Randomized-controlled Trial (RCT) on CPAP-withdrawal and Microvascular Function in OSA
NCT ID: NCT01797653
Last Updated: 2013-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2013-02-28
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
CPAP therapy withdrawal
CPAP (continuous positive airway pressure) with subtherapeutic pressure during two weeks
therapeutic CPAP
patients who are randomized to the active comparator, will continue with CPAP treatment with therapeutic pressure during two weeks
Continue CPAP treatment
Continue treatment with therapeutic continuous positive airway pressure device
Interventions
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CPAP therapy withdrawal
CPAP (continuous positive airway pressure) with subtherapeutic pressure during two weeks
Continue CPAP treatment
Continue treatment with therapeutic continuous positive airway pressure device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Malcolm Kohler, Prof MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zurich, Division of Pneumology
Locations
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University Hospital Zurich, Division of Pneumology
Zurich, Canton of Zurich, Switzerland
Countries
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References
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Schwarz EI, Furian M, Schlatzer C, Stradling JR, Kohler M, Bloch KE. Nocturnal cerebral hypoxia in obstructive sleep apnoea: a randomised controlled trial. Eur Respir J. 2018 May 30;51(5):1800032. doi: 10.1183/13993003.00032-2018. Print 2018 May.
Turnbull CD, Rossi VA, Santer P, Schwarz EI, Stradling JR, Petousi N, Kohler M. Effect of OSA on hypoxic and inflammatory markers during CPAP withdrawal: Further evidence from three randomized control trials. Respirology. 2017 May;22(4):793-799. doi: 10.1111/resp.12946. Epub 2016 Nov 18.
Schwarz EI, Schlatzer C, Rossi VA, Stradling JR, Kohler M. Effect of CPAP Withdrawal on BP in OSA: Data from Three Randomized Controlled Trials. Chest. 2016 Dec;150(6):1202-1210. doi: 10.1016/j.chest.2016.07.012. Epub 2016 Jul 21.
Stradling JR, Schwarz EI, Schlatzer C, Manuel AR, Lee R, Antoniades C, Kohler M. Biomarkers of oxidative stress following continuous positive airway pressure withdrawal: data from two randomised trials. Eur Respir J. 2015 Oct;46(4):1065-71. doi: 10.1183/09031936.00023215. Epub 2015 May 28.
Other Identifiers
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CPAP_V1.0 (01.11.2012)
Identifier Type: -
Identifier Source: org_study_id