Clinical trial NCT04900285: Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring
Official title: Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Snoring
Lead sponsor: Norton Healthcare
Sponsor class: OTHER
Collaborators: name: Delta Dental Foundation
First posted: 2021-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intensity of Snoring (Snore Lab App; range from Quiet to Epic snoring, Epic is a worse outcome)
timeFrame: Daily up to 15 days
measure: Frequency of Snoring (Snore Lab App, app records snoring through the night)
timeFrame: Daily up to 15 days
Secondary outcomes:
measure: Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)
timeFrame: Day 5 (end of no device use)
measure: Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)
timeFrame: Day 10 (end of lower device use)
measure: Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)
timeFrame: Day 15 (end of lower and upper device use)
measure: Device Tolerance and Comfort (Tolerance Form)
timeFrame: Day 5 (end of no device use)
measure: Device Tolerance and Comfort (Tolerance Form)
timeFrame: Day 10 (end of lower device use)
measure: Device Tolerance and Comfort (Tolerance Form)
timeFrame: Day 15 (end of lower and upper device use)
measure: Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item) )
timeFrame: Day 5 (end of no device use)
measure: Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)
timeFrame: Day 10 (end of lower device use)
measure: Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)
timeFrame: Day 15 (end of lower and upper device use)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Clinical Research Group
state: Kentucky
Study officials:
affiliation: Norton Healthcare
name: David Winslow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.
citation: 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.
citation: Meira e Cruz M., Cardiovascular Center of University of Lisbon, Lisbon School of Medicine, Lisbon, Portugal; Email: mcruz@medicina.ulisboa.pt
citation: 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.
citation: 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.
citation: 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.
citation: 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.