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

NCT04900285 | Unknown FDA Device

• 1 other identifier: 20-N0387
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Snoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)

  Day 5 (end of no device use)

• Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)

  Day 10 (end of lower device use)

• Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)

  Day 15 (end of lower and upper device use)

• Device Tolerance and Comfort (Tolerance Form)

  Day 5 (end of no device use)

• Device Tolerance and Comfort (Tolerance Form)

  Day 10 (end of lower device use)

Study Arms (1)

Dental Device Arm

OTHER

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

Interventions

Delta Dental Oral Device 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.

Dental Device Arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent
• Age 18 or older
• Self-report of snoring problems
• 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-

You may not qualify if:

• Missing teeth.
• Respiratory disorders requiring treatment including asthma, COPD
• Poor dental health including gum disease or loose teeth
• Dental implants placed within the last three months
• Temporomandibular joint dysfunction
• Presence of mouth or jaw pain
• Bruxism (teeth grinding)
• Full dentures
• No bed partner
• Braces
• Diagnosed with Obstructive or Central Sleep Apnea, Sleep Apnea
• Uncontrolled RLS
• Ongoing or prior use of a dental device
• Noise in bedroom i.e., fan, bed partner snoring
• Other medical or sleep issues which will interfere with the device per PI discretion

Sponsors & Collaborators

• Norton Healthcare: lead
• Delta Dental Foundation: collaborator

Study Sites (1)

Norton Clinical Research Group

Louisville, Kentucky, 40218, United States

RECRUITING

Related Publications (7)

• American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.

  BACKGROUND

• 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.

  PMID: 12117343 BACKGROUND

• Meira e Cruz M., Cardiovascular Center of University of Lisbon, Lisbon School of Medicine, Lisbon, Portugal; Email: mcruz@medicina.ulisboa.pt

  BACKGROUND

• 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.

  PMID: 16772315 RESULT

• 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.

  PMID: 24242702 RESULT

• 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.

  PMID: 11398550 RESULT

• 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.

  PMID: 26094920 RESULT

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Winslow, MD

  Norton Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy McDonald, BSN

CONTACT

502-559-5864; Nancy.McDonald@nortonhealthcare.org

David Winslow, MD

CONTACT

502-559-5864; David.Winslow@nortonhealthcare.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonologist, Staff Physician

Model Details: Subject serve as their own control sleeping without the device for five days and recording snoring on the SnoreLab app and filling out the Snore Outcomes Survey. The lower dental device is used for five days while recording snoring. The subject will then complete the Comfort and Difficulties Form and the bed partner completes the Snore Outcomes Survey. The process is repeated with the upper device for those who tolerate the lower device. use.

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 25, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)