Obstructive Sleep ApneaNCT01332175
The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal
A study testing Provent® and CPAP in people with Obstructive Sleep Apnea, run by University of Zurich at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Provent® and CPAP
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Apr 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Switzerland2 sites
Cantonal Hospital Munsterlingen, Departement of Internal Medicine, Pulmonary Division
Münsterlingen, 8596
University Hospital Zurich, Pulmonary Division
Zurich, 8091
United Kingdom1 site
Churchill Hospital, Oxford Centre for Respiratory Medicine
Oxford, OX3 7LJ
About this study
Official title: The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal: a Randomised Controlled Trial.
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.
Read the 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
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Provent®, Placebo-Provent®, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provent®Device
Nightly use of Provent® versus Placebo-Provent® versus CPAP
Placebo-Provent®Device
Nightly use of Provent® versus Placebo-Provent® versus CPAP
CPAPProcedure or surgery
Nightly use of Provent® versus Placebo-Provent® versus CPAP
| Study group | Role | What they receive |
|---|---|---|
| Provent | Active comparator | Not described Receives: Device: Provent® |
| Placebo-Provent | Placebo comparator | Not described Receives: Device: Provent®; Device: Placebo-Provent® |
| CPAP | Active comparator | Not described Receives: Device: Provent®; Procedure: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep apnoea severity, daytime symptoms of sleep apnoea
Measured: 2 weeks
Secondary outcomes (1)
Blood pressure
Comparison of changes in systolic and diastolic blood pressure from baseline to follow-up at 2 weeks.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm Kohler, MD, Leading Physician, Principal investigator, University Hospital Zurich, Division of Pneumology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332175
- Sponsor's protocol ID
- EK-1600
- Status last verified
- Aug 2012
- First submitted
- 1 Apr 2011
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30100576Stoberl 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.
PubMed 28548301Schwarz 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.
PubMed 27452767Rossi 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.
PubMed 23723343
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT01332175
- Acronym / sponsor ID
- EK-1600
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Provent | Active comparator | Device: Provent® |
| Placebo-Provent | Placebo comparator | Device: Provent®, Device: Placebo-Provent® |
| CPAP | Active comparator | Device: Provent®, Procedure: CPAP |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provent®Nightly use of Provent® versus Placebo-Provent® versus CPAP | Device | CPAP, Placebo-Provent, Provent |
| Placebo-Provent®Nightly use of Provent® versus Placebo-Provent® versus CPAP | Device | Placebo-Provent |
| CPAPNightly use of Provent® versus Placebo-Provent® versus CPAP | Procedure or surgery | CPAP |
Primary outcome
Sleep apnoea severity, daytime symptoms of sleep apnoea
Time frame: 2 weeks
1 secondary outcome
Blood pressure
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
- Derived from this study: PubMed 30100576Crook 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.
- Derived from this study: PubMed 28548301Stoberl 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.
- Derived from this study: PubMed 27452767Schwarz 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.
- Derived from this study: PubMed 23723343Rossi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm Kohler, MD, Leading Physician principal investigator
University Hospital Zurich, Division of Pneumology
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provent® and CPAP in people with Obstructive Sleep Apnea, run by University of Zurich at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep apnoea severity, daytime symptoms of sleep apnoea (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01332175, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012.