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NCT Number: NCT05748626

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

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.

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Key information

Conditions

Airway Obstruction Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Sounds Respiratory Tract Diseases Sedation Complication Signs and Symptoms Signs and Symptoms, Respiratory Snoring

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital and Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Anti-snoring device

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.

No anti -snoring device during their procedure.

Procedure

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

Other names: No intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maximum End-tidal CO2

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

    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.

  2. Number of Instances SpO2 Value < 92%

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

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

  3. Minimum End-title CO2 in mmHg

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

    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.

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

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

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

  5. Maximum SpO2 Value During the Case

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

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

  6. Minimum SpO2 Value During the Case

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

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

  7. Heart Rate Maximum

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

    Maximum heart rate during case using standard operating room cardiac monitor

  8. Heart Rate Minimum

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

    Minimum heart rate during case using standard operating room cardiac monitor

  9. Maximum Systolic Blood Pressure

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

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

  10. Minimum Systolic Blood Pressure

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

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

  11. Maximum Diastolic Blood Pressure

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

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

  12. Minimum Diastolic Blood Pressure

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

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

  13. Minimum Mean Blood Pressure

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

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

  14. Maximum Mean Blood Pressure

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

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

  15. Reintubation in the Post Anesthesia Care Unit

    Time frame: 1 Day

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

  16. Surgical Length of Time

    Time frame: 1 day

    Surgical length of time in hours.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Do Anti-Snoring Appliances Reduce the Amount of Airway Manipulation in Patients Undergoing Anesthetic Sedation? A Prospective Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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