Clinical trial NCT01797653: Randomized-controlled Trial (RCT) on CPAP-withdrawal and Microvascular Function in OSA
Official title: The Effects of CPAP-withdrawal on Microvascular Function in Patients With Obstructive Sleep Apnea: A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnoea
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: hyperaemic myocardial blood flow
timeFrame: 2 weeks
Secondary outcomes:
measure: Coronary flow reserve
timeFrame: 2 weeks
measure: Urine albumine excretion rate
timeFrame: 2 weeks
measure: Dermal microvascular vasodilatory response
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Pneumology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Pneumology
name: Malcolm Kohler, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.