Use of Heated Humidified High Flow Nasal Cannula Oxygen in Obstructive Sleep Apnea in Adolescents With Obesity and Complex Medical Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 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
- •OBESE SUBJECTS:
- •Inclusion Criteria:
- •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
研究组 & 干预措施
Obese
Obese subjects ages 10-18 years with OSA will be recruited from sleep clinic. As per standard clinic care, once a subject is diagnosed with OSA on a PSG they are reviewed in sleep clinic to discuss CPAP therapy. Families will be approached to participate in this study during the subject's regularly scheduled clinical visit. Obese subjects meeting eligibility criteria will be recruited from the sleep clinic. The patients agreeing to CPAP therapy will be invited to take part in the study.
干预措施: HHF (Other)
CMC
As per current standard clinical care, CMC diagnosed with moderate to severe OSA following a clinically indicated baseline PSG who have had a previous adenotonsillectomy or who are not considered candidates for surgery are reviewed in sleep clinic to discuss the prescription of CPAP for OSA. CMC subjects' meeting eligibility criteria will be recruited from the sleep clinic. The patients agreeing to CPAP therapy will be invited to take part in this study.
干预措施: HHF (Other)
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