A Study for Obstructive Sleep Apnea Using a New At-Home Sleep Test
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
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Encino、California、美国、91436
- Encino Center for Sleep and TMJ Disorders
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Loose teeth or advanced periodontal disease
- Full dentures
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：AMP测试组
所有个人都将使用自动滴定下颌定位器进行测试。
|
参与者将使用自动滴定下颌定位器进行诊断测试，以确定他们是否有资格使用口腔矫治器治疗阻塞性睡眠呼吸暂停。
该设备通过在参与者睡觉时响应呼吸事件向前移动下颌来工作。
所有参与者都将接受相同的测试。
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Integration of the device into the existing workflow of a dental sleep medicine practice
大体时间：6 months
|
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, time required to prepare device for use.
|
6 months
|
|
Convenience/feasibility of carrying out a multi-night AMP study in the home
大体时间：6 months
|
Participants will complete a questionnaire following their AMP tests to collect data on participants' opinion of the device (includes opinion of various device components, ease of use of the device).
|
6 months
|
|
Feasibility of instructing the participant on the use of the AMP device at the practitioner's office
大体时间：6 months
|
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.
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to therapy
大体时间：6 months
|
Time to therapy will be evaluated by tracking the time from the first consultation at the dentist's office to the setting of the temporary appliance (for individuals whose tests indicate they are predicted candidates for oral appliance therapy).
|
6 months
|
|
Number of study visits
大体时间：6 months
|
The number of study visits will be recorded.
This data will be collected from study records and does not require input from the participant.
|
6 months
|
|
Length of study visits
大体时间：6 months
|
The length of each visit (minutes) will be recorded.
This data will be collected from study records and does not require input from the participant.
|
6 months
|
|
Ease of scheduling study visits
大体时间：6 months
|
The ease of scheduling will be discussed with the study staff to collect data on ease of integration of the device into the practice.
|
6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.