Pilot Study for Feasibility of Using an Oral Appliance for Decreasing Snoring
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Frequency of Snoring (Snore Lab App, app records snoring through the night)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •. 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-
排除标准
- •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
结局指标
主要结局
Frequency of Snoring (Snore Lab App, app records snoring through the night)
时间窗: 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)
时间窗: Daily up to 15 days
To determine if use of a device to position the tongue forward will decrease the intensity of snoring.
次要结局
- 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))
研究者
David Winslow, Jr., MD, FCCP
Pulmonologist, Staff Physician
Norton Healthcare