Do Anti-Snoring Appliances Reduce the Amount of Airway Manipulation in Patients Undergoing Anesthetic Sedation? A Prospective Randomized Controlled Trial
Phase: NA
Conditions: Airway Obstruction, Snoring, Sedation Complication
Sponsor: Northwestern University

 
 
 
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PROTOCOL TITLE: Do Anti-Snoring Appliances Reduce the Amount of Airway 
Manipulation in Patients Undergoing Anesthetic Sedation? A Prospective Randomized 
Controlled Trial 
 
 
PRINCIPAL INVESTIGATOR: 
Mahesh Vaidyanathan, M.D. 
Department of Anesthesiology 
(312) 695-2500 
mahesh.vaidyanathan@northwestern.edu 
 
 
VERSION DATE: 1.0  January 30, 2023 
  
STUDY SUMMARY: 
 
Investigational Agent(s)  
(Drugs or Devices) 
Anti-snoring Appliances including: Zyppah 
IND / IDE / HDE #  Zyppah FDA #K182312  
 
Indicate 
Special Population(s) 
Children  
 Children who are wards of the state  
 Adults Unable to Consent   
 Cognitively Impaired Adults  
 Neonates of Uncertain Viability  
 Pregnant Women  
 Prisoners (or other detained/paroled individuals)  
 Students/Employees  
Sample Size 28 
Funding Source TBD 
Indicate the type of 
consent to be obtained 
Written  
Verbal/Waiver of Documentation of Informed 
Consent 
Waiver of HIPAA Authorization  
Waiver/Alteration of Consent Process   
Site 
 Lead Site (For A Multiple Site Research Study) 
 Data Coordinating Center (DCC) 
Research Related 
Radiation Exposure 
Yes  
 No  
DSMB / DMC / IDMC 
Yes  
No 
 
 
 
 
 

 
 
 
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OBJECTIVES: 
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?  
 
Null Hypothesis: 
There is no difference in the number of airway manipulations, interventions, and rescue 
maneuvers during anesthetic sedation procedures when an anti-snoring appliance is 
used.  
  
BACKGROUND:  
Surgical cases requiring sedation by an anesthesia provider, also known as monitored 
anesthesia care (MAC), are a popular choice for outpatient surgical procedures with 
benefits of “less physiologic disturbance and a more rapid recovery than general 
anesthesia” (Das 2015). However, MAC cases still come with risk: per the American 
Society of Anesthesiologists closed claim database, “the most common malpractice 
claim is inadequate oxygenation/ventilation, with more than 80% of claims of this nature 
resulting in brain damage or death” (McMurray 2020). Since 1908, anesthesia providers 
have been utilizing interventional airway devices that manipulate the soft tissues of the 
nasopharynx, oropharynx, and hypopharynx to relieve obstruction to support patient 
ventilation and oxygenation; however, there are few studies that directly compare the 
efficacy & side effect profiles between these devices (Matioc 2019). Additionally, a 
recent survey indicates that many anesthesia providers desire an alternative airway 
intervention device than the current ones most commonly used in current practice 
(McMurray 2020). We will examine the possibility of using at-home, over-the-counter 
anti-snoring devices as an intraoperative airway device.  
 
STUDY ENDPOINTS: 
PRIMARY ENDPOINT: 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 ENDPOINTS:  
- Satisfaction of Anesthetist via survey 
- Maximum/minimum end-tidal CO2 
- # of times SpO2 value < 92% 
- % of time during the case SpO2 < 92% 
- maximum/minimum SpO2 value 
- EKG analysis that were not recorded as “Normal Sinus rhythm”: 
- Heart rate maximum & minimum 
- maximum/minimum Systolic, diastolic, and mean blood pressure 
- Total dose and type of hypnotic & narcotic given 
- Case type 
- Case duration 
- Baseline characteristics (Age, Gender, BMI) 

 
 
 
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- Time spent in Phase 2 PACU Recovery 
- Adverse events (i.e. regurgitation and aspiration, bronchospasm, cough, case 
converted to GA) 
 
 
STUDY INTERVENTION(S) / INVESTIGATIONAL AGENT(S): 
We 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.  
 
We will be purchasing the device from the manufacturer’s website. We will be 
purchasing the devices via funds awarded by the James E. Eckenhoff Residents’ 
Research Award. 
 
The device will be stored in the PI’s key-locked office, until it is given to a research team 
member to be given to a subject after recruitment and prior to their procedure. Research 
personnel will bring the appliance to the preoperative holding area & will help mold it for 
the patient, and will insert it prior to transport to the operating suite. The device will 
remain in place until the completion of procedure, unless the anesthesia provider in the 
room feels it needs to be removed for any reason. The patient or anesthesia personnel 
can remove the device at their leisure after completion of the procedure. 
 
PROCEDURES INVOLVED: 
The study participants will be recruited into two groups: patients wearing an anti-snoring 
appliance device during an anesthetic sedation procedure; and those who do not wear 
an anti-snoring device. To ensure anesthetic providers have easy access to the 
patient’s airway for standard of care manipulation (if needed), the patients eligible for 
this study would be those who are undergoing procedures bellow the umbilicus (e.g. 
gynecological, urological, orthopedic, etc.) in addition to having a STOP-BANG score of 
2 or greater. This will ensure patient safety and provide a wide demographic of potential 
subjects to increase the generalizability of the study.  
 
For both patient groups, the study procedure is the same. Eligible patients will be 
identified by chart review of various elements of the electronic medical record, as 
follows: 
 
Patients will be identified and be seen by the study team in the pre-operative clinic on 
17th floor Lavin and in the  holding area to interview individuals who are to undergo 
eligible anesthetic sedation procedures as above. If the patient agrees to participate in 
the study, they will be randomized at that time to one of the two groups (anti-snoring 
appliance device to be used for procedure or not). 
 
The groups in the prospective, randomized, controlled trial in patients undergoing 
anesthetic sedation procedures will be as follows: 

 
 
 
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Group #1: Anti-snoring appliance (Zyppah) that will be utilized during their procedure 
Group #2: Control group, that will not utilize anti-snoring appliance 
 
Participants will be randomized to treatment groups based on a random computer-
generated (https://www.randomizer.org). Anesthesia providers will not be blinded to 
randomization, and research personnel will observe the procedure to collect all outcome 
measures in this study. 
 
For group 1, the study team will aid them in molding and preparing the device in the pre-
operative area. Anesthesia providers will be instructed on how the device works and 
when to place it (with aid from the research team) in addition to receiving a question and 
answer sheet and protocol they can follow to take with them to the operating room. Prior 
to the administration of anesthetic medications, the patient will be aided in inserting the 
device, and wear it throughout the entirety of the case. Regardless of the group, from 
the start of sedation until the patient leaves the procedure suite. When an anesthesia 
provider believes they make a clinically significant airway intervention (either via jaw lift, 
head turning, etc.) they will be instructed to use the “mark now” icon in the anesthetic 
record and utilize the free text to indicate what intervention was done and why.  
 
All standard practices and standard monitors for anesthetic sedation cases will be 
utilized.  
 
A post-survey will be administered to anesthesia providers in group 1 to gauge 
satisfaction. 
 
Anesthetic record will be reviewed by research team members following the end of the 
case.  
 
DATA AND SPECIMEN BANKING 
We will collect data including reason for procedure, type of procedure, and patient 
demographics (including medical history, sex, age, and weight); in addition to data 
collected via electronic chart review including: Documented Obstructive Sleep Apnea 
(OSA), date of procedure, surgical case length, anesthesia type requested, anesthesia 
type documented, Provider team staff composition, documented neuraxial or nerve 
block procedure (if applicable), “in room” time, max/min heart rate,  min/max  oxygen 
saturation, number of instance oxygen saturation fell below 92%, % of time during case 
where oxygen saturation was below 92%, min/max end tidal CO2, min/max blood 
pressure, total dose of hypnotic & narcotic given, “out of room” time, adverse events 
noted in charting, free-text written by providers, and total hospital length of stay.  
 
 
SHARING RESULTS WITH PARTICIPANTS 
Results will not be shared with participants.  
 
STUDY TIMELINES 

 
 
 
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Individual subjects and anesthetic providers will participate in the study for the duration 
of their procedure requiring anesthetic sedation. It will take approximately 3 months to 
enroll participants and approximately 3 months to perform data analysis.  
 
INCLUSION AND EXCLUSION CRITERIA 
Inclusion criteria  
Adult patients (age 18-89 years old)  
 
Undergoing procedures below the umbilicus requiring anesthetic sedation without an 
invasive airway  
  
STOP-BANG score of 2 or greater. 
 
English or Spanish language speaking 
 
Exclusion criteria  
Patients requiring general anesthesia. 
 
Sleep apnea 
 
Serious breathing or respiratory disorders such as COPD, asthma, emphysema 
 
Poor dental health including severe gum disease, loose teeth, abscess, mouth sores, 
bleeding gums 
 
Dental implant place within last 3 months 
 
TMJ disorder 
 
Mouth or jaw pain  
 
Full dentures 
 
Wear braces  
 
Sleep with CPAP or other devices 
 
Other special populations (individuals who are not yet adults, prisoners, vulnerable 
populations, pregnant) will also be excluded. 
 
 
VULNERABLE POPULATIONS:  
Will not be a part of study.  
 
PARTICIPANT POPULATION(S) 

 
 
 
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Accrual 
Number: 
Category/Group: 
(Adults/Children 
Special/Vulnerable 
Populations) 
Consented: 
Maximum Number to be 
Consented or 
Reviewed/Collected/Screen
ed 
Enrolled: 
Number to 
Complete the 
Study or Needed 
to Address the 
Research 
Question 
Local 
Adults 
28 
28 
 
 
 
Study-wide 
 
28 
24 
 
 
 
Total: 
 
28 
24 
 
 
RECRUITMENT METHODS 
Patients undergoing an eligible procedure requiring anesthetic sedation will be identified 
by the anesthesiology team by chart review and the schedule in the pre-operative clinic 
on the 17th floor Lavin pavilion prior to their procedure. They may also be approached 
by the research team the morning of their procedure for possible enrollment into the 
study.  If the potiental subject is interested in the study a study team member will ask for 
the subject’s email address to send an Econsent using REDCap for their review.  
 
The source of participants will be NMH pavilions (Galter, Feinberg, Lavin) in addition to 
Prentice Women’s Hospital. 
 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES 
There will be no compensation for participation; however, patients who are randomized 
into one of the anti-snoring device groups will be allowed to keep the device, if they 
wish.  
 
WITHDRAWAL OF PARTICIPANTS 
Patients can withdraw from the study at any time and their data will be deleted, and in 
no way will this impact their care since the study explicitly does not affect the standard 
of care. The study team will notify the PI by secure NM or NU email if a subject 
withdraws from the study. 
 
RISKS TO PARTICIPANTS 
No significant risk to the patient exists with the utilization of an anti-snoring device. The 
devices are non-invasive and can be easily removed by the patient or anesthesia 
provider, if needed. There is the potential for damage to loose teeth, gums or tongue 
since this is a moldable mouth guard. There is the potential for loss of confidentiality 
even with strict measures in place to prevent occurrence.  
 

 
 
 
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POTENTIAL BENEFITS TO PARTICIPANTS 
If functional, the participants may benefit from utilization of an anti-snoring device by 
reducing snoring and airway obstruction; which would lead to improved sleep and less 
fatigue. It may also prevent the use of more invasive rescue airway devices that can 
cause patient discomfort including damage to the lips, teeth, gums, tongue, naso- and 
oropharynx.  
 
DATA MANAGEMENT AND CONFIDENTIALITY 
Data Statistics: 
Preparation: In previous studies looking at patient satisfaction for snoring relief, 570 
participants were analyzed with one of the anti-snoring devices resulting in a statistically 
significant benefit. However, there are currently no large published studies that analyze 
the use of an anti-snoring devices in the setting of MAC anesthesia. Additionally, there 
are no large studies comparing the efficacy of traditional invasive airway rescue devices 
(e.g. oral/nasal airways). 
 
We utilized a study by Qiansong Xiao et al titled “Comparison of Nasopharyngeal 
Airway Device and Nasal Oxygen Tube in Obese Patients Undergoing Intravenous 
Anesthesia for Gastroscopy: A Prospective and Randomized Study”, which compared 
the oxygen saturation levels in patients who did or did not have an invasive 
nasopharyngeal airway at the beginning of the anesthetic sedation procedure, to 
perform our power analysis. 260 patients were included and randomized; with 3 patients 
excluded due to failure of the nasopharyngeal airway. Based on the differences in 
“change in SpO2” and “raising the mandible” between their test and control groups, and 
power analysis was completed with an alpha value of 0.05 and power value of 80%. 
The n per group that was calculated to provide the appropriate power to identify a 
statistical difference was 12 patients per study group. To compensate for patients in our 
study being less obese we increased the number per group to 14 subjects. We plan to 
approach 28 subjects and randomize 28 patients to 2 groups, allowing for patients who 
may not end up getting their procedure or instances where data collection is incomplete 
or absent. 
 
Statistical analysis: Data will be compared between all groups using paired t-test with p< 
0.05 required to reject the null hypothesis. 
 
Data Security: 
All collected data will be stored in REDcap using NM password protected computers for 
data entry. Data in REDcap is backed up nightly using NM servers which are only 
accessible to the NM IT administrator. Paper documents generated during the study  
will be stored in Arkes Pavilion 10th floor Department of Anesthesiology locked research 
cabinet. Data both paper and electronic will be destroyed 5 years after the completion of 
the study using current department policy and approved vendors.  
 
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF 
PARTICIPANTS N/A 

 
 
 
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PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS 
Patients in this study undergoing a procedure under anesthetic sedation can be 
stressful. If a subject does not feel comfortable with participating, they will have the 
option to opt out at any time and it will not impact their care if they choose to do so. 
 
Research staff will interact with anesthesia providers on two occasions (at the beginning 
for ~10 minutes in the pre-operative area and end of procedure for ~5 minutes in the 
post-operative care area), staff will interact with participants for ~30 minutes prior to the 
procedure in the pre-operative area in addition to helping mold the mouthpiece. 
 
COMPENSATION FOR RESEARCH-RELATED INJURY 
n/a 
 
ECONOMIC BURDEN TO PARTICIPANTS 
There is no cost to the patient to be in this study. The device is being paid for by the 
Department of Anesthesiology. 
 
CONSENT PROCESS 
Introduction of the study to the potential participant and consent will take place in 
Northwestern Hospital’s Lavin Anesthesia Pre-Operative Clinic. The potential participant 
will then be sent a consent document from REDcap which includes the electronic 
consent document for their review.  If the potential participant consents one of the study 
team members will contact them to discuss the day of surgery planThe participant will 
receive instructions on acquisition and preparation of the device, in addition to 
instructions on bringing it to the day of their procedure. REDcap electronic consent will 
be utilized to decrease the number of times the paper consent would be touched.  
Multiple times throughout the process, the participant will be reminded that this in no 
way affects their standard of care and that participation can be withdrawn at any time. 
 
NON-ENGLISH SPEAKING PARTICIPANTS  
While we do not anticipate non-English speaking participants on this study, if a non-
English speaking patient would benefit from enrollment in this study, the investigator will 
adhere to the IRB's standard requirements for non-English speaking participants.  
  
This includes providing the IRB the following in a timely fashion: 
• Certified translations of all documents the participant will be required to complete 
(such as surveys and questionnaires); 
• A qualified translation service will be used to translate patient facing documents and 
consent forms 
 
• Certified translations of the modified consent document in a language understandable 
to the non-English speaking participant if the English version of the approved consent 
document undergoes subsequent modification; 
 

 
 
 
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• All patient-facing documents, including consent forms, will be translated into the 
patient’s preferred language.  Any modified patient facing document or consent form will 
be translated by a qualified translation service, submitted to the IRB for approval, and 
presented to the patient with a translator present to communicate the changes to the 
patient and to translate any questions the patient might have, in the patient’s preferred 
language.  
 
• Ongoing communication with the participant will be in a language understandable to 
the participant 
 
• Northwestern Medicine Interpretation services will be contacted by calling (312) 926-
2521.  Face to face interpretation or video remote interpreting (VRI) will be scheduled 
via NM. This offers remote access to an interpreter via an iPad. 
 
• A qualified translator will be available to translate the consent and any other patient 
facing document in his or her preferred language.  The translator will communicate all 
questions to the study team member who is obtaining the patient’s consent.  
 
• A translator will be available for the entire duration of their participation on the study to 
translate any questions/requests from the participant to the study team and from the 
study team to the participant.  
 
Northwestern Medicine Interpretation services will be contacted by calling (312) 926-
2521.  Face to face interpretation or video remote interpreting (VRI) will be scheduled 
via NM. This offers remote access to an interpreter via an iPad. 
. 
WAIVER OR ALTERATION OF CONSENT PROCESS  
n/a  
 
PROTECTED HEALTH INFORMATION (PHI AND HIPAA) 
- Will a HIPAA Authorization be obtained from for all participants? Yes 
- Name 
- Age (years) 
- Date of procedure 
- Telephone numbers 
- Medical Record Numbers 
- Email address 
 
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE 
The PI has 10 plus years clinical research experience.  Northwestern Medical Center 
cares for thousands of patients who undergo anesthetic sedation procedures each year. 
The research team includes 2 resident physicians and a research assistant on the 
anesthesia care team who will assist the PI during the study period. 
 
MULTI-SITE OR COLLABORATIVE RESEARCH: 
n/a