Randomised, placebo-controlled trial of continuous positive airway pressure therapy (CPAP) versus Provent® and Placebo-Provent® to define the effects of Provent® on the severity of obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk.
Randomised, placebo-controlled trial of Provent® versus Placebo-Provent® versus continuous positive airway pressure therapy (CPAP) to define the effects of Provent® on the severity of obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk in patients with obstructive sleep apnea. Patients successfully treated with CPAP will be randomised to one of three arms for a duration of 2 weeks: 1. Withdraw CPAP and use Provent® 2. Withdraw CPAP and use Placebo-Provent® 3. Continue treatment with CPAP
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
67
Nightly use of Provent® versus Placebo-Provent® versus CPAP
Nightly use of Provent® versus Placebo-Provent® versus CPAP
Nightly use of Provent® versus Placebo-Provent® versus CPAP
Cantonal Hospital Munsterlingen, Departement of Internal Medicine, Pulmonary Division
Münsterlingen, Switzerland
University Hospital Zurich, Pulmonary Division
Zurich, Switzerland
Churchill Hospital, Oxford Centre for Respiratory Medicine
Oxford, United Kingdom
Sleep apnoea severity, daytime symptoms of sleep apnoea
Time frame: 2 weeks
Blood pressure
Comparison of changes in systolic and diastolic blood pressure from baseline to follow-up at 2 weeks.
Time frame: 2 weeks
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