Obstructive Sleep Apnea in Pulmonary Arterial Hypertension (OSA in PAH) (OSA in PAH)
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|ClinicalTrials.gov Identifier: NCT01835080|
Recruitment Status : Terminated (low enrollment)
First Posted : April 18, 2013
Last Update Posted : June 30, 2014
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.
|Condition or disease|
|Pulmonary Arterial Hypertension Obstructive Sleep Apnea|
|Study Type :||Observational|
|Actual Enrollment :||2 participants|
|Official Title:||Effect of Pulmonary Arterial Hypertension Treatment on Obstructive Sleep Apnea|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
U.S. FDA Resources
- Primary endpoint is a decrease in Respiratory Disturbance Index (RDI) by 10 events/hour [ Time Frame: 12-24 weeks ]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.
- • Secondary endpoints are decrease in neck circumference by 0.9 cm [ Time Frame: 12-24 weeks ]
- • Secondary endpoints are decrease in ankle circumference by 0.8 cm [ Time Frame: 12-24 weeks ]
- • Secondary endpoints are an improvement in Epworth Sleepiness Scale [ Time Frame: 12-24 weeks ]
- • Secondary endpoints are an improvement in Arousal Index [ Time Frame: 12-24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835080
|United States, Virginia|
|Inova Heart and Vascular Institute/Inova Fairfax Hospital|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Nargues Weir, MD||NIH/Inova Fairfax Hospital|