Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation: a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Mean nocturnal oxygen saturation (SpO2)
研究概览
简要总结
Nocturnal Non Invasive Ventilation (NIV) is the reference treatment for chronic alveolar hypoventilation in patients with neuro-muscular diseases. NIV can be provided by using different types of interfaces: Nasal masks are the most frequent type of interface used at home but oronasal masks are used by at least 25% of neuro-muscular patients mainly because of persistent unintentional mouth leaks. However, oronasal mask may cause persistent upper airway obstructive respiratory events because of the mechanical constraint on the chin induced by the traction of the straps that may push the mandible posteriorly during sleep.
No randomized study has specifically addressed the question of the impact of type of interface in patients with neuromuscular diseases treated by nocturnal NIV.
The investigators hypothesize that:
- the application of oronasal mask may jeopardize the pharyngeal patency in patients already proned to upper airway obstruction;
- the use of a nasal mask may improve upper airway stability and NIV efficacy while reducing side effects.
Authors objective will be to compare the impact of nasal mask versus oronasal mask on NIV efficacy and side-effects. Eligible patients are those with nocturnal NIV and neuromuscular disease.
After a scheduled hospital visit, patients willing to participate will undergo in random order 2 unattended nocturnal polygraphies under NIV at home: one polygraphy with nasal mask; one with an oronasal mask. Each polygraphy ans side effects assessment will be performed after one week of familiarization with each mask.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years old)
- •Affected by slowly progressive neuro-muscular diseases (Becker muscular dystrophy, facio-scapulo-humeral dystrophy, limb-girdle dystrophy, myotonic dystrophy…) or relatively rapid progression (Duchenne muscular dystrophy).
- •Treated with nocturnal non-invasive ventilation (<15 hours/day)
- •In stable state (no cardiorespiratory or ear-nose-throat event for at least 1 month before inclusion)
排除标准
- •Rapidly progressive neuro-muscular diseases (such as ALS)
- •Severe nasal obstruction, maxillofacial deformities or previous upper airway surgery preventing the usage of one type of mask (nasal or oronasal), or, at the discretion of investigator, any other contraindication for using the other type of mask
- •NIV Daily use >15h/day
- •Unwillingness or inability to provide consent to participation
- •Curatorship
- •Subject in exclusion period of another study
- •Vulnerable person or legally protected adult.
结局指标
主要结局
Mean nocturnal oxygen saturation (SpO2)
时间窗: After one week with each type of mask
Mean nocturnal SpO2, measured by oximetry.
次要结局
- Mean nocturnal PtcCO2(After one week with each type of mask)
- Non-intentional leaks(After one week with each type of mask)
- Mean mouth opening during sleep(After one week with each type of mask)
- Side-effects of Continuous Positive Airway Pressure (CPAP)(After one week with each type of mask)
- % sleep recording with SpO2<90%(After one week with each type of mask)
- Oxygen Desaturation Index(After one week with each type of mask)