Obstructive Sleep Apnea (OSA)NCT01249924
The Effectiveness of Perioperative CPAP to Reduce Obstructive Sleep Apnea Related Adverse Events
A study testing auto-titrated CPAP in people with Obstructive Sleep Apnea (OSA), run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Objective of the study: To determine whether Perioperative Auto-CPAP treatment prevent postoperative worsening of OSA and improve nocturnal oxygen saturation in surgical patients with moderate and severe OSA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- auto-titrated CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2009to Oct 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients who meet the following criteria will be recruited
- Patients who are scheduled for inpatient surgery that required a minimum of three nights of hospital stay
- Age: >18 and <80 years old.
- Identified as high risk of having OSA or diagnosed with OSA without using CPAP.
Who cannot join
- Undergoing nasal, eye, head/neck surgery, intracranial or cardiac/thoracic surgery.
- Unwilling or unable to give informed consent.
- Currently undergoing treatment for sleep apnea including CPAP.
- Requiring prolonged postoperative ventilation.
- New York Heart Association functional class III and IV.
- Having valvular heart disease, dilated cardiomyopathy, implanted cardiac pacemaker, or unstable angina.
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- Having myocardial infarction or cardiac surgery within 3 months.
- Having chronic obstructive pulmonary disease, or asthma.
- Having a presence of tracheostomy, facial, neck, or chest wall abnormalities.
- Having abdominal aortic aneurysm surgery, chemotherapy, or immunosuppressive therapy within 3 months.
- Visiting preoperative clinic less than 3 days before scheduled surgery date.
- On nasogastric tube postoperatively.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto Western Hospital, Department of Aneshtesia
Toronto, Ontario, M5T2S8
Mount Sinai Hospital, Department of Anesthesia
Toronto, Ontario
About this study
Official title: The Effectiveness of Perioperative CPAP to Reduce the Occurrence of Sleep Apnea Related Adverse Events in Surgical Patients With Obstructive Sleep Apnea
Objective of the study: To determine whether Perioperative Auto-CPAP treatment prevent postoperative worsening of OSA and improve nocturnal oxygen saturation in surgical patients with moderate and severe OSA.
Read the detailed description
The patients will be approached by the study coordinators at the preoperative clinic. If the patient is interested in participating the study, STOP-Bang and Epworth questionnaires will be implemented to determine the risk for OSA.If the patients are classified as high risk of having OSA, they are scheduled for an overnight sleep study at home. The patients with Apnea-Hypopnea Index (AHI)>15 from the sleep study will be randomized into two study groups: Perioperative CPAP group or control group (routine care). In the perioperative CPAP group, patients will be treated with auto-CPAP for 2-3 nights preoperatively and 5 nights postoperatively. All patients will undergo sleep study on the third postoperative night and be monitored by a pulse oximeter for 2-3 nights preoperatively and 5 nights postoperatively.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- auto-titrated CPAP, Control
- Keywords
- Obstructive sleep apnea (OSA), continuous positive airway pressure(CPAP), surgery, anesthesia
- 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.
auto-titrated CPAPDevice
Patients will be treated with auto-CPAP preoperatively for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.
ControlDevice
Patients in this group will receive routine care, undergo sleep study on the third postoperative night and be monitored by a pulse oximeter for oxygen saturation level for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.
| Study group | Role | What they receive |
|---|---|---|
| CPAP Group | Other | CPAP Treatment Receives: Device: auto-titrated CPAP |
| Control Group | Other | Routine care Receives: Device: auto-titrated CPAP; Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index
Apnea-hypopnea index.
Measured: On the third night after surgery
Secondary outcomes (1)
Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90)
Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90).
Measured: 2-3 nights before surgery and 5 nights after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2011
- Study completionOct 2011
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.
- More trials run by University Health Network, TorontoThe 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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frances Chung, University Health Network, Toronto
- Investigators
- Frances Chung, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249924
- Sponsor's protocol ID
- 0000
- Status last verified
- Jul 2012
- First submitted
- 26 Nov 2010
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Perioperative CPAP to Reduce the Occurrence of Sleep Apnea Related Adverse Events in Surgical Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01249924
- Acronym / sponsor ID
- 0000
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- Obstructive sleep apnea (OSA), continuous positive airway pressure(CPAP), surgery, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 Nov 2010 (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.
Objective of the study: To determine whether Perioperative Auto-CPAP treatment prevent postoperative worsening of OSA and improve nocturnal oxygen saturation in surgical patients with moderate and severe OSA.
Detailed description
The patients will be approached by the study coordinators at the preoperative clinic. If the patient is interested in participating the study, STOP-Bang and Epworth questionnaires will be implemented to determine the risk for OSA.If the patients are classified as high risk of having OSA, they are scheduled for an overnight sleep study at home. The patients with Apnea-Hypopnea Index (AHI)>15 from the sleep study will be randomized into two study groups: Perioperative CPAP group or control group (routine care). In the perioperative CPAP group, patients will be treated with auto-CPAP for 2-3 nights preoperatively and 5 nights postoperatively. All patients will undergo sleep study on the third postoperative night and be monitored by a pulse oximeter for 2-3 nights preoperatively and 5 nights postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP Group | Other | Device: auto-titrated CPAPCPAP Treatment |
| Control Group | Other | Device: auto-titrated CPAP, Device: ControlRoutine care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the patients who meet the following criteria will be recruited
- Patients who are scheduled for inpatient surgery that required a minimum of three nights of hospital stay
- Age: >18 and <80 years old.
- Identified as high risk of having OSA or diagnosed with OSA without using CPAP.
Key exclusion criteria (12 listed)
- Undergoing nasal, eye, head/neck surgery, intracranial or cardiac/thoracic surgery.
- Unwilling or unable to give informed consent.
- Currently undergoing treatment for sleep apnea including CPAP.
- Requiring prolonged postoperative ventilation.
- New York Heart Association functional class III and IV.
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 |
|---|---|---|
| auto-titrated CPAPPatients will be treated with auto-CPAP preoperatively for 2-3 nights preoperatively and 5 nights postoperatively during their sleep. | Device | CPAP Group, Control Group |
| ControlPatients in this group will receive routine care, undergo sleep study on the third postoperative night and be monitored by a pulse oximeter for oxygen saturation level for 2-3 nights preoperatively and 5 nights postoperatively during their sleep. | Device | Control Group |
Primary outcome
Apnea-hypopnea index
Time frame: On the third night after surgery
Apnea-hypopnea index.
1 secondary outcome
Nocturnal oxygen desaturation index (ODI) and percentage of time with SaO2<90%(CT90)
Time frame: 2-3 nights before surgery and 5 nights after surgery
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 18 Dec 2013.
Related trials for Obstructive Sleep Apnea (OSA)
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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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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.
Frances Chung, FRCPC principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auto-titrated CPAP in people with Obstructive Sleep Apnea (OSA), run by University Health Network, Toronto at 2 sites 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 4 inclusion and 12 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 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Apnea-hypopnea index (time frame: On the third night after surgery). 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 18 Dec 2013.