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

June 12, 2020 updated by: Inova Health Care Services

Effect of Pulmonary Arterial Hypertension Treatment on Obstructive Sleep Apnea

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Heart and Vascular Institute/Inova Fairfax Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diagnosis of Group 1 PAH Either lack of treatment for PAH or sub-optimally treated PAH

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12-24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in neck circumference by 0.9 cm
Time Frame: 12-24 weeks
All subjects will be assessed for decrease in neck circumference by 0.9 cm
12-24 weeks
Decrease in ankle circumference by 0.8 cm
Time Frame: 12-24 weeks
All subjects will be assessed for decrease in ankle circumference by 0.8 cm
12-24 weeks
improvement in Epworth Sleepiness Scale
Time Frame: 12-24 weeks
All subjects will be assessed for improvement in Epworth Sleepiness Scale
12-24 weeks
improvement in Arousal Index
Time Frame: 12-24 weeks
All subjects will be assessed for improvement in Arousal Index
12-24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Collaborators

Tufts University
Brown University
George Washington University

Investigators

  • Principal Investigator: Nargues Weir, MD, NIH/Inova Fairfax Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 10, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 18, 2013

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12.038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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