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NCT01332175

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

NCT ID: NCT01332175

Last Updated: 2012-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-08-31

Brief Summary

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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

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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

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Provent

Group Type ACTIVE_COMPARATOR

Provent®

Intervention Type DEVICE

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

Placebo-Provent

Group Type PLACEBO_COMPARATOR

Provent®

Intervention Type DEVICE

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

Placebo-Provent®

Intervention Type DEVICE

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

CPAP

Group Type ACTIVE_COMPARATOR

Provent®

Intervention Type DEVICE

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

CPAP

Intervention Type PROCEDURE

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

Interventions

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Provent®

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

Intervention Type DEVICE

Placebo-Provent®

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

Intervention Type DEVICE

CPAP

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

Intervention Type PROCEDURE

Eligibility Criteria

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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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malcolm Kohler, MD, Leading Physician

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Pneumology

Locations

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Cantonal Hospital Munsterlingen, Departement of Internal Medicine, Pulmonary Division

Münsterlingen, , Switzerland

Site Status

University Hospital Zurich, Pulmonary Division

Zurich, , Switzerland

Site Status

Churchill Hospital, Oxford Centre for Respiratory Medicine

Oxford, , United Kingdom

Site Status

Countries

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Switzerland United Kingdom

References

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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.

Reference Type DERIVED

PMID: 30100576 (View on PubMed)

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.

Reference Type DERIVED

PMID: 28548301 (View on PubMed)

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.

Reference Type DERIVED

PMID: 27452767 (View on PubMed)

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.

Reference Type DERIVED

PMID: 23723343 (View on PubMed)

Other Identifiers

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EK-1600

Identifier Type: -

Identifier Source: org_study_id