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

Northwestern University

Status: Completed

Conditions: Snoring; Sedation Complication; Airway Obstruction

Treatments: Procedure: No anti -snoring device during their procedure.; Device: Anti-snoring device

Study type: Interventional

Funder types: Other

Identifiers

NCT05748626

STU00218263

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

Group #1: Anti-snoring appliance

Experimental group

Description:

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

Treatment:

Device: Anti-snoring device

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

Active Comparator group

Description:

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

Treatment:

Procedure: No anti -snoring device during their procedure.