Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Tidal Volume
研究概览
简要总结
This study will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (>6 months post-injury).
详细描述
Patients with cervical spinal cord injury demonstrate central sleep disordered breathing manifesting as central sleep apnea or a periodic breathing pattern. Understanding the causes of central sleep apnea may be critically important to understanding upper airway obstruction in susceptible individuals, given the critical role of ventilatory motor output in maintaining upper airway patency as evidenced by upper airway narrowing or occlusion at the nadir of ventilator drive during periodic breathing. This study is likely to identify therapeutic strategies that could be tested in large clinical trials, with the ultimate goal of improving quality of life among patients with cervical SCI who also experience central sleep disordered breathing.
To this end the research proposal is aimed as follows:
Specific Aim 1: Test the hypothesis that patients with cervical SCI will demonstrate greater magnitude of long-term facilitation (LTF) following episodic hypoxia during sleep, compared to patients with thoracic Spinal cord injury. This aim will be accomplished by measuring the effect of acute episodic hypoxic ventilation and upper airway mechanics in both groups.
Specific Aim 2: Test the hypothesis that dampening peripheral chemoreceptor activity in patients with cervical SCI and central sleep disordered breathing (SDB) with supplemental oxygen will reduce central respiratory events and decrease respiratory variability during sleep. The aim will be accomplished by providing supplemental oxygen to participants with cervical SCI and central SDB.
Specific Aim 3: Test the hypothesis that administration of trazodone, in patients with cervical spinal cord injury and central SDB will decrease respiratory related arousals and central apnea index, and the propensity to develop central apnea, compared to placebo. To accomplish this aim, the investigators will test the acute effect of trazodone on respiratory related arousals and central sleep apnea, and the chronic effect on central apnea indices and the CO2 reserve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults between the ages of 18 - 89
- •chronic spinal cord injury patients (T6 and above), > 3 months since injury and not on mechanical ventilation, and have not received mechanical ventilation via tracheostomy in the past.
排除标准
- •subjects ≤ 17 yrs old
- •Pregnant and lactating females
- •History of head trauma that resulted in neurological symptoms or loss of consciousness
- •advanced heart, lung, metabolic, liver or chronic kidney disease.
- •severe obstructive or restrictive respiratory defect by PFTs or history of tracheostomy
- •extreme obesity defined for this protocol as BMI ≥ 40 kg/m2 (to avoid the effect of morbid obesity on ventilation).
研究组 & 干预措施
Trazodone or placebo
examine the effect of trazodone on breathing during sleep
干预措施: Trazodone (Drug)
Supplemental oxygen
To use supplemental oxygen to decrease peripheral chemoreceptor activity in patients with SCI and central SDB. In addition, perform a repeat evaluation after treatment with supplemental oxygen or sham O2 for 6 weeks to determine if correction of chronic intermittent hypoxia, which mitigates sensory LTF, results in decreased propensity to central apnea.
干预措施: Sham (Procedure)
Supplemental oxygen
To use supplemental oxygen to decrease peripheral chemoreceptor activity in patients with SCI and central SDB. In addition, perform a repeat evaluation after treatment with supplemental oxygen or sham O2 for 6 weeks to determine if correction of chronic intermittent hypoxia, which mitigates sensory LTF, results in decreased propensity to central apnea.
干预措施: Supplemental oxygen (Procedure)
Trazodone or placebo
examine the effect of trazodone on breathing during sleep
干预措施: Placebo (Drug)
Acute episodic hypoxia
To test development of ventilatory augmentation following episodic hypoxia, defined as increased Hypoxic Ventilatory Response (HVR) from early to late hypoxic exposure episodes.
干预措施: Acute episodic hypoxia (Procedure)
Acute episodic hypoxia
To test development of ventilatory augmentation following episodic hypoxia, defined as increased Hypoxic Ventilatory Response (HVR) from early to late hypoxic exposure episodes.
干预措施: Sham (Procedure)
结局指标
主要结局
Change in Tidal Volume
时间窗: 1 Week
Change in tidal volume from baseline to recovery period.
Change in Apnea Hypopnea Index (AHI)
时间窗: 1 week
AHI is used to indicate the severity of sleep apnea.
Change in CO2 reserve (Delta-PETCO2-AT)
时间窗: 1 Week
CO2 reserve is the requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative
Change in hypocapnic apneic threshold
时间窗: 1 week
The nadir pressure in the upper airway (supra-glotic pressure) prior to the occurrence of an arousal. This is a physiological parameter.
次要结局
未报告次要终点