Nasal Expiratory Positive Airway Pressure for the Treatment of Pediatric Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Apnea hypopnea index
研究概览
简要总结
This study will evaluate effectiveness and adherence of the nasal expiratory positive airway pressure (NEPAP) device as an an alternate therapy for children with Obstructive Sleep Apnea Syndrome (OSAS). NEPAP is currently approved for use only in adults.
详细描述
The nasal expiratory positive airway pressure (NEPAP) device has been used to treat OSAS in adults. A disposable device is placed in each nostril at night and attached with adhesive. The device acts as a one-way valve, during inspiration the valve opens, with negligible resistance to flow. During expiration, the valve closes and airflow is directed through small air channels, increasing resistance. The increased resistance helps to maintain the upper airway pressure during the critical end-expiratory period when the upper airway has been found to be most narrow in the breaths preceding an apnea event. In contrast to Continuous Positive Airway Pressure (CPAP) which provides positive pressure during both inspiration and expiration, NEPAP creates pressure during expiration. NEPAP is a potential alternative therapy which is less cumbersome than CPAP and may increase adherence.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects age 5-16 years (note: Due to the size of the devices, it is expected that most children will be at least 8 years old, but a few may be younger. Subjects will be evaluated in clinic to fit for size and habituate to the device)
- •OSAS (AHI > 5/hr)
- •Subject has had adenotonsillectomy or is not a candidate for adenotonsillectomy
- •Subject is non-adherent to CPAP or is seeking an alternative therapy
- •Tolerance of NEPAP device during a daytime session
- •Parental/guardian permission (informed consent) and if appropriate, child assent.
排除标准
- •Severe developmental delay thought to involve a high risk of aspiration
- •Family does not understand English well enough to perform the standardized, validated questionnaires.
- •Age >16 years since results may be similar to adult studies in these older patients.
- •Severe breathing disorder (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum)
- •Severe heart disease (including heart failure)
- •An acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection or perforation of the ear drum
- •Subjects that do not meet all of the enrollment criteria will not be enrolled. Any violations of these criteria will be reported in accordance with Institutional Review Board (IRB) Policies and Procedures.
- •Study members will not recruit females who are known to be pregnant. However, if a subject becomes pregnant during the study, we will continue to use the device. Pregnancy is not an exclusion criterion as positive airway pressure therapy does not harm the pregnant woman or fetus.
研究组 & 干预措施
Nasal Expiratory Positive Airway Pressure Devices
Nasal Expiratory Positive Airway Pressure Device
干预措施: Nasal Expiratory Positive Airway Pressure Device (Device)
placebo sham
A sham device
干预措施: placebo sham (Device)
结局指标
主要结局
Apnea hypopnea index
时间窗: Approximately one week
The apnea hypopnea index during polysomnography will be compared between the active device and the placebo nights
次要结局
- Adherence using daily logs(One month)
研究者
Ignacio Tapia, MD
Principal Investigator
Children's Hospital of Philadelphia