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

August 15, 2012 updated by: University of Zurich

The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal: a Randomised Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CPAP
Device: Provent®
Nightly use of Provent® versus Placebo-Provent® versus CPAP
Procedure: CPAP
Nightly use of Provent® versus Placebo-Provent® versus CPAP
ACTIVE_COMPARATOR: Provent
Device: Provent®
Nightly use of Provent® versus Placebo-Provent® versus CPAP
PLACEBO_COMPARATOR: Placebo-Provent
Device: Provent®
Nightly use of Provent® versus Placebo-Provent® versus CPAP
Device: Placebo-Provent®
Nightly use of Provent® versus Placebo-Provent® versus CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sleep apnoea severity, daytime symptoms of sleep apnoea
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 2 weeks
Comparison of changes in systolic and diastolic blood pressure from baseline to follow-up at 2 weeks.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 7, 2011

First Posted (ESTIMATE)

April 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 16, 2012

Last Update Submitted That Met QC Criteria

August 15, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK-1600

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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