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

Snoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04900285
• Other study ID #: 20-N0387
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2022
• Source: Norton Healthcare
• Contact: Nancy McDonald, BSN
• Phone: 502-559-5864
• Email: Nancy.McDonald[@]nortonhealthcare.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Snoring

Intervention

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.

Locations

Country	Name	City	State
United States	Norton Clinical Research Group	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Norton Healthcare	Delta Dental Foundation

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. Epub 2006 Jun 13. — View 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. — View 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. — View 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. — View Citation

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

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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)