Airway ObstructionNCT05748626
Anti-Snoring Appliances and Airway Manipulation in Patients Undergoing Anesthetic Sedation
A study testing Anti-snoring device and No anti -snoring device during their procedure. in people with Airway Obstruction and Snoring, run by Northwestern University at 1 site in United States.
Trial summary
Would patients using an anti-snoring appliance intraoperatively require less airway manipulation, interventions, and rescue maneuvers during anesthetic sedation cases compared to those who do not? The investigators will use anti-snoring appliance devices (specifically the FDA approved Zyppah) to attempt to relieve… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Airway Obstruction, Snoring, Sedation Complication
- What is being tested?
- Anti-snoring device and No anti -snoring device during their procedure.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2023to 24 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age 18-89 years old)
- Undergoing procedures below the umbilicus requiring anesthetic sedation without an invasive airway
- a STOP-BANG (survey) score of 2 or greater.
Who cannot join
- Patients who are unable to consent
- Non-English speaking
- Those requiring general anesthesia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital and Prentice Women's Hospital
Chicago, Illinois, 60611
About this study
Official title: Do Anti-Snoring Appliances Reduce the Amount of Airway Manipulation in Patients Undergoing Anesthetic Sedation? A Prospective Randomized Controlled Trial
Would patients using an anti-snoring appliance intraoperatively require less airway manipulation, interventions, and rescue maneuvers during anesthetic sedation cases compared to those who do not? The investigators will use anti-snoring appliance devices (specifically the FDA approved Zyppah) to attempt to relieve tissue obstructions that cause snoring during sleep. The application of the devices to the body is less invasive than other common intraoperative rescue airway devices (e.g. nasal trumpets and oral airways) which are not designed to be patient specific.
- Conditions
- Airway Obstruction, Snoring, Sedation Complication
- Being tested
- Anti-snoring device, No anti -snoring device during their procedure.
- Keywords
- Airway obstruction, Snoring, Monitored Anesthesia Care, Intravenous sedation
- Medical subject headings
- Airway Obstruction, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-snoring deviceDevice
For group 1, the study team will aid the subject in molding and preparing the device in the pre-operative area. They will wear the device throughout the entirety of the case.
No anti -snoring device during their procedure.Procedure or surgery
Also called No intervention
For group 2 there will be no anti snoring device used during the case.
| Study group | Role | What they receive |
|---|---|---|
| Group #1: Anti-snoring appliance | Experimental | Group #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure. Receives: Device: Anti-snoring device |
| Group #2: Control group, that will not utilize anti-snoring appliance | Active comparator | Group #2: Control group, that will not utilize (Zyppah) anti-snoring appliance during their procedure. Receives: Procedure: No anti -snoring device during their procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Total Number of Airway Interventions During an Anesthetic Sedation Case
Combined total number of airway interventions during an anesthetic sedation case - including head tilt/rotation, mandible thrust, chin lift, shoulder lift, neck extension or flexion, tongue pull.
Measured: Through study completion, an average of 1 day
Secondary outcomes (16)
Maximum End-tidal CO2
Maximum end-tidal CO2 using measures the partial pressure or maximal concentration of carbon dioxide (CO2) at the end of an exhaled breath, which is expressed as a percentage of CO2 or mmHg. The normal values are 5% to 6% CO2, which is equivalent to 35-45 mmHg.
Measured: Through study completion, an average of 1 day
Number of Instances SpO2 Value < 92%
Number of instances the SpO2 drops below 92% during the procedure
Measured: Through study completion, an average of 1 day
Minimum End-title CO2 in mmHg
Minimum end-tidal CO2 (capnography) using measures the partial pressure or maximal concentration of carbon dioxide (CO2) at the end of an exhaled breath, which is expressed as a percentage of CO2 or mmHg. The normal values are 5% to 6% CO2, which is equivalent to 35-45 mmHg.
Measured: Through study completion, an average of 1 day
Percent Time During the Case the SpO2 is Below 92%
Percent time during the case the SpO2 is below 92% using pulse oximetry.
Measured: Through study completion, an average of 1 day
Maximum SpO2 Value During the Case
Maximum SpO2 value during the case using pulse oximetry (percent saturated)
Measured: Through study completion, an average of 1 day
Minimum SpO2 Value During the Case
Minimum SpO2 value during the case using pulse oximetry (percent saturation)
Measured: Through study completion, an average of 1 day
Heart Rate Maximum
Maximum heart rate during case using standard operating room cardiac monitor
Measured: Through study completion, an average of 1 day
Heart Rate Minimum
Minimum heart rate during case using standard operating room cardiac monitor
Measured: Through study completion, an average of 1 day
Maximum Systolic Blood Pressure
Maximum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor.
Measured: Through study completion, an average of 1 day
Minimum Systolic Blood Pressure
Minimum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor.
Measured: Through study completion, an average of 1 day
Maximum Diastolic Blood Pressure
Maximum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Measured: Through study completion, an average of 1 day
Minimum Diastolic Blood Pressure
Minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Measured: Through study completion, an average of 1 day
Minimum Mean Blood Pressure
Mean minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Measured: Through study completion, an average of 1 day
Maximum Mean Blood Pressure
Maximum mean blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Measured: Through study completion, an average of 1 day
Reintubation in the Post Anesthesia Care Unit
Number of participants requiring reintubation with an endotracheal tube post surgery in the Post Anesthesia Care Unit
Measured: 1 Day
Surgical Length of Time
Surgical length of time in hours.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start6 Mar 2023
- Primary completion30 Aug 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Model description
- Randomized controlled interventional trial
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahesh Vaidyanathan, Northwestern University
- Investigators
- Mahesh Vaidyanathan, MD,MBA, Principal investigator, Northwestern Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748626
- Sponsor's protocol ID
- STU00218263
- Status last verified
- Jul 2025
- First submitted
- 14 Nov 2022
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lacquiere DA, Hodzovic I, Woollard A, Varvinskiy A, Chishti K, Hughes R. DAS 2015 guidelines for management of CICO. Br J Anaesth. 2016 Oct;117(4):532-533. doi: 10.1093/bja/aew285. No abstract available.
PubMed 28077547
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Anti-Snoring Appliances Reduce the Amount of Airway Manipulation in Patients Undergoing Anesthetic Sedation? A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05748626
- Acronym / sponsor ID
- STU00218263
- Conditions
- Airway Obstruction, Snoring, Sedation Complication
- Keywords
- Airway obstruction, Snoring, Monitored Anesthesia Care, Intravenous sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Posted 14 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Would patients using an anti-snoring appliance intraoperatively require less airway manipulation, interventions, and rescue maneuvers during anesthetic sedation cases compared to those who do not? The investigators will use anti-snoring appliance devices (specifically the FDA approved Zyppah) to attempt to relieve tissue obstructions that cause snoring during sleep. The application of the devices to the body is less invasive than other common intraoperative rescue airway devices (e.g. nasal trumpets and oral airways) which are not designed to be patient specific.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled interventional trial
| Arm | Type | Receives |
|---|---|---|
| Group #1: Anti-snoring appliance | Experimental | Device: Anti-snoring deviceGroup #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure. |
| Group #2: Control group, that will not utilize anti-snoring appliance | Active comparator | Procedure: No anti -snoring device during their procedure.Group #2: Control group, that will not utilize (Zyppah) anti-snoring appliance during their procedure. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age 18-89 years old)
- Undergoing procedures below the umbilicus requiring anesthetic sedation without an invasive airway
- a STOP-BANG (survey) score of 2 or greater.
Key exclusion criteria (3 listed)
- Patients who are unable to consent
- Non-English speaking
- Those requiring general anesthesia.
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 |
|---|---|---|
| Anti-snoring deviceFor group 1, the study team will aid the subject in molding and preparing the device in the pre-operative area. They will wear the device throughout the entirety of the case. | Device | Group #1: Anti-snoring appliance |
| No anti -snoring device during their procedure.Also: No interventionFor group 2 there will be no anti snoring device used during the case. | Procedure or surgery | Group #2: Control group, that will not utilize anti-snoring appliance |
Primary outcome
Combined Total Number of Airway Interventions During an Anesthetic Sedation Case
Time frame: Through study completion, an average of 1 day
Combined total number of airway interventions during an anesthetic sedation case - including head tilt/rotation, mandible thrust, chin lift, shoulder lift, neck extension or flexion, tongue pull.
16 secondary outcomes
Maximum End-tidal CO2
Time frame: Through study completion, an average of 1 day
Number of Instances SpO2 Value < 92%
Time frame: Through study completion, an average of 1 day
Minimum End-title CO2 in mmHg
Time frame: Through study completion, an average of 1 day
Percent Time During the Case the SpO2 is Below 92%
Time frame: Through study completion, an average of 1 day
Maximum SpO2 Value During the Case
Time frame: Through study completion, an average of 1 day
Minimum SpO2 Value During the Case
Time frame: Through study completion, an average of 1 day
Heart Rate Maximum
Time frame: Through study completion, an average of 1 day
Heart Rate Minimum
Time frame: Through study completion, an average of 1 day
Maximum Systolic Blood Pressure
Time frame: Through study completion, an average of 1 day
Minimum Systolic Blood Pressure
Time frame: Through study completion, an average of 1 day
Maximum Diastolic Blood Pressure
Time frame: Through study completion, an average of 1 day
Minimum Diastolic Blood Pressure
Time frame: Through study completion, an average of 1 day
Minimum Mean Blood Pressure
Time frame: Through study completion, an average of 1 day
Maximum Mean Blood Pressure
Time frame: Through study completion, an average of 1 day
Reintubation in the Post Anesthesia Care Unit
Time frame: 1 Day
Surgical Length of Time
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28077547Lacquiere DA, Hodzovic I, Woollard A, Varvinskiy A, Chishti K, Hughes R. DAS 2015 guidelines for management of CICO. Br J Anaesth. 2016 Oct;117(4):532-533. doi: 10.1093/bja/aew285. No abstract available.
- Individual participant dataSharing planned: No
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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.
Mahesh Vaidyanathan, MD,MBA principal investigator
Northwestern Univesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-snoring device and No anti -snoring device during their procedure. in people with Airway Obstruction and Snoring, run by Northwestern University at 1 site in United States.
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 3 inclusion and 3 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 14 Aug 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Combined Total Number of Airway Interventions During an Anesthetic Sedation Case (time frame: Through study completion, an average of 1 day). 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 NCT05748626, which also lists 1 linked publication.
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 14 Aug 2025.