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NCT01882257 · ClinicalTrials.gov registry record · NA
Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 93
- Enrollment target
NCT01882257: Completed NA study, sponsored by University of Michigan.
NCT01882257 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 93 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01882257, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 93 participants
- Enrollment target
Study Summary
* Patients with spinal cord injury (SCI) usually breathe without any mechanical assistance, but significant breathing problems occur often during sleep, either because the upper airway closes (obstructive sleep apnea; OSA), or because of weakness/paralysis of the breathing muscles. These problems often go unrecognized, as SCI patients face logistical barriers that cause them to refuse appropriate testing in sleep laboratories. We have devised a strategy for diagnosing sleep-disordered breathing in the patient's home, using placement of noninvasive devices that monitor breathing overnight. This project is designed to test the feasibility and utility of this strategy. * After collecting baseline data on symptoms and medical events for four months, the home-based studies are performed noninvasively with FDA-approved devices: a type III sleep system and a recording oxygen saturation/ transcutaneous carbon dioxide monitor. If these studies identify sleep-disordered breathing, noninvasive ventilatory support is prescribed according to standard clinical practice. Over the following twelve months, the subjects monitor their symptoms daily, and answer quality-of-life questionnaires every three months. After 3, 6, and 12 months, blood tests are performed to measure blood sugar and cholesterol/lipids. Data is downloaded from the ventilator device to monitor compliance and ventilator performance. This study is designed to determine the prevalence of sleep-disordered breathing in SCI, the feasibility of home-based testing to establish the diagnosis, and the short term effects on symptoms, quality-of-life, and associated conditions (glucose intolerance, blood lipid disorders).
Primary Outcome
After enrollment, the subject completes symptom logs for four months to collect baseline data. At that point, the home-based sleep study is performed, and the results determine whether the subject has sleep-disordered breathing. The primary outcome to be measured in this study is to determine the prevalence and type of sleep-disordered breathing in subjects with spinal cord injury. These results in turn determine the type of positive pressure device to be prescribed, as detailed in the descripti
Interventions
- DEVICE BiPAP
- DEVICE BiPAP/AVAPS (Phillips Respironics)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2011-10 |
| Est. Completion | 2016-02 |
| Phase | NA |
What the finished NCT01882257 record still lists
NCT01882257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which BiPAP is the first listed.
NCT01882257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01882257 about?
NCT01882257 is a clinical study titled "Home-Based Diagnosis and Management of Sleep-Related Breathing Disorders in Spinal Cord Injury". * Patients with spinal cord injury (SCI) usually breathe without any mechanical assistance, but significant breathing problems occur often during sleep, either because the upper airway closes (obstructive sleep apnea; OSA), or because of weakness/paralysis of the breathing muscles. These problems of...
What is the current status of trial NCT01882257?
This trial is currently completed. It is a NA study. The enrollment target is 93 participants. The study started on 2011-10. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01882257?
The interventions under investigation include: BiPAP (DEVICE), BiPAP/AVAPS (Phillips Respironics) (DEVICE).
Who is sponsoring clinical trial NCT01882257?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01882257's enrollment target sits among peer trials
93 937th of 2000 higher than 1,064 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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