← Back to Clinical Trials
Recruiting Phase 4 NCT02922894

Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury

Trial Parameters

Condition Sleep Apnea
Sponsor John D. Dingell VA Medical Center
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 89 Years
Start Date 2017-06-09
Completion 2026-01-31
Interventions
Acute episodic hypoxiaSupplemental oxygenTrazodone

Brief Summary

This study will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (\>6 months post-injury).

Eligibility Criteria

Inclusion Criteria: 1. healthy adults between the ages of 18 - 89 2. 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: 1. subjects ≤ 17 yrs old 2. Pregnant and lactating females 3. History of head trauma that resulted in neurological symptoms or loss of consciousness 4. advanced heart, lung, metabolic, liver or chronic kidney disease. 5. severe obstructive or restrictive respiratory defect by PFTs or history of tracheostomy 6. extreme obesity defined for this protocol as BMI ≥ 40 kg/m2 (to avoid the effect of morbid obesity on ventilation).

Related Trials