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NCT01047709 · ClinicalTrials.gov registry record · Phase 2
Positional Therapy After Stroke
A Phase 2 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT01047709 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 18 participants.
The verdict
NCT01047709, a Phase 2 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
Stroke is the leading cause of adult disability and the third leading cause of death in the United States. Unfortunately, there are few therapies that have been proven to improve stroke outcome. Sleep apnea is an emerging stroke risk factor and has a well established association with higher mortality and poor functional outcome following stroke. Over half of acute stroke patients have sleep apnea, suggesting that it may be a important target for therapy. Attenuation of sleep apnea severity may result in improved stroke outcomes. However, the standard treatment for sleep apnea is not well-tolerated among stroke patients. An alternative treatment is avoidance of supine sleep. Supine sleep is very common in acute stroke patients, and therefore this treatment may have particular relevance to the stroke population. The proposed study will be conducted in two phases. The first phase is a randomized, crossover design in which acute stroke patients will be given positional treatment (to avoid supine sleep) on one night during their stroke hospitalization. This will be compared with another night of sleeping without positional therapy. The order of treatments (standard vs positional therapy) will be random. The first phase will demonstrate the proof of concept: that stroke patients given positional therapy to avoid supine sleep will (1) sleep less on their backs, and (2) will have improved sleep apnea parameters with positional therapy. In the second phase, those identified to have sleep apnea will be randomized to receive positional therapy at home for three months, or standard therapy. This second phase will demonstrate the adherence/feasibility of three months of positional therapy, and will allow us to estimate effect size based on a functional outcome measure. The data obtained from this pilot clinical trial are essential to plan a large efficacy study.
Interventions
- DEVICE Positional therapy including the use of a special pillow
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01047709
The ClinicalTrials.gov registry entry for NCT01047709 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Positional therapy including the use of a special pillow is the first listed.
NCT01047709 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01047709 about?
NCT01047709 is a clinical study titled "Positional Therapy After Stroke". Stroke is the leading cause of adult disability and the third leading cause of death in the United States. Unfortunately, there are few therapies that have been proven to improve stroke outcome. Sleep apnea is an emerging stroke risk factor and has a well established association with higher mortalit...
What is the current status of trial NCT01047709?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2008-12. Estimated completion is 2010-05.
What interventions are being tested in trial NCT01047709?
The interventions under investigation include: Positional therapy including the use of a special pillow (DEVICE).
Who is sponsoring clinical trial NCT01047709?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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