Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to study the differential short-term effect of nocturnal oxygen, acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms, exercise capacity and nocturnal breathing disturbances in subjects with pulmonary hypertension and sleep related breathing disorders Trial with medicinal product

Official Title
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Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension (CSRPH)

Conditions
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Pulmonary Hypertension, Breathing-Related Sleep Disorder

Intervention / Treatment
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* Drug: acetazolamide
* Other: Supplemental oxygen
* Procedure: Non-invasive ventilation
* Other: Room air
* Drug: Placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: percapillary pulmonary hypertension diagnosed by right heart catheterisation -- stable therapy and clinical condition for at least 4 weeks sleep disordered breathing with apnea/hypopnea index > 10 events/h and/or median nocturnal oxygen saturation <90% Exclusion criteria: Pregnancy severe daytime hypoxemia (PaO2 < 7.2 kPA) patients with predominantly obstructive sleep apnea.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acetazolamide<br>1 week therapy, cross-over design | Drug: acetazolamide<br>* 250 mg bid<br>* Other names: Diamox;|
| Placebo Comparator: Placebo tablet<br>One week, cross-over design | Drug: Placebo tablet<br>* Placebo tablet (Mannitol) similar to acetazolamide<br>|
| Experimental: supplemental oxygen during nights<br>One week, cross-over design | Other: Supplemental oxygen<br>* Oxygen deliverded by nasal cannula<br>* Other names: Oxygen concentrator;|
| Experimental: Non-invasive ventilation<br>One week, cross-over design | Procedure: Non-invasive ventilation<br>* Bi-level non-invasive ventilation via nasal mask<br>|
| Sham Comparator: room air<br>room air applied via sham-oxygen-concentrator | Other: Room air<br>* Room air applied via sham oxygen concentrator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| exercise capacity | Assessment by the 6 minute walk distance | 1 week | 
| Quality of Life | Assessment by the short form of the SF 36 questionnaire | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep related breathing disorders | assessed by polysomnography according to standard techniques | 1 week | 
| hemodynamics measured by echocardiography | right ventricular dimension right ventricular over right atrial pressure | 1 week | 
| venous blood analysis | C reactive protein NT-proBNP IL-6 | 1 week | 
| Nocturnal oxygen desaturation | Assessed by fingertip puleoxymetry | 1 week | 
| arterial blood analysis | oxygenation electrolytes | 1 week | 
| Vigilance | Assessed by the MURT test | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breathing-Related Sleep Disorder, Pulmonary Hypertension