuries

Study ID

NCT02323945

Start date

Oct, 2014

Status verified date

Mar, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 18 and 75 years (the latter to reduce likelihood of heart disease)
  • Medical clearance to participate
  • Lesion at or below C2 and above T12 with non-progressive etiology
  • Classified as motor-incomplete with visible volitional leg movement
  • Injury greater than 1 year

Exclusion Criteria:

  • Concurrent severe medical illness (i.e., infection, cardiovascular disease, ossification, recurrent autonomic dysreflexia, unhealed decubiti, and history of pulmonary complications)
  • Pregnant women because of the unknown affects of AIH on pregnant women and fetus
  • History of seizures, brain injury, and/or epilepsy
  • Undergoing concurrent physical therapy
  • Diabetes
  • Cirrhosis
  • Caffeine and/or NSAID allergies or intolerances

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: AIH/Walk

Subjects with chronic, motor-incomplete SCI receive acute intermittent hypoxia (AIH) with walking practice, then AIH with strength practice and compare their efficacy on enhancing strength and/or walking performance.

active comparator: AIH/Strength

Subjects with chronic, motor-incomplete SCI receive AIH with strength practice, then AIH with walking practice and compare their efficacy on enhancing strength and/or walking performance.

Interventions

AIH

Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FiO2) = 0.10±0.02 (hypoxia). Participants will receive treatment on 5 consecutive days.

Walk

30 minutes of walking practice consisting of 5 repetitions of 6-minute walks

Strength

30 minutes of isometric ankle plantar flexion torque practice broken into 3 sets of 10 repetitions

Primary outcome measure

  • Change in overground walking endurance [ Time Frame: Baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two weeks) ]
  • Change in muscle strength [ Time Frame: Baseline, immediately after intervention (day 1 and day 5), and at follow-ups (one week and two weeks) ]

Central Contacts and Locations

Central contacts

Randy D Trumbower, PT, PhD

617-952-6951randy.trumbower@mgh.harvard.edu

Stella Barth, BA

617-952-6822sbarth@partners.org

Locations

Spaulding Rehabilitation Hospital

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Randy D Trumbower, PT, PhD

(617) 952-6951randy.trumbower@mgh.harvard.edu

Melissa DeChellis, BA

(617) 952-6953mpierre19@partners.org

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Keywords

  • acute intermittent hypoxia
  • incomplete spinal cord injury
  • strength
  • walking
  • breathing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2026-03-20.