Treatments for Sleep Apnea in Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new treatments for sleep apnea in individuals with chronic spinal cord injuries. Researchers are testing three approaches: supplemental oxygen, acute episodic hypoxia (short periods of low oxygen), and trazodone (a medication often used for sleep disorders). The goal is to determine which method best improves breathing during sleep. Individuals with a cervical spine injury for more than 6 months who struggle with sleep-disordered breathing might be suitable for the study. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, allowing researchers to understand how they benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for these treatments?
Research has shown that the treatments tested for sleep apnea in individuals with spinal cord injuries have varying safety levels.
For acute episodic hypoxia, studies indicate it is generally safe. This treatment helps the body adapt to reduced oxygen levels for short periods, potentially improving breathing. Importantly, research suggests it does not harm brain function or cerebral blood flow.
For supplemental oxygen, safety data is less detailed in this specific context. However, its widespread use in medical settings suggests it is generally safe.
Regarding trazodone, a medication sometimes used for sleep issues, evidence suggests it may not be very effective for breathing problems in spinal cord injury patients. However, studies have monitored side effects, indicating careful safety oversight.
Overall, these treatments are being tested in a Phase 4 trial, which typically confirms safety in larger groups after earlier studies have established safety.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for sleep apnea in individuals with spinal cord injury because they explore novel mechanisms of action. Unlike traditional treatments like CPAP machines, which primarily focus on physically maintaining open airways, the acute episodic hypoxia treatment aims to enhance the body's natural ventilatory response through controlled hypoxic episodes. This could potentially reduce the occurrence of central sleep apnea by training the body to better respond to low oxygen levels. Additionally, the use of supplemental oxygen targets the peripheral chemoreceptors, which may help decrease central apnea by addressing chronic intermittent hypoxia. These innovative approaches offer new ways to potentially improve sleep quality and breathing stability in affected individuals.
What evidence suggests that this trial's treatments could be effective for sleep apnea in spinal cord injury?
Research has shown that short periods of breathing low-oxygen air, tested in this trial as acute episodic hypoxia, can improve breathing in people with spinal cord injuries. This method might enhance the body's natural breathing response, leading to better breathing over time. Another treatment arm in this trial involves supplemental oxygen, which evidence suggests can improve sleep quality by reducing nighttime breathing problems, potentially decreasing episodes of sleep apnea. However, studies found that trazodone, also tested in this trial, does not effectively improve breathing issues during sleep for people with spinal cord injuries.23467
Who Is on the Research Team?
M Safwan Badr, M.D.
Principal Investigator
John D. Dingell VA Medical Center
Are You a Good Fit for This Trial?
This trial is for adults aged 18-89 with chronic cervical spinal cord injury (T6 and above), at least 3 months post-injury, who are not on mechanical ventilation. It excludes those with extreme obesity (BMI ≥ 40 kg/m2), under 17 years old, pregnant or lactating women, severe respiratory defects, history of significant head trauma, or advanced organ diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Polysomnography and upper airway collapsibility are measured to characterize the sleep and breathing state of each subject
Treatment
Participants undergo various experimental treatments including episodic hypoxia, supplemental oxygen, and trazodone administration
Crossover
Participants switch from trazodone to placebo or vice versa after a 1-week washout period
Follow-up
Participants are monitored for changes in CO2 reserve, tidal volume, hypocapnic apneic threshold, and Apnea Hypopnea Index
What Are the Treatments Tested in This Trial?
Interventions
- Acute episodic hypoxia
- Placebo
- Sham
- Supplemental oxygen
- Trazodone
Find a Clinic Near You
Who Is Running the Clinical Trial?
John D. Dingell VA Medical Center
Lead Sponsor
United States Department of Defense
Collaborator