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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01332175
Enrollment
67
Registered
2011-04-08
Start date
2011-04-30
Completion date
2012-08-31
Last updated
2012-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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: 1. Withdraw CPAP and use Provent® 2. Withdraw CPAP and use Placebo-Provent® 3. Continue treatment with CPAP

Interventions

DEVICEProvent®

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

DEVICEPlacebo-Provent®

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

PROCEDURECPAP

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

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Sleep apnoea severity, daytime symptoms of sleep apnoea2 weeks

Secondary

MeasureTime frameDescription
Blood pressure2 weeksComparison of changes in systolic and diastolic blood pressure from baseline to follow-up at 2 weeks.

Countries

Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026