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OpenTrials
Completed

NCT Number: NCT01427192

Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension

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

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Key information

Conditions

Pulmonary Hypertension Breathing-Related Sleep Disorder Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Respiratory Clinic, University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetazolamide

Drug

250 mg bid

Other names: Diamox

Supplemental Oxygen

Other

Oxygen deliverded by nasal cannula

Other names: Oxygen concentrator

Non-invasive ventilation

Procedure

Bi-level non-invasive ventilation via nasal mask

Room air

Other

Room air applied via sham oxygen concentrator

Placebo Tablet

Drug

Placebo tablet (Mannitol) similar to acetazolamide

Primary outcomes

  1. exercise capacity

    Time frame: 1 week

    Assessment by the 6 minute walk distance

  2. Quality of Life

    Time frame: 1 week

    Assessment by the short form of the SF 36 questionnaire

Secondary outcomes

  1. sleep related breathing disorders

    Time frame: 1 week

    assessed by polysomnography according to standard techniques

  2. hemodynamics measured by echocardiography

    Time frame: 1 week

    right ventricular dimension right ventricular over right atrial pressure

  3. venous blood analysis

    Time frame: 1 week

    C reactive protein NT-proBNP IL-6

  4. Nocturnal oxygen desaturation

    Time frame: 1 week

    Assessed by fingertip puleoxymetry

  5. arterial blood analysis

    Time frame: 1 week

    oxygenation electrolytes

  6. Vigilance

    Time frame: 1 week

    Assessed by the MURT test

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: CSRPH

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 1, 2011
Registry last updated
Dec 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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