Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of responders
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness, feasibility, and safety of mandibular advancement devices (MAD) for treating severe obstructive sleep apnea (OSA) in patients who are CPAP intolerant and have failed hypoglossal nerve stimulation (HGNS).
详细描述
ROHMA is a pilot/single intervention study aiming to evaluate effectiveness of a mandibular advancement device (MAD) for treating moderate to severe obstructive sleep apnea (OSA) in patients who have failed hypoglossal nerve stimulation therapy (HGNS). Individuals who received a HGNS therapy at Washington University from April 4 2019 to October 20 2024, or were enrolled in a prior study (HRPO #: 202309014) will be recruited for the study.
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
盲法说明
no masking required
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Ability to read, write, speak, and understand English.
- •Failure of hypoglossal nerve stimulation (HGNS) therapy, defined as intolerance to HGNS or insufficient AHI reduction based on modified Sher criteria while using HGNS.
- •Ability to insert and remove the mandibular advancement device (MAD) independently.
- •Ability to complete all study assessments and evaluations, including home sleep apnea tests (HSAT).
- •Ability to abstain from any other treatment for obstructive sleep apnea (OSA) during the entire study duration.
- •Access to an internet-connected device (phone, tablet, or laptop) with a camera.
排除标准
- •Age over 70 years.
- •Inability to use a mandibular advancement device (MAD), defined as having fewer than 9 healthy teeth per dental arch.
- •Prior intolerance to MAD therapy.
- •Previous participation in a trial involving the use of oral appliances.
- •Chronic nasal obstruction.
- •Dependence on or frequent use of medications that alter consciousness, respiration, or alertness.
- •Insomnia and/or use of medications to treat insomnia.
- •Sleep disorders such as narcolepsy, insomnia, restless leg syndrome, or other disorders affecting sleep, and/or use of medications to treat such disorders.
- •Substance abuse.
- •Unstable psychiatric disorders.
- •Current use of a GLP-1 receptor agonist (e.g., Zepbound, Wegovy, Ozempic, Mounjaro) with ongoing, active weight loss at the time of enrollment, or recent dose escalation within the prior 8 weeks.
研究组 & 干预措施
Mandibular Advancement Device (MAD)
This study is experimental. It involves a single-intervention design where participants who have failed hypoglossal nerve stimulation (HGNS) therapy for moderate to severe obstructive sleep apnea (OSA) will be treated with a mandibular advancement device (MAD).
干预措施: Mandibular advancement device (MAD) (Device)
结局指标
主要结局
Proportion of responders
时间窗: through study completion on average 8 weeks
The proportion of responders will be defined as number of participants with more than a 50% reduction in apnea-hypopnea index (AHI) and a final AHI less than 15 (modified Sher criteria) after treatment compared to baseline, divided by the total number of participants treated with mandibular advancement device. The AHI is a standardized index used to diagnose and determine the severity of sleep apnea. AHI will be obtained from a home sleep apnea test completed by the participants and reviewed by a trained sleep neurologist.
次要结局
- Magnitude of change in apnea-hypopnea index (AHI).(through study completion on average 8 weeks)
- Change in Oxygen desaturation index (ODI)(through study completion on average 8 weeks)
- Change in the time spent below oxygen saturation 90%(through study completion on average 8 weeks)
- Changes in the mean arterial oxygen saturation (SaO2)(through study completion on average 8 weeks)
- Adherence to MAD use(through study completion on average 8 weeks)
- Change in Epworth Sleepiness Scale (ESS)(through study completion on average 8 weeks)
- Epworth Sleepiness Scale (ESS) improvement(through study completion on average 8 weeks)
- Symptoms of Nocturnal Obstruction and Related Events (SNORE-25)(through study completion on average 8 weeks)
- Clinical Global Impression of Improvement (CGI-I) Scale(through study completion on average 8 weeks)
研究者
Jay F. Piccirillo, MD
Professor of Otolaryngology
Washington University School of Medicine