Home-Based Under-Mattress Monitoring Device to Estimate Mandibular Advancement in Oral Appliance Therapy for Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in apnea-hypopnea index (AHI).
研究概览
简要总结
The aim of the study is to evaluate the effectiveness of the under-mattress monitoring device to aid in the titration process of a mandibular advancement device (MAD) for the management of obstructive sleep apnea (OSA). A secondary aim is to evaluate changes in subjective OSA symptoms and patient's satisfaction with MAD. A third aim is to analyze if there are differences between the sleep parameters recorded by the under-mattress monitor between responders and non-responders to MAD therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Obstructive Sleep Apnea demonstrated with a sleep study polysomnography or home sleep study (PSG or HSAT), manually scored by a sleep physician according to the 2017 American Academy of Sleep medicine scoring guidelines.
- •Willingness to commute to the OFP clinic every 2 weeks during MAD titration period.
- •Consent to partake in the study.
排除标准
- •Diagnosis of central or mixed sleep apnea.
- •Neurocognitive disease.
- •Concomitant therapy with PAP therapy.
- •Allergic to the appliance material (Polyamide 12).
- •Presence of active dental decay, ill-fitting dental restorations, or crown to root ratio unfavorable.
- •Inadequate English language comprehension.
- •Lack of coordination or dexterity to insert/remove the MAD intraorally.
- •Inability to tolerate digital dental impressions.
- •Patients with concomitant diagnosed sleep disorders, including narcolepsy, restless leg syndrome, rapid eye movement sleep behavior disorder).
研究组 & 干预措施
Panthera DSAD mandibular advancement device users
Participants of the study that have been referred to the Orofacial Pain Clinic by their sleep physician for the management of their obstructive sleep apnea with a mandibular advancement device.
干预措施: Under-mattress monitor (Device)
Panthera DSAD mandibular advancement device users
Participants of the study that have been referred to the Orofacial Pain Clinic by their sleep physician for the management of their obstructive sleep apnea with a mandibular advancement device.
干预措施: level 3 Home Sleep Apnea Test (Device)
Panthera DSAD mandibular advancement device users
Participants of the study that have been referred to the Orofacial Pain Clinic by their sleep physician for the management of their obstructive sleep apnea with a mandibular advancement device.
干预措施: Mandibular Advancement Device (MAD) (Device)
结局指标
主要结局
Change in apnea-hypopnea index (AHI).
时间窗: Baseline and post-intervention (approximately 12 weeks)
Number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea, (5\< normal, 5-15 Mild, 15-30 moderate, \<30 severe)
Change in minimum oxygen desaturation level
时间窗: Baseline and post-intervention (approximately 12 weeks)
The minimum O2 level percentage during treatment
次要结局
- Change in Epworth Sleepiness Scale(Baseline and post-intervention (approximately 12 weeks))
- Change in Quality of Life Scale(Baseline and post-intervention (approximately 12 weeks))
- Change in Fatigue Assessment Scale(Baseline and post-intervention (approximately 12 weeks))
- Change in Pittsburgh Sleep Quality Index (PSQI)(Baseline and post-intervention (approximately 12 weeks))
- Change in Snore Outcomes Survey (SOS)(Baseline and post-intervention (approximately 12 weeks))
- Short Assessment of Patient Satisfaction(Post Intervention, approximately week 12)
研究者
Isabel Moreno Hay
Associate Professor
University of Kentucky