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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Snoring

Intervention / Treatment
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* Device: Delta Dental Oral Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: . 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- Exclusion Criteria: 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 Does not have a smart phone Other medical condition that PI believes will make the patient ineligible for participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dental Device Arm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) |