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

Obstructive Sleep Apnoea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797653
• Other study ID #: CPAP_V1.0 (01.11.2012)
• Status: Completed
• Phase: N/A
• First received: February 15, 2013
• Last updated: December 20, 2013
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• CPAP therapy withdrawal
CPAP (continuous positive airway pressure) with subtherapeutic pressure during two weeks

Procedure:
• Continue CPAP treatment
Continue treatment with therapeutic continuous positive airway pressure device

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Pneumology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hyperaemic myocardial blood flow		2 weeks	No
Secondary	Coronary flow reserve	Coronary flow reserve determined by PET	2 weeks	No
Secondary	Urine albumine excretion rate		2 weeks	No
Secondary	Dermal microvascular vasodilatory response		2 weeks	No