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

University of Zurich (UZH)

Status and phase: Completed; Phase 2

Conditions: Breathing-Related Sleep Disorder; Pulmonary Hypertension

Treatments: Drug: Placebo tablet; Procedure: Non-invasive ventilation; Other: Supplemental oxygen; Drug: acetazolamide; Other: Room air

Study type: Interventional

Funder types: Other

Identifiers

NCT01427192

CSRPH

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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23 participants in 5 patient groups, including a placebo group

acetazolamide

Experimental group

Description:

1 week therapy, cross-over design

Treatment:

Drug: acetazolamide

Placebo tablet

Placebo Comparator group

Description:

One week, cross-over design

Treatment:

Drug: Placebo tablet

supplemental oxygen during nights

Experimental group

Description:

One week, cross-over design

Treatment:

Other: Supplemental oxygen

Non-invasive ventilation

Experimental group

Description:

One week, cross-over design

Treatment:

Procedure: Non-invasive ventilation

room air

Sham Comparator group

Description:

room air applied via sham-oxygen-concentrator

Treatment:

Other: Room air