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NCT Number: NCT07739992

Dose Optimization Study of Acute Intermittent Hypoxia in Spinal Cord Injury

This study aims to evaluate how different doses of acute intermittent hypoxia (AIH) affect lower-limb strength, reaction time, and responsiveness in individuals with spinal cord injury (SCI). The objective is to identify the dose that most effectively improves motor output while also examining parameters that may account for variability in response.

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Key information

Conditions

Spinal Cord Injuries (SCI) Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic Spinal Cord Injury (>6 months)
  • Motor incomplete SCI classified as AIS C or D
  • Volitional ankle plantarflexion strength in at least one leg

Exclusion criteria

  • Uncontrolled hypertension (outside 140/90 and 90/60)
  • Concurrent medical illness
  • Traumatic brain injury
  • Cardiovascular complications
  • Pulmonary complications
  • Metabolic dysfunction
  • Continued use of anti-spasticity medications
  • Previously diagnosed obstructive sleep apnea

Treatment and study plan

Sham AIH

Other

In this intervention, participants will wear a fitted mask, and will be given 15 bouts of room air through the same delivery system as the AIH interventions

Acute Intermittent Hypoxia (AIH) 15

Other

In this intervention, participants will wear a fitted mask, and will be given 15, 60 second bouts of lowered oxygen (9% O2, akin to being on a tall mountain). Following the 60 seconds of hypoxia, participants will be given 60 seconds of room air

Acute Intermittent Hypoxia (AIH) 23

Other

In this intervention, participants will wear a fitted mask, and will be given 23, 60 second bouts of lowered oxygen (9% O2, akin to being on a tall mountain). Following the 60 seconds of hypoxia, participants will be given 60 seconds of room air

Primary outcomes

  1. Change in ankle plantarflexion and dorsiflexion

    Time frame: Immediately following Intervention

    Measurement of ankle force during a maximum voluntary contraction while pushing or pulling on a force plate

  2. Lower Limb Reaction time

    Time frame: Immediately following intervention

    Assessed using visual, auditory, and combined cueing tasks, reaction time will be quantified as the time from cue presentation to muscle activity onset

Secondary outcomes

  1. SpO2 burden

    Time frame: During intervention

    SpO2 data collected continuously throughout the hypoxic periods, defined as the area under the SpO2 time desaturation curve below a baseline threshold, this quantifies the cumulative hypoxic dose experienced

  2. Hypoxic Ventilatory Response

    Time frame: During intervention

    HVR will be assessed using breath-by-breath monitoring of ventilation via respiratory flow sensor or pneumotachograph during intervention. The relation between ventilation increases and the corresponding reduction SpO2 will quantify individual ventilatory responsiveness

Study contacts

Contact information is provided by the study sponsor or research team.

Milap Sandhu, PhD, PT

CONTACT

[email protected]

312-238-6529

Sponsors and collaborators

Lead sponsor

Milap Sandhu

Other

Collaborators

  • Shirley Ryan AbilityLab

Registry information

Official study title

Dose-Optimization Study of Acute Intermittent Hypoxia (DOSA-SCI): Effects on Lower-Limb Motor Function and Physiological Responsiveness in Individuals With Incomplete Spinal Cord Injury

Acronym: DOSA-SCI

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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