Snoring
Conditions
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.
Interventions
DEVICEDelta 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.
Sponsors
Delta Dental Foundation
Norton Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item) | Day 5 (end of no device use) | Evaluate the level of snoring of the subject by bed partner using approved questionnaire |
| Device Tolerance and Comfort (Tolerance Form) | Day 5 (end of no device use) | Subject Evaluation of tolerance and comfort of the oral device by 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 10 (end of lower device use) | Evaluate the quality of sleep of subject by bed partner by questionnaire |
Countries
United States
Contacts
Primary ContactNancy McDonald, BSN
Backup ContactDavid Winslow, MD
Outcome results
None listed