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OpenTrials
Completed

NCT Number: NCT01797653

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

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.

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Key information

Conditions

Obstructive Sleep Apnoea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Division of Pneumology

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP therapy withdrawal

Other

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

Other names: CPAP treatment with subtherapeutic pressure

Continue CPAP treatment

Procedure

Continue treatment with therapeutic continuous positive airway pressure device

Other names: therapeutic continuous positive airway pressure device

Primary outcomes

  1. hyperaemic myocardial blood flow

    Time frame: 2 weeks

Secondary outcomes

  1. Coronary flow reserve

    Time frame: 2 weeks

    Coronary flow reserve determined by PET

  2. Urine albumine excretion rate

    Time frame: 2 weeks

  3. Dermal microvascular vasodilatory response

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 22, 2013
Registry last updated
Dec 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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