NCT02922894 Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury
| NCT ID | NCT02922894 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | John D. Dingell VA Medical Center |
| Condition | Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2017-06-09 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2017-06-09 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Contact & Investigator
M Safwan Badr, M.D.
PRINCIPAL INVESTIGATOR
John D. Dingell VA Medical Center
Frequently Asked Questions
Who can join the NCT02922894 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02922894 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT02922894 currently recruiting?
Yes, NCT02922894 is actively recruiting participants. Contact the research team at m.badr@va.gov for enrollment information.
Where is the NCT02922894 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT02922894 clinical trial?
NCT02922894 is sponsored by John D. Dingell VA Medical Center. The principal investigator is M Safwan Badr, M.D. at John D. Dingell VA Medical Center. The trial plans to enroll 100 participants.