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CompletedNCT01332175Updated Aug 16, 2012

The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal

An interventional study of Provent® and Placebo-Provent® in Obstructive Sleep Apnea, sponsored by University of Zurich. Completed at 3 sites in 2 countries. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-08-16.

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

Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

Randomised, placebo-controlled trial of continuous positive airway pressure therapy (CPAP) versus Provent® and Placebo-Provent® to define the effects of Provent® on the severity of obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk.

Read the detailed description

Randomised, placebo-controlled trial of Provent® versus Placebo-Provent® versus continuous positive airway pressure therapy (CPAP) to define the effects of Provent® on the severity of obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk in patients with obstructive sleep apnea.

Patients successfully treated with CPAP will be randomised to one of three arms for a duration of 2 weeks:

  1. Withdraw CPAP and use Provent®
  2. Withdraw CPAP and use Placebo-Provent®
  3. Continue treatment with CPAP
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Conditions studied

  • Obstructive Sleep Apnea
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In context

Apnea

1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.

This study's enrollment of 67 is above the median of 51 across 966 interventional studies indexed under Apnea.

Browse Apnea 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.

04

Who can participate

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

Inclusion criteria

  1. Objectively confirmed obstructive sleep apnoea (at the time of original diagnosis) with an oxygen desaturation index (ODI, >4% dips) of between 10 and 50/h and an ESS of >10 (these thresholds will exclude subjects with borderline and very severe forms of OSA in whom there may be a disproportionate treatment effect).
  2. Currently >10/h oxygen desaturations (>4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP.
  3. Treated with NCPAP for more than 12 months, minimum compliance 4h per night.
  4. Current ESS \< 10.
  5. Written informed consent.

Exclusion criteria

Exclusion criteria:

  1. Previous ventilatory failure (awake resting arterial oxygen saturation \<93% or arterial PCO2 > 6kPa).
  2. Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (>180/110mmHg).
  3. Previously diagnosed with Cheyne-Stokes breathing.
  4. Current professional driver.
  5. Any sleep related accident.
  6. Age \<20 or >75 years at trial entry.
  7. History of chronic nasal obstruction.
  8. Mental or physical disability precluding informed consent or compliance with the protocol .
  9. Non-feasible trial follow-up (for example, distance from follow-up centre, physical inability).
05

Study design

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

Study arms

  • Active comparator
    Provent

    Device: Provent®

  • Placebo comparator
    Placebo-Provent

    Device: Provent® · Device: Placebo-Provent®

  • Active comparator
    CPAP

    Device: Provent® · Procedure: CPAP

Interventions

  • DeviceProvent®

    Nightly use of Provent® versus Placebo-Provent® versus CPAP

  • DevicePlacebo-Provent®

    Nightly use of Provent® versus Placebo-Provent® versus CPAP

  • ProcedureCPAP

    Nightly use of Provent® versus Placebo-Provent® versus CPAP

06

What researchers measure

Primary outcomes

  1. Sleep apnoea severity, daytime symptoms of sleep apnoea

    Time frame: 2 weeks

Secondary outcomes

  1. Blood pressure

    Comparison of changes in systolic and diastolic blood pressure from baseline to follow-up at 2 weeks.

    Time frame: 2 weeks

07

Study locations

3 sites
  • Cantonal Hospital Munsterlingen, Departement of Internal Medicine, Pulmonary Division
    Munsterlingen, 8596, Switzerland
  • University Hospital Zurich, Pulmonary Division
    Zurich, 8091, Switzerland
  • Churchill Hospital, Oxford Centre for Respiratory Medicine
    Oxford, OX3 7LJ, United Kingdom
08

References and documents

Publications

  • Crook S, Sievi NA, Bloch KE, Stradling JR, Frei A, Puhan MA, Kohler M. Minimum important difference of the Epworth Sleepiness Scale in obstructive sleep apnoea: estimation from three randomised controlled trials. Thorax. 2019 Apr;74(4):390-396. doi: 10.1136/thoraxjnl-2018-211959. Epub 2018 Aug 12. PubMed 30100576 ↗
  • Stoberl AS, Schwarz EI, Haile SR, Turnbull CD, Rossi VA, Stradling JR, Kohler M. Night-to-night variability of obstructive sleep apnea. J Sleep Res. 2017 Dec;26(6):782-788. doi: 10.1111/jsr.12558. Epub 2017 May 26. PubMed 28548301 ↗
  • 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 ↗
  • Rossi VA, Winter B, Rahman NM, Yu LM, Fallon J, Clarenbach CF, Bloch KE, Stradling JR, Kohler M. The effects of Provent on moderate to severe obstructive sleep apnoea during continuous positive airway pressure therapy withdrawal: a randomised controlled trial. Thorax. 2013 Sep;68(9):854-9. doi: 10.1136/thoraxjnl-2013-203508. Epub 2013 May 30. PubMed 23723343 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2012, 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
NCT01332175
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Apr 8, 2011
Start date
Apr 2011
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Aug 16, 2012

Study contacts

Malcolm Kohler, MD, Leading Physician
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 Aug 2012. You cannot join it, but the record below documents what was studied.

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