RecruitingPhase 4

Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury

United States100 participantsStarted 2017-06-09

Plain-language summary

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

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Tidal Volume

Timeframe: 1 Week

Change in CO2 reserve (Delta-PETCO2-AT)

Timeframe: 1 Week

Change in Apnea Hypopnea Index (AHI)

Timeframe: 1 week

Change in hypocapnic apneic threshold

Timeframe: 1 week

Trial details

NCT IDNCT02922894

SponsorJohn D. Dingell VA Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

M Safwan Badr, M.D.

313-576-3548 m.badr@va.gov

View on ClinicalTrials.gov More Sleep Apnea trials