Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Norton Healthcare
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Frequency of Snoring (Snore Lab App, app records snoring through the night)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Dental Device Arm
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.
Intervention: Delta Dental Oral Device (Device)
Outcomes
Primary Outcomes
Frequency of Snoring (Snore Lab App, app records snoring through the night)
Time Frame: 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)
Time Frame: Daily up to 15 days
To determine if use of a device to position the tongue forward will decrease the intensity of snoring.
Secondary Outcomes
- Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)(Day 15 (end of lower and upper device use))
- Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item) )(Day 5 (end of no device use))
- Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)(Day 15 (end of lower and upper device use))
- Device Tolerance and Comfort (Tolerance Form)(Day 15 (end of lower and upper device use))
- Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)(Day 5 (end of no device use))
- Partner Assessment of Snoring (Snore Outcomes Survey, response scale varies per item)(Day 10 (end of lower device use))
- Device Tolerance and Comfort (Tolerance Form)(Day 5 (end of no device use))
- Device Tolerance and Comfort (Tolerance Form)(Day 10 (end of lower device use))
- Quality of Sleep Assessment (Snore Outcomes Survey, response scale varies per item)(Day 10 (end of lower device use))
Investigators
David Winslow, Jr., MD, FCCP
Pulmonologist, Staff Physician
Norton Healthcare