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

University of Zurich (UZH)

Status: Completed

Conditions: Obstructive Sleep Apnoea

Treatments: Other: CPAP therapy withdrawal; Procedure: Continue CPAP treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01797653

CPAP_V1.0 (01.11.2012)

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

Placebo CPAP

Placebo Comparator group

Description:

patients established on CPAP therapy, who are randomized to the placebo comparator, will use a CPAP device with subtherapeutic pressure during two weeks.

Treatment:

Other: CPAP therapy withdrawal

therapeutic CPAP

Active Comparator group

Description:

patients who are randomized to the active comparator, will continue with CPAP treatment with therapeutic pressure during two weeks

Treatment:

Procedure: Continue CPAP treatment