Trial Outcomes & Findings for Anti-Snoring Appliances and Airway Manipulation in Patients Undergoing Anesthetic Sedation (NCT NCT05748626)
NCT ID: NCT05748626
Last Updated: 2025-08-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
Through study completion, an average of 1 day
Results posted on
2025-08-14
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anti-Snoring Appliances and Airway Manipulation in Patients Undergoing Anesthetic Sedation
Baseline characteristics by cohort
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
66.5 Years
n=5 Participants
|
63.2 Years
n=7 Participants
|
64.8 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Height (Inches)
|
66.0 Inches
STANDARD_DEVIATION 4.2 • n=5 Participants
|
68.1 Inches
STANDARD_DEVIATION 4.0 • n=7 Participants
|
67 Inches
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Weight (Kilograms)
|
89.3 Kilograms
STANDARD_DEVIATION 19.6 • n=5 Participants
|
90 Kilograms
STANDARD_DEVIATION 18.3 • n=7 Participants
|
89.6 Kilograms
STANDARD_DEVIATION 19.1 • n=5 Participants
|
|
Body Mass Index
|
31.8 (kg) / height (m)^2
STANDARD_DEVIATION 6.9 • n=5 Participants
|
30.0 (kg) / height (m)^2
STANDARD_DEVIATION 5.2 • n=7 Participants
|
30.88 (kg) / height (m)^2
STANDARD_DEVIATION 5.88 • n=5 Participants
|
|
American Society of Anesthesiology Status
ASA 2 Status
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
American Society of Anesthesiology Status
ASA 3 Status
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Documented Mallampati Score
Mallampati Score Class 1
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Documented Mallampati Score
Mallampati Score Class 2
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Documented Mallampati Score
Mallampati Score Class 3
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Documented Mallampati Score
Mallampati Score Class 4
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Documented Obstructive Sleep Apnea
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
STOP Bang Score
|
3.3 Score on Scale (0 low risk -8 high risk)
STANDARD_DEVIATION .8 • n=5 Participants
|
3.0 Score on Scale (0 low risk -8 high risk)
STANDARD_DEVIATION .8 • n=7 Participants
|
3.14 Score on Scale (0 low risk -8 high risk)
STANDARD_DEVIATION .8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 dayCombined 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.
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Combined Total Number of Airway Interventions During an Anesthetic Sedation Case
|
7 Airway Interventions
|
5 Airway Interventions
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayMaximum 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.
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Maximum End-tidal CO2
|
41 mmHG
Standard Deviation 9.4
|
44.4 mmHG
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayNumber of instances the SpO2 drops below 92% during the procedure
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Number of Instances SpO2 Value < 92%
|
.6 Episodes
Standard Deviation .9
|
.1 Episodes
Standard Deviation .3
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayMinimum 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.
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Minimum End-title CO2 in mmHg
|
7 mmHG
Standard Deviation 7.4
|
6.7 mmHG
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayPercent time during the case the SpO2 is below 92% using pulse oximetry.
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Percent Time During the Case the SpO2 is Below 92%
|
.7 Percent of Time
Standard Deviation 1.2
|
.1 Percent of Time
Standard Deviation .3
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayMaximum SpO2 value during the case using pulse oximetry (percent saturated)
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Maximum SpO2 Value During the Case
|
99.9 Percent
Standard Deviation .3
|
99.5 Percent
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayMinimum SpO2 value during the case using pulse oximetry (percent saturation)
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Minimum SpO2 Value During the Case
|
91.3 Percent
Standard Deviation 5.9
|
94.8 Percent
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayMaximum heart rate during case using standard operating room cardiac monitor
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Heart Rate Maximum
|
80.8 Heart Rate (Beats Per Minute)
Standard Deviation 14.3
|
82.5 Heart Rate (Beats Per Minute)
Standard Deviation 15
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayMinimum heart rate during case using standard operating room cardiac monitor
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Heart Rate Minimum
|
53.4 Heart Rate (Beats Per Minute)
Standard Deviation 6.5
|
58.5 Heart Rate (Beats Per Minute)
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayMaximum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor.
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Maximum Systolic Blood Pressure
|
140 mmHG
Standard Deviation 16.9
|
152.2 mmHG
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayMinimum systolic blood pressure (mmHg) using standard operating room blood pressure cuff and monitor.
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Minimum Systolic Blood Pressure
|
88.9 mmHG
Standard Deviation 9.1
|
88.1 mmHG
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayMaximum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Maximum Diastolic Blood Pressure
|
75.3 mmHG
Standard Deviation 14.3
|
77.1 mmHG
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayMinimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Minimum Diastolic Blood Pressure
|
51.2 mmHG
Standard Deviation 5.1
|
53.2 mmHG
Standard Deviation 14.7
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayMean minimum diastolic blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Minimum Mean Blood Pressure
|
65.1 mmHG
Standard Deviation 6.4
|
64.6 mmHG
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 dayMaximum mean blood pressure (mmHG) using standard operating room blood pressure cuff and monitor.
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Maximum Mean Blood Pressure
|
98.4 mmHG
Standard Deviation 12.5
|
104.5 mmHG
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: 1 DayNumber of participants requiring reintubation with an endotracheal tube post surgery in the Post Anesthesia Care Unit
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Reintubation in the Post Anesthesia Care Unit
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 daySurgical length of time in hours.
Outcome measures
| Measure |
Group #1: Anti-snoring Appliance
n=12 Participants
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 Participants
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.
|
|---|---|---|
|
Surgical Length of Time
|
2.5 Hours
Standard Deviation .5
|
2.6 Hours
Standard Deviation .4
|
Adverse Events
Group #1: Anti-snoring Appliance
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group #1: Anti-snoring Appliance
n=12 participants at risk
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.
|
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance
n=13 participants at risk
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • 1 Day
|
0.00%
0/13 • 1 Day
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/12 • 1 Day
|
0.00%
0/13 • 1 Day
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/12 • 1 Day
|
0.00%
0/13 • 1 Day
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/12 • 1 Day
|
0.00%
0/13 • 1 Day
|
|
Respiratory, thoracic and mediastinal disorders
Case converted to general anesthesia
|
0.00%
0/12 • 1 Day
|
0.00%
0/13 • 1 Day
|
|
Cardiac disorders
Rapid Response Team Alerted
|
0.00%
0/12 • 1 Day
|
0.00%
0/13 • 1 Day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place