The Effects of Provent® on Obstructive Sleep Apnea During... | NCT01332175

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

NCT01332175

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Aug 16, 2012Estimated

Enrollment

67Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

Provent®
Placebo-Provent®
CPAP

Countries

Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Apr 1, 2011

First Submission Date that Met QC Criteria

Apr 7, 2011

First Posted Date

Apr 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2012

Last Update Posted Date

Aug 16, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Provent	Active Comparator	Device: Provent®
Placebo-Provent	Placebo Comparator	Device: Provent® Device: Placebo-Provent®
CPAP	Active Comparator	Device: Provent® Procedure: CPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Provent®	Device	Nightly use of Provent® versus Placebo-Provent® versus CPAP	CPAP Placebo-Provent Provent

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malcolm Kohler, MD, Leading Physician	University Hospital Zurich, Division of Pneumology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cantonal Hospital Munsterlingen, Departement of Internal Medicine, Pulmonary Division		Münsterlingen		8596	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30100576	Derived	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.
28548301	Derived

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases