NCT05748626

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

Completed NA Results posted Last updated 14 August 2025

What this trial tests

NA trial testing Anti-snoring device in Airway Obstruction in 25 participants. Completed in 24 October 2023.

Timeline

6 March 2023

Primary endpoint
30 August 2023

24 October 2023

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	6 March 2023
Primary completion	30 August 2023
Estimated completion	24 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Anti-snoring device
• No anti -snoring device during their procedure.

Conditions studied

• Airway Obstruction — all drugs for Airway Obstruction →
• Snoring — all drugs for Snoring →
• Sedation Complication — all drugs for Sedation Complication →

Sponsor

Northwestern University

Who can join

Adults 18 to 89, any sex, with Airway Obstruction or Snoring. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Combined Total Number of Airway Interventions During an Anesthetic Sedation Case Primary · 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.

Group	Value	95% CI
Group #1: Anti-snoring Appliance	7
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	5

Maximum End-tidal CO2 Secondary · 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.

Group	Value	95% CI
Group #1: Anti-snoring Appliance	41	± 9.4
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	44.4	± 5.5

Number of Instances SpO2 Value < 92% Secondary · Through study completion, an average of 1 day

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

Group	Value	95% CI
Group #1: Anti-snoring Appliance	.6	± .9
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	.1	± .3

Minimum End-title CO2 in mmHg Secondary · 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.

Group	Value	95% CI
Group #1: Anti-snoring Appliance	7	± 7.4
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	6.7	± 5.0

Percent Time During the Case the SpO2 is Below 92% Secondary · Through study completion, an average of 1 day

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

Group	Value	95% CI
Group #1: Anti-snoring Appliance	.7	± 1.2
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	.1	± .3

Maximum SpO2 Value During the Case Secondary · Through study completion, an average of 1 day

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

Group	Value	95% CI
Group #1: Anti-snoring Appliance	99.9	± .3
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	99.5	± 1.7

Minimum SpO2 Value During the Case Secondary · Through study completion, an average of 1 day

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

Group	Value	95% CI
Group #1: Anti-snoring Appliance	91.3	± 5.9
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	94.8	± 3.0

Heart Rate Maximum Secondary · Through study completion, an average of 1 day

Maximum heart rate during case using standard operating room cardiac monitor

Group	Value	95% CI
Group #1: Anti-snoring Appliance	80.8	± 14.3
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	82.5	± 15

Heart Rate Minimum Secondary · Through study completion, an average of 1 day

Minimum heart rate during case using standard operating room cardiac monitor

Group	Value	95% CI
Group #1: Anti-snoring Appliance	53.4	± 6.5
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	58.5	± 11.1

Maximum Systolic Blood Pressure Secondary · Through study completion, an average of 1 day

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

Group	Value	95% CI
Group #1: Anti-snoring Appliance	140	± 16.9
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	152.2	± 21.7

Minimum Systolic Blood Pressure Secondary · Through study completion, an average of 1 day

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

Group	Value	95% CI
Group #1: Anti-snoring Appliance	88.9	± 9.1
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	88.1	± 13.7

Maximum Diastolic Blood Pressure Secondary · Through study completion, an average of 1 day

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

Group	Value	95% CI
Group #1: Anti-snoring Appliance	75.3	± 14.3
Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance	77.1	± 8.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 Day. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group #1: Anti-snoring Appliance

Serious: 0/12 (0%)

Deaths: 0/12

Group #2: Control Group, That Will Not Utilize Anti-snoring Appliance

Serious: 0/13 (0%)

Deaths: 0/13

Other adverse events (6 terms — click to expand)

Reaction	System	Group #1: Anti-snoring App…	Group #2: Control Group, T…
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Bronchospasm	Respiratory, thoracic and mediastinal disorders	—	—
Regurgitation	Gastrointestinal disorders	—	—
Aspiration	Respiratory, thoracic and mediastinal disorders	—	—
Case converted to general anesthesia	Respiratory, thoracic and mediastinal disorders	—	—
Rapid Response Team Alerted	Cardiac disorders	—	—

Data from ClinicalTrials.gov NCT05748626 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.