NCT05354401已完成不适用
Use of Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents With Obesity and Complex Medical Conditions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in apnea-hypopnea index (AHI) with HHF compared to the change in AHI with CPAP
研究概览
简要总结
The research study is being done to test heated humidified high-flow air (HHF), as a treatment for OSA.
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 (Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity, defined as a BMI > 95th percentile for age and gender
- •Age 10 through 18 years
- •Informed consent with assent in accordance with the institutional policies (institutional IRB approval) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study
- •Moderate-severe OSA or Central Sleep Apnea (CSA) as defined by OAHI or CAHI
排除标准
- •Patients with other neurological problems, including but not limited to neurocutaneous disorders such as neurofibromatosis or tuberous sclerosis
- •Obesity due to other diseases and syndromes (e.g. Prader-Willi syndrome)
- •Pregnancy
- •Currently unwell, hospitalized or recent viral/bacterial infection in the previous 4 weeks
- •Adenoidal and/or tonsillar hypertrophy which may be amenable to surgical intervention to help alleviate OSA
- •Patients with severe respiratory distress
- •Patients with increased risk of pneumothorax including but not limited to previous pneumothorax, bronchiectasis or severe untreated asthma.
- •CHILDREN WITH MEDICAL COMPLEXITY SUBJECTS:
- •Inclusion Criteria:
- •CMC recently diagnosed with moderate to severe OSA or CSA requiring CPAP therapy
- •0-18 years of age
- •Informed consent with assent in accordance with the institutional policies (institutional IRB approval) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study
- •Exclusion Criteria:
- •Current upper respiratory tract infection
- •Subjects who are receiving oxygen therapy
结局指标
主要结局
Change in apnea-hypopnea index (AHI) with HHF compared to the change in AHI with CPAP
时间窗: week 1-4
Determine whether a participant's AHI changes with HHF vs CPAP
次要结局
- Comparative COMFORT scales with HHF and CPAP.(week 1-4)
研究者
Indra Narang
Principal Investigator
The Hospital for Sick Children
研究点 (2)
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