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

December 20, 2013 updated by: University of Zurich

The Effects of CPAP-withdrawal on Microvascular Function in Patients With Obstructive Sleep Apnea: A Randomized-controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Pneumology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Objectively confirmed OSA (at the time of original diagnosis) with an oxygen desaturation index (ODI, =4% dips) of >20/h and an ESS of >10.
  • Currently >20/h oxygen desaturations (=4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP.
  • Treated with CPAP for more than 12 months, minimum compliance 4h per night, AHI<10 with treatment (according to CPAP machine download data).
  • Current ESS <10.

Exclusion criteria:

  • Previous ventilatory failure (awake SpO2 <93% and PaCO2>6kPa).
  • Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension or hypotension (>180/110 or <90/60mmHg)
  • Previously diagnosed with Cheyne-Stokes breathing.
  • Current professional driver; Any previous sleep related accident.
  • Age <20 or >75 years at trial entry.
  • Acute inflammatory disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo CPAP
patients established on CPAP therapy, who are randomized to the placebo comparator, will use a CPAP device with subtherapeutic pressure during two weeks.
Other: CPAP therapy withdrawal
CPAP (continuous positive airway pressure) with subtherapeutic pressure during two weeks
Other Names:
  • CPAP treatment with subtherapeutic pressure
ACTIVE_COMPARATOR: therapeutic CPAP
patients who are randomized to the active comparator, will continue with CPAP treatment with therapeutic pressure during two weeks
Procedure: Continue CPAP treatment
Continue treatment with therapeutic continuous positive airway pressure device
Other Names:
  • therapeutic continuous positive airway pressure device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hyperaemic myocardial blood flow
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary flow reserve
Time Frame: 2 weeks
Coronary flow reserve determined by PET
2 weeks
Urine albumine excretion rate
Time Frame: 2 weeks
2 weeks
Dermal microvascular vasodilatory response
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 20, 2013

First Posted (ESTIMATE)

February 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 23, 2013

Last Update Submitted That Met QC Criteria

December 20, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPAP_V1.0 (01.11.2012)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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