Clinical Trial: Sleep Disorder Breathing in Chronic Thromboembolic Pulmonary Hypertension

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension - a Prospective, Descriptive Cohort Study

Brief Summary:

There is evidence for a high prevalence of Sleep Disorder Breathing (SDB) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Central Sleep Apnea, Cheyne-Stokes Breathing and Obstructive Sleep Apnea appear to occur in CTEPH. However, there is no information on the impact of CTEPH treatment modalities on concomitant SDB. Furthermore, the use of PAP therapy in CTEPH has not yet been investigated. CTEPH is a rare and serious disease and there may be a bidirectional association of SDB and CTEPH.

This study plans to investigate the prevalence of SDB in CTEPH and compare it to datasets of large epidemiological studies on SDB. Furthermore, the impact of CTEPH treatment on SDB will be analyzed and CTEPH patients for possible PAP treatment will be defined.


Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome: AHI change under CTEPH treatment [ Time Frame: 6 months ]

Change from baseline AHI (Apnoe-Hypopnoe Index, events/h) after 6 months of CTEPH treatment


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of patients with persisting elevated AHI (= ≥15/h) after CTEPH treatment [ Time Frame: Time point: 6 months after the individual start of the CTEPH treatment ]

Patients with persisting elevated AHI will be assessed for further PAP treatment


Original Secondary Outcome: Definitions for PAP treatment [ Time Frame: Time point: 6 months after the individual start of the CTEPH treatment ]

Number of patients with persisting elevated AHI (= ≥15/h) after CTEPH treatment


Information By: Medical University of Vienna

Dates:
Date Received: February 14, 2017
Date Started: February 1, 2017
Date Completion: December 1, 2018
Last Updated: March 8, 2017
Last Verified: March 2017