Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care Group
研究概览
简要总结
This is a randomized, single blinded, non-placebo controlled that will compare one group of Bells Palsy patients receiving the current standard of care including oral corticosteroids and oral antivirals against an experimental group receiving the current standard of care in addition to hyperbaric oxygen therapy. Outcome assessment will be based on both objective analyses of facial movements as well as subjective quality of life scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •18 years or older exhibiting unilateral facial paralysis progressing to completion in 4 days or less.
排除标准
- •No patients from vulnerable populations as listed above will be included.
- •Subjects must be able to travel to NYULMC continually during the first 12 months following enrollment.
- •During the initial visit candidates must have no associated clinical signs or symptoms consistent with other causes of facial palsy. This includes but is not limited to: auricular papules, skin rashes, parotid masses, craniofacial trauma, and the presence of other cranial or distal neuropathies excluding facial numbness, change in taste, and/or hyperacusis.
- •Patients with atypical presentations will be referred for cross-sectional imaging and excluded.
- •Patients with histories consistent with possible recent tick exposure, rashes, headaches, or excessive fatigue will be serologically tested for Lyme disease and excluded if it returns positive.
- •Pneumothorax within the last two years is the only absolute medical exclusion criteria (FF).
- •Patients who are epileptics, or are claustrophobic, will be carefully counseled on the risks of HBOT before being allowed to enroll.
- •Patients with severe comorbidities will undergo evaluation by their primary care doctor and require physician approval prior to enrollment.
研究组 & 干预措施
Standard of Care Therapy
Reference Therapy
干预措施: Oral antivirals (Drug)
Standard of Care Therapy
Reference Therapy
干预措施: Oral Corticosteroids (Drug)
Standard of Care + HOTB
Reference therapy in addition to Hyperbaric Oxygen Therapy
干预措施: Oral Corticosteroids (Drug)
Standard of Care + HOTB
Reference therapy in addition to Hyperbaric Oxygen Therapy
干预措施: Oral antivirals (Drug)
Standard of Care + HOTB
Reference therapy in addition to Hyperbaric Oxygen Therapy
干预措施: Hyperbaric Oxygen Therapy (Device)
结局指标
主要结局
Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care Group
时间窗: 3, 6 and 12 months
Change in the percentage of subjects that return to baseline facial function 1 year following the onset of paralysis Standard of Care + Hyperbaric Oxygen Therapy on Bells Palsy (HBOT) Group
时间窗: 3, 6 and 12 months
次要结局
- Short Form 36 (SF-36) Score Standard of Care Group(3, 6 and 12 months)
- Facial Disability Index (FDI) Score Standard of Care + HBOT(3, 6 and 12 months)
- Short Form 36 (SF-36) Score Standard of Care + HBOT(3, 6 and 12 months)
- Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care Group(3, 6 and 12 months)
- Facial Clinimetric Evaluation Scale (FaCE) Score Standard of Care + HBOT(3, 6 and 12 months)
- Facial Disability Index (FDI) Score Standard of Care Group(3, 6 and 12 months)