The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Provent®; Device: Placebo-Provent®; Procedure: CPAP

• Registration Number: NCT01332175
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-15
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Provent	Provent®	-
Placebo-Provent	Provent®	-
Placebo-Provent	Placebo-Provent®	-
CPAP	Provent®	-
CPAP	CPAP	-

Primary Outcome Measures

Name	Time	Method
Sleep apnoea severity, daytime symptoms of sleep apnoea	2 weeks

Secondary Outcome Measures

Name	Time	Method
Blood pressure	2 weeks	Comparison of changes in systolic and diastolic blood pressure from baseline to follow-up at 2 weeks.

Trial Locations

Locations (3)

Churchill Hospital, Oxford Centre for Respiratory Medicine; 🇬🇧 Oxford, United Kingdom

Cantonal Hospital Munsterlingen, Departement of Internal Medicine, Pulmonary Division; 🇨🇭 Munsterlingen, Switzerland

University Hospital Zurich, Pulmonary Division; 🇨🇭 Zurich, Switzerland