Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: John D. Dingell VA Medical Center
• Collaborator: United States Department of Defense
• Treatments: Trazodone

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).