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

Not Applicable

• Conditions: Snoring
• Interventions: Device: Delta Dental Oral Device

• Registration Number: NCT04900285
• Lead Sponsor: Norton Healthcare

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.

Study Timeline

• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-25
• Study Start: 2021-06-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dental Device Arm	Delta Dental Oral Device	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Norton Clinical Research Group; 🇺🇸 Louisville, Kentucky, United States