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CompletedNCT01797653Updated Dec 23, 2013

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

An interventional study of CPAP therapy withdrawal and Continue CPAP treatment in Obstructive Sleep Apnoea, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-12-23.

Sponsored by University of Zurich · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Obstructive Sleep Apnoea
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In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.

This study's enrollment of 45 is below the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Placebo comparator
    Placebo CPAP

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

    Other: CPAP therapy withdrawal

  • Active comparator
    therapeutic CPAP

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

    Procedure: Continue CPAP treatment

Interventions

  • OtherCPAP therapy withdrawal

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

    Also known as: CPAP treatment with subtherapeutic pressure

  • ProcedureContinue CPAP treatment

    Continue treatment with therapeutic continuous positive airway pressure device

    Also known as: therapeutic continuous positive airway pressure device

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What researchers measure

Primary outcomes

  1. hyperaemic myocardial blood flow

    Time frame: 2 weeks

Secondary outcomes

  1. Coronary flow reserve

    Coronary flow reserve determined by PET

    Time frame: 2 weeks

  2. Urine albumine excretion rate

    Time frame: 2 weeks

  3. Dermal microvascular vasodilatory response

    Time frame: 2 weeks

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Study locations

1 site
  • University Hospital Zurich, Division of Pneumology
    Zurich, ZH 8091, Switzerland
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References and documents

Publications

  • 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. PubMed 29700104 ↗
  • 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. PubMed 27860068 ↗
  • 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. PubMed 27452767 ↗
  • 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. PubMed 26022961 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01797653
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Feb 22, 2013
Start date
Feb 2013
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Dec 23, 2013

Study contacts

Malcolm Kohler, Prof MD
principal investigator · University Hospital Zurich, Division of Pneumology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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