Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring
NCT ID: NCT04900285
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-06-01
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
99 Years
ALL
Yes
Sponsors
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Delta Dental Foundation
OTHER
Norton Healthcare
OTHER
Responsible Party
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David Winslow, Jr., MD, FCCP
Pulmonologist, Staff Physician
Principal Investigators
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David Winslow, MD
Role: PRINCIPAL_INVESTIGATOR
Norton Healthcare
Locations
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Norton Clinical Research Group
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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References
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American Academy of Sleep Medicine. International Classification of Sleep Disorders. 3rd ed. Darien, IL: American Academy of Sleep Medicine; 2014.
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: [email protected]
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.
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.
Other Identifiers
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20-N0387
Identifier Type: -
Identifier Source: org_study_id
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