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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797653
First Posted: February 22, 2013
Last Update Posted: December 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  Purpose
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.

Condition Intervention
Obstructive Sleep Apnoea Other: CPAP therapy withdrawal Procedure: Continue CPAP treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of CPAP-withdrawal on Microvascular Function in Patients With Obstructive Sleep Apnea: A Randomized-controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • hyperaemic myocardial blood flow [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • Coronary flow reserve [ Time Frame: 2 weeks ]
    Coronary flow reserve determined by PET

  • Urine albumine excretion rate [ Time Frame: 2 weeks ]
  • Dermal microvascular vasodilatory response [ Time Frame: 2 weeks ]

Enrollment: 45
Study Start Date: February 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: therapeutic continuous positive airway pressure device

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797653


Locations
Switzerland
University Hospital Zurich, Division of Pneumology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Malcolm Kohler, Prof MD University Hospital Zurich, Division of Pneumology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01797653     History of Changes
Other Study ID Numbers: CPAP_V1.0 (01.11.2012)
First Submitted: February 15, 2013
First Posted: February 22, 2013
Last Update Posted: December 23, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases