Obstructive Sleep ApneaNCT01852305
Obstructive Sleep Apnea in Bariatric Surgical Patients
A study testing Lab Sleep Study Group and Oximetry in people with Obstructive Sleep Apnea, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Purpose: The purpose of this study is to develop a novel pathway to decrease the cost and waiting time to manage bariatric surgical patients with obstructive sleep apnea. Hypotheses: Compared to the current perioperative pathway, the proposed novel pathway incorporating overnight oximetry and perioperative sleep apnea… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Lab Sleep Study Group and Oximetry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Apr 2021
- 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
Inclusion/Exclusion criteria: The patients who meet the following criteria will be recruited.
- Patients undergoing bariatric surgery with American Society of Anaesthesiologists (ASA) score 1-4 will be approached.
- The patients with any of the following conditions will be excluded:
- Unable or not willing to give an informed consent;
- Potential problems with EEG;
- Patients with diagnosed OSA.
- Patients having sleep study before.
- Age: < 18 years having sleep study before. -
Trial locations and contacts
1 site in 1 country.
Canada1 site
399 Bathurst St.,Toronto Western Hopsital, Preadmission Clinic, Dept. of Anesthesia
Toronto, Ontario, M5T2S8
About this study
Official title: Would A New Pathway Managing Obstructive Sleep Apnea in Bariatric Surgical Patients Be Safe and Cost-effective?
Purpose:
The purpose of this study is to develop a novel pathway to decrease the cost and waiting time to manage bariatric surgical patients with obstructive sleep apnea.
Read more
Hypotheses:
Compared to the current perioperative pathway, the proposed novel pathway incorporating overnight oximetry and perioperative sleep apnea precautions is safe and more cost effective for evaluating and managing obstructive sleep apnea in the bariatric surgical patients.
To decrease the cost and waiting time, we proposed a novel perioperative pathway to manage obstructive sleep apnea in the bariatric patients. In this pathway, the patient will be screened by the STOP-Bang questionnaire. The recruited patients will be randomized into two groups:
The STOP-Bang questionnaire score is ≥4 then you will be assigned to any one of these groups
- sleep study group (group 1) or
- oximetry group (group 2).
Read the detailed description
The potential patients will be screened by the STOP-Bang questionnaire. Those with a score ≥4 will be randomized into Sleep Study group or Oximetry group. The patients in the Sleep Study group will be referred to a sleep medicine specialist who is part of the Bariatric Surgery Psychosocial Program. In the Sleep Study group, patients will undergo sleep studies overnight in a sleep laboratory. At the same time, they will also wear the oximeter wristwatch to measure overnight oximetry. Depending on the sleep study results and medical history, a decision will be made regarding therapeutic options. If the patient has severe sleep apnea (AHI>30) or moderate sleep apnea (AHI>15 to <30) with significant co-morbidities (e.g. cardiovascular disease, diabetes), CPAP treatment will be recommended. For mild sleep apnea (AHI>5 to <15) or moderate sleep apnea without significant co-morbidities, CPAP will not be required. If patient is not able to tolerate or refuses CPAP, dental device and positional therapy will be recommended.
The patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI>10 events/hour will be referred to the sleep medicine specialist. Since the patients with ODI>10 had a high probability 69%) to have moderate and severe OSA. A split- night PSG will be employed to confirm OSA diagnosis and to titrate CPAP with in patients with ODI>10. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night. Compared to Sleep Study group, only one night instead of two nights of sleep studies is needed in patients with ODI>10 events/hour. The patients with ODI ≤ 10 events/h will undergo surgery with routine care plus sleep apnea perioperative precautions.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Lab Sleep Study Group, Oximetry
- Keywords
- Obstructive sleep apnea, Continuous positive airway pressure (CPAP), Oximetry, Bariatric Surgery, Anesthesia, Oxygen desaturation index (ODI)
- 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.
Lab Sleep Study GroupOther
Also called Lab polysomnography study
Patients in this group will under go lab sleep study overnight at the sleep clinic.If the patient has severe sleep apnea (AHI>30) or moderate sleep apnea (AHI>15 to <30) with significant co-morbidities (e.g. cardiovascular disease, diabetes), CPAP treatment will be recommended. For mild sleep apnea (AHI>5 to <15) or moderate sleep apnea without significant co-morbidities, CPAP will not be required. If patient is not able to tolerate or refuses CPAP, dental device and positional therapy will be recommended.
OximetryDevice
Also called oximeter/group 2
The patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI>10 events/hour will be referred to the sleep medicine specialist.A split- night PSG will be employed to confirm OSA diagnosis. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night
| Study group | Role | What they receive |
|---|---|---|
| Lab Sleep Study (group 1) | Experimental | The patients in the Sleep Study group will be referred to a sleep medicine specialist who is part of the Bariatric Surgery Psychosocial Program. In the Sleep Study group, patients will undergo sleep studies overnight in a sleep laboratory. At the same time, they will also wear the oximeter wristwatch to measure overnight oximetry. Receives: Other: Lab Sleep Study Group |
| Oximetry group (group 2) | Active comparator | The patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI>10 events/hour will be referred to the sleep medicine specialist.A split- night polysomnography(PSG) will be employed to confirm obstructive sleep apnea OSA) diagnosis. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night. Receives: Device: Oximetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average cost for obstructive sleep apnea management
The average cost for obstructive sleep apnea management during the period from the initial assessment visit to 30 days after surgery.
Measured: 30 days after surgery
The incidence of postoperative adverse events
The composite incidence of postoperative adverse events
Measured: 30 days after surfery
Secondary outcomes (1)
Number of visits to the health care professionals
The secondary outcomes will be the number of visits to MDs, emergency and the length of hospital stay within the same period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2021
- Study completionApr 2021
Why it stopped: due to lack resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Unity Health Toronto, Michael Garron Hospital
- Responsible party
- Principal investigator, Dr. Frances Chung, University Health Network, Toronto
- Investigators
- Frances Chung, MBBS FRCPC, Principal investigator, University Health Network,University of TorontoDavid Mazer, MD, Principal investigator, St. Michael's Hospital, University of TorontoJames Kulchyk, MD, Principal investigator, Toronto East General Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852305
- Sponsor's protocol ID
- 27/2/2013
- Status last verified
- Apr 2021
- First submitted
- 29 Apr 2013
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Would A New Pathway Managing Obstructive Sleep Apnea in Bariatric Surgical Patients Be Safe and Cost-effective?
- ClinicalTrials.gov ID
- NCT01852305
- Acronym / sponsor ID
- 27/2/2013
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, Continuous positive airway pressure (CPAP), Oximetry, Bariatric Surgery, Anesthesia, Oxygen desaturation index (ODI)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to lack resources
- Enrolment
- 316 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Unity Health Toronto, Michael Garron Hospital
- Study start
- Apr 2013
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 13 May 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.
Purpose:
The purpose of this study is to develop a novel pathway to decrease the cost and waiting time to manage bariatric surgical patients with obstructive sleep apnea.
Hypotheses:
Compared to the current perioperative pathway, the proposed novel pathway incorporating overnight oximetry and perioperative sleep apnea precautions is safe and more cost effective for evaluating and managing obstructive sleep apnea in the bariatric surgical patients.
To decrease the cost and waiting time, we proposed a novel perioperative pathway to manage obstructive sleep apnea in the bariatric patients. In this pathway, the patient will be screened by the STOP-Bang questionnaire. The recruited patients will be randomized into two groups:
The STOP-Bang questionnaire score is ≥4 then you will be assigned to any one of these groups
- sleep study group (group 1) or
- oximetry group (group 2).
Detailed description
The potential patients will be screened by the STOP-Bang questionnaire. Those with a score ≥4 will be randomized into Sleep Study group or Oximetry group. The patients in the Sleep Study group will be referred to a sleep medicine specialist who is part of the Bariatric Surgery Psychosocial Program. In the Sleep Study group, patients will undergo sleep studies overnight in a sleep laboratory. At the same time, they will also wear the oximeter wristwatch to measure overnight oximetry. Depending on the sleep study results and medical history, a decision will be made regarding therapeutic options. If the patient has severe sleep apnea (AHI>30) or moderate sleep apnea (AHI>15 to <30) with significant co-morbidities (e.g. cardiovascular disease, diabetes), CPAP treatment will be recommended. For mild sleep apnea (AHI>5 to <15) or moderate sleep apnea without significant co-morbidities, CPAP will not be required. If patient is not able to tolerate or refuses CPAP, dental device and positional therapy will be recommended.
The patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI>10 events/hour will be referred to the sleep medicine specialist. Since the patients with ODI>10 had a high probability 69%) to have moderate and severe OSA. A split- night PSG will be employed to confirm OSA diagnosis and to titrate CPAP with in patients with ODI>10. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night. Compared to Sleep Study group, only one night instead of two nights of sleep studies is needed in patients with ODI>10 events/hour. The patients with ODI ≤ 10 events/h will undergo surgery with routine care plus sleep apnea perioperative precautions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lab Sleep Study (group 1) | Experimental | Other: Lab Sleep Study GroupThe patients in the Sleep Study group will be referred to a sleep medicine specialist who is part of the Bariatric Surgery Psychosocial Program. In the Sleep Study group, patients will undergo sleep studies overnight in a sleep laboratory. At the same time, they will also wear the oximeter wristwatch to measure overnight oximetry. |
| Oximetry group (group 2) | Active comparator | Device: OximetryThe patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI>10 events/hour will be referred to the sleep medicine specialist.A split- night polysomnography(PSG) will be employed to confirm obstructive sleep apnea OSA) diagnosis. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Lab Sleep Study GroupAlso: Lab polysomnography studyPatients in this group will under go lab sleep study overnight at the sleep clinic.If the patient has severe sleep apnea (AHI>30) or moderate sleep apnea (AHI>15 to <30) with significant co-morbidities (e.g. cardiovascular disease, diabetes), CPAP treatment will be recommended. For mild sleep apnea (AHI>5 to <15) or moderate sleep apnea without significant co-morbidities, CPAP will not be required. If patient is not able to tolerate or refuses CPAP, dental device and positional therapy will be recommended. | Other | Lab Sleep Study (group 1) |
| OximetryAlso: oximeter/group 2The patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI>10 events/hour will be referred to the sleep medicine specialist.A split- night PSG will be employed to confirm OSA diagnosis. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night | Device | Oximetry group (group 2) |
Primary outcome
The average cost for obstructive sleep apnea management
Time frame: 30 days after surgery
The average cost for obstructive sleep apnea management during the period from the initial assessment visit to 30 days after surgery.
The incidence of postoperative adverse events
Time frame: 30 days after surfery
The composite incidence of postoperative adverse events
1 secondary outcome
Number of visits to the health care professionals
Time frame: 1 year
Results and safety
The study was stopped early (reason given: due to lack resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
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)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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, MBBS FRCPC principal investigator
University Health Network,University of Toronto
David Mazer, MD principal investigator
St. Michael's Hospital, University of Toronto
James Kulchyk, MD principal investigator
Toronto East General Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lab Sleep Study Group and Oximetry in people with Obstructive Sleep Apnea, run by University Health Network, Toronto 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?
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 28 Apr 2021. 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: due to lack resources). 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?
The average cost for obstructive sleep apnea management (time frame: 30 days after surgery). The study lists 2 primary outcomes in all. 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 28 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.