Sleep Apnea, ObstructiveNCT04017767
Motor Plasticity, Intermittent Hypoxia and Sleep Apnea
A study testing Induced Acute Intermittent Hypoxia (AIH) and AIH mask in people with Sleep Apnea, Obstructive and Spinal Cord Injuries, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to learn about the effect of sleep apnea and low oxygen on muscle strength and lung function in people with chronic spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Spinal Cord Injuries, Hypoxia
- What is being tested?
- Induced Acute Intermittent Hypoxia (AIH) and AIH mask
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older,
- Chronic (≥ 1-year post-injury), non-progressive SCI,
- Asia Impairment Scale (AIS) C or D,
- Resting Saturated oxygen (SaO2) ≥ 95%,
- Cervical injury (C5-C8)
Who cannot join
- Currently hospitalized,
- Resting heart rate ≥120 Beats per minute (BPM),
- Resting systolic blood pressure >180 mmHg,
- Resting diastolic Blood Pressure >100 mmHg,
- Self-reported history of unstable angina or myocardial infarction within the previous month,
- OSA that is being treated with positive airway pressure therapy,
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- Women who know or suspect they may be pregnant or who may become pregnant,
- Known underlying lung disease,
- Pregnant Women,
- Prisoners,
- Unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Hypoxia (IH), Respiratory and Motor Plasticity, and Sleep Apnea in Spinal Cord Injury (SCI)
The purpose of this study is to learn about the effect of sleep apnea and low oxygen on muscle strength and lung function in people with chronic spinal cord injury.
- Conditions
- Sleep Apnea, Obstructive, Spinal Cord Injuries, Hypoxia
- Being tested
- Induced Acute Intermittent Hypoxia (AIH), AIH mask
- Keywords
- Neuroplasticity, Respiratory Function, Motor Function
- Medical subject headings
- Sleep Apnea, Obstructive, Spinal Cord Injuries, Hypoxia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced Acute Intermittent Hypoxia (AIH)Procedure or surgery
AIH will be administered on days 1-3. Each day entails 15 and 90 second hypoxic intervals (Fraction of Inspired Oxygen (FIO2) = 0.09) alternating with 60-second normoxic intervals (FIO2 = 0.21).
AIH maskDevice
Induced Intermitted hypoxia will be delivered via the AIH mask. The mask has two one-way valves restricting inspiration to the top valve and expiration to the bottom valve. Hypoxic and normoxic gas mixtures will be delivered through the top valve.
| Study group | Role | What they receive |
|---|---|---|
| Moderate to Severe Obstructive Sleep Apnea (OSA) | Experimental | Individuals with moderate to severe OSA defined as having an Apnea-hypopnea Index (AHI) that is greater than or equal to 15. Receives: Procedure: Induced Acute Intermittent Hypoxia (AIH); Device: AIH mask |
| Without OSA | Active comparator | Individuals without OSA defined as having AHI less than 5. Receives: Procedure: Induced Acute Intermittent Hypoxia (AIH); Device: AIH mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in Motor Function assessed via hand grip strength measured by maximum grip strength (MGS) between participants with moderate to severe OSA and without OSA.
Participants will be instructed to squeeze the hand grip dynamometer with maximal effort for 3-5 seconds. This will be repeated three times for each hand with 1 minute of rest between trials. The highest value obtained will be used as the MGS.
Measured: Baseline
The difference in Motor Function assessed via hand grip strength measured by electromyographic (EMG) recordings between participants with moderate to severe OSA and without OSA.
Electrodes will be secured on the participant to measure EMG. Participants will then be asked to press the index finger against a custom lever. The participant will perform three brief maximal voluntary contractions (MVC) for 3-5 seconds separated by 60 seconds of rest. The highest of the three values will be used.
Measured: Baseline
Secondary outcomes (3)
Change in Motor Function assessed via hand grip strength measured by MGS.
Participants will be instructed to squeeze the hand grip dynamometer with maximal effort for 3-5 seconds. This will be repeated three times for each hand with 1 minute of rest between trials. The highest value obtained will be used as the MGS.
Measured: Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
Change in Motor Function assessed via hand grip strength measured by EMG recordings.
Electrodes will be secured on the participant to measure EMG. Participants will then be asked to press the index finger against a custom lever. The participant will perform three brief maximal voluntary contractions (MVC) for 3-5 seconds separated by 60 seconds of rest. The highest of the three values will be used.
Measured: Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
Change in biomarker levels
Serum Brain-Derived Neurotrophic Factor (BDNF) and Vascular Endothelial Growth Factor (VEGF) biomarker levels in pg/ml will be evaluated. At baseline, the blood samples will be collected after 12 hours of overnight fasting.
Measured: Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start16 Jul 2021
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- subjects with OSA compared to subjects without OSA based on their response to IH (intermittent hypoxia) exposure
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Shirin Shafazand, University of Miami
- Investigators
- Shirin Shafazand, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017767
- Sponsor's protocol ID
- 20190415
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2019
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Hypoxia (IH), Respiratory and Motor Plasticity, and Sleep Apnea in Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT04017767
- Acronym / sponsor ID
- 20190415
- Conditions
- Sleep Apnea, Obstructive, Spinal Cord Injuries, Hypoxia
- Keywords
- Neuroplasticity, Respiratory Function, Motor Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 12 Jul 2019 (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.
The purpose of this study is to learn about the effect of sleep apnea and low oxygen on muscle strength and lung function in people with chronic spinal cord injury.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- subjects with OSA compared to subjects without OSA based on their response to IH (intermittent hypoxia) exposure
| Arm | Type | Receives |
|---|---|---|
| Moderate to Severe Obstructive Sleep Apnea (OSA) | Experimental | Procedure: Induced Acute Intermittent Hypoxia (AIH), Device: AIH maskIndividuals with moderate to severe OSA defined as having an Apnea-hypopnea Index (AHI) that is greater than or equal to 15. |
| Without OSA | Active comparator | Procedure: Induced Acute Intermittent Hypoxia (AIH), Device: AIH maskIndividuals without OSA defined as having AHI less than 5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older,
- Chronic (≥ 1-year post-injury), non-progressive SCI,
- Asia Impairment Scale (AIS) C or D,
- Resting Saturated oxygen (SaO2) ≥ 95%,
- Cervical injury (C5-C8)
Key exclusion criteria (11 listed)
- Currently hospitalized,
- Resting heart rate ≥120 Beats per minute (BPM),
- Resting systolic blood pressure >180 mmHg,
- Resting diastolic Blood Pressure >100 mmHg,
- Self-reported history of unstable angina or myocardial infarction within the previous month,
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 |
|---|---|---|
| Induced Acute Intermittent Hypoxia (AIH)AIH will be administered on days 1-3. Each day entails 15 and 90 second hypoxic intervals (Fraction of Inspired Oxygen (FIO2) = 0.09) alternating with 60-second normoxic intervals (FIO2 = 0.21). | Procedure or surgery | Moderate to Severe Obstructive Sleep Apnea (OSA), Without OSA |
| AIH maskInduced Intermitted hypoxia will be delivered via the AIH mask. The mask has two one-way valves restricting inspiration to the top valve and expiration to the bottom valve. Hypoxic and normoxic gas mixtures will be delivered through the top valve. | Device | Moderate to Severe Obstructive Sleep Apnea (OSA), Without OSA |
Primary outcome
The difference in Motor Function assessed via hand grip strength measured by maximum grip strength (MGS) between participants with moderate to severe OSA and without OSA.
Time frame: Baseline
Participants will be instructed to squeeze the hand grip dynamometer with maximal effort for 3-5 seconds. This will be repeated three times for each hand with 1 minute of rest between trials. The highest value obtained will be used as the MGS.
The difference in Motor Function assessed via hand grip strength measured by electromyographic (EMG) recordings between participants with moderate to severe OSA and without OSA.
Time frame: Baseline
Electrodes will be secured on the participant to measure EMG. Participants will then be asked to press the index finger against a custom lever. The participant will perform three brief maximal voluntary contractions (MVC) for 3-5 seconds separated by 60 seconds of rest. The highest of the three values will be used.
3 secondary outcomes
Change in Motor Function assessed via hand grip strength measured by MGS.
Time frame: Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
Change in Motor Function assessed via hand grip strength measured by EMG recordings.
Time frame: Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
Change in biomarker levels
Time frame: Baseline to Day 1 post AIH, Baseline to Day 3 post AIH, Baseline to Day 10, Baseline to Day 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Shirin Shafazand, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induced Acute Intermittent Hypoxia (AIH) and AIH mask in people with Sleep Apnea, Obstructive and Spinal Cord Injuries, run by University of Miami 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 8 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in Motor Function assessed via hand grip strength measured by maximum grip strength (MGS) between participants with moderate to severe OSA and without OSA. (time frame: Baseline). 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 8 Sep 2025.