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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05748626

Enrollment

Registered

2023-03-01

Start date

2023-03-06

Completion date

2023-10-24

Last updated

2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Obstruction, Sedation Complication, Snoring

Keywords

Airway obstruction, Snoring, Monitored Anesthesia Care, Intravenous sedation

Brief 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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized controlled interventional trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Combined Total Number of Airway Interventions During an Anesthetic Sedation Case	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

Measure	Time frame	Description
Number of Instances SpO2 Value < 92%	Through study completion, an average of 1 day	Number of instances the SpO2 drops below 92% during the procedure
Minimum End-title CO2 in mmHg	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.
Percent Time During the Case the SpO2 is Below 92%	Through study completion, an average of 1 day	Percent time during the case the SpO2 is below 92% using pulse oximetry.
Maximum SpO2 Value During the Case	Through study completion, an average of 1 day	Maximum SpO2 value during the case using pulse oximetry (percent saturated)
Minimum SpO2 Value During the Case	Through study completion, an average of 1 day	Minimum SpO2 value during the case using pulse oximetry (percent saturation)
Heart Rate Maximum	Through study completion, an average of 1 day	Maximum heart rate during case using standard operating room cardiac monitor
Heart Rate Minimum	Through study completion, an average of 1 day	Minimum heart rate during case using standard operating room cardiac monitor
Maximum End-tidal CO2	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.
Minimum Systolic Blood Pressure	Through study completion, an average of 1 day	Minimum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor.
Maximum Diastolic Blood Pressure	Through study completion, an average of 1 day	Maximum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Minimum Diastolic Blood Pressure	Through study completion, an average of 1 day	Minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Minimum Mean Blood Pressure	Through study completion, an average of 1 day	Mean minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Maximum Mean Blood Pressure	Through study completion, an average of 1 day	Maximum mean blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Reintubation in the Post Anesthesia Care Unit	1 Day	Number of participants requiring reintubation with an endotracheal tube post surgery in the Post Anesthesia Care Unit
Surgical Length of Time	1 day	Surgical length of time in hours.
Maximum Systolic Blood Pressure	Through study completion, an average of 1 day	Maximum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Group #1: Anti-snoring Appliance Group #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure. Anti-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.	12
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. No anti -snoring device during their procedure.: For group 2 there will be no anti snoring device used during the case.	13
Total	25

Baseline characteristics

Characteristic	Group #1: Anti-snoring Appliance	Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	7 Participants	4 Participants	11 Participants
Age, Categorical Between 18 and 65 years	5 Participants	9 Participants	14 Participants
Age, Continuous	66.5 Years	63.2 Years	64.8 Years
American Society of Anesthesiology Status ASA 2 Status	9 Participants	5 Participants	14 Participants
American Society of Anesthesiology Status ASA 3 Status	3 Participants	8 Participants	11 Participants
Body Mass Index	31.8 (kg) / height (m)^2 STANDARD_DEVIATION 6.9	30.0 (kg) / height (m)^2 STANDARD_DEVIATION 5.2	30.88 (kg) / height (m)^2 STANDARD_DEVIATION 5.88
Documented Mallampati Score Mallampati Score Class 1	2 Participants	5 Participants	7 Participants
Documented Mallampati Score Mallampati Score Class 2	5 Participants	4 Participants	9 Participants
Documented Mallampati Score Mallampati Score Class 3	4 Participants	3 Participants	7 Participants
Documented Mallampati Score Mallampati Score Class 4	1 Participants	1 Participants	2 Participants
Documented Obstructive Sleep Apnea	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	0 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants	13 Participants	23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Height (Inches)	66.0 Inches STANDARD_DEVIATION 4.2	68.1 Inches STANDARD_DEVIATION 4	67 Inches STANDARD_DEVIATION 4.5
Region of Enrollment United States	12 participants	13 participants	25 participants
Sex: Female, Male Female	6 Participants	10 Participants	16 Participants
Sex: Female, Male Male	6 Participants	3 Participants	9 Participants
STOP Bang Score	3.3 Score on Scale (0 low risk -8 high risk) STANDARD_DEVIATION 0.8	3.0 Score on Scale (0 low risk -8 high risk) STANDARD_DEVIATION 0.8	3.14 Score on Scale (0 low risk -8 high risk) STANDARD_DEVIATION 0.8
Weight (Kilograms)	89.3 Kilograms STANDARD_DEVIATION 19.6	90 Kilograms STANDARD_DEVIATION 18.3	89.6 Kilograms STANDARD_DEVIATION 19.1

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 12	0 / 13
other Total, other adverse events	1 / 12	0 / 13
serious Total, serious adverse events	0 / 12	0 / 13

Outcome results

Primary

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.