Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring

This research study proposes to determine how well tolerated and effective lower and upper oral dental devices are at reducing snoring. The device is designed to move the genioglossus muscle forward, with interior attachment to maintain forward placement of of he tongue on the bottom of the mouth.

Study Overview

• Status: Recruiting
• Conditions: Snoring
• Intervention / Treatment: Device: Delta Dental Oral Device

Detailed Description

This study proposed to determine if the use of an oral device which causes forward positioning of the tongue will decrease the intensity and frequency of snoring as measured by the SnoreLab phone app, evaluate the level of snoring as measured by the bed partner, evaluate tolerance and comfort of the device and evaluate the quality of sleep of the subject by the bed partner.

Subjects will sleep at home using the SnoreLab app to record snoring for five nights and fill out the Snore Outcomes Survey. They will then utilize the lower dental device for five nights recording their snoring. At the end of the five nights of using the lower dental device, the subjects will fill out the comfort and difficulties form with the bed partner completing the Snore Outcomes Survey. If the lower device is tolerated, the process is repeated with the upper device added to the lower device.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy McDonald, BSN; Phone Number: 17787 502-559-5864; Email: Nancy.McDonald@nortonhealthcare.org
• Study Contact Backup: Name: David Winslow, MD; Phone Number: 17773 502-559-5864; Email: David.Winslow@nortonhealthcare.org

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40218
      • Recruiting
      • Norton Clinical Research Group
      • Contact: Nancy McDonald, BSN; Phone Number: 17787 502-559-5864; Email: Nancy.McDonald@nortonhealthcare.org
      • Contact: David Winslow, MD; Phone Number: 17773 502-559-5864; Email: David.Winslow@nortonhealthcare.org
      • Principal Investigator: David H Winslow, MD
      • Principal Investigator: Kevin K Trice, MD, MBA
      • Sub-Investigator: Stephen W Wyatt, DMD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. . Able to provide informed consent
2. Age 18 or older
3. Self-report of snoring problems
4. Has a bed partner that is willing and able to consent as well as answer questions related to partner's snoring both with and without oral device-

Exclusion Criteria:

1. Missing teeth.
2. Respiratory disorders requiring treatment including asthma, COPD
3. Poor dental health including gum disease or loose teeth
4. Dental implants placed within the last three months
5. Temporomandibular joint dysfunction
6. Presence of mouth or jaw pain
7. Bruxism (teeth grinding)
8. Full dentures
9. No bed partner
10. Braces
11. Diagnosed with Obstructive or Central Sleep Apnea, Sleep Apnea
12. Uncontrolled RLS
13. Ongoing or prior use of a dental device
14. Noise in bedroom i.e., fan, bed partner snoring
15. Other medical or sleep issues which will interfere with the device per PI discretion
16. Does not have a smart phone
17. Other medical condition that PI believes will make the patient ineligible for participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Dental Device Arm; Subjects in this single arm study serve as their own control by recording snoring on the SnoreLab device for five days and completing the Snore Outcomes survey. After five nights with now device, the lower dental device is used for five nights and snoring is recorded in the SnoreLab app. At the end of the five nights the subjects complete the Comfort and Difficulties Form and the bed partner completes the Snore Outcomes Survey. If the lower device was tolerated well, the process is repeated with the upper dental device used with the lower device.

Device: Delta Dental Oral Device; The oral device is designed to move the genioglossus forward, with interior attachments to maintain the placement of the tongue on the floor of the mouth forward. In addition, bite plates made of the Ethylene-vinyl acetate (EVA) plastic were fabricated and embedded with the mouthpiece to encourage subjects to bite down and push the tongue under the interior lower attachment. The upper plate is made of the same material and slightly opens the bite to improve oral air flow further. The primary component of the mouthpiece is fabricated with Vistamaxx material, which is semi-crystalline 2mm co-polymer that can be molded by the user with Nurse assistance to provide a custom fit. The subject will be fitted by moistening and heating in a microwave. Tthe research staff member will assist to ensure proper fit with both the lower and upper dental devices. The subject then completes the data collection portion regarding using the SnoreLab app and survey completion as previously described.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of Snoring (Snore Lab App; range from Quiet to Epic snoring, Epic is a worse outcome)	To determine if use of a device to position the tongue forward will decrease the intensity of snoring.	Daily up to 15 days
Frequency of Snoring (Snore Lab App, app records snoring through the night)	To determine if use of a device to position the tongue forward will decrease the frequency of snoring.	Daily up to 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)	Evaluate the level of snoring of the subject by bed partner using approved questionnaire	Day 5 (end of no device use)
Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)	Evaluate the level of snoring of the subject by bed partner using approved questionnaire	Day 10 (end of lower device use)
Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)	Evaluate the level of snoring of the subject by bed partner using approved questionnaire	Day 15 (end of lower and upper device use)
Device Tolerance and Comfort (Tolerance Form)	Subject Evaluation of tolerance and comfort of the oral device by questionnaire	Day 5 (end of no device use)
Device Tolerance and Comfort (Tolerance Form)	Subject Evaluation of tolerance and comfort of the oral device by questionnaire	Day 10 (end of lower device use)
Device Tolerance and Comfort (Tolerance Form)	Subject Evaluation of tolerance and comfort of the oral device by questionnaire	Day 15 (end of lower and upper device use)
Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item) )	Evaluate the quality of sleep of subject by bed partner by questionnaire	Day 5 (end of no device use)
Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)	Evaluate the quality of sleep of subject by bed partner by questionnaire	Day 10 (end of lower device use)
Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)	Evaluate the quality of sleep of subject by bed partner by questionnaire	Day 15 (end of lower and upper device use)

Collaborators and Investigators

• Sponsor: Norton Healthcare
• Collaborators: Delta Dental Foundation
• Investigators: Principal Investigator: David Winslow, MD, Norton Healthcare

Publications and helpful links

General Publications

• Cartwright RD. Alcohol and NREM parasomnias: evidence versus opinions in the international classification of sleep disorders, 3rd edition. J Clin Sleep Med. 2014 Sep 15;10(9):1039-40. doi: 10.5664/jcsm.4050. No abstract available.
• Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015 Jul 15;11(7):773-827. doi: 10.5664/jcsm.4858.
• Gliklich RE, Wang PC. Validation of the snore outcomes survey for patients with sleep-disordered breathing. Arch Otolaryngol Head Neck Surg. 2002 Jul;128(7):819-24. doi: 10.1001/archotol.128.7.819.
• Meira e Cruz M., Cardiovascular Center of University of Lisbon, Lisbon School of Medicine, Lisbon, Portugal; Email: mcruz@medicina.ulisboa.pt
• Cooke ME, Battagel JM. A thermoplastic mandibular advancement device for the management of non-apnoeic snoring: a randomized controlled trial. Eur J Orthod. 2006 Aug;28(4):327-38. doi: 10.1093/ejo/cji122. Epub 2006 Jun 13.
• Deeb R, Judge P, Peterson E, Lin JC, Yaremchuk K. Snoring and carotid artery intima-media thickness. Laryngoscope. 2014 Jun;124(6):1486-91. doi: 10.1002/lary.24527. Epub 2014 Jan 28.
• Johnston CD, Gleadhill IC, Cinnamond MJ, Peden WM. Oral appliances for the management of severe snoring: a randomized controlled trial. Eur J Orthod. 2001 Apr;23(2):127-34. doi: 10.1093/ejo/23.2.127.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring
• Other Study ID Numbers: 20-N0387

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No, this is a limited feasibility study and data will not be generalizable to the public due to small sample size. (n=30)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes