Treatment for sleep apnea in patients with cervical spinal cord injuries
Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury
This study tests new ways to help people with cervical spinal cord injuries who have sleep apnea by looking at how low oxygen levels and extra oxygen can affect their breathing during sleep.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | John D. Dingell VA Medical Center Federal |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT02922894 on ClinicalTrials.gov |
What this trial studies
This study investigates therapeutic approaches for sleep-disordered breathing in patients with chronic cervical spinal cord injuries. It aims to understand the causes of central sleep apnea and its relationship with upper airway obstruction. The research will test the effects of acute episodic hypoxia and supplemental oxygen on respiratory events during sleep. The ultimate goal is to identify strategies that can improve the quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-89 with chronic spinal cord injuries at T6 and above, who are not on mechanical ventilation.
Not a fit: Patients with severe obstructive or restrictive respiratory defects, advanced chronic diseases, or extreme obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of sleep apnea in patients with cervical spinal cord injuries, enhancing their overall quality of life.
How similar studies have performed: While there is ongoing research in sleep apnea treatments, this specific approach targeting cervical spinal cord injury patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Detroit, Michigan
- John D. Dingell VA Medical Center — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: M Safwan Badr, M.D. — John D. Dingell VA Medical Center
- Study coordinator: M Safwan Badr, M.D.
- Email: m.badr@va.gov
- Phone: 313-576-3548
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.