Randomized-controlled Trial (RCT) on CPAP-withdrawal and Microvascular Function in OSA

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnoea
• Interventions: Other: CPAP therapy withdrawal; Procedure: Continue CPAP treatment

• Registration Number: NCT01797653
• Lead Sponsor: University of Zurich

Brief Summary

Randomized controlled trial (therapeutic vs. placebo CPAP) including 46 patients with obstructive sleep apnea (OSA) to define the physiological effects of continuous positive airway pressure (CPAP) therapy withdrawal on myocardial perfusion and dermal and renal microvascular function during a 2 week period.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-20
• Last Update Posted: 2013-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo CPAP	CPAP therapy withdrawal	patients established on CPAP therapy, who are randomized to the placebo comparator, will use a CPAP device with subtherapeutic pressure during two weeks.
therapeutic CPAP	Continue CPAP treatment	patients who are randomized to the active comparator, will continue with CPAP treatment with therapeutic pressure during two weeks

Primary Outcome Measures

Name	Time	Method
hyperaemic myocardial blood flow	2 weeks

Secondary Outcome Measures

Name	Time	Method
Coronary flow reserve	2 weeks	Coronary flow reserve determined by PET
Urine albumine excretion rate	2 weeks
Dermal microvascular vasodilatory response	2 weeks

Trial Locations

Locations (1)

University Hospital Zurich, Division of Pneumology; 🇨🇭 Zurich, ZH, Switzerland