NCT01332175

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 16, 2012

Status Verified

August 1, 2012

Enrollment Period

1.3 years

First QC Date

April 1, 2011

Last Update Submit

August 15, 2012

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Sleep apnoea severity, daytime symptoms of sleep apnoea

    2 weeks

Secondary Outcomes (1)

  • Blood pressure

    2 weeks

Study Arms (3)

Provent

ACTIVE COMPARATOR
Device: Provent®

Placebo-Provent

PLACEBO COMPARATOR
Device: Provent®Device: Placebo-Provent®

CPAP

ACTIVE COMPARATOR
Device: Provent®Procedure: CPAP

Interventions

Provent®DEVICE

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

CPAPPlacebo-ProventProvent
Placebo-Provent®DEVICE

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

Placebo-Provent
CPAPPROCEDURE

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

CPAP

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • Currently \>10/h oxygen desaturations (\>4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP.
  • Treated with NCPAP for more than 12 months, minimum compliance 4h per night.
  • Current ESS \< 10.
  • Written informed consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cantonal Hospital Munsterlingen, Departement of Internal Medicine, Pulmonary Division

Münsterlingen, 8596, Switzerland

Location

University Hospital Zurich, Pulmonary Division

Zurich, 8091, Switzerland

Location

Churchill Hospital, Oxford Centre for Respiratory Medicine

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 30100576DERIVED

  • 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.

    PMID: 28548301DERIVED

  • 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.

    PMID: 27452767DERIVED

  • 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.

    PMID: 23723343DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Malcolm Kohler, MD, Leading Physician

    University Hospital Zurich, Division of Pneumology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2011

First Posted

April 8, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 16, 2012

Record last verified: 2012-08

Locations

CH(2)GB(1)