Cardiovascular Endpoints for Obstructive Sleep Apnea With Twelfth Nerve Stimulation (CARDIOSA-12): A Randomized, Sham-Controlled, Double-Blind, Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Mean 24-Hour Systolic Ambulatory Blood Pressure Values
研究概览
简要总结
A new, well-tolerated treatment for obstructive sleep apnea - tongue stimulation - is a device which opens the airway during sleep and can provide treatment for patients unable to use the mask and hose treatment. The study will evaluate the effect of this new treatment on blood pressure and heart-related measures to see if it lowers patients' risk of heart problems.
详细描述
Obstructive sleep apnea, repetitive airway blockage during sleep, affects 1 in 10 Americans. If left untreated, it results in decreased quality of life and increased risk of heart problems. Only half of these people are able to use the main treatment, continuous positive airway pressure (CPAP) therapy, which involves wearing a mask and hose at night. A new, well-tolerated treatment - tongue stimulation - is a device which opens the airway during sleep and can provide treatment for patients unable to use the mask and hose treatment. The study will evaluate the effect of this new treatment on blood pressure and heart-related measures to see if it lowers patients' risk of heart problems.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients recruited into the study will have already been implanted with the Inspire® HGNS device.
- •Additional Inclusion Criteria include:
- •As tolerating the therapeutic level during sleep can take time (weeks to months), all patients must be able to use the device at the therapeutic setting (> 20 hours/week for > 1 month) prior to enrollment, based on compliance data.
- •All patients will be English-speaking and able to give written informed consent.
排除标准
- •Inspire® remote Model 2500 or later is required. Patients with older remotes are not candidates due to limited adherence monitoring capabilities.
- •Patients who have fallen asleep while driving resulting in accident or "near miss" accident within 1 year prior to HGNS implantation.
- •Actively using positive airway pressure (PAP) therapy for treatment of OSA.
- •Patients in whom the difference between sham and therapeutic voltages is less than 30% the therapeutic voltage.
- •Pregnant women will be excluded.*
- •Women of childbearing potential must NOT be pregnant or plan on becoming pregnant. This study involves temporarily stopping treatment of obstructive sleep apnea, which may harm the fetus. If applicable, the patient will need to take a urine pregnancy test after enrollment (prior to washout #1), and again prior to washout #2.
研究组 & 干预措施
Therapeutic HGNS
Therapeutic Hypoglossal Nerve Stimulation (HGNS). Prior to enrollment in this study, the HGNS will have been implanted as part of clinical care, and a therapeutic voltage setting will have been determined via overnight sleep study.
干预措施: Therapeutic HGNS (Device)
Subtherapeutic 'Sham' HGNS
Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice and the average value is used to determine "sham-HGNS". The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds.
干预措施: Subtherapeutic 'Sham' HGNS (Device)
结局指标
主要结局
Mean 24-Hour Systolic Ambulatory Blood Pressure Values
时间窗: Study Week 6, Day 1; study Week 11, Day 1
Patients will undergo 24-hour ambulatory blood pressure testing (ABP) using a noninvasive, portable device. The monitor is programmed to record blood pressure every 30 minutes. The patient will be asked to record bedtime and wake time to corroborate the sleep and wake time from the recorder. Mean 24-hour systolic ambulatory blood pressure values will be calculated.
次要结局
- Mean Peripheral Arterial Stiffness (PAS)(Study Week 6, Day 2; Study Week 11, Day 2)
- Mean 24-Hour Diastolic Ambulatory Blood Pressure Values(Study Week 6, Day 1; study Week 11, Day 1)
- Mean Muscle Sympathetic Nerve Activity (MSNA) Frequency (Bursts/Minute)(Study Week 6, Day 2; Study Week 11, Day 2)
- Mean Muscle Sympathetic Nerve Activity (MSNA) Tonal Activity (Units/Minute)(Study Week 6, Day 2; Study Week 11, Day 2)
- Mean Pre-Ejection Period (PEP)(Study Week 6, Day 2; Study Week 11, Day 2)
- Mean Flow-mediated Dilation (FMD)(Study Week 6, Day 2; Study Week 11, Day 2)
- Mean Nocturnal Systolic and Diastolic Ambulatory Blood Pressure Values(Study Week 6, Day 1; study Week 11, Day 1)
- Mean Psychomotor Vigilance Test (PVT) Reciprocal Reaction Time(Study Week 6, Day 2; Study Week 11, Day 2)
- Mean Digit Symbol Substitution Test (DSST) Reaction Time(Study Week 6, Day 2; Study Week 11, Day 2)
研究者
Raj Dedhia, MD
Associate Professor of Otorhinolaryngology: Head and Neck Surgery
University of Pennsylvania