Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-89
SponsorJohn D. Dingell VA Medical Center
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Acute episodic hypoxia
- Supplemental oxygen
- Trazodone
- Placebo
- Sham
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
John D. Dingell VA Medical Center
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov