Obstructive Sleep ApneaNCT03361553
Obstructive Sleep Apnea Airway Evaluation
An observational study of Obstructive Sleep Apnea, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Current practice guidelines recommend obstructive sleep apnea (OSA) patients to stay in the post anesthetic care unit (PACU) until the risk of respiratory depression has subsided. Inevitably, a greater demand on hospital resource utilization in these patients will increase health care cost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jul 2017to 30 Sep 2022
- Phase
- Observational
- 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
Study population: Suspected / Recently diagnosed untreated Obstructive Sleep Apnea (amendment authorized 20/12/2017) / Non-compliant to OSA treatment
Who may be able to join
- age≥18
- ASA physical status I - IV;
- Suspected to have OSA for clinical reasons such as high risk on screening questionnaire i.e., a STOP-Bang score >3, and referred to have a sleep study for OSA diagnosis by the clinical team at any point of care during the perioperative period (such as the clinic using the screening tool, during or after surgery in the ward experiencing recurrent upper airway obstructive events, need for CPAP in the postoperative period and / or suspected to have obstructive airway events). Or;
- Patients who were recently diagnosed to have OSA and underwent a laboratory sleep study within the last year.
- Patients who were recently diagnosed to have OSA but are non-compliant with treatment. Compliance defined as: median nightly CPAP or APAP use > 70% of the nights, and for longer than 4 hours of nightly use during the last 3 months),43 or using oral appliance use (use > 70% of nights, and for longer than 4 hours of nightly use in the last 3 months.
Who cannot join
- failure to understand and provide consent
- past history of oral, head and neck surgery (e.g., OSA corrective surgery)
- active head \& neck disease (e.g., cancer, infection and radiotherapy);
- inability to perform breathing tests per instruction
- Patients currently on treatment for OSA (as this may interfere with the upper airway dimensions and the US assessment may not be accurate)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Novel Clinical Tool to Evaluate Obstructive Sleep Apnea (OSA) with Airway Ultrasound
Current practice guidelines recommend obstructive sleep apnea (OSA) patients to stay in the post anesthetic care unit (PACU) until the risk of respiratory depression has subsided. Inevitably, a greater demand on hospital resource utilization in these patients will increase health care cost. Polysomnography (PSG) and screening questionnaires can identify OSA but they are limited by accessibility and false positive results, respectively. Inaccurate OSA identification misguides postoperative surveillance plan. In contrast with MRI and CT scans, ultrasound is more accessible and more likely a practical tool for OSA screening. However, before clinical application, airway ultrasound (US) exam must undergo vigorous testing to check its utility, accuracy, inter-observer reliability and its ability to identify OSA and its severity.
Read the detailed description
The investigators plan to recruit surgical patients at risk of OSA, exposed to sedatives,and/or general anesthesia. Surface ultrasound measurements will be conducted in a separate setting, and be correlated with the sleep study results, and a set of ultrasound parameters will be validated in this setting. Relevant clinical outcomes will be captured as well.
- Conditions
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of airway parameter measurements with Apnea-Hypopnea Index (AHI) values on Polysomnography (PSG)
The primary study outcome will be the discriminatory performance of each one of the airway parameters, against the OSA status (moderate/severe) as diagnosed by PSG.
Measured: 2 years
Secondary outcomes (1)
Feasibility of airway Ultrasound (US) examination;
- The feasibility and efficiency of completing the US exam and reading the measurements;
- The inter-rater reliability for measuring each one of the airway parameters;
- The statistical association between each airway parameter and OSA severity level (none/mild/moderate/severe);
- The diagnostic accuracy for STOPBang (SB) score (ROC curve, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, negative likelihood ratios, and diagnostic odds ratio (DOR) for different cut off levels);
- The correlation between each one of the airway parameters and the SB score; and
- The benefit of considering airway parameters in addition to SB in a prediction model for OSA.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start20 Jul 2017
- Primary completion30 Jun 2022
- Study completion30 Sep 2022
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Special Surgery, New York
- Responsible party
- Sponsor
- Investigators
- Mandeep Singh, Principal investigator, Department of Anesthesia, Toronto Western Hospital- UHN, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361553
- Sponsor's protocol ID
- 16-6160
- Status last verified
- Dec 2024
- First submitted
- 14 Nov 2017
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Novel Clinical Tool to Evaluate Obstructive Sleep Apnea (OSA) with Airway Ultrasound
- ClinicalTrials.gov ID
- NCT03361553
- Acronym / sponsor ID
- 16-6160
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Hospital for Special Surgery, New York
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 5 Dec 2017 (actual)
- 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.
Current practice guidelines recommend obstructive sleep apnea (OSA) patients to stay in the post anesthetic care unit (PACU) until the risk of respiratory depression has subsided. Inevitably, a greater demand on hospital resource utilization in these patients will increase health care cost. Polysomnography (PSG) and screening questionnaires can identify OSA but they are limited by accessibility and false positive results, respectively. Inaccurate OSA identification misguides postoperative surveillance plan. In contrast with MRI and CT scans, ultrasound is more accessible and more likely a practical tool for OSA screening. However, before clinical application, airway ultrasound (US) exam must undergo vigorous testing to check its utility, accuracy, inter-observer reliability and its ability to identify OSA and its severity.
Detailed description
The investigators plan to recruit surgical patients at risk of OSA, exposed to sedatives,and/or general anesthesia. Surface ultrasound measurements will be conducted in a separate setting, and be correlated with the sleep study results, and a set of ultrasound parameters will be validated in this setting. Relevant clinical outcomes will be captured as well.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected / Recently diagnosed untreated Obstructive Sleep Apnea (amendment authorized 20/12/2017) / Non-compliant to OSA treatment
Key inclusion criteria (5 listed)
- age≥18
- ASA physical status I - IV;
- Suspected to have OSA for clinical reasons such as high risk on screening questionnaire i.e., a STOP-Bang score >3, and referred to have a sleep study for OSA diagnosis by the clinical team at any point of care during the perioperative period (such as the clinic using the screening tool, during or after surgery in the ward experiencing recurrent upper airway obstructive events, need for CPAP in the postoperative period and / or suspected to have obstructive airway events). Or;
- Patients who were recently diagnosed to have OSA and underwent a laboratory sleep study within the last year.
- Patients who were recently diagnosed to have OSA but are non-compliant with treatment. Compliance defined as: median nightly CPAP or APAP use > 70% of the nights, and for longer than 4 hours of nightly use during the last 3 months),43 or using oral appliance use (use > 70% of nights, and for longer than 4 hours of nightly use in the last 3 months.
Key exclusion criteria (5 listed)
- failure to understand and provide consent
- past history of oral, head and neck surgery (e.g., OSA corrective surgery)
- active head \& neck disease (e.g., cancer, infection and radiotherapy);
- inability to perform breathing tests per instruction
- Patients currently on treatment for OSA (as this may interfere with the upper airway dimensions and the US assessment may not be accurate)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of airway parameter measurements with Apnea-Hypopnea Index (AHI) values on Polysomnography (PSG)
Time frame: 2 years
The primary study outcome will be the discriminatory performance of each one of the airway parameters, against the OSA status (moderate/severe) as diagnosed by PSG.
1 secondary outcome
Feasibility of airway Ultrasound (US) examination;
Time frame: 2 years
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 11 Dec 2024.
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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.
Mandeep Singh principal investigator
Department of Anesthesia, Toronto Western Hospital- UHN, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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?
The sponsor lists 5 inclusion and 5 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 11 Dec 2024. 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 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?
Correlation of airway parameter measurements with Apnea-Hypopnea Index (AHI) values on Polysomnography (PSG) (time frame: 2 years). 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 11 Dec 2024.