Ignite Creation Date:
2024-05-06 @ 1:33 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01835080
Status:
TERMINATED
Last Update Posted:
2020-06-16
First Post:
2013-04-10
Brief Title:
Obstructive Sleep Apnea OSA in Pulmonary Arterial Hypertension PAH
Sponsor:
Inova Health Care Services
Organization:
Inova Health Care Services
Study Overview
Official Title:
Effect of Pulmonary Arterial Hypertension Treatment on Obstructive Sleep Apnea
Status:
TERMINATED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None