Acute Intermittent Hypoxia to Improve Airway Protection in Chronic Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Duration of laryngeal vestibule closure (dLVC)
研究概览
简要总结
Acute intermittent hypoxia (AIH) involves 1-2min of breathing low oxygen air to stimulate neuroplasticity. Animal and human studies show that AIH improves motor function after neural injury, particularly when paired with task-specific training. Using a double blind cross-over study we will test whether AIH and task-specific airway protection training improves airway protection more than training alone in individuals with chronic mild-moderate traumatic brain injury (TBI).
详细描述
Recent studies have found that acute intermittent hypoxia (AIH)-or repetitive exposure to brief episodes of low inspired oxygen--is a promising new strategy that can help restore motor function by promoting neuroplasticity throughout the central nervous system (CNS). Both rodent and human studies show that motor function is further enhanced when AIH is paired with task-specific training/rehabilitation (TST). Therefore, this study will investigate the therapeutic potential of combining AIH with a task-specific airway protection training. We propose that the combined use of AIH + TST will enhance the magnitude and duration of TST training alone in individuals with chronic traumatic brain injury.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and assessors will be blinded to group allocation.
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 21-80 years
- •A mild to moderate traumatic brain injury (TBI) confirmed by medical records
- •A Glasgow Coma Scale score between 9-15
- •Able to consent independently
- •Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study
排除标准
- •Other neurological diagnoses or a diagnosis of a severe psychiatric disorder
- •Severe aphasia preventing a participant from understanding the protocol and consent form
- •Pre-existing hypoxic pulmonary disease
- •History of obstructive lung diseases such as chronic obstructive pulmonary disease (COPD) or significant asthma)
- •Severe hypertension (>160/100)
- •History of head and neck cancer
- •Allergy to barium sulfate
- •Ischemic cardiac disease
研究组 & 干预措施
AIH + TST
Participants will complete a 5-day intervention blocks where they receive daily AIH followed by task specific airway protection training 60 minutes after the AIH exposure. Each exposure involves a 1-minute delivery of low oxygen (9-11% inspired O2), followed by a 1.5-min interval of room air breathing (21% O2). This method of waiting 45-60 minutes after the delivery of AIH and prior to engaging in task-specific training/rehabilitation enables sufficient time to increase brain derived neurotrophic factor (BDNF) following AIH, thereby augmenting the impact of task-specific training.
干预措施: Acute Intermittent Hypoxia (AIH) (Other)
AIH + TST
Participants will complete a 5-day intervention blocks where they receive daily AIH followed by task specific airway protection training 60 minutes after the AIH exposure. Each exposure involves a 1-minute delivery of low oxygen (9-11% inspired O2), followed by a 1.5-min interval of room air breathing (21% O2). This method of waiting 45-60 minutes after the delivery of AIH and prior to engaging in task-specific training/rehabilitation enables sufficient time to increase brain derived neurotrophic factor (BDNF) following AIH, thereby augmenting the impact of task-specific training.
干预措施: Task specific Airway Protection Training (Behavioral)
Sham AIH + TST
Participants will complete a 5-day intervention blocks where they receive sham AIH followed by task specific airway protection training 60 minutes after the AIH sham exposure. Sham AIH will be delivered using methods identical to AIH, except a normoxic gas mixture (~21% O2) will be delivered. The gas mixture with normoxic air will effectively serve as a sham.
干预措施: Task specific Airway Protection Training (Behavioral)
Sham AIH + TST
Participants will complete a 5-day intervention blocks where they receive sham AIH followed by task specific airway protection training 60 minutes after the AIH sham exposure. Sham AIH will be delivered using methods identical to AIH, except a normoxic gas mixture (~21% O2) will be delivered. The gas mixture with normoxic air will effectively serve as a sham.
干预措施: Sham AIH (Other)
结局指标
主要结局
Duration of laryngeal vestibule closure (dLVC)
时间窗: Pre-intervention, 1 day after intervention block and 1-week post intervention
Time in (msec) the laryngeal vestibule stays closed during a swallow
Time to laryngeal vestibule closure (Time-to-LVC)
时间窗: Pre-intervention, 1 day after intervention block and 1-week post intervention
Time in (msec) it takes to close the laryngeal vestibule after swallow initiation
次要结局
- Penetration-Aspiration Scale Scores(Pre-intervention, 1 day after intervention block and 1-week post intervention)