Characterizing Mechanisms of Upper Airway Obstruction During Drug-Induced Sleep Endoscopy (DISE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Amax
研究概览
简要总结
The current study is designed to examine underlying mechanisms of action of lingual muscles in the maintenance of airway patency during sleep. The investigators' major hypothesis is that specific tongue muscles are responsible for relieving upper airway obstruction during sleep.
详细描述
Obstructive sleep apnea (OSA) is characterized by recurrent upper airway obstruction due to inadequate muscle tone during sleep leading to nocturnal hypercapnia, repeated oxyhemoglobin desaturations and arousals. Continuous positive airway pressure (CPAP) is the therapeutic mainstay for OSA, but adherence remains poor. The loss of motor input to the tongue during sleep has been implicated as a cause for upper airway collapse. Activation of tongue muscles with implanted hypoglossal nerve stimulators is an effective therapy for some OSA patients. Nevertheless, approximately 1/3 of OSA patients did not respond to hypoglossal nerve stimulation despite rigorous selection criteria, leaving large segments of CPAP intolerant patients at risk for OSA-related morbidity. Thus, there is a critical knowledge gap in the role of lingual muscle activity in the maintenance of airway patency.
The current study is designed to examine underlying mechanisms of action of lingual muscles in the maintenance of airway patency during sleep. The investigators' major hypothesis is that specific tongue muscles are responsible for relieving upper airway obstruction during sleep. To address this hypothesis, the investigators will (1) selectively stimulate specific lingual muscle groups (viz., protrudors and retractors) and measure effects on airway patency during Drug Induced Sleep Endoscopy (DISE). The investigators will (2) correlate responses in patency to alterations in tongue morphology (as assessed with ultrasound imaging). The investigators will (3) examine the impact of anatomic factors (e.g., the size of the maxillo-mandibular enclosure) on airway responses to stimulation. Patients will (4) undergo magnetic resonance imaging (MRI) determine the extent to which maxillo-mandibular size and tongue size and fat content compress pharyngeal structures. The investigators will (5) assess apnea severity and hypoglossal nerve stimulation with Inspire to measure response to therapy via split-night PSGs. The investigators will (6) examine digital morphometrics to quantify pharyngeal anatomy. A final goal is to (7) measure tongue force, as tongue force measurements may elucidate mechanisms of therapy response as related to neuromuscular control.
The study will contain two distinct pathways, Study A and Study B, in order to efficiently execute the protocol. Study A will focus primarily on measurements obtained as part of routine clinical care. Study B will focus on enhanced imaging and physiology techniques in patients using lingual muscle stimulation (Inspire).
*As of 6/11/2021, the target recruitment for Study A was completed*
Study A:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Participants and investigators are aware of intervention status.
入排标准
- 年龄范围
- 22 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults (≥ 22yrs)
- •Implanted with the MRI-conditional Inspire hypoglossal nerve stimulator (Model 3028 or later)
- •Compliant with Inspire therapy (> 20 hours/week over 2+ weeks) as a standalone treatment for sleep-disordered breathing
- •Inspire remote model 2500 or later
排除标准
- •MRI contraindications (claustrophobia, ferromagnetic implants, foreign bodies, etc)
- •Inspire Implant Model 3024
- •Inspire Remote Model 3032
- •Patients who have fallen asleep while driving resulting in an accident or "near miss" accident within 1 year prior to device implantation
- •Inability to sleep in the supine position (by self-report)
- •History of severe difficulty initiating or maintaining sleep in the laboratory
- •Pregnant women
研究组 & 干预措施
Lingual Muscle Stimulation Patients
DISE
干预措施: Lingual Muscle Stimulation (Device)
Lingual Muscle Stimulation Patients
DISE
干预措施: Mandibular advancement (Other)
Lingual Muscle Stimulation Patients
DISE
干预措施: Postural maneuvers (Other)
Lingual Muscle Stimulation Patients
DISE
干预措施: Digital Morphometrics (Other)
Lingual Muscle Stimulation Patients
DISE
干预措施: Tongue Force Exercise (Other)
Lingual Muscle Stimulation Patients
DISE
干预措施: Magnetic resonance imaging (MRI) (Other)
Lingual Muscle Stimulation Patients
DISE
干预措施: Polysomnography (PSG) - Split Night (Other)
结局指标
主要结局
Amax
时间窗: Within 3 months of enrollment
Measurement of maximal pharyngeal cross-sectional area (in cm-squared)
Segmental Airway Resistances
时间窗: Within 3 months of enrollment
Measurement of pharyngeal resistances upstream and downstream to site of collapse (cmH2O/l/s)
Pharyngeal compliance
时间窗: Within 3 months of enrollment
area/pressure in cm2 per cmH2O
Upper airway critical pressure (Pcrit)
时间窗: Within 3 months of enrollment
Measurement of airway collapsibility (cmH2O)
次要结局
- Digital Morphometrics(Within 3 months of enrollment)
- Tongue Force(Within 3 months of enrollment)
研究者
Raj Dedhia, MD
Associate Professor, Director, Division of Sleep Surgery
University of Pennsylvania
