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

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ClinicalTrials.gov Identifier: NCT01797653
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : December 23, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnoea Other: CPAP therapy withdrawal Procedure: Continue CPAP treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
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
Study Start Date : February 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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 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




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

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

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


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
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

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