Obstructive Sleep Apnea (OSA)NCT01877928
Post-extubation Boussignac CPAP System in Adults With Moderate to Severe Obstructive Sleep Apnea
A study testing Boussignac CPAP device and standard CPAP in people with Obstructive Sleep Apnea (OSA), run by Queen's University at 1 site in Canada.
Trial summary
The purpose of this study is to assess the efficacy of the Boussignac positive airway pressure system (a mask) applied immediately following post-operative extubation in improving lung function in patients with obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Boussignac CPAP device and standard CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Jul 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -> 18 years of age
- ASA II-IV
- Previous diagnosis of moderate to severe obstructive sleep apnea
- diagnosed via polysomnography
- BMI < 40
- scheduled for an abdominal or peripheral surgical procedure requiring endotracheal intubation and admission to hospital
Who cannot join
- BMI > 40
- Age <18 years
- inability to provide signed informed consent
- intra-thoracic
- head or neck surgery
- contraindication for immediate post-extubation application of CPAP
- not expected to be eligible for timely extubation following the surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the Boussignac CPAP System Immediately Following Extubation to Improve Lung Function in Adults With Moderate to Severe Obstructive Sleep Apnea
The purpose of this study is to assess the efficacy of the Boussignac positive airway pressure system (a mask) applied immediately following post-operative extubation in improving lung function in patients with obstructive sleep apnea (OSA). Assessments will be done before surgery and then at 1, 2 and 24 hours following extubation and will be compared to standard care for perioperative airway support. The study aims to give a broader and more inclusive picture (than the current literature) in terms of whether the Boussignac CPAP system should be considered for utilization by anesthesiologists caring for surgical patients with OSA.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Boussignac CPAP device, standard CPAP
- Keywords
- Obstructive sleep apnea, CPAP, Boussignac
- Medical subject headings
- Sleep Apnea, Obstructive, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boussignac CPAP deviceDevice
Also called Boussignac CPAP device,
Is a continuous positive airway pressure (CPAP) system marketed in Canada and the US for the treatment of Obstructive Sleep Apnea. The main difference is that this system is portable wheres the standard hospital CPAP is not. This allows for the application immediately post-extubation.
standard CPAPDevice
Also called standard of care CPAP
Standard of care postoperative treatment for OSA.
| Study group | Role | What they receive |
|---|---|---|
| Boussignac CPAP device | Experimental | Patients previously diagnosed with obstructive sleep apnea and who are undergoing abdominal or peripheral surgery will have the Boussignac CPAP mask applied for 1 hour starting immediately post-extubation Receives: Device: Boussignac CPAP device |
| standard CPAP | Active comparator | Patients previously diagnosed with obstructive sleep apnea who are undergoing peripheral or abdominal surgical procedures will receive the standard-of-care for obstructive sleep apnea. This typically involves CPAP application only at night Receives: Device: standard CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent forced vital capacity %(FVC)
%FVC will be assessed 24 hours postoperatively in patients who received the Boussignac CPAP mask immediately post-extubation and these values compared to those of patients who received the standard-of-care treatment for obstructive sleep apnea
Measured: 24 hours postoperatively
Secondary outcomes (1)
% forced expiratory volume in 1 second (FEV1)
Measured: 1,2 and 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Most OSA patients were not obese and/or admitted over night so the study was not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kim Turner, Queen's University
- Investigators
- Kim E Turner, MD, FRCPC, Principal investigator, Queen's University & Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877928
- Sponsor's protocol ID
- SMED-079-12
- Other IDs
- 6006956
- Status last verified
- Mar 2018
- First submitted
- 12 Jun 2013
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Boussignac CPAP System Immediately Following Extubation to Improve Lung Function in Adults With Moderate to Severe Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01877928
- Acronym / sponsor ID
- SMED-079-12
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- Obstructive sleep apnea, CPAP, Boussignac
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Most OSA patients were not obese and/or admitted over night so the study was not feasible.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Jun 2013 (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.
The purpose of this study is to assess the efficacy of the Boussignac positive airway pressure system (a mask) applied immediately following post-operative extubation in improving lung function in patients with obstructive sleep apnea (OSA). Assessments will be done before surgery and then at 1, 2 and 24 hours following extubation and will be compared to standard care for perioperative airway support. The study aims to give a broader and more inclusive picture (than the current literature) in terms of whether the Boussignac CPAP system should be considered for utilization by anesthesiologists caring for surgical patients with OSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boussignac CPAP device | Experimental | Device: Boussignac CPAP devicePatients previously diagnosed with obstructive sleep apnea and who are undergoing abdominal or peripheral surgery will have the Boussignac CPAP mask applied for 1 hour starting immediately post-extubation |
| standard CPAP | Active comparator | Device: standard CPAPPatients previously diagnosed with obstructive sleep apnea who are undergoing peripheral or abdominal surgical procedures will receive the standard-of-care for obstructive sleep apnea. This typically involves CPAP application only at night |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- -> 18 years of age
- ASA II-IV
- Previous diagnosis of moderate to severe obstructive sleep apnea
- diagnosed via polysomnography
- BMI < 40
Key exclusion criteria (7 listed)
- BMI > 40
- Age <18 years
- inability to provide signed informed consent
- intra-thoracic
- head or neck surgery
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 |
|---|---|---|
| Boussignac CPAP deviceAlso: Boussignac CPAP device,Is a continuous positive airway pressure (CPAP) system marketed in Canada and the US for the treatment of Obstructive Sleep Apnea. The main difference is that this system is portable wheres the standard hospital CPAP is not. This allows for the application immediately post-extubation. | Device | Boussignac CPAP device |
| standard CPAPAlso: standard of care CPAPStandard of care postoperative treatment for OSA. | Device | standard CPAP |
Primary outcome
percent forced vital capacity %(FVC)
Time frame: 24 hours postoperatively
%FVC will be assessed 24 hours postoperatively in patients who received the Boussignac CPAP mask immediately post-extubation and these values compared to those of patients who received the standard-of-care treatment for obstructive sleep apnea
1 secondary outcome
% forced expiratory volume in 1 second (FEV1)
Time frame: 1,2 and 24 hours post-operatively
Results and safety
The study was stopped early (reason given: Most OSA patients were not obese and/or admitted over night so the study was not feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
Related trials for Obstructive Sleep Apnea (OSA)
RecruitingObservational study
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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DRonabinol Treatment of OSA
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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.
Kim E Turner, MD, FRCPC principal investigator
Queen's University & Kingston General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boussignac CPAP device and standard CPAP in people with Obstructive Sleep Apnea (OSA), run by Queen's University at 1 site in Canada.
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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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 was stopped early (reason given: Most OSA patients were not obese and/or admitted over night so the study was not feasible.). Results are not available in the source record.
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?
percent forced vital capacity %(FVC) (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2018.