Sleep ApneaPhase 4NCT02922894
Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury
A Phase 4 study testing Acute episodic hypoxia, Supplemental oxygen and Trazodone in people with Sleep Apnea and Spinal Cord Injury, run by John D. Dingell VA Medical Center at 1 site in United States.
Trial summary
This study will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (>6 months post-injury). Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Spinal Cord Injury
- What is being tested?
- Acute episodic hypoxia, Supplemental oxygen and Trazodone
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2017to 30 Jan 2027
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults between the ages of 18 - 89
- chronic spinal cord injury patients (T6 and above), > 3 months since injury and not on mechanical ventilation, and have not received mechanical ventilation via tracheostomy in the past.
Who cannot join
- subjects ≤ 17 yrs old
- Pregnant and lactating females
- History of head trauma that resulted in neurological symptoms or loss of consciousness
- advanced heart, lung, metabolic, liver or chronic kidney disease.
- severe obstructive or restrictive respiratory defect by PFTs or history of tracheostomy
- extreme obesity defined for this protocol as BMI ≥ 40 kg/m2 (to avoid the effect of morbid obesity on ventilation).
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, Michigan, 48201
M. Safwan Badr, MD, 313-576-3548
About this study
This study will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (>6 months post-injury).
Read the detailed description
Patients with cervical spinal cord injury demonstrate central sleep disordered breathing manifesting as central sleep apnea or a periodic breathing pattern. Understanding the causes of central sleep apnea may be critically important to understanding upper airway obstruction in susceptible individuals, given the critical role of ventilatory motor output in maintaining upper airway patency as evidenced by upper airway narrowing or occlusion at the nadir of ventilator drive during periodic breathing. This study is likely to identify therapeutic strategies that could be tested in large clinical trials, with the ultimate goal of improving quality of life among patients with cervical SCI who also experience central sleep disordered breathing.
To this end the research proposal is aimed as follows:
Specific Aim 1: Test the hypothesis that patients with cervical SCI will demonstrate greater magnitude of long-term facilitation (LTF) following episodic hypoxia during sleep, compared to patients with thoracic Spinal cord injury. This aim will be accomplished by measuring the effect of acute episodic hypoxic ventilation and upper airway mechanics in both groups.
Specific Aim 2: Test the hypothesis that dampening peripheral chemoreceptor activity in patients with cervical SCI and central sleep disordered breathing (SDB) with supplemental oxygen will reduce central respiratory events and decrease respiratory variability during sleep. The aim will be accomplished by providing supplemental oxygen to participants with cervical SCI and central SDB.
Specific Aim 3: Test the hypothesis that administration of trazodone, in patients with cervical spinal cord injury and central SDB will decrease respiratory related arousals and central apnea index, and the propensity to develop central apnea, compared to placebo. To accomplish this aim, the investigators will test the acute effect of trazodone on respiratory related arousals and central sleep apnea, and the chronic effect on central apnea indices and the CO2 reserve.
The investigators will study subjects with SCI at T6 or above who are not on artificial ventilation. To characterize the sleep and breathing state of each subject, polysomnography and upper airway collapsibility will be measured at baseline. Then the following experiments will be conducted: an episodic hypoxia protocol vs normoxia will be used to determine whether cervical SCI will demonstrate greater magnitude of LTF. Experiments will be conducted to see whether dampening peripheral chemoreceptor activity in cervical SCI by giving supplemental oxygen will reduce the central respiratory events and reduce the breathing variability during sleep. A cross over experiment will be done to see whether administration of trazodone in patients with cervical SCI and central SDB decreases respiratory-related arousals and central apnea. The participant will be given the drug/placebo for one week then cross over after a 1 week wash out period to placebo.
- Conditions
- Sleep Apnea, Spinal Cord Injury
- Being tested
- Acute episodic hypoxia, Supplemental oxygen, Trazodone, Placebo, Sham
- Medical subject headings
- Sleep Apnea Syndromes, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute episodic hypoxiaProcedure or surgery
The subjects will undergo 30 minutes of baseline monitoring followed by 15 episodes of one minute of episodic hypoxia with supplemental CO2 to maintain isocapnia. This is followed by a 45 minute recovery period.
Supplemental oxygenProcedure or surgery
Supplemental oxygen therapy for 6 weeks
TrazodoneDrug
100mg before bedtime
PlaceboDrug
One placebo pill before-bedtime
ShamProcedure or surgery
Room air will be administered instead of episodic hypoxia or supplemental oxygen..
| Study group | Role | What they receive |
|---|---|---|
| Acute episodic hypoxia | Experimental | To test development of ventilatory augmentation following episodic hypoxia, defined as increased Hypoxic Ventilatory Response (HVR) from early to late hypoxic exposure episodes. Receives: Procedure: Acute episodic hypoxia; Procedure: Sham |
| Supplemental oxygen | Experimental | To use supplemental oxygen to decrease peripheral chemoreceptor activity in patients with SCI and central SDB. In addition, perform a repeat evaluation after treatment with supplemental oxygen or sham O2 for 6 weeks to determine if correction of chronic intermittent hypoxia, which mitigates sensory LTF, results in decreased propensity to central apnea. Receives: Procedure: Supplemental oxygen; Procedure: Sham |
| Trazodone or placebo | Experimental | examine the effect of trazodone on breathing during sleep Receives: Drug: Trazodone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tidal Volume
Change in tidal volume from baseline to recovery period.
Measured: 1 Week
Change in CO2 reserve (Delta-PETCO2-AT)
CO2 reserve is the requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative
Measured: 1 Week
Change in Apnea Hypopnea Index (AHI)
AHI is used to indicate the severity of sleep apnea.
Measured: 1 week
Change in hypocapnic apneic threshold
The nadir pressure in the upper airway (supra-glotic pressure) prior to the occurrence of an arousal. This is a physiological parameter.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start9 Jun 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 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.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John D. Dingell VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- M Safwan Badr, M.D., Principal investigator, John D. Dingell VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922894
- Sponsor's protocol ID
- 1607015110
- Other IDs
- CDMRP-SC150201
- Status last verified
- Jun 2026
- First submitted
- 23 Sep 2016
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02922894
- Acronym / sponsor ID
- 1607015110
- Conditions
- Sleep Apnea, Spinal Cord Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- John D. Dingell VA Medical CenterUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 4 Oct 2016 (estimated)
- 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 will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (>6 months post-injury).
Detailed description
Patients with cervical spinal cord injury demonstrate central sleep disordered breathing manifesting as central sleep apnea or a periodic breathing pattern. Understanding the causes of central sleep apnea may be critically important to understanding upper airway obstruction in susceptible individuals, given the critical role of ventilatory motor output in maintaining upper airway patency as evidenced by upper airway narrowing or occlusion at the nadir of ventilator drive during periodic breathing. This study is likely to identify therapeutic strategies that could be tested in large clinical trials, with the ultimate goal of improving quality of life among patients with cervical SCI who also experience central sleep disordered breathing.
To this end the research proposal is aimed as follows:
Specific Aim 1: Test the hypothesis that patients with cervical SCI will demonstrate greater magnitude of long-term facilitation (LTF) following episodic hypoxia during sleep, compared to patients with thoracic Spinal cord injury. This aim will be accomplished by measuring the effect of acute episodic hypoxic ventilation and upper airway mechanics in both groups.
Specific Aim 2: Test the hypothesis that dampening peripheral chemoreceptor activity in patients with cervical SCI and central sleep disordered breathing (SDB) with supplemental oxygen will reduce central respiratory events and decrease respiratory variability during sleep. The aim will be accomplished by providing supplemental oxygen to participants with cervical SCI and central SDB.
Specific Aim 3: Test the hypothesis that administration of trazodone, in patients with cervical spinal cord injury and central SDB will decrease respiratory related arousals and central apnea index, and the propensity to develop central apnea, compared to placebo. To accomplish this aim, the investigators will test the acute effect of trazodone on respiratory related arousals and central sleep apnea, and the chronic effect on central apnea indices and the CO2 reserve.
The investigators will study subjects with SCI at T6 or above who are not on artificial ventilation. To characterize the sleep and breathing state of each subject, polysomnography and upper airway collapsibility will be measured at baseline. Then the following experiments will be conducted: an episodic hypoxia protocol vs normoxia will be used to determine whether cervical SCI will demonstrate greater magnitude of LTF. Experiments will be conducted to see whether dampening peripheral chemoreceptor activity in cervical SCI by giving supplemental oxygen will reduce the central respiratory events and reduce the breathing variability during sleep. A cross over experiment will be done to see whether administration of trazodone in patients with cervical SCI and central SDB decreases respiratory-related arousals and central apnea. The participant will be given the drug/placebo for one week then cross over after a 1 week wash out period to placebo.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute episodic hypoxia | Experimental | Procedure: Acute episodic hypoxia, Procedure: ShamTo test development of ventilatory augmentation following episodic hypoxia, defined as increased Hypoxic Ventilatory Response (HVR) from early to late hypoxic exposure episodes. |
| Supplemental oxygen | Experimental | Procedure: Supplemental oxygen, Procedure: ShamTo use supplemental oxygen to decrease peripheral chemoreceptor activity in patients with SCI and central SDB. In addition, perform a repeat evaluation after treatment with supplemental oxygen or sham O2 for 6 weeks to determine if correction of chronic intermittent hypoxia, which mitigates sensory LTF, results in decreased propensity to central apnea. |
| Trazodone or placebo | Experimental | Drug: Trazodone, Drug: Placeboexamine the effect of trazodone on breathing during sleep |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy adults between the ages of 18 - 89
- chronic spinal cord injury patients (T6 and above), > 3 months since injury and not on mechanical ventilation, and have not received mechanical ventilation via tracheostomy in the past.
Key exclusion criteria (6 listed)
- subjects ≤ 17 yrs old
- Pregnant and lactating females
- History of head trauma that resulted in neurological symptoms or loss of consciousness
- advanced heart, lung, metabolic, liver or chronic kidney disease.
- severe obstructive or restrictive respiratory defect by PFTs or history of tracheostomy
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 |
|---|---|---|
| Acute episodic hypoxiaThe subjects will undergo 30 minutes of baseline monitoring followed by 15 episodes of one minute of episodic hypoxia with supplemental CO2 to maintain isocapnia. This is followed by a 45 minute recovery period. | Procedure or surgery | Acute episodic hypoxia |
| Supplemental oxygenSupplemental oxygen therapy for 6 weeks | Procedure or surgery | Supplemental oxygen |
| Trazodone100mg before bedtime | Drug | Trazodone or placebo |
| PlaceboOne placebo pill before-bedtime | Drug | Trazodone or placebo |
| ShamRoom air will be administered instead of episodic hypoxia or supplemental oxygen.. | Procedure or surgery | Acute episodic hypoxia, Supplemental oxygen |
Primary outcome
Change in Tidal Volume
Time frame: 1 Week
Change in tidal volume from baseline to recovery period.
Change in CO2 reserve (Delta-PETCO2-AT)
Time frame: 1 Week
CO2 reserve is the requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative
Change in Apnea Hypopnea Index (AHI)
Time frame: 1 week
AHI is used to indicate the severity of sleep apnea.
Change in hypocapnic apneic threshold
Time frame: 1 week
The nadir pressure in the upper airway (supra-glotic pressure) prior to the occurrence of an arousal. This is a physiological parameter.
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 1 Jul 2026.
- 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.
M Safwan Badr, M.D. principal investigator
John D. Dingell VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acute episodic hypoxia, Supplemental oxygen and Trazodone in people with Sleep Apnea and Spinal Cord Injury, run by John D. Dingell VA Medical Center 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 2 inclusion and 6 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 1 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 M Safwan Badr, M.D. (313-576-3548, m.badr@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tidal Volume (time frame: 1 Week). The study lists 4 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 1 Jul 2026.