Sleep ApneaRECOV2SCINCT05536076
Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury
A study testing Hypercapnia treatment in people with Sleep Apnea and SCI/D, run by VA Office of Research and Development at 1 site in United States.
Trial summary
It is estimated that 1,275,000 people in the United States alone live with spinal cord injury, including around 100,000 Veterans with spinal cord injury, making the V.A. the largest integrated health care system in the world for spinal cord injuries injury care. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Sleep Apnea, SCI/D, Hypercapnia
- What is being tested?
- Hypercapnia treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 28 Feb 2027
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with chronic SCI/D (>6 months post-injury)
- American Spinal Injury Association (ASIA) classification A-D who have evidence of SDB (excluding those with no evidence of a neurologic deficit based on ASIA classification)
- Able-bodied patients (without SCI/D0 who have OSA.
Who cannot join
- Receiving continuous mechanical ventilation (except PAP therapy which is considered usual treatment for SDB
- Severe congestive heart failure with ejection fraction <35%
- Recent health event that may affect sleep
- stroke
- acute myocardial infarction
- recent surgery
Show all 11Show fewer
- hospitalization
- Alcohol or substance abuse (<90 days sobriety)
- Self-described as too ill to engage in study procedures
- Evidence of hypercapnia on spontaneous breathing (end-tidal CO2 >50 mmHg)
- Unable to provide self-consent for participation
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
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201-1916
Abdulghani Sankari, MD PhD, 313-576-1000 ext. 63499, Abdulghani.Sankari@va.gov
Abdulghani Sankari, MD PhD
About this study
It is estimated that 1,275,000 people in the United States alone live with spinal cord injury, including around 100,000 Veterans with spinal cord injury, making the V.A. the largest integrated health care system in the world for spinal cord injuries injury care. New therapies are needed to prevent the morbidities and mortalities associated with the high prevalence of respiratory disorders in Veterans with spinal cord injury. The current research project and future studies would set the base for developing innovative therapies for this disorder. This proposal addresses a new therapeutic intervention for sleep apnea in spinal cord injury. The investigators hypothesized that daily hypercapnia treatments improve respiratory symptoms and alleviate sleep apnea in patients with chronic spinal cord injury. The investigators will perform a pilot study to examine the impact of daily hypercapnia treatments for-two week durations among Veterans with spinal cord injury. The investigators believe that this novel approach to treating sleep apnea and will yield significant new knowledge that improves the health and quality of life of these patients.
Read the detailed description
One of the most devastating consequences of cervical spinal cord injury (SCI) is damage to the phrenic motor network, controlling the diaphragm (primary muscle of breathing). Subsequent diaphragm paralysis or paresis results in life-threatening impairments in breathing and can necessitate a need for ventilator assistance. Respiratory and cardiovascular complications are the most common causes of death in the first year post-injury (51% combined). Thus, there is an urgent need to develop strategies for improving function for people with acute and chronic spinal cord injury. Currently, treatments for respiratory dysfunction in spinal cord injury patients are limited to mechanical devices or nerve pacing. Moreover, the proposed plan of studying respiratory muscle training in spinal cord injury patients is novel. However, it is based on animal and human studies that have shown with validity that respiratory muscle training using mild intermittent hypoxia improves respiratory function following SCI. However, the effect of intermittent hypoxia has shown to be dependent on the level of alveolar CO2 and may pose undesirable cardiovascular effects. Previous studies showed that respiratory recovery following SCI manifests by a delayed and partial restorative spontaneous plasticity. The current research project and future anticipated studies would set the base for developing innovative therapies that can stimulate respiratory plasticity hence recovery for this prevalent disorder.
The proposed pilot/feasibility study will test the effect of daily acute intermittent hypercapnia (dAIHc) in individuals with SCI. The objectives of this study are to (1) determine recruitment rates and test the feasibility of recruitment, (2) calculate withdrawal and dropout rates, (3) test the feasibility and tolerability and acceptability of the proposed intervention in an SCI population, (4) develop and refine a new respiratory training intervention using dAIHc paradigm (5) derive effect size estimates for clinical endpoints and their associated variability at the end of treatment to calculate an appropriate sample size for an adequately powered clinical trial. Compared to sham therapy, the central hypothesis is that the daily respiratory muscle training (dAIHc) approach is acceptable and feasible in patients with SCI and will strengthen respiratory muscles and reduce the severity of sleep-disordered breathing (SDB), and will improve daytime symptoms.
This study is highly innovative and the first of its kind in patients with SCI, as it seeks first to use a new set of rehabilitative exercises to improve ventilation and respiratory muscles strength; secondly, it aims to use controlled randomized design; finally, it will determine the role of respiratory muscle exercises in reducing the severity of sleep symptoms and daytime function in SCI. Each aim is independently testable and does not depend on the result of the other aims. The findings will likely apply to a broad range of other neuromuscular diseases (such as Multiple Sclerosis and Stroke). The team of this pilot project has the resources and IRB approval necessary to execute the project.
- Conditions
- Sleep Apnea, SCI/D, Hypercapnia
- Being tested
- Hypercapnia treatment
- Keywords
- Sleep apnea, SCI/D, Hypercapnia
- Medical subject headings
- Sleep Apnea Syndromes, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypercapnia treatmentOther
Intermittent hypercapnia treatment five days per week for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention hypercapnia arm | Active comparator | Intermittent hypercapnia treatment five days per week for two weeks. Receives: Other: Hypercapnia treatment |
| SCD | Experimental | Intermittent hypercapnia treatment five days per week for two weeks. Receives: Other: Hypercapnia treatment |
| Able-Bodoed | Experimental | Intermittent hypercapnia treatment five days per week for two weeks. Receives: Other: Hypercapnia treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Determine the recruitment rate in the intervention arm and determine how many continue into the sham arm. (Number of patients enrolled and completed the study)
Measured: 2 weeks
Secondary outcomes (2)
Minute Ventilation
To measure the change in minute ventilation (L/min)
Measured: 2 weeks
Change in sleep apnea severity
Severity of sleep apnea (Apnea-hypopnea index -events/hour)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Mar 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Controlled pilot trial to assess the feasibility of using daily chemical stimuli (acute intermittent hypercapnia) in patients with chronic SCI/D in comparison to able-bodied patients with OSA.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Detroit Healthcare System
- Responsible party
- Sponsor
- Investigators
- Abdulghani Sankari, MD PhD, Principal investigator, John D. Dingell VA Medical Center, Detroit, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536076
- Sponsor's protocol ID
- B4114-P
- Acronym
- RECOV2SCI
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2022
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publications from research will be made available to the public through the national Library of Medicine PubMed within one year after the date of publication. Final data sets underlying all publications resulting form the proposed research will be shared outside if the following criteria is met: A limited Dataset will be created and shared pursuant to Data Use Agreement (DUA) appropriately limiting use for dataset and prohibiting the recipient from identifying or re-identifying any individuals whose data are included in the dataset.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypercapnia Treatment on Respiratory Recovery After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05536076
- Acronym / sponsor ID
- RECOV2SCI / B4114-P
- Conditions
- Sleep Apnea, SCI/D, Hypercapnia
- Keywords
- Sleep apnea, SCI/D, Hypercapnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Detroit Healthcare System
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 10 Sep 2022 (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.
It is estimated that 1,275,000 people in the United States alone live with spinal cord injury, including around 100,000 Veterans with spinal cord injury, making the V.A. the largest integrated health care system in the world for spinal cord injuries injury care. New therapies are needed to prevent the morbidities and mortalities associated with the high prevalence of respiratory disorders in Veterans with spinal cord injury. The current research project and future studies would set the base for developing innovative therapies for this disorder. This proposal addresses a new therapeutic intervention for sleep apnea in spinal cord injury. The investigators hypothesized that daily hypercapnia treatments improve respiratory symptoms and alleviate sleep apnea in patients with chronic spinal cord injury. The investigators will perform a pilot study to examine the impact of daily hypercapnia treatments for-two week durations among Veterans with spinal cord injury. The investigators believe that this novel approach to treating sleep apnea and will yield significant new knowledge that improves the health and quality of life of these patients.
Detailed description
One of the most devastating consequences of cervical spinal cord injury (SCI) is damage to the phrenic motor network, controlling the diaphragm (primary muscle of breathing). Subsequent diaphragm paralysis or paresis results in life-threatening impairments in breathing and can necessitate a need for ventilator assistance. Respiratory and cardiovascular complications are the most common causes of death in the first year post-injury (51% combined). Thus, there is an urgent need to develop strategies for improving function for people with acute and chronic spinal cord injury. Currently, treatments for respiratory dysfunction in spinal cord injury patients are limited to mechanical devices or nerve pacing. Moreover, the proposed plan of studying respiratory muscle training in spinal cord injury patients is novel. However, it is based on animal and human studies that have shown with validity that respiratory muscle training using mild intermittent hypoxia improves respiratory function following SCI. However, the effect of intermittent hypoxia has shown to be dependent on the level of alveolar CO2 and may pose undesirable cardiovascular effects. Previous studies showed that respiratory recovery following SCI manifests by a delayed and partial restorative spontaneous plasticity. The current research project and future anticipated studies would set the base for developing innovative therapies that can stimulate respiratory plasticity hence recovery for this prevalent disorder.
The proposed pilot/feasibility study will test the effect of daily acute intermittent hypercapnia (dAIHc) in individuals with SCI. The objectives of this study are to (1) determine recruitment rates and test the feasibility of recruitment, (2) calculate withdrawal and dropout rates, (3) test the feasibility and tolerability and acceptability of the proposed intervention in an SCI population, (4) develop and refine a new respiratory training intervention using dAIHc paradigm (5) derive effect size estimates for clinical endpoints and their associated variability at the end of treatment to calculate an appropriate sample size for an adequately powered clinical trial. Compared to sham therapy, the central hypothesis is that the daily respiratory muscle training (dAIHc) approach is acceptable and feasible in patients with SCI and will strengthen respiratory muscles and reduce the severity of sleep-disordered breathing (SDB), and will improve daytime symptoms.
This study is highly innovative and the first of its kind in patients with SCI, as it seeks first to use a new set of rehabilitative exercises to improve ventilation and respiratory muscles strength; secondly, it aims to use controlled randomized design; finally, it will determine the role of respiratory muscle exercises in reducing the severity of sleep symptoms and daytime function in SCI. Each aim is independently testable and does not depend on the result of the other aims. The findings will likely apply to a broad range of other neuromuscular diseases (such as Multiple Sclerosis and Stroke). The team of this pilot project has the resources and IRB approval necessary to execute the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Controlled pilot trial to assess the feasibility of using daily chemical stimuli (acute intermittent hypercapnia) in patients with chronic SCI/D in comparison to able-bodied patients with OSA.
| Arm | Type | Receives |
|---|---|---|
| Intervention hypercapnia arm | Active comparator | Other: Hypercapnia treatmentIntermittent hypercapnia treatment five days per week for two weeks. |
| SCD | Experimental | Other: Hypercapnia treatmentIntermittent hypercapnia treatment five days per week for two weeks. |
| Able-Bodoed | Experimental | Other: Hypercapnia treatmentIntermittent hypercapnia treatment five days per week for two weeks. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients with chronic SCI/D (>6 months post-injury)
- American Spinal Injury Association (ASIA) classification A-D who have evidence of SDB (excluding those with no evidence of a neurologic deficit based on ASIA classification)
- Able-bodied patients (without SCI/D0 who have OSA.
Key exclusion criteria (11 listed)
- Receiving continuous mechanical ventilation (except PAP therapy which is considered usual treatment for SDB
- Severe congestive heart failure with ejection fraction <35%
- Recent health event that may affect sleep
- stroke
- acute myocardial infarction
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 |
|---|---|---|
| Hypercapnia treatmentIntermittent hypercapnia treatment five days per week for two weeks. | Other | Able-Bodoed, Intervention hypercapnia arm, SCD |
Primary outcome
Recruitment rate
Time frame: 2 weeks
Determine the recruitment rate in the intervention arm and determine how many continue into the sham arm. (Number of patients enrolled and completed the study)
2 secondary outcomes
Minute Ventilation
Time frame: 2 weeks
Change in sleep apnea severity
Time frame: 2 weeks
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 2 Apr 2026.
- Individual participant dataSharing planned: Yes. Publications from research will be made available to the public through the national Library of Medicine PubMed within one year after the date of publication. Final data sets underlying all publications resulting form the proposed research will be shared outside if the following criteria is met: A limited Dataset will be created and shared pursuant to Data Use Agreement (DUA) appropriately limiting use for dataset and prohibiting the recipient from identifying or re-identifying any individuals whose data are included in the dataset.
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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.
Abdulghani Sankari, MD PhD principal investigator
John D. Dingell VA Medical Center, Detroit, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypercapnia treatment in people with Sleep Apnea and SCI/D, run by VA Office of Research and Development 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 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: looking for participants now, as of the sponsor's last update on 2 Apr 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 Abdulghani Sankari, MD PhD ((313) 576-1000 ext. 63499, Abdulghani.Sankari@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 2 weeks). 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 2 Apr 2026.