Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury
John D. Dingell VA Medical Center
100 participants
Jun 9, 2017
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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.
Exclusion Criteria6
- 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.
- severe obstructive or restrictive respiratory defect by PFTs or history of tracheostomy
- extreme obesity defined for this protocol as BMI ≥ 40 kg/m2 (to avoid the effect of morbid obesity on ventilation).
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Interventions
The subjects will undergo 30 minutes of baseline monitoring followed by 15 episodes of one minute of episodic hypoxia with supplemental CO2 to maintain isocapnia. This is followed by a 45 minute recovery period.
Supplemental oxygen therapy for 6 weeks
100mg before bedtime
One placebo pill before-bedtime
Room air will be administered instead of episodic hypoxia or supplemental oxygen..
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02922894