Workflow Validation of an In-home Auto-titrating Mandibular Positioner
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Integration of the device into the existing workflow of a dental sleep medicine practice
研究概览
简要总结
The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance therapy and provide feedback on usability of the device.
详细描述
One treatment for obstructive sleep apnea is oral appliance therapy during sleep, in which an appliance that covers the upper and lower teeth acts to pull the lower jaw forward, opening the throat passage and allowing for normal breathing. However, oral appliance therapy does not treat sleep apnea effectively in all individuals. In order to identify those individuals for whom oral appliance therapy will work, the study sponsor has developed an investigational device called an auto-titrating mandibular positioner. The device automatically pulls the lower jaw forward in response to respiratory events while the individual sleeps. Study participants will learn the outcome of their sleep tests and will provide feedback on the ease of use of the 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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 18 years of age
- •Participant has been deemed suitable for oral appliance therapy
- •Prescription for oral appliance
- •Adequate range of motion
- •Adequate dentition
- •Ability to understand and provide informed consent
- •Ability and willingness to meet the required schedule
排除标准
- •Loose teeth or advanced periodontal disease
- •Full dentures or dental implants
研究组 & 干预措施
AMP test group
All individuals will undergo a test using the auto-titrating mandibular positioner.
干预措施: Auto-titrating mandibular positioner test (Device)
结局指标
主要结局
Integration of the device into the existing workflow of a dental sleep medicine practice
时间窗: 1 year
Data for this outcome are largely directed at the study staff, not study participants. Data collected for this outcome include: time required to evaluate eligibility for device use, prepare device for use, and ease of scheduling of study visits
Feasibility of instructing the participant on the use of the AMP device at the practitioner's office
时间窗: 1 year
Data for this outcome are directed at study staff, not study participants. Data collected will include feedback on ease of training participants on device use. Participants will be asked if they felt they received adequate training from the study staff via a questionnaire.
Convenience and feasibility of carrying out a multi-night AMP study in the home
时间窗: 1 year
Participants will complete a questionnaire following their AMP tests to collect data on ease of use of the device and opinion of the various device components.
次要结局
- Number of study visits(1 year)
- Time to treatment(1 year)
- Length of study visits(1 year)