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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01797653

Enrollment

Registered

2013-02-22

Start date

2013-02-28

Completion date

2013-12-31

Last updated

2013-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnoea

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.

Interventions

OTHERCPAP therapy withdrawal

CPAP (continuous positive airway pressure) with subtherapeutic pressure during two weeks

PROCEDUREContinue CPAP treatment

Continue treatment with therapeutic continuous positive airway pressure device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
hyperaemic myocardial blood flow	2 weeks

Secondary

Measure	Time frame	Description
Coronary flow reserve	2 weeks	Coronary flow reserve determined by PET
Urine albumine excretion rate	2 weeks	—
Dermal microvascular vasodilatory response	2 weeks	—

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026