Effect of Pulmonary Arterial Hypertension Treatment on Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Inova Health Care Services
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Primary endpoint is a decrease in Respiratory Disturbance Index (RDI) by 10 events/hour
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •• Diagnosis of Group 1 PAH
- •Either lack of treatment for PAH or sub-optimally treated PAH as defined by NYHA FC 3 or 4
- •Age 18 or older
- •Ability to give consent
- •Ability to undergo overnight polysomnogram
- •Previously diagnosed OSA not on therapy
Exclusion Criteria
- •Age younger than 18
- •Pregnancy
- •Previously diagnosed OSA and receiving therapy
- •Inability to undergo overnight polysomnography in laboratory
Outcomes
Primary Outcomes
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 Outcomes
- Decrease in neck circumference by 0.9 cm(12-24 weeks)
- Decrease in ankle circumference by 0.8 cm(12-24 weeks)
- improvement in Epworth Sleepiness Scale(12-24 weeks)
- improvement in Arousal Index(12-24 weeks)