Back to resultsThe Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Provent®
Placebo-Provent®
CPAP
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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).
Sites / Locations
- Cantonal Hospital Munsterlingen, Departement of Internal Medicine, Pulmonary Division
- University Hospital Zurich, Pulmonary Division
- Churchill Hospital, Oxford Centre for Respiratory Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Provent
Placebo-Provent
CPAP
Arm Description
Outcomes
Primary Outcome Measures
Sleep apnoea severity, daytime symptoms of sleep apnoea
Secondary Outcome Measures
Blood pressure
Comparison of changes in systolic and diastolic blood pressure from baseline to follow-up at 2 weeks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01332175
Brief Title
The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal
Official Title
The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal: a Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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:
Withdraw CPAP and use Provent®
Withdraw CPAP and use Placebo-Provent®
Continue treatment with CPAP
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Provent
Arm Type
Active Comparator
Arm Title
Placebo-Provent
Arm Type
Placebo Comparator
Arm Title
CPAP
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Provent®
Intervention Description
Nightly use of Provent® versus Placebo-Provent® versus CPAP
Intervention Type
Device
Intervention Name(s)
Placebo-Provent®
Intervention Description
Nightly use of Provent® versus Placebo-Provent® versus CPAP
Intervention Type
Procedure
Intervention Name(s)
CPAP
Intervention Description
Nightly use of Provent® versus Placebo-Provent® versus CPAP
Primary Outcome Measure Information:
Title
Sleep apnoea severity, daytime symptoms of sleep apnoea
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Comparison of changes in systolic and diastolic blood pressure from baseline to follow-up at 2 weeks.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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.
Exclusion criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm Kohler, MD, Leading Physician
Organizational Affiliation
University Hospital Zurich, Division of Pneumology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cantonal Hospital Munsterlingen, Departement of Internal Medicine, Pulmonary Division
City
Munsterlingen
ZIP/Postal Code
8596
Country
Switzerland
Facility Name
University Hospital Zurich, Pulmonary Division
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Churchill Hospital, Oxford Centre for Respiratory Medicine
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30100576
Citation
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.
Results Reference
derived
PubMed Identifier
28548301
Citation
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.
Results Reference
derived
PubMed Identifier
27452767
Citation
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.
Results Reference
derived
PubMed Identifier
23723343
Citation
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.
Results Reference
derived
Learn more about this trial
The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal
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