Treatment of Sleep Related Breathing Disorders in Patients With Pulmonary Hypertension

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01427192

Acronym

CSRPH

Enrollment

Registered

2011-09-01

Start date

2010-11-30

Completion date

2012-12-31

Last updated

2012-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension, Breathing-Related Sleep Disorder

Keywords

Breathing-Related Sleep Disorder, Pulmonary Hypertension

Brief summary

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

Interventions

DRUGacetazolamide

250 mg bid

OTHERSupplemental oxygen

Oxygen deliverded by nasal cannula

PROCEDURENon-invasive ventilation

Bi-level non-invasive ventilation via nasal mask

OTHERRoom air

Room air applied via sham oxygen concentrator

DRUGPlacebo tablet

Placebo tablet (Mannitol) similar to acetazolamide

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026