Clinical trial NCT01835080: Obstructive Sleep Apnea (OSA) in Pulmonary Arterial Hypertension (PAH)
Official title: Effect of Pulmonary Arterial Hypertension Treatment on Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Arterial Hypertension
Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea, ,
Pulmonary Arterial Hypertension
sleep study,
polysomnogram,
Respiratory Disturbance Index (RDI)
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
Collaborators: name: Brown University
name: Tufts University
name: George Washington University
First posted: 2013-04-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of Group 1 PAH Either lack of treatment for PAH or sub-optimally treated PAH

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.

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 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

Primary outcomes:
measure: Primary endpoint is a decrease in Respiratory Disturbance Index (RDI) by 10 events/hour
timeFrame: 12-24 weeks
Secondary outcomes:
measure: Decrease in neck circumference by 0.9 cm
timeFrame: 12-24 weeks
measure: Decrease in ankle circumference by 0.8 cm
timeFrame: 12-24 weeks
measure: improvement in Epworth Sleepiness Scale
timeFrame: 12-24 weeks
measure: improvement in Arousal Index
timeFrame: 12-24 weeks
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Heart and Vascular Institute/Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: NIH/Inova Fairfax Hospital
name: Nargues Weir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.