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NCT01835080 · ClinicalTrials.gov registry record
Obstructive Sleep Apnea (OSA) in Pulmonary Arterial Hypertension (PAH)
A clinical trial, sponsored by Inova Health Care Services.
- Terminated
- Registry status
- 2
- Enrollment target
NCT01835080: Clinical Trial study, sponsored by Inova Health Care Services.
NCT01835080 is a clinical trial that was terminated before completion, run by Inova Health Care Services. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01835080 was terminated before completion, sponsored by Inova Health Care Services.
- TERMINATED
- Registry status
- 2 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether pulmonary arterial hypertension can worsen or even cause sleep apnea. It is hypothesized that if pulmonary arterial hypertension does indeed worsen or cause sleep apnea, then the treatment should first focus on the underlying pulmonary arterial hypertension instead of the sleep apnea. To determine if a person has sleep apnea, they will undergo one overnight polysomnogram (sleep study). If it is found that they have mild to moderate sleep apnea, then the subject will be invited to continue in the study and their pulmonary arterial hypertension will be treated by their managing primary physician. After the subject has had treatment for their pulmonary arterial hypertension, the study center will have them return for a follow up sleep study to learn the effects of pulmonary arterial hypertension treatment management on their sleep apnea, 12-24 weeks after the first sleep study.
Primary Outcome
All patients will undergo a sleep study (polysomnogram) before their PAH is treated (or treated optimally) and each patient will have a repeat sleep study at 12- 24 weeks after their PAH treatment is optimally managed by their primary managing physician. These sleep studies will be centrally scored to determine whether a decrease in RDI of at least 10 events/hour has been met.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-03 |
Why NCT01835080 stopped before completion
NCT01835080 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01835080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01835080 about?
NCT01835080 is a clinical study titled "Obstructive Sleep Apnea (OSA) in Pulmonary Arterial Hypertension (PAH)". The purpose of this study is to determine whether pulmonary arterial hypertension can worsen or even cause sleep apnea. It is hypothesized that if pulmonary arterial hypertension does indeed worsen or cause sleep apnea, then the treatment should first focus on the underlying pulmonary arterial hyper...
What is the current status of trial NCT01835080?
This trial is currently terminated. The enrollment target is 2 participants. The study started on 2013-04. Estimated completion is 2014-03.
Who is sponsoring clinical trial NCT01835080?
This trial is sponsored by Inova Health Care Services, which has 75 total clinical trials registered on ClinicalTrials.gov.
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