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

NCT05748626 | Completed Results DMC FDA Device

• 1 other identifier: STU00218263
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Obstruction; Snoring; Sedation Complication

Keywords

Airway obstruction; Snoring; Monitored Anesthesia Care; Intravenous sedation

Outcome Measures

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.

  Through study completion, an average of 1 day

Secondary Outcomes (16)

• Maximum End-tidal CO2

  Through study completion, an average of 1 day

• Number of Instances SpO2 Value < 92%

  Through study completion, an average of 1 day

• Minimum End-title CO2 in mmHg

  Through study completion, an average of 1 day

• Percent Time During the Case the SpO2 is Below 92%

  Through study completion, an average of 1 day

• Maximum SpO2 Value During the Case

  Through study completion, an average of 1 day

Study Arms (2)

Group #1: Anti-snoring appliance

EXPERIMENTAL

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

Device: Anti-snoring device

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

ACTIVE COMPARATOR

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

Procedure: No anti -snoring device during their procedure.

Interventions

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.

Group #1: Anti-snoring appliance

No anti -snoring device during their procedure. PROCEDURE

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

Also known as: No intervention

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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital and Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 28077547 RESULT

MeSH Terms

Conditions

Airway Obstruction; Snoring

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Paul C. Fitzgerald, RN, BSN,MS
• Organization: Northwestern University

p-fitzgerald2@northwestern.edu

312-695-1064

Study Officials

• Mahesh Vaidyanathan, MD,MBA

  Northwestern Univesity

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled interventional trial

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: March 1, 2023
• Study Start: March 6, 2023
• Primary Completion: August 30, 2023
• Study Completion: October 24, 2023
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)