NCT02922894 · John D. Dingell VA Medical Center
Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury
What this study is about
This study will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (\>6 months post-injury).
View original scientific description
This study will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (\>6 months post-injury).
Interventions
PROCEDURE
Acute episodic hypoxia
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.
PROCEDURE
Supplemental oxygen
Supplemental oxygen therapy for 6 weeks
DRUG
Trazodone
100mg before bedtime
DRUG
Placebo
One placebo pill before-bedtime
PROCEDURE
Sham
Room air will be administered instead of episodic hypoxia or supplemental oxygen..
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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).
Where
- Detroit, Michigan
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations