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

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ClinicalTrials.gov Identifier: NCT01835080
Recruitment Status : Terminated (low enrollment)
First Posted : April 18, 2013
Last Update Posted : June 30, 2014
Information provided by (Responsible Party):

April 10, 2013
April 18, 2013
June 30, 2014
April 2013
March 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01835080 on ClinicalTrials.gov Archive Site
  • • Secondary endpoints are decrease in neck circumference by 0.9 cm [ Time Frame: 12-24 weeks ]
  • • Secondary endpoints are decrease in ankle circumference by 0.8 cm [ Time Frame: 12-24 weeks ]
  • • Secondary endpoints are an improvement in Epworth Sleepiness Scale [ Time Frame: 12-24 weeks ]
  • • Secondary endpoints are an improvement in Arousal Index [ Time Frame: 12-24 weeks ]
Same as current
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Obstructive Sleep Apnea in Pulmonary Arterial Hypertension (OSA in PAH)
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.

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).
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Diagnosis of Group 1 PAH Either lack of treatment for PAH or sub-optimally treated PAH
  • Pulmonary Arterial Hypertension
  • Obstructive Sleep Apnea
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Inova Health Care Services
Inova Health Care Services
  • Brown University
  • Tufts University
  • George Washington University
Principal Investigator: Nargues Weir, MD NIH/Inova Fairfax Hospital
Inova Health Care Services
June 2014