Cardiometabolic Risk Effects of Short-term Cessation of Effective Neurostimulation Therapy in OSA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Free living energy expenditure
研究概览
简要总结
Hypoglossal nerve stimulation (HGNS) is an implantable therapy that treats obstructive sleep apnea.
The study will evaluate the effect of this treatment on cardiovascular and metabolism-related measures to see if it affects patients' risk of medical problems associated with obstructive sleep apnea (OSA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •English-speaking adults (18+ years) who have met surgical efficacy criteria with HGNS, as defined by at least a 50% reduction in apnea-hypopnea index (AHI) to <20 (with hypopneas defined by 4% oxyhemoglobin desaturations)
- •Have been using HGNS therapy for at least 3 months and used HGNS for >20 hours/week during the past 4 weeks
- •Were not using any OSA therapy for at least one month prior to HGNS activation or have had a one-month period of untreated OSA after HGNS activation
排除标准
- •Chronic use of opiate medications, illicit drugs, or alcohol dependency
- •Women who are pregnant or planning to become pregnant
- •Shift workers, heavy machinery operators, or commercial drivers
- •History of severe excessive daytime sleepiness (Epworth Sleepiness Scale score >16 at time of screening or prior to HGNS), motor vehicle accidents or near-miss incidents due to drowsy driving within the year prior to enrollment
- •Significant cardiopulmonary (such as home oxygen requirement), liver, renal, or oncologic disease; neurodegenerative disease; active or recent history of an eating disorder (within the last 5 years)
- •Inability to provide informed consent
研究组 & 干预措施
Therapeutic HGNS (HGNS-on)
Prior to enrollment in this study, participants will have been implanted with and stabilized on HGNS therapy. As part of clinical care, a therapeutic voltage setting will have been confirmed via overnight sleep study. This arm of the study maintains the participants on the HGNS therapy at the therapeutic voltage they have been using. This is a representation of the patient's baseline status.
No HGNS therapy (HGNS-off)
HGNS therapy will be turned off by the participant for this arm of the study. This arm will mimic the participant's untreated OSA statement before they had HGNS therapy activated.
干预措施: No HGNS therapy (HGNS-off) (Device)
结局指标
主要结局
Free living energy expenditure
时间窗: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off)
The investigators will measure energy expenditure using the doubly labeled water (DLW) technique and actigraphy.
Free living energy expenditure
时间窗: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off)
The investigators will measure energy expenditure using the doubly labeled water (DLW) technique and actigraphy.
Hypoxic burden
时间窗: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off).
The investigators will measure hypoxic burden based on the home sleep testing obtained during the study.
次要结局
- Insulin resistance(These measures will be taken at the end of each study phase (duration of 2-4 weeks))
研究者
Yi Cai
Director of Sleep Surgery
Columbia University