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NCT01482065 · ClinicalTrials.gov registry record · Phase 2
The Sleep, Liver Evaluation and Effective Pressure Study
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01482065: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT01482065 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01482065, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This research is being done to examine: 1) how common obstructive sleep apnea (OSA) is in patients with non-alcoholic fatty liver disease (NAFLD), 2) whether the severity of OSA is related to the severity of NAFLD, and 3) whether treatment of OSA with continuous positive airway pressure (CPAP) improved NAFLD progression. OSA is a condition caused by repetitive collapse of throat tissue during sleep that leads to falls in oxygen level and sleep disruption. OSA can be caused by obesity, and especially by fat found in the neck and belly. NAFLD is a common disease linked to obesity. NAFLD is part of a disease spectrum, which can progress from steatosis (fatty liver) to nonalcoholic steatohepatitis (NASH), a progressive fibrotic disease, in which cirrhosis and liver-related death can occur. Recent evidence in patients with obstructive sleep apnea (OSA) indicates that OSA is associated with NASH. How common OSA is in patients with biopsy-confirmed NAFLD and the effect of OSA treatment with CPAP on NASH is unknown.
Interventions
- DEVICE CPAP (ResMed S9 autoset CPAP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01482065
The ClinicalTrials.gov registry entry for NCT01482065 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CPAP (ResMed S9 autoset CPAP) is the first listed.
NCT01482065 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01482065 about?
NCT01482065 is a clinical study titled "The Sleep, Liver Evaluation and Effective Pressure Study". This research is being done to examine: 1) how common obstructive sleep apnea (OSA) is in patients with non-alcoholic fatty liver disease (NAFLD), 2) whether the severity of OSA is related to the severity of NAFLD, and 3) whether treatment of OSA with continuous positive airway pressure (CPAP) impro...
What is the current status of trial NCT01482065?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2011-11. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01482065?
The interventions under investigation include: CPAP (ResMed S9 autoset CPAP) (DEVICE).
Who is sponsoring clinical trial NCT01482065?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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