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

Study Overview
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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: Withdraw CPAP and use Provent® Withdraw CPAP and use Placebo-Provent® Continue treatment with CPAP

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Provent®
* Device: Placebo-Provent®
* Procedure: CPAP


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Provent<br> | Device: Provent®<br>* Nightly use of Provent® versus Placebo-Provent® versus CPAP<br>|
| Placebo Comparator: Placebo-Provent<br> | Device: Provent®<br>* Nightly use of Provent® versus Placebo-Provent® versus CPAP<br>Device: Placebo-Provent®<br>* Nightly use of Provent® versus Placebo-Provent® versus CPAP<br>|
| Active Comparator: CPAP<br> | Device: Provent®<br>* Nightly use of Provent® versus Placebo-Provent® versus CPAP<br>Procedure: CPAP<br>* Nightly use of Provent® versus Placebo-Provent® versus CPAP<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 |