Recruiting

Acute Intermittent Hypoxia

Sponsor:

Zev Rymer

Code:

NCT07583498

Conditions

Spinal Cord Injuries (SCI)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acute Intermittent Hypoxia (AIH)

Study Details

Brief summary:

This study aims to observe the effects of administration of a breathing intervention (Acute Intermittent Hypoxia (AIH)) on spasticity (tightness) in individuals with incomplete Spinal Cord Injury. It is hypothesized that hypoxia will decrease the reflex threshold of the biceps brachii, indicating an increase in spasticity following the AIH.

Conditions

Spinal Cord Injuries (SCI)

Study ID

NCT07583498

Start date

Mar 17, 2026

Status verified date

May, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >= 18
  • Non-progressive spinal Cord injury at least 6 months prior
  • Level of injury between C1-C8
  • ISNCSCI ASIA classification C or D
  • Measurable Spasticity

Exclusion Criteria:

  • Pre-existing hypoxic pulmonary disease
  • Positive Covid-Pneumonia diagnosis within 1 year of visit
  • Uncontrolled hypertension >140/90 mmHg
  • Individuals who are currently pregnant/nursing or planning on becoming pregnant
  • Individuals with a tracheostomy or who utilize mechanical ventilation
  • A botulinum toxin injection to upper extremity musculature within the past 3 months
  • Currently taking Baclofen
  • Congestive Heart Failure
  • Cardiac arrhythmias
  • Uncontrolled diabetes mellitus
  • Chronic obstructive pulmonary disease
  • Emphysema
  • Severe Asthma
  • Previous myocardial infarction
  • Carotid/intracerebral artery stenosis
  • Orthopedic injuries or surgeries that impact the ability to use the upper extremity
  • History of Epilepsy

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: AIH intervention

In this Arm, participants will receive the Acute Intermittent Hypoxia Intervention. In this AIH, participants will breath alternating bouts of lowered oxygen and room air (approximately 60 seconds of each) for around 30 minutes.

Interventions

Acute Intermittent Hypoxia (AIH)

This intervention involves breathing lowered levels of oxygen for 60 seconds, alternating with 60 seconds of room air breathing. Participants will be monitored and observed during the entire session for any changes in vital signs

Primary outcome measure

  • Change in reflex indentation threshold [ Time Frame: Day 1 of Intervention ]

Central Contacts and Locations

Central contacts

William Z Rymer, MD, PhD

312-238-3919w-rymer@northwestern.edu

Alexander Barry, MS

312-238-1435abarry@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Alexander Barry, MS

312-238-1435abarry@sralab.org

Principal Investigator:

William z Rymer, MD, PhD

More Information

Sponsor

Zev Rymer

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

  • Hypoxia
  • Spasticity
  • Reflex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Zev Rymer on 2026-05-13.