Obstructive Sleep Apnea (OSA) in Pulmonary Arterial Hypertension (PAH)

Sponsor

Inova Health Care Services (Other)

Overall Status

Terminated

CT.gov ID

NCT01835080

Collaborator

Brown University (Other), Tufts University (Other), George Washington University (Other)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension Obstructive Sleep Apnea

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

Actual Enrollment :

2 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effect of Pulmonary Arterial Hypertension Treatment on Obstructive Sleep Apnea

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Outcome Measures

Primary Outcome Measures

Primary endpoint is a decrease in Respiratory Disturbance Index (RDI) by 10 events/hour [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 Outcome Measures

Decrease in neck circumference by 0.9 cm [12-24 weeks]
All subjects will be assessed for decrease in neck circumference by 0.9 cm
Decrease in ankle circumference by 0.8 cm [12-24 weeks]
All subjects will be assessed for decrease in ankle circumference by 0.8 cm
improvement in Epworth Sleepiness Scale [12-24 weeks]
All subjects will be assessed for improvement in Epworth Sleepiness Scale
improvement in Arousal Index [12-24 weeks]
All subjects will be assessed for improvement in Arousal Index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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