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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01332175
First received: April 1, 2011
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
 Device: Provent®
Device: Placebo-Provent®
Procedure: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal: a Randomised Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Sleep apnoea severity, daytime symptoms of sleep apnoea [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Comparison of changes in systolic and diastolic blood pressure from baseline to follow-up at 2 weeks.


Enrollment: 67
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332175

Locations
Switzerland
Cantonal Hospital Munsterlingen, Departement of Internal Medicine, Pulmonary Division
Munsterlingen, Switzerland, 8596
University Hospital Zurich, Pulmonary Division
Zurich, Switzerland, 8091
United Kingdom
Churchill Hospital, Oxford Centre for Respiratory Medicine
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Malcolm Kohler, MD, Leading Physician University Hospital Zurich, Division of Pneumology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01332175     History of Changes
Other Study ID Numbers: EK-1600
Study First Received: April 1, 2011
Last Updated: August 15, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013