Obstructive Sleep Apnea in Pulmonary Arterial Hypertension (OSA in 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 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.
Pulmonary Arterial Hypertension
Obstructive Sleep Apnea
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effect of Pulmonary Arterial Hypertension Treatment on Obstructive Sleep Apnea|
- Primary endpoint is a decrease in Respiratory Disturbance Index (RDI) by 10 events/hour [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- • Secondary endpoints are decrease in ankle circumference by 0.8 cm [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
- • Secondary endpoints are an improvement in Epworth Sleepiness Scale [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
- • Secondary endpoints are an improvement in Arousal Index [ Time Frame: 12-24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Pulmonary Arterial Hypertension (PAH) is associated with fluid retention. Currently, the treatment paradigm for newly diagnosed PAH patients includes evaluation for Obstructive Sleep Apnea (OSA). The investigators propose that untreated or sub-optimally managed PAH patients have significant fluid retention which redistributes to the upper body during sleep and exacerbates or even mimics OSA. The investigators hypothesize that treatment of PAH patients with vasodilators and diuretics to optimize fluid balance will attenuate or even resolve OSA prior to the initiation of specific therapy for OSA (CPAP).
Please refer to this study by its ClinicalTrials.gov identifier: 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|