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CompletedNCT05748626Updated Aug 14, 2025Results posted

Anti-Snoring Appliances and Airway Manipulation in Patients Undergoing Anesthetic Sedation

An interventional study of Anti-snoring device and No anti -snoring device during their procedure. in Airway Obstruction, Snoring and Sedation Complication, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by Northwestern University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Airway Obstruction
  • Snoring
  • Sedation Complication

Keywords

  • Airway obstruction
  • Snoring
  • Monitored Anesthesia Care
  • Intravenous sedation
03

In context

Airway Obstruction

147 studies on the registry are indexed under Airway Obstruction; 25 are open to participants now.

This study's enrollment of 25 is below the median of 53 across 92 interventional studies indexed under Airway Obstruction.

Browse Airway Obstruction studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.

Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.

Browse Northwestern University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients who are unable to consent
  • Non-English speaking
  • Those requiring general anesthesia.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Group #1: Anti-snoring appliance

    Group #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure.

    Device: Anti-snoring device

  • Active comparator
    Group #2: Control group, that will not utilize anti-snoring appliance

    Group #2: Control group, that will not utilize (Zyppah) anti-snoring appliance during their procedure.

    Procedure: No anti -snoring device during their procedure.

Interventions

  • DeviceAnti-snoring device

    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.

  • ProcedureNo anti -snoring device during their procedure.

    For group 2 there will be no anti snoring device used during the case.

    Also known as: No intervention

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 1 day

Secondary outcomes

  1. 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.

    Time frame: Through study completion, an average of 1 day

  2. Number of Instances SpO2 Value < 92%

    Number of instances the SpO2 drops below 92% during the procedure

    Time frame: Through study completion, an average of 1 day

  3. 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.

    Time frame: Through study completion, an average of 1 day

  4. Percent Time During the Case the SpO2 is Below 92%

    Percent time during the case the SpO2 is below 92% using pulse oximetry.

    Time frame: Through study completion, an average of 1 day

  5. Maximum SpO2 Value During the Case

    Maximum SpO2 value during the case using pulse oximetry (percent saturated)

    Time frame: Through study completion, an average of 1 day

  6. Minimum SpO2 Value During the Case

    Minimum SpO2 value during the case using pulse oximetry (percent saturation)

    Time frame: Through study completion, an average of 1 day

  7. Heart Rate Maximum

    Maximum heart rate during case using standard operating room cardiac monitor

    Time frame: Through study completion, an average of 1 day

  8. Heart Rate Minimum

    Minimum heart rate during case using standard operating room cardiac monitor

    Time frame: Through study completion, an average of 1 day

  9. Maximum Systolic Blood Pressure

    Maximum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor.

    Time frame: Through study completion, an average of 1 day

  10. Minimum Systolic Blood Pressure

    Minimum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor.

    Time frame: Through study completion, an average of 1 day

  11. Maximum Diastolic Blood Pressure

    Maximum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.

    Time frame: Through study completion, an average of 1 day

  12. Minimum Diastolic Blood Pressure

    Minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.

    Time frame: Through study completion, an average of 1 day

  13. Minimum Mean Blood Pressure

    Mean minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.

    Time frame: Through study completion, an average of 1 day

  14. Maximum Mean Blood Pressure

    Maximum mean blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.

    Time frame: Through study completion, an average of 1 day

  15. Reintubation in the Post Anesthesia Care Unit

    Number of participants requiring reintubation with an endotracheal tube post surgery in the Post Anesthesia Care Unit

    Time frame: 1 Day

  16. Surgical Length of Time

    Surgical length of time in hours.

    Time frame: 1 day

07

Results

Posted Aug 14, 2025

Participant flow

Participant flow — Overall Study
MilestoneGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Started1213
Completed1213
Not completed00

Outcome measures

PrimaryCombined 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.

Time frame:
Through study completion, an average of 1 day
Reported as:
Number · Airway Interventions
Combined Total Number of Airway Interventions During an Anesthetic Sedation Case
Airway InterventionsGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Combined Total Number of Airway Interventions During an Anesthetic Sedation Case75
SecondaryMaximum 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.

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · mmHG
Maximum End-tidal CO2
mmHGGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Maximum End-tidal CO241 ± 9.444.4 ± 5.5
SecondaryNumber of Instances SpO2 Value < 92%

Number of instances the SpO2 drops below 92% during the procedure

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · Episodes
Number of Instances SpO2 Value < 92%
EpisodesGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Number of Instances SpO2 Value < 92%.6 ± .9.1 ± .3
SecondaryMinimum 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.

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · mmHG
Minimum End-title CO2 in mmHg
mmHGGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Minimum End-title CO2 in mmHg7 ± 7.46.7 ± 5.0
SecondaryPercent Time During the Case the SpO2 is Below 92%

Percent time during the case the SpO2 is below 92% using pulse oximetry.

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · Percent of Time
Percent Time During the Case the SpO2 is Below 92%
Percent of TimeGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Percent Time During the Case the SpO2 is Below 92%.7 ± 1.2.1 ± .3
SecondaryMaximum SpO2 Value During the Case

Maximum SpO2 value during the case using pulse oximetry (percent saturated)

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · Percent
Maximum SpO2 Value During the Case
PercentGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Maximum SpO2 Value During the Case99.9 ± .399.5 ± 1.7
SecondaryMinimum SpO2 Value During the Case

Minimum SpO2 value during the case using pulse oximetry (percent saturation)

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · Percent
Minimum SpO2 Value During the Case
PercentGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Minimum SpO2 Value During the Case91.3 ± 5.994.8 ± 3.0
SecondaryHeart Rate Maximum

Maximum heart rate during case using standard operating room cardiac monitor

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · Heart Rate (Beats Per Minute)
Heart Rate Maximum
Heart Rate (Beats Per Minute)Group #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Heart Rate Maximum80.8 ± 14.382.5 ± 15
SecondaryHeart Rate Minimum

Minimum heart rate during case using standard operating room cardiac monitor

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · Heart Rate (Beats Per Minute)
Heart Rate Minimum
Heart Rate (Beats Per Minute)Group #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Heart Rate Minimum53.4 ± 6.558.5 ± 11.1
SecondaryMaximum Systolic Blood Pressure

Maximum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor.

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · mmHG
Maximum Systolic Blood Pressure
mmHGGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Maximum Systolic Blood Pressure140 ± 16.9152.2 ± 21.7
SecondaryMinimum Systolic Blood Pressure

Minimum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor.

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · mmHG
Minimum Systolic Blood Pressure
mmHGGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Minimum Systolic Blood Pressure88.9 ± 9.188.1 ± 13.7
SecondaryMaximum Diastolic Blood Pressure

Maximum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · mmHG
Maximum Diastolic Blood Pressure
mmHGGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Maximum Diastolic Blood Pressure75.3 ± 14.377.1 ± 8.7
SecondaryMinimum Diastolic Blood Pressure

Minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · mmHG
Minimum Diastolic Blood Pressure
mmHGGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Minimum Diastolic Blood Pressure51.2 ± 5.153.2 ± 14.7
SecondaryMinimum Mean Blood Pressure

Mean minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · mmHG
Minimum Mean Blood Pressure
mmHGGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Minimum Mean Blood Pressure65.1 ± 6.464.6 ± 9.2
SecondaryMaximum Mean Blood Pressure

Maximum mean blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.

Time frame:
Through study completion, an average of 1 day
Reported as:
Mean · mmHG
Maximum Mean Blood Pressure
mmHGGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Maximum Mean Blood Pressure98.4 ± 12.5104.5 ± 15.6
SecondaryReintubation in the Post Anesthesia Care Unit

Number of participants requiring reintubation with an endotracheal tube post surgery in the Post Anesthesia Care Unit

Time frame:
1 Day
Reported as:
Count of participants · Participants
Reintubation in the Post Anesthesia Care Unit
ParticipantsGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Reintubation in the Post Anesthesia Care Unit00
SecondarySurgical Length of Time

Surgical length of time in hours.

Time frame:
1 day
Reported as:
Mean · Hours
Surgical Length of Time
HoursGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Surgical Length of Time2.5 ± .52.6 ± .4

Adverse events

Collected over 1 Day. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group #1: Anti-snoring Appliance0/12 (0%)0/12 (0%)1/12 (8.3%)
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance0/13 (0%)0/13 (0%)0/13 (0%)
Most frequent other events
Most frequent other events
EventGroup #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring Appliance
CoughRespiratory, thoracic and mediastinal disorders1/120/13
BronchospasmRespiratory, thoracic and mediastinal disorders0/120/13
RegurgitationGastrointestinal disorders0/120/13
AspirationRespiratory, thoracic and mediastinal disorders0/120/13
Case converted to general anesthesiaRespiratory, thoracic and mediastinal disorders0/120/13
Rapid Response Team AlertedCardiac disorders0/120/13

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring ApplianceTotal
<=18 years000
Between 18 and 65 years5914
>=65 years7411
Age, Continuous
Age, Continuous(Years)Group #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring ApplianceTotal
Median66.5 (38 to 84)63.2 (50 to 80)64.8 (38 to 84)
Sex: Female, Male
Sex: Female, Male(Participants)Group #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring ApplianceTotal
Female61016
Male639
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring ApplianceTotal
Hispanic or Latino202
Not Hispanic or Latino101323
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Group #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring ApplianceTotal
United States121325
Height (Inches)
Height (Inches)(Inches)Group #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring ApplianceTotal
Mean66.0 ± 4.268.1 ± 4.067 ± 4.5
Weight (Kilograms)
Weight (Kilograms)(Kilograms)Group #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring ApplianceTotal
Mean89.3 ± 19.690 ± 18.389.6 ± 19.1
Body Mass Index
Body Mass Index((kg) / height (m)^2)Group #1: Anti-snoring ApplianceGroup #2: Control Group, That Will Not Utilize Anti-snoring ApplianceTotal
Mean31.8 ± 6.930.0 ± 5.230.88 ± 5.88

4 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Northwestern Memorial Hospital and Prentice Women's Hospital
    Chicago, Illinois 60611, United States
09

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Aug 2023, 5 months.

Results were first posted in Aug 2025, 1 year 11 months after primary completion.

Of 36 non-industry interventional studies with no phase under Airway Obstruction, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 37. This study's 5 months is below that.

Counting every sponsor, half of 44 studies reached it within 16 months; a quarter within 3 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2022
First posted
Mar 1, 2023
StartActual
Mar 6, 2023
Primary completionActual
Aug 30, 2023
CompletionActual
Oct 24, 2023
Results first posted
Aug 14, 2025
Last update
Aug 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05748626
Lead sponsor
Northwestern University
Responsible party
Mahesh Vaidyanathan (Principal Investigator, Northwestern University) — Principal investigator
First posted
Mar 1, 2023
Start date
Mar 6, 2023
Primary completion
Aug 30, 2023
Completion
Oct 24, 2023
Results posted
Aug 14, 2025
Last update
Aug 14, 2025

Study contacts

Mahesh Vaidyanathan, MD,MBA
principal investigator · Northwestern Univesity

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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