Sleep Apnea Treatment for Spinal Cord Injury
This study is looking into ways to treat sleep apnea (when breathing repeatedly stops and starts during sleep) in people with chronic cervical (neck) spinal cord injury. Researchers are testing several approaches: short periods of low oxygen (acute episodic hypoxia), supplemental oxygen therapy for 6 weeks, and a medication called Trazodone (100mg before bedtime). They will compare these to a placebo pill or sham procedures (like breathing room air). The main goals are to see how these interventions change your breathing volume, your body's CO2 reserve, and the number of times you stop breathing or have shallow breaths during sleep (Apnea Hypopnea Index or AHI) after one week. You can join if you are a healthy adult between 18 and 89 years old with a chronic spinal cord injury (T6 and above) that happened more than 3 months ago and you are not on a ventilator. The current status of this study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 100 participants. It compares different treatments like acute episodic hypoxia, supplemental oxygen, Trazodone, placebo, and sham procedures.
- What's involved
- Participants will undergo 30 minutes of baseline monitoring, followed by 15 episodes of one minute of episodic hypoxia with supplemental CO2, and a 45-minute recovery period. Some participants will receive supplemental oxygen therapy for 6 weeks, while others will take a pill (Trazodone or placebo) before bedtime.
- Compensation
- Not stated in the trial record.
- Follow-up
- Changes in breathing are measured at 1 week after the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- M Safwan Badr, M.D. · PRINCIPAL_INVESTIGATOR · John D. Dingell VA Medical Center
Who to contact
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What this trial measures
- Change in Tidal Volume1 Week
Change in tidal volume from baseline to recovery period.
- Change in CO2 reserve (Delta-PETCO2-AT)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)1 week
AHI is used to indicate the severity of sleep apnea.
- Change in hypocapnic apneic threshold1 week
The nadir pressure in the upper airway (supra-glotic pressure) prior to the occurrence of an arousal. This is a physiological parameter.