Spinal Cord Injuries (SCI)DOSA-SCINCT07739992
Dose Optimization Study of Acute Intermittent Hypoxia in Spinal Cord Injury
A study testing Acute Intermittent Hypoxia (AIH) 15 and Acute Intermittent Hypoxia (AIH) 23 in people with Spinal Cord Injuries (SCI), run by Milap Sandhu at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- Acute Intermittent Hypoxia (AIH) 15 and Acute Intermittent Hypoxia (AIH) 23
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Spinal Cord Injury (>6 months)
- Motor incomplete SCI classified as AIS C or D
- Volitional ankle plantarflexion strength in at least one leg
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Milap Sandhu, PT, PhD, 312-238-6493, msandhu@sralab.org
Alexander Barry, MS, 312-238-1435, abarry@sralab.org
About this study
Official 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
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.
- Conditions
- Spinal Cord Injuries (SCI)
- Being tested
- Sham AIH, Acute Intermittent Hypoxia (AIH) 15, Acute Intermittent Hypoxia (AIH) 23
- Keywords
- spinal cord injury, incomplete, Acute Intermittent Hypoxia
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham AIHOther
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) 15Other
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) 23Other
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
| Study group | Role | What they receive |
|---|---|---|
| Sham + AIH 15 + AIH 23 | Other | 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 Receives: Other: Sham AIH |
| AIH 15 + Sham + AIH 23 | Other | 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 Receives: Other: Acute Intermittent Hypoxia (AIH) 15 |
| AIH 23 + AIH 15 + Sham | Other | 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 Receives: Other: Acute Intermittent Hypoxia (AIH) 23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ankle plantarflexion and dorsiflexion
Measurement of ankle force during a maximum voluntary contraction while pushing or pulling on a force plate
Measured: Immediately following Intervention
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
Measured: Immediately following intervention
Secondary outcomes (2)
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
Measured: During intervention
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
Measured: During intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start27 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, cross over design, participants will complete both arms
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milap Sandhu
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Responsible party
- Sponsor-investigator, Milap Sandhu, Shirley Ryan AbilityLab
- Investigators
- Milap Sandhu, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739992
- Sponsor's protocol ID
- STU00226149
- Acronym
- DOSA-SCI
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data can be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07739992
- Acronym / sponsor ID
- DOSA-SCI / STU00226149
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- spinal cord injury, incomplete, Acute Intermittent Hypoxia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Milap SandhuUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized, cross over design, participants will complete both arms
| Arm | Type | Receives |
|---|---|---|
| Sham + AIH 15 + AIH 23 | Other | Other: Sham AIHIn 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) 15In 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) 23In 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic Spinal Cord Injury (>6 months)
- Motor incomplete SCI classified as AIS C or D
- Volitional ankle plantarflexion strength in at least one leg
Key exclusion criteria (8 listed)
- Uncontrolled hypertension (outside 140/90 and 90/60)
- Concurrent medical illness
- Traumatic brain injury
- Cardiovascular complications
- Pulmonary complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham AIHIn 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 | Other | Sham + AIH 15 + AIH 23 |
| Acute Intermittent Hypoxia (AIH) 15In 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 | Other | AIH 15 + Sham + AIH 23 |
| Acute Intermittent Hypoxia (AIH) 23In 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 | Other | AIH 23 + AIH 15 + Sham |
Primary outcome
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
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
2 secondary outcomes
SpO2 burden
Time frame: During intervention
Hypoxic Ventilatory Response
Time frame: During intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified study data can be shared upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Milap Sandhu, PT, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Intermittent Hypoxia (AIH) 15 and Acute Intermittent Hypoxia (AIH) 23 in people with Spinal Cord Injuries (SCI), run by Milap Sandhu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Milap Sandhu, PhD, PT (312-238-6529, msandhu@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ankle plantarflexion and dorsiflexion (time frame: Immediately following Intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.