Health TrialsbyHealthPanel

Dose Optimization Study of Acute Intermittent Hypoxia in Spinal Cord Injury

ConditionSpinal Cord Injuries (SCI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMilap Sandhu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Chronic Spinal Cord Injury (>6 months)

Motor incomplete SCI classified as AIS C or D

Volitional ankle plantarflexion strength in at least one leg

Disqualifiers

Uncontrolled hypertension (outside 140/90 and 90/60)

Concurrent medical illness

Traumatic brain injury

Cardiovascular complications

Trial design

Design model

Crossover

Treatments tested in this trial

  • Sham AIH

    Other intervention

    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 intervention

    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 intervention

    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

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Sham + AIH 15 + AIH 23Other 1 intervention
Group B: AIH 15 + Sham + AIH 23Other 1 intervention
Group C: AIH 23 + AIH 15 + ShamOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in ankle plantarflexion and dorsiflexion

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

Time frame
Immediately following Intervention
2

Lower Limb Reaction time

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

Time frame
Immediately following intervention

Secondary outcomes

1

SpO2 burden

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

Time frame
During intervention
2

Hypoxic Ventilatory Response

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

Time frame
During intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Milap Sandhu

Lead sponsor

Shirley Ryan AbilityLab

Sponsor institution

Shirley Ryan AbilityLab

Collaborator

Source ClinicalTrials.gov
Apply now