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

This study has been terminated.
(low enrollment)
Sponsor:
Collaborators:
Brown University
Tufts University
George Washington University
Information provided by (Responsible Party):
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT01835080
First received: April 10, 2013
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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
Pulmonary Arterial Hypertension
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Pulmonary Arterial Hypertension Treatment on Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Inova Health Care Services:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • • 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 ]

Enrollment: 2
Study Start Date: April 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835080

Locations
United States, Virginia
Inova Heart and Vascular Institute/Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inova Health Care Services
Brown University
Tufts University
George Washington University
Investigators
Principal Investigator: Nargues Weir, MD NIH/Inova Fairfax Hospital
  More Information

Publications:

Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT01835080     History of Changes
Other Study ID Numbers: 12.038
Study First Received: April 10, 2013
Last Updated: June 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Inova Health Care Services:
Obstructive Sleep Apnea, OSA, Pulmonary Arterial Hypertension, PAH, sleep study, polysomnogram, Respiratory Disturbance Index, RDI

Additional relevant MeSH terms:
Apnea
Hypertension, Pulmonary
Hypertension
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 01, 2014