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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332175
• Other study ID #: EK-1600
• Status: Completed
• Phase: N/A
• First received: April 1, 2011
• Last updated: August 15, 2012
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Provent®
Nightly use of Provent® versus Placebo-Provent® versus CPAP
• Placebo-Provent®
Nightly use of Provent® versus Placebo-Provent® versus CPAP

Procedure:
• CPAP
Nightly use of Provent® versus Placebo-Provent® versus CPAP

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital Munsterlingen, Departement of Internal Medicine, Pulmonary Division	Munsterlingen
Switzerland	University Hospital Zurich, Pulmonary Division	Zurich
United Kingdom	Churchill Hospital, Oxford Centre for Respiratory Medicine	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Countries where clinical trial is conducted

Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep apnoea severity, daytime symptoms of sleep apnoea		2 weeks	No
Secondary	Blood pressure	Comparison of changes in systolic and diastolic blood pressure from baseline to follow-up at 2 weeks.	2 weeks	No