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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
30
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.
Norton Clinical Research Group
Louisville, Kentucky, United States
RECRUITINGIntensity 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.
Time frame: 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.
Time frame: Daily up to 15 days
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 15 (end of lower and upper device use)