Clinical Trials Logo
  1. Home
  2. Sleep Disordered Breathing
  3. NCT03074539
  4. Details
NCT03074539 Clinical Trial

Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension

Sleep Disordered Breathing Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03074539
Other study ID # CTEPH_SDB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date December 31, 2022

Study information
Verified date March 2023
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Recently diagnosed untreated CTEPH - NYHA I-III Exclusion Criteria: - Age<18 - Pulmonary Hypertension other than CTEPH - Previous diagnosis of SDB - Ongoing PAP treatment - Use of nasal oxygen

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Riociguat
Patients will be treated with Riociguat according to guidelines (2015 ERS/ESC guidelines for the diagnosis and treatment of pulmonary hypertension) and manufacturers recommendation.
Procedure:
• Pulmonary Endarteriectomy
Patients will receive Pulmonary Endarteriectomy if they are suitable for this procedure according to the recommendation of the local CTEPH board. Patients must also consent to this surgical procedure.
• Ballon Pulmonary Angioplasty
Patients will receive Ballon Pulmonary Angioplasty if they are suitable for this procedure according to the recommendation of the local CTEPH board (e.g. not suitable for PEA). Patients must also consent to this procedure.The BPA will be accomplished in several interventions.

Locations
Country Name City State
Austria Medical Unviersity Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary AHI change under CTEPH treatment Change from baseline AHI (Apnoe-Hypopnoe Index, events/h) after 6 months of CTEPH treatment 6 months
Secondary Number of patients with persisting elevated AHI (= =15/h) after CTEPH treatment Patients with persisting elevated AHI will be assessed for further PAP treatment Time point: 6 months after the individual start of the CTEPH treatment
See also
  Status Clinical Trial Phase
Completed NCT03927547 - Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders N/A
Completed NCT03105297 - To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep. Phase 2
Completed NCT02894242 - The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) N/A
Completed NCT02086448 - Sleep Disordered Breathing, Obesity and Pregnancy Study (SOAP) N/A
Completed NCT02188498 - Electrocardiography Data Analysis in Sleep Disorders
Completed NCT01120548 - Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients N/A
Completed NCT01004471 - An Exploratory Study of a Nasal Dilator Strip Phase 2
Completed NCT02851628 - The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort N/A
Completed NCT03748264 - User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application N/A
Active, not recruiting NCT02191085 - Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing N/A
Completed NCT01467856 - Sleep Disordered Breathing N/A
Completed NCT00909259 - Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing Phase 1
Terminated NCT03353064 - Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure N/A
Completed NCT03752580 - An Investigation to Test a Prototype Nasal Mask in the Home Setting N/A
Completed NCT02987985 - Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy Phase 3
Suspended NCT03964376 - Nasal High Flow Therapy in Surgical Patients With Unrecognized Obstructive Sleep Apnea N/A
Completed NCT03725839 - The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA) N/A
Completed NCT02938208 - An Investigation to Test a Prototype Full-face Mask in the Home Setting N/A
Completed NCT04086407 - Apnea Hypopnea Index Severity Versus Head Position During Sleep N/A
Terminated NCT02296840 - Post-operative Pain Control After Pediatric Adenotonsillectomy Phase 4