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Pulmonary Arterial HypertensionNCT01835080

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

An observational study of Pulmonary Arterial Hypertension and Obstructive Sleep Apnea, run by Inova Health Care Services at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
2 participants
Where
1 siteUnited States
Study dates
Apr 2013to Mar 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • • 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

Who cannot join

  • Age younger than 18
  • Pregnancy
  • Previously diagnosed OSA and receiving therapy
  • Inability to undergo overnight polysomnography in laboratory

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Inova Heart and Vascular Institute/Inova Fairfax Hospital

    Falls Church, Virginia, 22042

Other trials in United States

About this study

Official title: 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.

Read the 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).

Keywords
Obstructive Sleep Apnea, ,, Pulmonary Arterial Hypertension, sleep study,, polysomnogram,, Respiratory Disturbance Index (RDI)
Medical subject headings
Pulmonary Arterial Hypertension, Sleep Apnea, Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary endpoint is a decrease in Respiratory Disturbance Index (RDI) by 10 events/hour

    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.

    Measured: 12-24 weeks

Secondary outcomes (4)

  1. Decrease in neck circumference by 0.9 cm

    All subjects will be assessed for decrease in neck circumference by 0.9 cm

    Measured: 12-24 weeks

  2. Decrease in ankle circumference by 0.8 cm

    All subjects will be assessed for decrease in ankle circumference by 0.8 cm

    Measured: 12-24 weeks

  3. improvement in Epworth Sleepiness Scale

    All subjects will be assessed for improvement in Epworth Sleepiness Scale

    Measured: 12-24 weeks

  4. improvement in Arousal Index

    All subjects will be assessed for improvement in Arousal Index

    Measured: 12-24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMar 2014
  4. Study completionMar 2014

Why it stopped: low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01835080
Sponsor's protocol ID
12.038
Status last verified
Jun 2014
First submitted
10 Apr 2013
Last updated
16 Jun 2020
Results posted
No
Data monitoring committee
No

Publications

  • Proceedings of the 4th World Symposium on Pulmonary Hypertension, February 2008, Dana Point, California, USA. J Am Coll Cardiol. 2009 Jun 30;54(1 Suppl):S1-117. No abstract available.

    PubMed 19630151

  • Bady E, Achkar A, Pascal S, Orvoen-Frija E, Laaban JP. Pulmonary arterial hypertension in patients with sleep apnoea syndrome. Thorax. 2000 Nov;55(11):934-9. doi: 10.1136/thorax.55.11.934.

    PubMed 11050263

  • Ulrich S, Fischler M, Speich R, Bloch KE. Sleep-related breathing disorders in patients with pulmonary hypertension. Chest. 2008 Jun;133(6):1375-1380. doi: 10.1378/chest.07-3035. Epub 2008 Mar 13.

    PubMed 18339776

  • Badesch DB, Raskob GE, Elliott CG, Krichman AM, Farber HW, Frost AE, Barst RJ, Benza RL, Liou TG, Turner M, Giles S, Feldkircher K, Miller DP, McGoon MD. Pulmonary arterial hypertension: baseline characteristics from the REVEAL Registry. Chest. 2010 Feb;137(2):376-87. doi: 10.1378/chest.09-1140. Epub 2009 Oct 16.

    PubMed 19837821

  • Brown LM, Chen H, Halpern S, Taichman D, McGoon MD, Farber HW, Frost AE, Liou TG, Turner M, Feldkircher K, Miller DP, Elliott CG. Delay in recognition of pulmonary arterial hypertension: factors identified from the REVEAL Registry. Chest. 2011 Jul;140(1):19-26. doi: 10.1378/chest.10-1166. Epub 2011 Mar 10.

    PubMed 21393391

  • Atwood CW Jr, McCrory D, Garcia JG, Abman SH, Ahearn GS; American College of Chest Physicians. Pulmonary artery hypertension and sleep-disordered breathing: ACCP evidence-based clinical practice guidelines. Chest. 2004 Jul;126(1 Suppl):72S-77S. doi: 10.1378/chest.126.1_suppl.72S.

    PubMed 15249496

  • Redolfi S, Arnulf I, Pottier M, Lajou J, Koskas I, Bradley TD, Similowski T. Attenuation of obstructive sleep apnea by compression stockings in subjects with venous insufficiency. Am J Respir Crit Care Med. 2011 Nov 1;184(9):1062-6. doi: 10.1164/rccm.201102-0350OC.

    PubMed 21836140

  • Friedman O, Bradley TD, Chan CT, Parkes R, Logan AG. Relationship between overnight rostral fluid shift and obstructive sleep apnea in drug-resistant hypertension. Hypertension. 2010 Dec;56(6):1077-82. doi: 10.1161/HYPERTENSIONAHA.110.154427. Epub 2010 Nov 8.

    PubMed 21060007

  • Elias RM, Bradley TD, Kasai T, Motwani SS, Chan CT. Rostral overnight fluid shift in end-stage renal disease: relationship with obstructive sleep apnea. Nephrol Dial Transplant. 2012 Apr;27(4):1569-73. doi: 10.1093/ndt/gfr605. Epub 2011 Nov 5.

    PubMed 22058175

  • Redolfi S, Arnulf I, Pottier M, Bradley TD, Similowski T. Effects of venous compression of the legs on overnight rostral fluid shift and obstructive sleep apnea. Respir Physiol Neurobiol. 2011 Mar 15;175(3):390-3. doi: 10.1016/j.resp.2011.01.001. Epub 2011 Jan 8.

    PubMed 21220055

  • Jafari B, Mohsenin V. Overnight rostral fluid shift in obstructive sleep apnea: does it affect the severity of sleep-disordered breathing? Chest. 2011 Oct;140(4):991-997. doi: 10.1378/chest.11-0044. Epub 2011 Mar 24.

    PubMed 21436243

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Arterial Hypertension and Obstructive Sleep Apnea, run by Inova Health Care Services at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: low enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary endpoint is a decrease in Respiratory Disturbance Index (RDI) by 10 events/hour (time frame: 12-24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01835080, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.

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