Dose Optimization Study of Acute Intermittent Hypoxia in Spinal Cord Injury

NCT07739992 — Not applicable, Recruiting, 40 participants, Milap Sandhu

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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

Registry	NCT07739992, acronym DOSA-SCI
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: single, other
Enrollment	40 (Estimated)
Sponsor	Milap Sandhu (Other); collaborators: Shirley Ryan AbilityLab
Conditions	Spinal Cord Injuries (SCI)
Interventions	Sham AIH, Acute Intermittent Hypoxia (AIH) 15, Acute Intermittent Hypoxia (AIH) 23 (Other)
Dates	start 2026-07-27, primary completion 2027-07-01 (estimated), completion 2028-07-01 (estimated), first posted 2026-07-31, last updated 2026-07-31
Locations	1 site in United States

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
Sham + AIH 15 + AIH 23	Other	Other: Sham AIH	In this group, participants will undergo Sham AIH intervention first, with room oxygen, the following visit they will undergo 15, 60 second bouts of lowered oxygen, following that they will undergo 23, 60 second bouts of lowered oxygen
AIH 15 + Sham + AIH 23	Other	Other: Acute Intermittent Hypoxia (AIH) 15	In this group, participants will undergo15, 60 second bouts of lowered oxygen intervention first, the following visit they will undergo sham training with room air, following that they will undergo 23, 60 second bouts of lowered oxygen
AIH 23 + AIH 15 + Sham	Other	Other: Acute Intermittent Hypoxia (AIH) 23	In this group, participants will undergo 23, 60 second bouts of lowered oxygen intervention first, the following visit they will undergo 15, 60 second bouts of lowered oxygen, following that sham training with room air, following that they will undergo

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

+Outcome measures

Primary outcomes

Change in ankle plantarflexion and dorsiflexion [Immediately following Intervention]: Measurement of ankle force during a maximum voluntary contraction while pushing or pulling on a force plate
Lower Limb Reaction time [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

SpO2 burden [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
Hypoxic Ventilatory Response [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

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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

+Locations (1)

Facility	City	Country	Status
Shirley Ryan AbilityLab	Chicago, Illinois	United States	Recruiting

+Investigators

Milap Sandhu, PT, PhD, Principal investigator, Shirley Ryan AbilityLab